Professional Documents
Culture Documents
&
GREEN BOOK 3
Vegetable Oils
Nut Oils
GREEN BOOK 2
Oils
Memorandum
To:
From:
Date:
Subject:
The Scientific Literature Review (SLR) for this group of edible vegetable (and fruit) oils was announced April 23,
2010. A related SLR on edible nut oils was announced in June of this year, and is to be reviewed by the Panel at this
meeting as well. If the Panel does not see any major differences in the overall toxicity potential of these two oil
groups, it may consider combining the reports into one major edible oil report.
Both reports are taking a slightly new approach to reviewing multiple related ingredients at one time and are
including oil ingredients that have previously been reviewed by the CIR Expert Panel, which are designated in italic
print.
At the time that the SLR was announced, CIR sought the following additional information:
1.
Manufacturing information about oils used in cosmetic formulation, particularly on methods used
to remove non-fatty acid components (e.g., glycidol fatty acid esters);
2.
Cosmetic grade specifications, if such exist, for oils used in cosmetic formulations.
3.
Fatty acid composition for those oils covered in this report (where such information has not been
provided or differs from what is presented).
4.
5.
Irritation and sensitization testing on those fatty acids present in the oils covered in this report that
have previously not been reviewed by CIR.
6.
Any other information that pertains to the safety of the use in cosmetics of the oils covered in this
report.
Data on fatty acid compositions and cosmetic grade specifications, as well as an HRIPT studies on numerous oils
have been received from the Personal Care Products Council and are incorporated in this draft report in Tables 3, 4,
and 7, respectively. Due to the voluminous amount of unpublished data (800+ pages), data will be accessible online.
Paper copies will be mailed out only by request.
Please note that the new use table is being employed in this report. The raw data from which the table was created
along with any available concentration of use information have been included in the book materials.
If the data provided are sufficient for the Panel to assess the safety of these ingredients, a tentative conclusion should
be developed regarding their safety in cosmetics, along with a rationale for that conclusion. The report will then be
issued as a Tentative Safety Assessment. If additional data are needed, these should be identified and an Insufficient
Data Announcement should be issued.
For your convenience, the materials for this report can also be found at http://www.cir-safety.org/aug10.shtml.
Ingredients
Toxline
PubMed
ChemIDplus
HSDB
CAplus
NTIS
HPV
Merck USP
Ingredients were searched by Latin botanical (INCI) names, common names, and CAS numbers, when available. The list of ingredients searched
is found in Table 1 of the vegetable oil report.
Literature searches included chemical composition, fatty acid composition, dermal toxicity, irritation, and sensitization qualifiers.
Searches were performed between November 20, 2009 and March 30, 2010 and updated June 30 through July 8, 2010.
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Report
Draft Report
The 2010 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.;
Donald V. Belsito, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; Ronald A Hill, Ph.D. James G.
Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR
Director is F. Alan Andersen, Ph.D. This report was prepared by Christina L. Burnett and Monice Fiume, Scientific
Analyst/Writers.
TABLE OF CONTENTS
INTRODUCTION ................................................................................................................................................................. 1
Chemistry............................................................................................................................................................................... 1
Processing ...................................................................................................................................................................... 2
Analytical Methods ............................................................................................................................................................ 2
Impurities ....................................................................................................................................................................... 2
Use ......................................................................................................................................................................................... 3
Cosmetic ............................................................................................................................................................................ 3
Non-Cosmetic .................................................................................................................................................................... 4
ANIMAL TOXICOLOGY .................................................................................................................................................... 4
OILS .............................................................................................................................................................................. 4
Dermal Irritation/Sensitization/Phototoxicity .................................................................................................................... 4
Adansonia Digitata Seed Oil [Baobab] .......................................................................................................................... 4
Carthamus Tinctorius (Safflower) Oil ........................................................................................................................... 4
Gossypium Herbaceum (Cotton) Seed Oil..................................................................................................................... 4
Elaeis Guineensis (Palm) Oil ......................................................................................................................................... 5
Olea Europea (Olive) Fruit Oil ...................................................................................................................................... 5
Oryza Sativa (Rice) Bran Oil and Germ Oil .................................................................................................................. 5
Sesamum Indicum (Sesame) Seed Oil ........................................................................................................................... 5
Triticum Vulgare (Wheat) Germ Oil ............................................................................................................................. 6
Zea Mays (Corn) Oil ...................................................................................................................................................... 6
Ocular Irritation ................................................................................................................................................................. 6
Adansonia Digitata Seed Oil [Baobab] .......................................................................................................................... 6
Elaeis Guineensis (Palm) Oil ......................................................................................................................................... 6
Gossypium Herbaceum (Cotton) Seed Oil..................................................................................................................... 6
Linum Usitatissimum (Linseed) Seed Oil...................................................................................................................... 6
Olea Europea (Olive) Fruit Oil ...................................................................................................................................... 7
Oryza Sativa (Rice) Bran and Rice Germ Oil ................................................................................................................ 7
Ribes Nigrum (Black Currant) Seed Oil ........................................................................................................................ 7
Sesamum Indicum (Sesame) Seed Oil ........................................................................................................................... 7
Triticum Vulgare (Wheat) Germ Oil ............................................................................................................................. 7
Zea Mays (Corn) Oil ...................................................................................................................................................... 7
CARCINOGENICITY .......................................................................................................................................................... 7
CLINICAL ASSESSMENT OF SAFETY ............................................................................................................................ 8
Irritation/Sensitization/Allergenicity ................................................................................................................................. 8
Carthamus Tinctorius (Safflower) Oil ........................................................................................................................... 9
Elaeis Guineensis (Palm) Oil ......................................................................................................................................... 9
Gossypium Herbaceum (Cotton) Seed Oil..................................................................................................................... 9
Oryza Sativa (Rice) Bran Oil ......................................................................................................................................... 9
Persea Gratissima (Avocado) Oil................................................................................................................................... 9
Sesamum Indicum (Sesame) Seed Oil ........................................................................................................................... 9
Triticum Vulgare (Wheat) Germ Oil ............................................................................................................................. 9
Ocular Irritation ................................................................................................................................................................. 9
Linum Usitatissimum (Linseed) Seed Oil...................................................................................................................... 9
Ribes Nigrum (Black Currant) Seed Oil ...................................................................................................................... 10
Comedogenicity ............................................................................................................................................................... 10
Ribes Nigrum (Black Currant) Seed Oil ...................................................................................................................... 10
Case Studies ..................................................................................................................................................................... 10
Glycine Soja (Soybean) Oil ......................................................................................................................................... 10
Helianthus Annuus (Sunflower) Oil ............................................................................................................................ 10
Olea Europea (Olive) Fruit Oil .................................................................................................................................... 11
Persea Gratissima (Avocado) Oil................................................................................................................................. 11
SUMMARY......................................................................................................................................................................... 11
FIGURES AND TABLES ................................................................................................................................................... 14
Figure 2. Basic oil refinement flowchart.3.................................................................................................................... 15
Table 2. Previously reviewed oil and fatty acid ingredients. ........................................................................................... 18
Table 3. Fatty acid composition. ...................................................................................................................................... 20
Table 4. Chemical properties. .......................................................................................................................................... 26
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Table 5. Frequency of use according to duration and exposure. ......................................Error! Bookmark not defined.
Table 6. Non-food, non-cosmetic uses of edible oils.3 ................................................................................................... 42
REFERENCES .................................................................................................................................................................... 48
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INTRODUCTION
Vegetable oil and related edible seed oils have been safely consumed by humans for millennia. Because there is no
significant safety concern with these ingredients following oral exposure and their general biology is well characterized due to
extensive use in food materials, this safety assessment will focus solely on the basic chemistry, manufacturing/production, uses,
and irritation and sensitization data available on these oils as they are used in cosmetic ingredients. Various oils have been used on
the skin since antiquity. Initially used for anointing in religious ceremonies, oils and their components have long been used on the
skin for cosmetic purposes. The full list of ingredients this report covers, which includes oils, hydrogenated oils, unsaponifiables,
oil fatty acids, and simple salts, is found in Table 1. For the sake of brevity, the common name of the oil, when available, will be
used throughout this report. While a large number of oils derived from plants are included in this literature review, there is a
commonality in that they all are mixtures of triglycerides containing fatty acids and fatty acid derivatives, the safety of which in
cosmetics have been established.
This report includes cosmetic ingredients that have been previously reviewed by the Cosmetic Ingredient Review Expert
Panel. The ingredients, their conclusion, and published citations are found in Table 2. Previously reviewed fatty acids and
glyceryl triesters are also found in Table 2. This report excludes tree and ground nut oils, are covered in another safety
assessment.
CHEMISTRY
The group of ingredients characterized as fats and oils are the glyceryl esters of fatty acids (triglycerides) normally found
in plant tissues, including those which have been hydrogenated to reduce or eliminate unsaturation.1 Figure 1 is the general
structure of fats and oils. The raw oil may include plant sterols, pigments, glucosides, proteins, vitamins and impurities. The
extent to which these components are removed during processing varies. The available fatty acid compositions for the oils in this
report are found in Table 3. The available information on chemical properties and other constituents, including Food Chemicals
Codex specifications when provided, are found in Table 4.2
The percentage of chemical constituents in individual oil types is dependent on region where the oilseed plant is grown,
individual cultivars, and plant genetics.3 This is especially true in with rapeseed, where the erucic acid content varies from 1% to
58.6%. Low erucic acid rapeseed oil is also known as canola oil.
The nutritional content of these oils varies with oil type. For example, sunflower oil contains high levels of vitamins A,
D, and K, while palm oil is a rich source of vitamins A and E. Crude sunflower oil also has the highest content of vitamin E in the
form of -tocopherol amongst vegetable oils.3
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Processing
Oils used in cosmetics are probably produced using the same process used in the food industry. Depending on the source,
oil may be directly expressed from the source (seed or pulp) followed by solvent extraction. Baileys Industrial Oil and Fat
Products states that the removal of pigments and polar materials is mandatory for most cosmetic applications.4 The process used
for oil refining for foods may be adequate for this purpose, or additional steps may be required. Special refining methods to yield
colorless and odorless oils are used by the cosmetic industry and include proprietary adsorption chromatography and supercritical
fluid extractions.
The majority of the oils presented in this report are produced either from mechanical extraction or solvent extraction or a
hybrid of both methods, known as prepress solvent extraction.3 In solvent extraction, hexane is the most commonly used solvent
as it is economical and has low toxicity potential when compared to other solvents. Seeds that are rich in oil can be cold pressed to
extract oil without the use of solvents.5
After the initial extraction by methods such as solvent extraction, the crude (degummed) oil is often refined.3 The first
step is treating the oil with caustic soda to neutralize free fatty acids, hydrolyze phosphatides, and remove some colored pigments
and unsaponifiable materials. Soap stock is usually a by-product of this step. The next step involves bleaching the neutralized oil
with activated earth to further absorb pigments. The last major step in refining oil is deodorizing, which removes all oxidative
cleavage products that impart odor or flavor to the oil. Deodorization also removes tocopherols, sterols, and other minor
constituents of free fatty acids and undesirable foreign materials. Figure 2 is a flowchart of the basic refinement process.
After deodorization, oils can be further processed by hydrogenation, which makes oil more resistant to oxidative and
thermal damage, and by winterization, where oil is slowly cooled to promote formation of crystals that cause cloudiness and
filtered to remove the crystals.
Cosmetic grade vegetable oils may include a physical refining step that involves heating crude vegetable oil under
vacuum.5 This step allows for the removal of volatile components such as color compounds, odor compounds, and free fatty acids,
which gives the refined oil a lighter color, less odor, and lower acid values.
Analytical Methods
According to Crevel et al., a validated analytical methodology for establishing the protein content of oil is needed.6
Impurities
Many edible oils are derived from foods that are recognized as potent food allergens. It has been shown that often an
individual that is allergic to a food will generally not react to the refined oil.6 It should be noted that while the Panel has found a
general lack of clinical effects for edible oils already reviewed,7-15 other researchers have raised concerns. Halsey et al. reported
that Lowry protein determinations of cold-pressed and refined sunflower oil found 2-8 g/ml protein,16 while Zitouni et al.
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reported trace amounts of protein in the refined oil.17 Olszewski et al. found 0.1-0.2 g protein per g of peanut oil,18 while
Ramazzotti et al. reported finding IgE responsive residual proteins in peanut oil extracts.19 Porras et al. found soy protein is some
samples of soy oil, but not others.20 Awazuhara et al. reported 1.4-4.0 g protein per 100 g of soy oil.21 Although Paschke et al.
found approximately 35 g/ml protein content in refined soybean oil, no IgE-binding activity was detectable.22 The European
Medicines Agency (EMEA) Working Party on Herbal Medicinal Products concluded that soy and peanut products should be
treated as allergenic unless they have an analytically-monitored non-allergenic specification and a safe maximum daily dose.23
The EMEA found that threshold concentrations for induction of a protein contact dermatitis were not available and recommended
that all medications for topical use containing soya or peanut products should be treated as allergenic.
USE
Cosmetic
Oils are used in a wide variety of cosmetic products for their skin conditioning, occlusive, emollient, moisturizing and
other properties. A total of 124 of the 208 oil ingredients included in this safety assessment are reported to be used; 108 of the inuse ingredients have never been reviewed by CIR, while 16 have been reviewed previously. For the ingredients being reviewed
for the first time, the frequency of use, as supplied to the Food and Drug Administration (FDA) by industry as part of the
Voluntary Cosmetic Registration Program (VCRP),24 and/or concentration of use, as supplied by industry in response to a Personal
Care Products Council (Council) survey,25,26 can be found in Table 5a. For the ingredients that have been reviewed previously, the
current and historical8,10,11,15,27-30 frequency and concentration of use is given in Table 5b. The 84 ingredients not currently
reported to be used are listed in Table 5c. Table 5d lists the 41 ingredients for which a concentration of use survey has not yet
been completed.
Sunflower seed oil has the greatest number of reported uses in cosmetic and personal care products, with a total of 1414.
Many other ingredients are used in an extensive number of formulations. For example, olive oil and soybean oil have 915 and 912
uses, respectively. Most of the in-use ingredients have uses in both leave-on and rinse-off product types, and many are used in
products that are applied around the eye or that can possibly be ingested. Some are used in products that involve mucous
membrane exposure, and a few are used in underarm deodorant formulations. Many of the products are used in formulations at
relatively high concentrations. Olive oil is used at up to 100%, avocado oil is used at up to 98%, sunflower seed oil at up to 96%,
and soybean oil at 95%.
The oil ingredients described in this report may be used in hair sprays, and effects on the lungs that may be induced by
aerosolized products containing these ingredients are of concern. The aerosol properties that determine deposition in the
respiratory system are particle size and density. The parameter most closely associated with deposition is the aerodynamic
diameter, da, defined as the diameter of a sphere of unit density possessing the same terminal settling velocity as the particle in
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question. In humans, particles with an aerodynamic diameter of 10m are respirable. Particles with a da from 0.1 - 10m settle
in the upper respiratory tract and particles with a da < 0.1 m settle in the lower respiratory tract.31,32
Particle diameters of 60-80 m and 80 m have been reported for anhydrous hair sprays and pump hairsprays,
respectively.33 In practice, aerosols should have at least 99% of their particle diameters in the 10 110 m range and the mean
particle diameter in a typical aerosol spray has been reported as ~38 m.34 Therefore, most aerosol particles are deposited in the
nasopharyngeal region and are not respirable.
None of the oils or their related counterparts described in this report were restricted from use in any way under the rules
governing cosmetic products in the European Union.35
Non-Cosmetic
The primary uses for edible oils are for cooking. Palm oil is the world's most widely consumed edible oil (41.7 million
metric tons), followed by soybean oil, rapeseed oil, sunflower seed oil, cottonseed oil, peanut oil, palm kernel oil, coconut oil, ,and
olive oil.3,36 Non-food, non-cosmetic uses for edible oils are found in Table 6.
ANIMAL TOXICOLOGY
OILS
Irritation, sensitization and phototoxicity data available were reviewed and are summarized below. Information from
previous CIR reports on edible oils is identified by italics. No information was found for some of the oils listed in this report.
Dermal Irritation/Sensitization/Phototoxicity
Adansonia Digitata Seed Oil [Baobab]
In an alternative to the Draize test, 100% baobab oil was tested for dermal irritation in a MatTek EpiDerm MTT
viability assay.37 The MatTek EpiDerm tissue samples were incubated with 100 l of the test material for 1, 4, or 24 h along
with the positive control material, 1% Triton X-100, which was incubated for 4 or 9 h, and the negative control, undosed tissues,
which were incubated for 4 h. After treatment, the viability of the tissues was determined with MTT uptake and conversion. The
positive control provided expected results. The test material was classified as non-irritating.
Carthamus Tinctorius (Safflower) Oil
Undiluted safflower oil was minimally irritating in a repeat open patch test using rabbits and was not a primary irritant
or sensitizer in a maximization study using guinea pigs15.
Gossypium Herbaceum (Cotton) Seed Oil
Cosmetic formulations containing 3.4-8.97% hydrogenated cottonseed oil were not irritating to rabbit skin.10
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CARCINOGENICITY
The safety of glycidol fatty acid esters in refined vegetable oils was assessed by IARC. Glycidol was determined to be a
Group2A (probably carcinogenic to humans) chemical while Glycidol Fatty Acid Esters was determined to be a Group 3 (not
classifiable as to carcinogenicity to humans) chemical.43,44
The Federal Institute for Risk Assessment in Germany released a summary of their initial evaluation of the assessment of
levels of glycidol fatty acid esters detected in refined vegetable fats.45 While acknowledging that the levels of glycidol that may be
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released from glycidol fatty acid esters are not known, the evaluation noted that glycidol is classified as probably carcinogenic to
humans. The evaluation was based on findings of the German Chemical and Veterinary Test Agency (CVUA).
In a presentation by Weisshauer from the CVUA, the conversion of glycidol to 3-chloropropanediol was presented as an
artifact of the analytical method, and it appeared to be the 3-chloropropanediol that was detected its indicative of the presence of
glycidol.46 The levels of 3-chloropropanediol were negligible at the crude oil, degummed, neutralized, and bleached stages, but
levels were significant at the deodorized stage.
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regarding ocular sensation following product use as well as with objective ophthalmic findings. Trace increases in palpebral
conjunctival irritation were observed in only one subject, but this result was thought to be non-treatment related by the study
investigators. No subjective irritation was reported and no adverse events were reported. The study concluded that the test
material was clinically safe for use by contact lens wearers and self-assessed sensitive eye non-contact wearers.
Ribes Nigrum (Black Currant) Seed Oil
An in-use 4 week study was conducted on an eye mask that contained 0.2% black currant seed oil (undiluted) in 52
subjects.50 Subjects were evaluated by an ophthalmologist and a dermatologist at baseline and at the end of the study. No adverse
reactions were observed. The eye mask was considered ophthalmologist tested and safe for contact lens wearers.
Comedogenicity
Ribes Nigrum (Black Currant) Seed Oil
A comedogenicity study of an eye mask containing 0.2% black currant seed oil (undiluted) was performed on 6
subjects.51 The test material was applied with occlusive patches. The average score was 0.00 comedones/cm2. The eye mask was
found to be non-comedogenic.
Case Studies
Glycine Soja (Soybean) Oil
Seven patients with a history of immediate hypersensitivity reaction after the ingestion of soybeans were enrolled in a
double-blind crossover study.48 The patients were first skin tested by the puncture method with a crude whole soybean extract, a
partially hydrogenated oil, a non-hydrogenated oil, and a cold-pressed soybean oil. Olive oil from a retailer was used as a negative
control. Since all 7 patients had negative skin tests to the oils and positive reactions to the crude soybean extract, they were
challenged orally with capsules of each of the oils in random order on 4 separate days. None of the patients reacted to the oral
challenges. The researchers remarked that while a reaction to the cold-pressed soybean oil did not occur in this study, cold-pressed
oils may contain soybean protein and should be avoided.
The sera from 4 patients with known allergy to soybean was used to examine the allergenicity of soy oil proteins.21
Neither the IgE nor the IgG4 in the sera reacted to protein in the soy oil.
Helianthus Annuus (Sunflower) Oil
Two cases were reported of patients having anaphylactic reactions following ingestion of sunflower seeds.16 No
reactions were seen upon oral or open challenge with refined or cold-pressed sunflower oils, both of which were shown to contain
detectable amounts of protein. However, in a case report of a woman who had been desensitized to mugwort (a member of the
Compositae family) pollen for a year, but then had an anaphylactic reaction to sunflower (also a member of the Compositae
family) seeds, it was found that she had a delayed positive reaction to sunflower oil in a skin prick test.52 Prick test results with 10
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control subjects were negative. In an oral challenge test, a delayed reaction was again observed, with symptoms occurring 2.25-8
h after administration.
Olea Europea (Olive) Fruit Oil
Throughout the literature, it is stated that sensitization to olive oil is considered rare. Case reports have been described,
however, and generally involved patients with venous eczema, some type of dermatitis or lesion, or an occupational exposure.
Patch testing with olive oil produced positive reactions in most of these cases, and these results were usually regarded as
allergenic. The concentrations of olive oil tested were not always given, but when stated, test concentrations giving positive
results, ranged from 30-100%. In some cases, the constituents of olive oil were tested as well, but the results of that testing were
negative.53-60
Krnke et al. investigated whether the reactions to olive oil were contact sensitization or irritation, using open and
occlusive testing. They concluded that olive oil presented as a weak irritant rather than a contact sensitizer in the few case studies
they observed. The capacity to produce an irritant result was increased using occlusive conditions.61 Zipprich and Hauser
remarked that components capable of inducing an irritant reaction can form if the olive oil isnt stored properly.62
Persea Gratissima (Avocado) Oil
A case study was reported in which a female subject had dermatitis around the eyes and earlobes.63 Patch testing with her
sunscreen resulted in positive results. In subsequent patch testing of the individual ingredients, a positive reaction to undiluted
avocado oil, but not to the active ingredient, was observed. Twenty controls subjects were used, and reactions to avocado oil were
not seen.
Sesamum Indicum (Sesame) Seed Oil
A case study was reported in which a woman applied a Chinese ointment containing sesame oil, resulting in pruritic
erythema, papules, and vesicles. 64 Patch testing was performed with the ointment and with the individual ingredients, including
undiluted sesame oil. Both the ointment and sesame oil produced positive reactions on days 2, 3, 4, and 11. The other components
did not cause a reaction. Results were negative in patch testing of sesame oil using 20 healthy subjects.
SUMMARY
The oils derived from vegetable and fruit plants are composed of mono-, di-, and triglycerides, free fatty acids and other
minor components, including natural antioxidants and fat-soluble vitamins. The percentage of chemical constituents and
nutritional content of individual oil types is dependent on region where the oil plant is grown, individual cultivars, and plant
genetics. Oils used in cosmetics are likely produced in the same manner as those used in the food industry. Oils may be expressed
11
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through mechanical or solvent extraction. The oils may undergo further refining to remove pigments, odors, unsaponifiable
materials, and other undesirables.
It has been shown that often an individual that is allergic to a food will generally not react to the refined oil. The CIR
Expert Panel has found a general lack of clinical effects for edible oils that they have already reviewed; however, other researchers
have raised concerns about the presence of residual proteins oils, such as peanut and soy. These ingredients may also contain
aflatoxins, a metabolic products of certain molds that are carcinogenic to humans. The FDA action level for aflatoxin in foods is
20 ppb.
Of the oils described in this report, sunflower seed oil has the most reported uses in cosmetic and personal care products
with a total of 1414 and is used at a maximum concentration of 96%. Oils are used in a wide variety of cosmetic products,
including use in hair spray and other aerosolized products. None of the oils or the related counterparts described in this report
were restricted from use in the European Union.
Oils not summarized in the animal toxicity section or clinical studies section of this report had no available data for
review.
In dermal irritation studies in animals, Adansonia Digitata seed oil [baobab], hydrogenated cottonseed oil, rice bran oil,
and rice germ oil were not irritating. Undiluted safflower oil was minimally irritating in rabbits, but it was not a primary irritant in
guinea pigs. Undiluted palm oil, sesame oil, and wheat germ oil were practically non-irritating to minimally irritating in rabbits.
Safflower oil, palm oil, rice bran oil, rice germ oil, and wheat germ oil were non-sensitizing in animal studies. Rice bran oil, rice
germ oil, and palm oil were not phototoxic in animals studies.
In animal ocular studies, Adansonia Digitata seed oil [baobab], olive oil, rice germ oil, black currant seed oil, 10-11%
sesame seed oil, 2% wheat germ oil, and corn oil were non-irritating. Undiluted palm oil and palm oil at 2% were minimally
irritating to rabbit eyes. Hydrogenated palm oil and 3.4% - 12.3% hydrogenated cottonseed oil were considered mildly irritating.
In a HET-CAM study, 9.4% linseed oil was slightly irritating. Undiluted rice bran oil and undiluted wheat germ oil were
minimally irritating to eyes, while undiluted sesame oil was non- to minimal ocular irritants.
Glycidol and glycidol fatty acid esters, possible constituents in refined vegetable oils, were determined to be Group 2A
(probably carcinogenic to humans) and Group 3 (not classifiable as to carcinogenicity to humans) chemicals, respectively, by
IARC.
Edible oils are believed to be safe for use on the skin and very few reports of adverse reactions have been reported. The
proteins that are responsible for allergenic responses in individuals with food allergies do not partition into refined oils.
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In previously reviewed oils, safflower oil, palm oil, hydrogenated cottonseed oil, rice bran oil, avocado oil, sesame oil,
and wheat oil were non-irritating and/or non-sensitizing in human studies. In many of the oils found in this report, no irritation
and/or sensitization reactions were observed in human repeated insult patch tests.
In clinical studies, 0.2% black currant seed and 9.4% linseed oil were not ocular irritants. Black currant seed oil at 0.2%
was also non-comedogenic. Cases of contact allergy have been reported for soybean oil, sunflower oil, olive oil, avocado oil, and
sesame seed oil.
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H2 C
OCR
O
OCR'
HC
O
OCR"
H2 C
-OCR, -OCR', and -OCR" may be the same or diff erent f atty acid radicals.
14
CIR Panel Book Page 23
Crude Oil
Water
Degummed Oil
Lecithin Sludge
Alkali
Deodorization
Salad Oil
Soap Stock
Activated Earth
Deodorization
Salad Oil
Bleached Oil
H2, Catalyst
Deodorization
Cooking Oil
Partially
Hydrogenated Oil
Winterization &
Deodorization
Deodorization
Deodorization
Shortening
Stock
Blended Oils
Deodorization
Margarine Stock
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CIR Panel Book Page 24
Salad and
Cooking Oil
16
17
Ingredients
Oil Ingredients
18
Safe
Insufficient data
Safe
Safe
JACT 12 (5):481-559, 1993
Safe
Safe
Safe
Safe
Safe
Safe
Safe
Conclusion
Publication Date
Glyceryl Triesters
Trilaurin
Triarachidin
Tribehenin
Tricaprin
Tricaprylin
Trierucin
Triheptanoin
Triheptylundecanoin
Triisononanoin
Triisopalmitin
Triisostearin
Trilinolein
Trimyristin
Trioctanoin
Triolein
Tripalmitin
Tripalmitolein
Triricinolein
Tristearin
Triundecanoin
Glyceryl Triacetyl Hydroxystearate
Glyceryl Triacetyl Ricinoleate
Glyceryl Stearate Diacetate
Ingredients
19
Safe
Conclusion
21
Trace
30
45
8-12; 8-16.5
0.2 - 1.6
0.1 - 1.7
Cotton
Seed Oil10
Others
Oleic/Linoleic
Saturated, General
Fatty Acids
Caproic (C6)
Caprylic (C8)
Capric (C10)
Lauric (C12)
Myristic (C14)
Myristoleic (C14:1)
Palmitic (C16)
Palmitoleic (C16:1)
Heptadecanoic (C17:0)
Stearic (C18)
Oleic (C18:1)
Linoleic (C18:2)
Linolenic (C18:3)
Arachidic (C20)
Eicosenoic (C20:1)
Eicosadienoic (C20:2)
Behenic (C22)
Erucic (C22:1)
Docosadienoic (C22:2)
Docosahexaenoic (C22:6)
Lignoceric (C24)
Arachidonic (C20:4n6)
Arachidontrienoic
Corn
Oil28,65,66 *
Trace
Trace
0.5 - 3.5
53 - 86
3.5 - 20
0 - 1.5
Trace
7.5 - 20
0.3 - 3.5
Trace
Olive Oil
4.5
39.2
10.1
0.4
0.4
44
0.1
0.2
1.1
Palm
Oil8
0.2
2
15.1
2.7
7.8
Palm Kernel
Oil8
0.3
4.4
3.7
48.3
15.6
20
1 - 58.6
5.6 - 3.1
0.7 - 1.3
12.1 - 57.4
11.4 - 22.1
8.3 - 12.5
1.5 - 3
Rapeseed
Oil3
1-2.0
42-50
< 1.0
8-10.0
< 1.0
38-42
1
< 1.0
3-5.0
< 1.0
Fully
Hydrogenated
Rapeseed Oil2
< 0.2
< 0.5
< 2.0
< 2.5
> 50
< 40.0
< 14
< 1.0
< 2.0
< 6.0
< 1.0
< 0.2
Canola Oil2
26
68
Trace
Trace
Safflower
Seed Oil15,67
Trace of
components
below C14
<0.5
3.5 - 6.0
35 - 50
35 - 50
<1.0
<1.0
<0.5
7.0 - 12.0
<0.5
<0.5
Sesame Seed
Oil7,30
Others
Oleic/Linoleic
Saturated, General
Fatty Acids
Caproic (C6)
Caprylic (C8)
Capric (C10)
Lauric (C12)
Myristic (C14)
Myristoleic (C14:1)
Palmitic (C16)
Palmitoleic (C16:1)
Heptadecanoic (C17:0)
Stearic (C18)
Oleic (C18:1)
Linoleic (C18:2)
Linolenic (C18:3)
Arachidic (C20)
Eicosenoic (C20:1)
Eicosadienoic (C20:2)
Behenic (C22)
Erucic (C22:1)
Docosadienoic (C22:2)
Docosahexaenoic (C22:6)
Lignoceric (C24)
Arachidonic (C20:4n6)
Arachidontrienoic
12 - 13.5
11.5 - 60.0
25 - 63.1
2.9 - 12.1
Soybean
Oil3
Acai
Oil68
22
2
2
60
12
Trace
2.5
Sunflower
Seed Oil3
5.0 - 7.2
2.0 - 6.5
14.7 - 37.2
51.5 - 73.5
Trace - 0.3
0.3 - 1
3
22 - 26
46 - 50
19 - 20
Amaranth
Oil69
90-93
Small quantity
Apricot
Kernel Oil3
21
3
25
60
12
Artichoke
Oil70
67-72
10 to 12
13-17
3 - 5.1
Avocado
Oil3
3 to 5
10 to 12
1 to 3
Trace
8.6
7.4
65.7
9.3
Trace
4 to 8
4 to 8
44 - 47
15 - 20
6 to 9
Ben
Oil71
Babassu
Oil3
3.4
2.8
11.99
2.96
16.77
23.08
31.2
7.8
Camelina (False
Flax) Seed Oil72
Others
Oleic/Linoleic
Saturated, General
Fatty Acids
Caproic (C6)
Caprylic (C8)
Capric (C10)
Lauric (C12)
Myristic (C14)
Myristoleic (C14:1)
Palmitic (C16)
Palmitoleic (C16:1)
Heptadecanoic (C17:0)
Stearic (C18)
Oleic (C18:1)
Linoleic (C18:2)
Linolenic (C18:3)
Arachidic (C20)
Eicosenoic (C20:1)
Eicosadienoic (C20:2)
Behenic (C22)
Erucic (C22:1)
Docosadienoic (C22:2)
Docosahexaenoic (C22:6)
Lignoceric (C24)
Arachidonic (C20:4n6)
Arachidontrienoic
9.5
3
10
1
34-36
30-40
2.4
7.5
6.5
46.5
16
Cohune
Oil3
24-29
Cocoa
Seed
Butter3
20 - 24
32 - 37
30 - 35
4.0 - 6
Cranberry
Seed Oil73
6.0 - 9
14 - 20
60 - 68
<1
9.0 - 13
Cucumber
Oil74
7.2
0.1
0.2
30.8
43.9
4.6
Trace
11
Trace
Cupuacu
Seed
Butter75
22
3.5-5.5
14-44
46-74
7-9.5
Grape
Seed Oil3
3.5
19.1
15.3
57
5.5
Linseed
Oil3
1.0-7
33-48
35-50
4.0-8
5.0-8
Mango
Seed
Oil3**
0.1 - 0.5
5 to 8
70 - 78
4.0 - 7.0
0.1 - 0.6
0.3 - 0.7
0.1 - 0.5
9 to 12
0.05 - 0.15
Marula
Oil76
8.0 - 29
7.0 - 20
52 - 77
Meadowfoam
Seed Oil3
2.0 - 7
0.5 - 3.5
55 - 70
22 - 33
<1
6.28
2.65
12.56
2.87
1.85
1.85
47.46
26
Peach
Kernel
Oil78
Others
Oleic/Linoleic
Saturated, General
***Reported as Fragaria Ananassa (Strawberry) Seed Oil.
Fatty Acids
Caproic (C6)
Caprylic (C8)
Capric (C10)
Lauric (C12)
Myristic (C14)
Myristoleic (C14:1)
Palmitic (C16)
Palmitoleic (C16:1)
Heptadecanoic (C17:0)
Stearic (C18)
Oleic (C18:1)
Linoleic (C18:2)
Linolenic (C18:3)
Arachidic (C20)
Eicosenoic (C20:1)
Eicosadienoic (C20:2)
Behenic (C22)
Erucic (C22:1)
Docosadienoic (C22:2)
Docosahexaenoic (C22:6)
Lignoceric (C24)
Arachidonic (C20:4n6)
Arachidontrienoic
Murumuru
Seed Butter77
6.0-12
14-23
16
63-70
Perilla
Oil3
0.7 - 0.8
22 - 24.5
50.2 - 56
5.4 - 7
0.7
9.9 - 11
0.1
0.2
Quinoa
Seed Oil79
23
2 max
2.0-11
6.0-40
45-77
5.0-13
Ramtil/Niger
Oil3
5.48
5.21
7.91
17.81
16.22
15.56
3.08
9.28
4.41
6.92
Rice
Germ
Oil11
5.5 - 8.5
16.5 - 19.5
28.5 - 41.5
33.5 - 36.5
Strawberry
Seed Oil80
***
< 1.0
< 2.0
< 1.0
8.0 - 12.0
15.0 - 30.0
55.0 - 65.0
< 1.0
< 1.0
< 1.0
8.0 - 13.0
< 1.0
Watermelon
Seed Oil81
0 - 1.2 C20-22
Saturated
acids
1.0 - 6
8.0 - 30
44 - 65
4.0 - 10
11.0 - 16
Wheat Germ
Oil13,27
2-8
30-40
24-34
1-3
18-30
1
Baobab Oil82,83
Others
Oleic/Linoleic
Saturated, General
Fatty Acids
Caproic (C6)
Caprylic (C8)
Capric (C10)
Lauric (C12)
Myristic (C14)
Myristoleic (C14:1)
Palmitic (C16)
Palmitoleic (C16:1)
Heptadecanoic (C17:0)
Stearic (C18)
Oleic (C18:1)
Linoleic (C18:2)
Linolenic (C18:3)
Arachidic (C20)
Eicosenoic (C20:1)
Eicosadienoic (C20:2)
Behenic (C22)
Erucic (C22:1)
Docosadienoic (C22:2)
Docosahexaenoic (C22:6)
Lignoceric (C24)
Arachidonic (C20:4n6)
Arachidontrienoic
4-10
1-4
23-55
30-55
13
2
14
2
45
34
1
Eleostearic
(C18:3 conj) =
10%
Cherry Kernel
Oil85,86
Rice Bran
Oil84
5-6.5
45-55
28-36
10-15
Argan
Oil87,88
-Linolenic
(C18:3) =
0.4%;
-Linolenic
= 1-3.5%
1-3.5
2-6
3-5
10-22
33-46
18-25
9-13
Borage
Oil89,90
24
0.8-2
72-87
5.3-14.3
6.1-15
Camellia
Oleifera
Seed Oil91,92
-Linolenic
(C18:3) =
2%;
2-6
60-77
3-25
0.8
8-18
2
Papaya
Seed Oil93,94
3-8
20-38
30-45
5-15
2
20-30
Lime Seed
Oil95,96
2-6
26-35
35-45
2-6
0.5
14-22
Orange Seed
Oil97,98
2-8
20-38
30-48
2-6
18-30
1.5
1
Grapefruit
Seed Oil99,100
3-7
18-38
40-62
1
10-16
Pumpkin Seed
Oil101,102
Others
Oleic/Linoleic
Saturated, General
Fatty Acids
Caproic (C6)
Caprylic (C8)
Capric (C10)
Lauric (C12)
Myristic (C14)
Myristoleic (C14:1)
Palmitic (C16)
5-9Palmitoleic (C16:1)
Heptadecanoic (C17:0)
Stearic (C18)
Oleic (C18:1)
Linoleic (C18:2)
Linolenic (C18:3)
Arachidic (C20)
Eicosenoic (C20:1)
Eicosadienoic (C20:2)
Behenic (C22)
Erucic (C22:1)
Docosadienoic (C22:2)
Docosahexaenoic (C22:6)
Lignoceric (C24)
Arachidonic (C20:4n6)
Arachidontrienoic
2-4
5-12
60-85
1
24
35
-Linolenic
(C18:3) = 1%
-Linolenic = 712%
4-10
5-5.4
-Linolenic
(C18:3) =
34-35%
Evening
Primrose
Oil105,106
Cranberry
Seed
Oil103,104
25
3
60-80
15-25
1
4-9
1
Plum
Oil107,108
-Linolenic
(C18:3) = 1117%
-Linolenic =
11-14%
Stearidonic
(18:4) = 22.5%
1
1
1
3
1-4
9-16
40-50
6-10
Blackcurrant
Seed Oil109,110
0.9-1
10.9-11
52.6-53
31.9-32
2-2.3
Red Raspberry
Seed Oil111,112
8
3
3-8
65-80
1.5-5
1-1.5
2-5
2.5-4
5-9
1.5-3
Moringa
Oil113,114
180-198
10 max
178-193
10 max
Saponification value
Unsaponifiable matter
(%)
Refractive index
Iodine value
Saponification value
10 max
2.0 max
1.5 max
135-150
4 max
Appearance
Specific gravity
Safflower Oil2
Hydrogenated
Rapeseed Oil2
Properties and
Constituents
Unsaponifiable matter
(%)
1.5 max
90-113
1.465-1.467 (40C)
110-126
1.5 max
Appearance
Specific gravity
Refractive index
Iodine value
Cottonseed Oil2,3
Canola Oil2
Properties and
Constituents
195-205
0.05-0.7
0.1 max
0.3-0.6
10 max
120.9-151.4
Soybean Oil2,3
26
1.4672-1.4722
81-123
191
0.3-0.5
10 max
0
0.923
Apricot Oil3
1.5 max
10 max
25-30
245-255
14-33
Nearly colorless
0.894-0.899 (60C)
Sunflower Oil2,3
0.2-0.8
10 max
25-50
Almost colorless to
yellow, greenish, or
brown in color
0.914-0.918
1.469-1.484
64-88; refined 75-94
20 max (refined)
Palm Oil2,3
Olive Oil3
1.461-1.465
71-95
177-198
0.910-0.916
Avocado Oil3
0.5 - 2
168-192
81-112
Rapeseed Oil3
0.890-0.910 (25C)
20.0 max
25-37
Peroxide value
(meq/kg)
Melting point (C)
Unsaponifiable matter
(%)
15 max
270-350
Refractive index
Iodine value
Saponification value
5.0 max (refined)
0.4-3
0.5-1
1.467-1.471
126-139
180-195
0.910-0.920 (20C)
refined
90-115 (refined)
0.910-0.928
Appearance
Specific gravity
Murumuru Butter3,77
Ramtil/Niger Oil3
< 15
150.1
Light green
0.923
Cranberry Seed
Oil3,73
Properties and
Constituents
Unsaponifiable matter
(%)
Peroxide value
(meq/kg)
Melting point (C)
33.5
190-200
247-251
Saponification value
0.950-0.998
1.453-1.458
35-40
0.916-0.918 (15C)
1.449-1.451 (40C)
14-18
Appearance
Specific gravity
Refractive index
Iodine value
Cocoa Oil3
Babassu Oil3
Properties and
Constituents
27
< 15
0.95
Light golden
Strawberry Seed
Oil3,80
176-206
0.91-0.93
1.470-1.476
125-143
< 5.0
1.4668
113-123
193-195
0.8930-0.9166
Watermelon Seed
Oil3,81
0.5-1.5
189-196
0.927-0.931 (20C)
1.4786-1.4815
170-204
Linseed Oil3
5.0-10
65-95
190-210
Pale yellow
Baobab Oil82,83
0.8-2.9
34-43
190-195
Mango Oil3
10.0 max
10.0 max
0.8 max
5-10
5.0 max
10.0 max
1.466-1.475 (20C)
90-110
185-200
65-100
Refractive index
Iodine value
Saponification value
Clear yellow
Pale yellow
0.2 max
0.910-0.920 (20C)
1.0 max
10.0 max
185-195
Corn Oil65,66
Specific gravity
Appearance
0.5% max
105-135
180-195
Saponification value
Appearance
Specific gravity
Refractive index
Iodine value
Cherry Kernel
Oil85,86
28
1.0 max
5-10
80-125
1.5 ( as oleic)
1.5
5.0 max
110-330
174-197
Dark green
Pumpkin Seed
Oil101,102
Grapefruit Seed
Oil99,100
Clear yellow
1.0 max
10.0 max
184-194
Borage Oil89,90
3-4
10.0 max
95
Yellow
0.908-0.918 (20C)
Argan Oil87,88
2.0 max
5.0 max
140-180
170-200
Cranberry Seed
Oil103,104
1.0 max
1.5 max
10.0 max
188-196
80-94
Camellia Oleifera
Seed Oil91,92
1-2
0.2
1-10
29
5.0 max
10.0 max
10.0 max
175-195
180-200
145-185
Red Raspberry
Seed Oil111,112
180-195
90-108
Light yellow
0.920-0.930 (20C)
1.475-1.480 (20C)
145-165
Appearance
Specific gravity
Refractive index
Iodine value
Blackcurrant Seed
Oil109,110
Saponification value
Plum Oil107,108
Evening Primrose
Oil105,106
10.0
192
0.908 (20C)
Moringa Oil113,114
Totals
Duration of Use
Leave-On
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Totals
Duration of Use
Leave-On
Rinse-Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Conc. of Use
(2010) (%)
0.0005-11
0.002-31
0.01-11
0.03-11
0.0005-0.02
0.0005-31
--0.02-2
--2
0.03-2
0.002-0.02
---
135
30
11
74
1
143
NR
2
18
1
1
2
1
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
2
1
NR
NR
NR
3
NR
NR
NR
NR
NR
NR
NR
0.0005-31
165
No. of Uses
(2010)
Conc. of Use
(2010) (%)
0.008-49
0.8-60
3
0.005-60
NR
0.0005-0.09
0.0004-1
0.2
2-4
0.5
NR
0.0005-60
0.0004-8
0.0004-60
0.2-12
NR
0.2-12
NR
NR
NR
0.2-12
NR
NR
NR
NR
0.2-3
NR
NR
72
3
69
NR
NR
NR
71
NR
1
NR
NR
64
NR
NR
102
216
1
450
NR
2
NR
1
2
NR
NR
439
18
457
No. of Uses
(2010)
Conc. of Use
(2010) (%)
NR
9
NR
0.007-17
NR
0.1
NR
NR
NR
NR
NR
0.007-17
0.1-1
0.007-17
NR
NR
NR
NR
NR
2
3
NR
NR
NR
NR
NR
5
30
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
2
1
NR
27
NR
NR
NR
NR
1
NR
NR
23
4
27
Brassica Campestris
(Rapeseed) Seed Oil
No. of Uses
(2010)
Conc. of
Use (2010)
(%)
NR
NR
1
33
NR
NR
NR
NR
31
NR
NR
1
32
33
NR
NR
NR
1
NR
NR
NR
NR
NR
NR
NR
NR
1
Palm Acid
NR
NR
NR
1-17
NR
NR
NR
NR
1-4
NR
NR
NR
1-17
1-17
2
NR
NR
0.3-4
NR
NR
NR
NR
NR
NR
NR
0.3-4
NR
0.3-4
Hydrogenated Rapeseed
Oil
No. of Uses
(2010)
0.002-0.03
0.3-70
0.0002-17
0.0002-73
NR
0.006-24
NR
5
0.02-1
1-33
NR
0.002-73
0.02-33
0.0002-73
NR
NR
NR
5
NR
NR
NR
NR
2
NR
NR
NR
5
NR
NR
NR
0.3-3
NR
NR
NR
NR
0.3-3
NR
NR
NR
0.3-3
0.3-3
Potassium Palmate
3
62
1
113
NR
19
NR
NR
2
1
NR
112
20
132
Conc. of Use
(2010) (%)
Canola Oil
No. of Uses
(2010)
Conc. of Use
(2010) (%)
NR
NR
NR
NR
NR
0.001
NR
NR
NR
NR
NR
NR
0.0001
0.001
NR
NR
NR
7
NR
NR
NR
NR
1
NR
NR
NR
7
NR
NR
NR
0.3-30
NR
NR
NR
NR
0.3-30
NR
NR
NR
0.3-30
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
No. of Uses
(2010)
Totals
Duration of Use
Leave-On
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Totals
Duration of Use
Leave-On
Rinse-Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Conc. of Use
(2010) (%)
NR
3-68
NR
NR
NR
3-68
NR
NR
NR
NR
3-68
NR
NR
7
205
NR
NR
1
212
NR
NR
NR
NR
189
1
3
0.005-2
0.005-2
0.002
0.02
NR
NR
0.005-2
NR
NR
NR
NR
0.002
NR
NR
10
10
NR
2
NR
NR
10
NR
NR
NR
NR
NR
NR
NR
3-68
212
Sodium Palmate
No. of Uses
(2010)
NR
NR
NR
12-44
NR
NR
NR
NR
16-44
NR
NR
NR
12-44
12-44
6-35
15-35
7
6
NR
6-35
NR
NR
15-35
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
Hydrogenated Sunflower
Seed Oil
NR
6-35
NR
NR
1
194
NR
NR
NR
NR
173
3
4
10
184
194
0.04-2
0.6-4
0.03-0.5
0.0005-93
0.01-0.5
0.0002-95
NR
0.02-95
0.01-52
0.1-78
2
0.0005-95
0.0002-95
0.0002-95
26
26
6
711
3
190
NR
5
121
14
9
617
298
31
0.2
1-40
0.0005-3
0.9-17
0.004-17
0.7-26
0.2-5
0.0005-100
0.02-0.1
0.006-94
0.2-0.5
0.001-100
0.0005-94
53
103
6
800
NR
97
5
6
70
19
21
718
194
912
NR
NR
NR
0.0001-0.2
NR
NR
NR
NR
NR
NR
NR
0.0001-0.2
NR
0.0001-0.2
13
7
NR
34
NR
11
NR
NR
1
NR
NR
36
14
50
0.01-0.1
NR
NR
0.0005
NR
0.4
0.1-3
0.1-12
NR
0.0005-12
NR
0.1-12
0.0005-0.1
0.0005-12
NR
NR
NR
12
NR
NR
NR
NR
NR
NR
NR
12
NR
12
0.03-7
0.1-39
NR
0.01-39
NR
0.1
NR
0.001-25
0.05-6
5-42
NR
0.001-39
0.05-42
0.001-42
NR
NR
NR
2
NR
NR
NR
NR
NR
NR
NR
2
NR
0.3-2
NR
NR
0.05-5
NR
NR
NR
NR
NR
NR
NR
0.05-5
NR
4
3
NR
34
NR
1
NR
NR
NR
NR
NR
33
3
36
No. of Uses
(2010)
Conc. of Use
(2010) (%)
0.0005-19
0.08-41
0.0002-85
0.0002-96
0.0003-4
0.000007-92
0.03-35
0.05-30
0.0003-4
0.005-75
0.2
0.0002-96
0.000007-92
0.000007-96
12
1
NR
67
NR
6
NR
NR
4
NR
NR
68
9
0.02-0.3
NR
NR
NR
NR
0.04
0.02-0.4
0.08
3
0.0001-3
NR
0.0001-3
0.04-0.3
64
260
3
707
1
179
85
8
52
11
18
1054
360
1414
Helianthus Annuus
(Sunflower) Seed Oil
No. of Uses
(2010)
Totals
Duration of Use
Leave-On
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Totals
Duration of Use
Leave-On
Rinse-Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Conc. of Use
(2010) (%)
NR
NR
NR
0.002-0.005
NR
NR
NR
NR
0.002
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
41
NR
2
NR
NR
2
1
6
37
6
0.002
0.002-0.005
NR
NR
NR
4-18
NR
NR
NR
NR
4-18
NR
NR
NR
4-18
4-18
0.2
2
NR
0.001-3
NR
0.1
NR
NR
0.01-0.1
NR
0.1
0.1-3
0.001-0.1
0.01-3
NR
NR
NR
16
NR
NR
NR
NR
9
NR
1
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
3
NR
NR
NR
NR
1
NR
NR
5
11
43
NR
NR
NR
3
16
Sodium Olivate
Sodium Astrocaryum
Murumuruate
NR
0.002-0.005
NR
Potassium Olivate
No. of Uses
(2010)
NR
NR
NR
NR
NR
0.1
NR
NR
NR
NR
NR
NR
0.1
0.1
7
NR
3
168
NR
10
NR
NR
4
1
3
160
20
180
32
0.001-0.5
0.01
0.1
0.001-1
NR
NR
NR
NR
0.001-0.01
NR
NR
0.001-1
0.001-0.01
0.001-1
NR
1
1
5
NR
2
NR
NR
NR
NR
NR
5
2
NR
0.01
NR
0.01
NR
NR
NR
NR
NR
NR
NR
0.01
NR
0.01
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
0.001-3
NR
NR
NR
NR
3
0.001-0.5
NR
NR
NR
5
NR
1
NR
NR
NR
NR
1
4
2
0.1-1
0.1-1
0.01
0.001-10
0.001
0.01-1
0.07-0.1
0.001-0..1
0.001-2
0.05
NR
0.001-10
0.001-2
0.001-10
NR
34
NR
47
NR
29
NR
NR
NR
NR
NR
61
15
NR
NR
NR
NR
0.05
0.05-0.5
NR
0.002-1
NR
1
NR
0.002-1
1
11
9
NR
88
NR
8
NR
2
2
1
NR
87
13
100
No. of Uses
(2010)
Conc. of Use
(2010) (%)
0.06-0.5
1-7
NR
0.001-7
NR
0.001-0.2
NR
NR
NR
NR
NR
0.001-7
0.001-0.2
0.001-7
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
0.1
NR
NR
0.1
NR
NR
0.01
0.1
NR
0.01-0.2
0.01
0.01-0.2
0.1
0.01-0.2
21
22
NR
178
NR
11
3
NR
3
NR
NR
171
21
192
Astrocaryum Murumuru
Seed Butter [Murumura]
No. of Uses
(2010)
Totals
Duration of Use
Leave-On
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Totals
Duration of Use
Leave-On
Rinse-Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Conc. of Use
(2010) (%)
2
3
NR
0.003-3
NR
2
NR
NR
0.01-0.1
0.05
NR
NR
3
NR
23
NR
2
NR
NR
NR
NR
NR
2
NR
NR
NR
NR
2
NR
NR
NR
NR
NR
NR
NR
1
NR
NR
NR
NR
1
NR
NR
NR
NR
NR
NR
NR
Citrullus Lanatus
(Watermelon) Seed Oil
1
2
0.003-3
0.01-0.1
23
2
No. of Uses
(2010)
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
1
NR
NR
NR
NR
NR
NR
NR
1
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
Citrus Vulgaris
(Watermelon) Seed Oil
1
NR
NR
NR
NR
1
NR
NR
NR
NR
NR
NR
NR
1
NR
Hydrogenated Camellia
Oleifera Seed Oil
1
NR
NR
0.1
NR
0.1
0.1
0.1
NR
NR
0.1
NR
NR
0.1
0.1
0.1
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
33
NR
0.1
NR
0.1
NR
0.1
NR
NR
0.1
NR
NR
0.1
0.1
NR
1
NR
10
NR
2
NR
NR
2
NR
NR
8
4
12
NR
NR
NR
0.1
NR
NR
NR
NR
NR
NR
NR
0.1
NR
0.1
NR
NR
NR
6
NR
NR
NR
NR
1
NR
NR
5
1
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
0.2
NR
0.0005-0.2
NR
NR
NR
NR
NR
NR
NR
0.0005-2
NR
NR
NR
NR
5
NR
NR
NR
NR
1
NR
NR
3
2
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
12
12
NR
30
NR
1
NR
NR
NR
NR
NR
29
2
No. of Uses
(2010)
Conc. of Use
(2010) (%)
NR
NR
NR
NR
NR
NR
0.3
NR
NR
NR
NR
NR
0.3
1
NR
NR
5
NR
1
NR
NR
NR
NR
NR
5
1
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
1
NR
NR
NR
NR
NR
1
NR
No. of Uses
(2010)
Totals
Duration of Use
Leave-On
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Totals
Duration of Use
Leave-On
Rinse-Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Conc. of Use
(2010) (%)
0.003
NR
NR
0.003-0.1
NR
NR
NR
NR
NR
NR
NR
1
NR
1
18
NR
1
NR
NR
NR
NR
NR
0.003-6
0.003-6
0.05-0.2
5
0.03-6
NR
0.003-6
NR
0.05-0.2
0.05
NR
0.1
NR
NR
72
64
8
13
7
1
60
NR
12
NR
NR
2
NR
NR
0.003-0.1
NR
17
1
No. of Uses
(2010)
NR
NR
NR
NR
0.5
0.002
NR
0.00001-0.5
NR
NR
NR
0.00001-0.5
0.05
6
25
2
147
NR
12
16
NR
10
1
3
134
41
175
0.02
1-5
0.02
0.0005-5
NR
0.02-0.5
NR
0.5
0.0005-0.5
NR
NR
0.01-5
0.0005-0.5
0.0005-3
2
1
1
14
NR
15
NR
NR
3
NR
NR
19
10
NR
NR
0.003-0.3
NR
0.003-0.4
NR
NR
NR
NR
NR
NR
0.003-0.4
NR
NR
NR
NR
1
NR
NR
NR
NR
1
NR
NR
NR
1
34
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
Sodium Mangoseedate
2
64
NR
108
NR
1
NR
NR
NR
NR
NR
109
NR
0.1-20
0.6-26
0.1-3
0.002-74
NR
0.1-1
0.2-2
0.5
0.001-0.6
0.5-0.9
NR
0.002-74
0.01-2
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
0.001
NR
NR
NR
NR
NR
NR
NR
0.001
NR
0.001
30
67
1
211
NR
47
46
NR
4
2
1
225
91
Limnanthes Alba
(Meadowfoam) Seed Oil
316
0.002-74
0.01
0.01
NR
0.003-4
0.05-0.1
0.001-0.1
NR
0.002-0.05
0.003-0.4
0.02-0.2
NR
0.002-10
0.001-0.4
0.001-10
4
1
NR
11
NR
1
NR
NR
NR
NR
NR
13
2
15
3
NR
NR
0.003-3
NR
0.02
NR
NR
0.003
NR
NR
0.004-3
0.003
0.003-3
Moringa Pterygosperma
Seed Oil
3
NR
3
58
NR
42
NR
2
5
1
2
52
50
102
Linum Usitatissimum
(Linseed) Seed Oil
No. of Uses
(2010)
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
4
14
2
109
NR
37
NR
4
4
2
3
113
37
150
0.00002-0.5
0.1-15
NR
0.00002-58
0.2
0.05-0.1
NR
0.001-3
0.1-0.2
0.2
NR
0.00002-58
0.002-0.2
0.00002-58
NR
NR
NR
3
NR
NR
NR
NR
NR
NR
1
3
NR
Conc. of Use
(2010) (%)
Linseed Acid
No. of Uses
(2010)
Totals
Duration of Use
Leave-On
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Totals
Duration of Use
Leave-On
Rinse-Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Conc. of Use
(2010) (%)
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
14
NR
1
NR
NR
14
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
15
15
NR
NR
11
NR
15
NR
NR
NR
NR
NR
NR
NR
NR
14
Hydrogenated Evening
Primrose Oil
No. of Uses
(2010)
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
9
2
4
56
NR
2
NR
3
NR
4
1
57
6
63
0.5
3
NR
0.2-3
NR
6
NR
NR
NR
NR
NR
0.5-6
0.2
0.2-6
NR
NR
NR
NR
NR
1
NR
NR
NR
NR
NR
NR
1
0.02-2
NR
NR
27
0.01-0.1
NR
0.5-0.6
0.001-2
0.02-2
0.0009-27
NR
0.0009-4
0.01-27
0.0009-27
NR
NR
NR
1
NR
NR
NR
NR
1
NR
NR
NR
1
35
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
Sodium Avocadoate
7
57
5
110
NR
43
8
NR
5
2
NR
118
43
161
NR
NR
NR
8
NR
NR
NR
NR
8
NR
NR
NR
8
1
3
NR
13
NR
NR
NR
NR
NR
NR
NR
12
1
13
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
Sodium Babassuate
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
25
38
5
486
1
78
10
10
24
8
7
449
139
588
0.002-18
0.001-5
0.0009-1
0.00001-18
0.003-0.1
0.0001-89
0.1
0.002-40
0.01-9
4
NR
0.0001-40
0.00001-89
0.00001-89
2
NR
NR
5
NR
2
NR
NR
NR
NR
NR
5
2
No. of Uses
(2010)
Conc. of Use
(2010) (%)
NR
NR
NR
NR
NR
0.5
NR
NR
NR
NR
NR
NR
0.5
0.5
NR
NR
NR
2
NR
NR
NR
NR
NR
NR
NR
2
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
Hydrogenated Apricot
Kernel Oil
NR
2
NR
8
NR
3
NR
NR
NR
NR
NR
9
2
11
No. of Uses
(2010)
Totals
Duration of Use
Leave-On
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Totals
Duration of Use
Leave-On
Rinse-Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Conc. of Use
(2010) (%)
NR
0.01-+0.02
NR
NR
NR
0.01-0.02
NR
NR
NR
NR
0.01-0.02
NR
NR
NR
2
NR
NR
NR
2
NR
NR
NR
NR
2
NR
NR
1
1
1
NR
NR
NR
1
NR
1
NR
NR
NR
NR
NR
29
23
6
NR
6
2
23
NR
6
NR
NR
2
NR
NR
0.01-0.02
No. of Uses
(2010)
NR
NR
NR
NR
0.04
NR
NR
NR
NR
NR
NR
NR
0.04
0.04
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
0.5
NR
NR
NR
NR
NR
NR
NR
0.5
NR
0.5
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
0.1
NR
NR
0.1-1
NR
NR
0.04-22
2
0.003-22
NR
0.05-22
0.003-6
0.003-22
NR
NR
NR
1
NR
NR
NR
NR
NR
NR
NR
1
NR
36
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
Solanum Lycopersicum
(Tomato) Seed Oil
NR
NR
NR
18
NR
4
NR
NR
1
1
NR
16
6
22
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
0.01
0.001
NR
0.001-1
NR
NR
NR
NR
NR
NR
NR
0.001-1
NR
0.01-1
Solanum Lycopersicum
(Tomato) Fruit Oil
NR
1
NR
8
NR
NR
NR
NR
NR
NR
NR
8
NR
0.08
0.03-0.1
NR
0.000001-0.3
NR
NR
NR
0.2
NR
NR
NR
0.000001-0.3
0.05
0.000001-0.3
11
33
2
417
NR
24
NR
NR
35
4
8
367
75
442
0.0002-9
37
0.4
0.000002-37
0.001-1
0.01-2
0.1
0.1-1
0.02-2
0.1-1
0.01
0.000002-37
0.0001-2
0.000002-37
2
7
NR
43
NR
5
NR
5
2
NR
NR
45
8
53
No. of Uses
(2010)
Conc. of Use
(2010) (%)
NR
NR
NR
0.1-5
NR
NR
NR
NR
NR
NR
NR
0.1-5
NR
0.1-5
21
49
NR
141
NR
9
3
NR
19
4
NR
119
34
153
0.1-2
7
NR
0.00005-7
0.1
0.001-1
NR
NR
0.05-0.1
NR
NR
0.00005-7
0.001-1
0.00005-7
Theobroma Grandiflorum
Seed Butter [Capuacu]
NR
1
NR
8
NR
NR
NR
NR
2
1
NR
8
2
10
No. of Uses
(2010)
Totals
Duration of Use
Leave-On
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Totals
Duration of Use
Leave-On
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Conc. of Use
(2010) (%)
0.2
NR
NR
NR
NR
0.2
NR
NR
NR
NR
NR
NR
NR
17
NR
1
NR
NR
17
NR
NR
NR
NR
NR
NR
NR
0.3-0.5
0.3-0.5
0.5
NR
0.5
NR
0.5
NR
NR
NR
0.3
NR
NR
NR
4
3
NR
1
NR
5
NR
1
NR
1
1
NR
NR
0.2
17
No. of Uses
(2010)
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
22
17
5
4
NR
NR
22
NR
NR
NR
NR
5
NR
NR
NR
NR
NR
NR
NR
NR
NR
16
NR
NR
NR
3
13
16
0.01-0.1
NR
NR
0.003-0.1
NR
NR
NR
0.3
NR
0.002-2
NR
0.002-2
0.003-0.1
0.002-2
4
1
NR
36
NR
11
NR
NR
1
1
NR
34
13
47
37
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
NR
NR
17
NR
4
NR
NR
1
NR
NR
18
3
21
Vaccinium Macrocarpon
(Cranberry) Seed Oil
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
1
NR
8
NR
14
4
NR
NR
NR
NR
15
11
26
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NR
NR
NR
4
NR
NR
NR
NR
NR
NR
NR
3
1
Vaccinium Oxycoccos
(Cranberry) Seed Oil
0.01-5
0.03-7
0.001-7
0.001-41
0.001-0.2
0.01-0.3
43
0.001-35
0.001-7
0.01-2
NR
0.001-41
0.001-43
0.001-43
1
3
NR
30
NR
NR
NR
NR
1
NR
NR
27
3
30
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
34
6
401
NR
46
10
8
21
8
5
368
97
465
No. of Uses
(2010)
Conc. of Use
(2010) (%)
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
1
NR
NR
6
NR
NR
NR
1
NR
NR
NR
7
NR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Hippophae Rhamnoides
Fruit Oil
NR
NR
NR
NR
NR
4
NR
NR
NR
NR
NR
4
NR
Sodium Grapeseedate
No. of Uses
(2010)
Totals
Duration of Use
Leave-On
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Totals
Duration of Use
Leave-On
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (Underarm)
Hair - Non-Coloring
Hair - Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
Conc. of Use
(2010) (%)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
10
5
NR
NR
NR
1
NR
6
NR
8
1
NR
NR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
46
44
2
2
30
NR
46
NR
NR
NR
NR
2
NR
NR
NS
15
No. of Uses
(2010)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
17
7
1
109
NR
9
NR
1
3
1
NR
106
15
121
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
9
NR
21
NR
NR
NR
NR
NR
NR
NR
21
NR
21
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NR
NR
NR
3
NR
NR
NR
NR
NR
NR
NR
3
NR
38
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NR
NR
NR
1
NR
NR
NR
NR
NR
NR
NR
1
NR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NR
29
NR
33
NR
NR
NR
NR
NR
NR
NR
32
1
33
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
1
NR
2
NR
NR
NR
NR
NR
NR
NR
2
NR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NR
NR
NR
1
NR
NR
NR
8
NR
NR
NR
9
NR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NR
NR
NR
NR
NR
5
3
NR
NR
NR
NR
1
7
No. of Uses
(2010)
Conc. of Use
(2010) (%)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
NR
NR
9
NR
NR
NR
NR
1
NR
NR
8
1
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
3
14
3
49
NR
10
3
NR
1
NR
NR
53
9
62
No. of Uses
(2010)
15
83
5
395
NR
79
20
32
31
3
6
47
45
2
2
5
1
47
NR
NR
NR
NR
2
NR
NR
5
18
3
113
NR
28
NR
1
NR
NR
NR
1997
29
27
2
5
2
NR
24
NR
NR
NR
NR
2
NR
NR
Hair-Coloring
Nail
Mucous Membrane
Bath Products
Baby Products
data year
Totals
Duration of Use
Leave-On
Rinse-Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (underarm)
Hair - Non-Coloring
Hair-Coloring
Nail
Hair - Non-Coloring
Baby Products
NR - not reported to the VCRP or the Council
Bath Products
Mucous Membrane
1-6
0.1-60
5
0.001-72
NR
0.0000527
1
84
NR
7
10
0.0000584
0.001-72
2003
0.0000584
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2010
NS
NR
NR
2-10
3-13
NR
0.4-13
NR
NR
NR
NR
0.9-2
0.4-13
0.6-2
0.4-13
NR
NR
68
NR
2
12
11
3
229
NR
43
101
171
2010
272
**
**
**
**
**
**
**
**
**
**
**
**
**
1997
**
NR
NR
0.002-48
NR
NR
0.04-2
2
NR
0.002-48
NR
2-34
0.002-48
0.008-13
2010
0.002-48
NR
NR
NR
NR
NR
4
NR
NR
NR
NR
NR
1
3
NR
NR
4
9
12
78
1
2
NR
1
7
68
15
83
**
**
**
**
**
**
**
**
**
**
**
**
**
39
NR
0.1-11
0.2-1
0.2
0.004-29
0.2
NR
NR
0.5-32
0.0040.01
NR
0.08-32
0.004-29
0.004-32
NR
NR
7
NR
1
NR
NR
1
36
NR
NR
28
1997
36
**
**
**
**
**
**
**
**
**
**
**
**
**
**
106
Rinse Off
Exposure Type
Eye Area
Possible Ingestion
Inhalation
Dermal Contact
Deodorant (underarm)
Leave-On
28
2010
508
402
2002
142
NR
NR
116
151
NR
156
NR
NR
NR
NR
NR
272
NR
272
1998
NR
NR
NR
NR
NR
NR
NR
NR
11
NR
NR
1997
11
**
**
**
**
**
**
**
**
**
**
**
**
**
1997
**
NR
3
0.05
NR
NR
0.8
NR
NR
0.05-2
NR
0.9-23
0.05-23
0.8-3
2010
0.05-23
NR
155
NR
NR
356
NR
4
NR
NR
NR
358
4
362
**
**
**
**
**
**
**
**
**
**
**
**
**
**
NR
NR
NR
0.5-24
8-12
NR
0.001-24
NR
0.01-0.1
NR
NR
0.001-24
0.01-0.1
0.001-24
NR
NR
10
1
NR
10
6
NR
71
NR
6
17
60
2010
77
NR
NR
NR
NR
36
NR
3
NR
2
NR
32
7
39
2002
NR
NR
NR
NR
NR
1
3
NR
12
NR
NR
NR
13
1997
13
**
**
**
**
**
**
**
**
**
**
**
**
**
**
1997
NR
NR
2
NR
NR
0.2-30
2-30
1
0.4-30
NR
NR
0.2-30
17
5
17
11
321
NR
33
NR
5
48
267
104
,1-39
NR
0.1-1
0.1-1
NR
0.1-39
NR
0.3
NR
NR
0.1-8
0.2-39
NR
0.2
0.5-0.8
0.1-8
0.1
0.0003-27
0.5
0.005-0.5
0.3
0.02-78
0.0006-6
0.0003-78
0.005-6
NR
NR
17
NR
NR
61
12
NR
123
NR
NR
134
18
152
2010
2010
0.2-30
Table 5b. Current amd historical frequency and concentration of use according to duration and type of exposure - previously reviewed ingredients
# of Uses
Conc. of Use (%)
# of Uses
Conc. of Use (%)
# of Uses
Conc. of Use (%)
# of Uses
114
Duration of Use
Totals
data year
4
NR
32
NR
NR
NR
NR
1
NR
NR
NR
6
NR
NR
NR
NR
NR
NR
NR
Deodorant (underarm)
Dermal Contact
Eye Area
Possible Ingestion
Inhalation
29
NR
NR
NR
NR
NR
Baby Products
Bath Products
Mucous Membrane
Nail
Hair-Coloring
Hair - Non-Coloring
NR
NR
NR
NR
0.1
NR
NR
0.1
NR
NR
0.0030.005
0.5
NR
0.003
NR
0.1-3
NR
0.003-3
0.01-1
0.003-3
0.003-3
3
NR
NR
NR
11
59
NR
233
218
35
7
28
NR
NR
59
52
5
414
14
106
374
1-50
1-50
1-10
NR
NR
1-50
NR
1-50
1 - 10
NR
1 - >50
1 - >50
1 - >50
40
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
11
NR
17
NR
NR
17
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NR
1
2
182
1
38
29
1
276
39
257
241
NR
3
2
183
4
40
30
1
371
35
237
361
0.00080.2
0.003-10
0.001-0.1
0.0000314
NR
0.00010.02
0.0040.007
0.001-5
0.0040.01
0.0010.01
0.004
0.0000314
0.0010.07
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Table 5b. Current amd historical frequency and concentration of use* according to duration and type of exposure - previously reviewed ingredients (continued)
# of Uses
Conc. of Use (%)
# of Uses
Conc. of Use (%)
# of Uses
Conc. of Use (%)
# of Uses
Conc. of Use (%)
Sesamum Indicum (Sesame) Oil
Zea Mays (Corn) Oil
Oryza Sativa (Rice) Germ Oil
Sesamum Indicum (Sesame) Seed Oil
Unsaponifiables
20002002
2010
2010
1987
2010
1987
2010
1987
2010
1987
2010
2007
2010
2006
2010
2003
0.00003NS
6
34
0.1
0.003-3
253
480
1 - >50
NS
NR
17
NR
NS
498
14
598
NR
Exposure Type
Rinse Off
Leave-On
Duration of Use
Totals
data year
Deodorant (underarm)
Hair - Non-Coloring
Hair-Coloring
Nail
Mucous Membrane
Bath Products
Dermal Contact
Inhalation
Rinse-Off
Exposure Type
Eye Area
Possible Ingestion
Leave-On
Duration of Use
Totals
data year
34
19
NR
NR
NR
50
NR
3
NR
NR
3
4
25
12
NR
NR
NR
31
NR
4
NR
NR
4
3
2007
37
NR
0.2
NR
NR
3
NR
3-25
NR
NR
NR
3-25
0.2-3
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
1
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
41
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NR
NR
11
8
4
NR
5
165
8
29
2
148
40
NR
189
NR
7
43
25
685
24
60
11
657
226
NR
NR
0.002-3
NR
0.4-19
0.1-5
0.1-5
0.001-23
0.1-3
0.7-21
0.02-3
0.001-23
0.1-5
NR
0.1
0.0001-41
0.3
0.001-34
0.002-3
0.6-6
0.0005--98
0.05-2
0.05-26
0.01-8
0.0001-15
0.0005-98
NR
63
12
4
3
1
220
9
33
2
223
80
NR
142
20
2
22
2
360
12
29
7
154
373
0.5
0.00004-3
0.1-3
0.00020.01
0.0000218
0.02
0.0001-2
0.1
0.1-4
0.02-1
0.001-2
0.0000218
0.00002-5
NR
NR
0.0001-<1
0.01-0.2
0.1-28
0.01-0.5
0.5
0.0005-23
0.0001-0.5
0.3-5
0.0001-0.0005
0.001-2
0.0001-28
Table 5b. Current amd historical frequency and concentration of use* according to duration and type of exposure - previously reviewed ingredients (continued)
# of Uses
Conc. of Use (%)
# of Uses
Conc. of Use (%)
# of Uses
Conc. of Use (%)
# of Uses
2
4
NR
Baby Products
NR - not reported to the VCRP or the Council
** concentration of use data were not given in the original report
42
CIR Panel Book Page 51
5d. Ingredients for which concentration of use information has not yet been provided
43
CIR Panel Book Page 52
manufacturing of lacquers, copolymers, polyester films, modified resins, plasticizers, alkyld resins, other similar
products
crayon and candle manufacturing tin plate industry
detergent production pharmaceutical crayon and candle manufacturing tin plate industry
paint lubricant pharmaceutical
textile industry pharmaceutical
pharmaceutical
substitute for linseed oil in the manufacture of paints, and varnishes
substitute for linseed oil in the manufacture of paints, varnishes, linoleum, oilclothes, and printing inks
drying oil manufacturing of varnishes and paints
illumination
pharmaceutical
manufacturing of soaps, candles, and nightlights cotton dyeing ointment base substitute for cocoa butter in
food
manufacturing of linoleum, cloth oil, printing and lithographic inks, core oils, linings, packings, oil-modified
alkyd resins, caulking compounds, putties, leather-finishing compounds, lubricants, greases, polishes,
pyrotechnic compositions pigment binder in petrochemicals concrete protector stabilizer/plasticizer for vinyl
plastics industrial stains jute textiles drying oil in paints and varnishes
sunflower
palm
palm kernel
niger
olive
cocoa
grapeseed
perilla
false flax
watermelon
apricot
cohune
linseed
44
Use
rubber additive lubricants fat liquoring of leather varnishes and lacquers textile chemicals detergent
additives plasticizers weed control medicinal procedures
Oil
rapeseed/canola
105
102
108
108
101
100
105
104
50
106
106
213
108
108
100
108
97
108
107
106
HRIPT, occluded
45
HRIPT, semi-occluded
HRIPT, occluded
HRIPT, occluded
HRIPT, occluded
HRIPT, occluded
HRIPT, occluded
HRIPT, occluded
Results
135
134
133
132
131
130
129
128
127
126
125
124
123
122
121
120
119
118
117
116
Reference
102
100
104
600
105
102
57
50
108
107
105
109
100
52
100
102
100
108
46
HRIPT, occluded
HRIPT, occluded
HRIPT, semi-occluded
HRIPT, occluded
HRIPT, semi-occluded
HRIPT, occluded
HRIPT, semi-occluded
HRIPT, semi-occluded
HRIPT, occluded
not a sensitizer
Results
147
136
135
135
146
145
144
143
142
141
140
139
138
137
135
135
135
136
Reference
107
104
105
228
195
102
104
106
106
53
115
106
106
105
53
47
HRIPT, semi-occluded
HRIPT, semi-occluded
HRIPT, occluded
HRIPT, occluded
HRIPT, occluded
HRIPT, semi-occluded
not a sensitizer
not a sensitizer
Results
159
150
158
157
156
135
155
154
153
135
152
151
150
149
148
Reference
REFERENCES
1. Gottschalck TE and Bailey JE. International Cosmetic Ingredient Dictionary and Handbook. 2008.
12th:(3):Washington, DC: CTFA.
2. US Pharmacopeia. 2008-2009 Food Chemicals Codex. 6th ed. Baltimore: United Book Press, Inc., 2008.
3. Salunkhe, DK, Chavan, JK, Adsule, RN, and Kadam, SS. World Oilseeds: Chemistry, Technology, and Utilization.
New York: Van Nostrand Reinhold, 1992.
4.
Bailey's Industrial Oil & Fat Products. John Wiley & Sons., 1996.
5. John L. Seaton & Co, Ltd. Oil seed processing. Unpublished data. 2010.
6. Crevel, R. W., Kerkhoff, M. A., and Koning, M. M. Allergenicity of refined vegetable oils. Food Chem Toxicol.
2000;38:(4):385-393.
7. Andersen,F.A.(ed). Final report on the safety assessment of sesame oil. J Am coll Toxicol. 1993;12:(3):261-277.
8. Andersen,F.A.(ed). Final report on the safety assessment of Elaeis guineensis (palm) oil, Elaeis guineensis (palm)
kernel oil, hydrogenated palm oil and hydrogenated palm kernel oil. Int J Toxicol. 2000;19:(Suppl 2):7-28.
9. Andersen,F.A.(ed). Final report on the safety assessment of peanut (arachis hypogaea) oil, hydrogenated peanut oil,
peanut acid, peanut glycerides, and peanut (arachis hypogaea) flour. Int J Toxicol. 2001;20:(Suppl 2):6577.
10. Andersen,F.A.(ed). Final report on the safety assessment of hydrogenated cottonseed oil cottonseed (Gossypium)
oil, cottonseed acid, cottonseed glyceride, and hydrogenated cottonseed glyceride. Int J Toxicol.
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128. Product Investigations, Inc. Determination of the irritating and sensitizing propensities of a hair conditioner
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54
CIR Panel Book Page 63
145. Clinical Research Laboratories, Inc. Repeated insult patch test on a body moisturizer containing 22% Olea Europaea
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146. Consumer Product Testing Co. Repeated insult patch test on a conditioning hair oil containing 58.70% Olea
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Theobroma Grandiflorum Seed Butter) on human skin. Unpublished data. 2008. Product Investigations,
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55
CIR Panel Book Page 64
Data
06A - Hair Dyes and Colors (all types requiring caution statements and patch tests)
07E - Lipstick
12F - Moisturizing
01B - Baby Lotions, Oils, Powders, and Creams
02A - Bath Oils, Tablets, and Salts
02D - Other Bath Preparations
03C - Eye Shadow
03D - Eye Lotion
03F - Mascara
03G - Other Eye Makeup Preparations
04E - Other Fragrance Preparation
05F - Shampoos (non-coloring)
06H - Other Hair Coloring Preparation
07C - Foundations
07E - Lipstick
07I - Other Makeup Preparations
08C - Nail Creams and Lotions
10A - Bath Soaps and Detergents
12A - Cleansing
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12F - Moisturizing
12G - Night
12H - Paste Masks (mud packs)
12J - Other Skin Care Preps
13A - Suntan Gels, Creams, and Liquids
17
3
1
1
1
1
1
1
2
7
1
1
1
3
71
6
1
1
5
5
7
8
4
3
10
3
29
38
11
9
4
11
1
2
1
8
216
27
1
1
1
12
7
21
1
30
7
2
15
1
1
1
1
1
1
3
4
9
3
1
1
2
12A - Cleansing
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
CANOLA OIL
1
1
1
1
6
2
7
4
62
4
2
1
4
13
1
15
2
5
12A - Cleansing
12J - Other Skin Care Preps
1
2
1
1
61
3
2
2
2
1
1
3
PALM ACID
PALM ACID
PALM ACID
1
31
1
27
2
POTASSIUM PALMATE
POTASSIUM PALMATE
2
3
1
3
3
SODIUM PALMATE
SODIUM PALMATE
SODIUM PALMATE
SODIUM PALMATE
SODIUM PALMATE
3
1
1
184
5
SODIUM PALMATE
SODIUM PALMATE
SODIUM PALMATE
SODIUM PALMATE
5
10
2
1
4
3
1
169
4
1
3
5
4
1
17
3
13
1
5
7
20
13
2
3
8
3
25
2
19
23
1
27
5
12
21
22
103
3
14
1
19
2
2
2
23
47
1
1
2
2
36
4
50
82
1
152
19
7
9
49
7
19
2
1
3
1
07C - Foundations
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12J - Other Skin Care Preps
1
7
1
3
03B - Eyeliner
03C - Eye Shadow
03D - Eye Lotion
03G - Other Eye Makeup Preparations
05F - Shampoos (non-coloring)
05G - Tonics, Dressings, and Other Hair Grooming Aids
07D - Leg and Body Paints
07E - Lipstick
07I - Other Makeup Preparations
12A - Cleansing
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12F - Moisturizing
12J - Other Skin Care Preps
1
1
1
1
1
1
1
3
3
2
4
7
8
2
1
16
1
3
1
1
6
12
17
21
1
13
12
68
4
3
30
25
1
48
81
3
1
23
7
19
260
2
19
1
2
2
3
46
1
07E - Lipstick
52
2
7
2
34
1
93
100
3
225
25
19
2
76
4
9
6
1
1
1
1
2
1
1
1
1
1
7
2
7
7
1
3
6
9
7
2
4
54
8
39
55
34
9
6
3
26
3
10
2
1
1
1
95
3
26
1
1
12
2
03B - Eyeliner
03C - Eye Shadow
03D - Eye Lotion
03F - Mascara
03G - Other Eye Makeup Preparations
05A - Hair Conditioner
05F - Shampoos (non-coloring)
05I - Other Hair Preparations
07E - Lipstick
10A - Bath Soaps and Detergents
11F - Shaving Soap
12A - Cleansing
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12F - Moisturizing
12G - Night
12I - Skin Fresheners
12J - Other Skin Care Preps
1
1
1
5
5
4
6
1
7
1
1
1
3
2
4
2
3
2
07C - Foundations
12D - Body and Hand (exc shave)
1
1
2
4
6
2
1
2
1
1
1
2
4
14
2
26
4
3
2
1
2
SODIUM OLIVATE
SODIUM OLIVATE
SODIUM OLIVATE
SODIUM OLIVATE
1
9
2
4
2
40
58
111
183
9
6
35
3
18
3
1
2
1
3
1
1
2
1
1
1
1
3
2
1
2
2
1
2
3
1
1
9
1
1
1
2
1
1
1
1
2
8
12
12
3
2
3
3
11
6
03B - Eyeliner
03D - Eye Lotion
03G - Other Eye Makeup Preparations
05A - Hair Conditioner
05E - Rinses (non-coloring)
05F - Shampoos (non-coloring)
05G - Tonics, Dressings, and Other Hair Grooming Aids
05I - Other Hair Preparations
06H - Other Hair Coloring Preparation
07B - Face Powders
07C - Foundations
07E - Lipstick
07I - Other Makeup Preparations
10A - Bath Soaps and Detergents
10E - Other Personal Cleanliness Products
11A - Aftershave Lotion
12A - Cleansing
12C - Face and Neck (exc shave)
3
7
11
4
1
3
1
2
3
5
23
22
6
1
2
1
4
5
21
57
6
3
1
2
4
1
1
1
1
1
3
27
1
1
3
1
2
3
2
1
3
2
2
3
2
1
1
1
2
2
7
30
23
54
8
3
17
7
8
7
1
13
34
3
4
6
1
1
3
1
2
7
8
2
12F - Moisturizing
1
1
1
1
2
2
4
12
1
12
2
2
1
1
QUINOA OIL
1
1
1
3
1
1
1
2
1
1
1
1
2
1
1
1
1
4
3
5
1
1
1
1
2
1
4
5
3
1
2
1
1
2
3
2
2
1
64
1
11
8
15
1
1
2
3
1
2
13
4
12
1
17
7
17
6
43
2
1
6
67
7
3
1
2
1
9
24
18
1
28
9
3
1
9
1
2
1
1
2
1
13
3
10
14
2
1
2
4
1
2
18
7
5
8
2
1
2
LINSEED ACID
LINSEED ACID
LINSEED ACID
1
1
1
03B - Eyeliner
04E - Other Fragrance Preparation
05A - Hair Conditioner
05F - Shampoos (non-coloring)
05G - Tonics, Dressings, and Other Hair Grooming Aids
05I - Other Hair Preparations
07E - Lipstick
07I - Other Makeup Preparations
10E - Other Personal Cleanliness Products
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12F - Moisturizing
12G - Night
12H - Paste Masks (mud packs)
12J - Other Skin Care Preps
13
1
2
3
1
6
7
7
2
8
7
9
1
1
4
3
1
3
4
2
2
2
3
4
3
13
3
3
5
1
25
3
7
5
5
3
4
15
39
2
3
10
2
SODIUM MANGOSEEDATE
#REF!
MORINGA PTERYGOSPERMA SEED OIL
MORINGA PTERYGOSPERMA SEED OIL
MORINGA PTERYGOSPERMA SEED OIL
MORINGA PTERYGOSPERMA SEED OIL
MORINGA PTERYGOSPERMA SEED OIL
MORINGA PTERYGOSPERMA SEED OIL
MORINGA PTERYGOSPERMA SEED OIL
03F - Mascara
07E - Lipstick
07I - Other Makeup Preparations
12A - Cleansing
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12F - Moisturizing
12J - Other Skin Care Preps
4
1
1
2
2
2
2
1
3
1
1
4
16
2
5
6
8
1
2
14
2
1
2
1
4
1
6
10
15
24
8
3
9
1
03B - Eyeliner
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12F - Moisturizing
1
2
5
6
2
1
1
5
16
5
7
10
5
5
3
57
4
3
2
1
4
3
9
12
3
3
2
2
1
2
1
1
1
2
6
07E - Lipstick
12F - Moisturizing
11
4
1
4
1
4
2
2
4
2
2
2
2
1
2
4
6
16
2
5
1
SODIUM AVOCADOATE
1
3
4
2
2
1
5
2
5
3
1
03B - Eyeliner
03D - Eye Lotion
03E - Eye Makeup Remover
03F - Mascara
03G - Other Eye Makeup Preparations
04E - Other Fragrance Preparation
05A - Hair Conditioner
05E - Rinses (non-coloring)
05F - Shampoos (non-coloring)
05G - Tonics, Dressings, and Other Hair Grooming Aids
05I - Other Hair Preparations
06A - Hair Dyes and Colors (all types requiring caution statements and patch tests)
06D - Hair Shampoos (coloring)
06G - Hair Bleaches
07B - Face Powders
07C - Foundations
07E - Lipstick
07I - Other Makeup Preparations
08A - Basecoats and Undercoats
08B - Cuticle Softeners
08C - Nail Creams and Lotions
08E - Nail Polish and Enamel
08G - Other Manicuring Preparations
10A - Bath Soaps and Detergents
10B - Deodorants (underarm)
10E - Other Personal Cleanliness Products
11A - Aftershave Lotion
11E - Shaving Cream
11G - Other Shaving Preparation Products
12A - Cleansing
12B - Depilatories
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12F - Moisturizing
12G - Night
12H - Paste Masks (mud packs)
12I - Skin Fresheners
12J - Other Skin Care Preps
13B - Indoor Tanning Preparations
1
1
1
2
2
1
1
2
1
4
2
6
07E - Lipstick
12F - Moisturizing
7
1
1
8
2
4
9
5
33
1
22
3
19
5
3
2
1
4
38
10
1
4
2
1
2
11
1
12
2
1
3
31
2
47
87
124
13
3
4
46
5
1
2
2
1
7
2
1
1
2
1
1
1
2
7
1
14
2
1
2
1
1
2
1
2
1
2
2
2
1
3
6
2
1
1
3
5
2
1
8
4
2
1
3
5
1
1
10
7
2
2
3
2
33
5
1
10
1
26
9
1
1
2
5
4
2
13
72
2
147
7
5
4
26
7
8
4
1
1
13
1
6
3
2
2
2
3
49
4
7
12
1
1
6
6
25
1
2
1
1
11
1
2
1
1
13
2
1
2
1
3
1
2
2
12F - Moisturizing
12G - Night
12H - Paste Masks (mud packs)
12J - Other Skin Care Preps
3
3
1
3
12F - Moisturizing
12A - Cleansing
12D - Body and Hand (exc shave)
12F - Moisturizing
1
1
1
1
SODIUM GRAPESEEDATE
1
1
1
1
1
1
1
4
1
4
3
1
4
3
6
17
6
9
14
4
1
2
3
1
2
34
6
2
3
1
2
15
19
1
1
3
2
11
18
59
134
15
6
5
27
1
15
4
1
5
1
4
7
1
4
3
1
2
2
3
2
1
1
1
4
3
7
7
2
1
2
1
5
1
1
5
2
4
1
2
1
3
1
3
5
1
2
2
2
9
5
1
1
3
2
3
1
2
1
1
3
3
1
1
3
1
9
2
1
1
1
2
1
1
2
2
1
3
1
2
2
3
1
1
3
3
2
14
1
2
6
2
16
1
2
2
1
30
2
3
5
1
2
1
4
7
2
4
1
4
2
1
2
3
7
2
1
3
4
23
7
22
9
1
7
3
1
2
1
07E - Lipstick
12A - Cleansing
12D - Body and Hand (exc shave)
12F - Moisturizing
29
1
1
2
1
1
3
3
1
1
1
2
1
4
5
1
2
1
6
4
2
3
5
26
1
10
37
5
2
11
3
3
83
1
7
1
4
2
16
9
19
12
1
1
1
22
4
15
62
70
5
5
3
33
4
1
2
1
1
2
4
1
1
1
1
1
1
5
1
3
3
16
3
3
4
17
11
3
8
59
9
7
4
8
17
34
28
6
2
13
5
1
1
5
1
2
2
5
1
6
3
8
9
1
7
9
12
2
1
2
13
9
2
29
8
1
12
3
13
15
2
1
9
9
17
4
2
1
2
1
1
1
5
2
6
10
13
1
5
2
03B - Eyeliner
03F - Mascara
04B - Perfumes
04E - Other Fragrance Preparation
05I - Other Hair Preparations
07C - Foundations
07E - Lipstick
08B - Cuticle Softeners
10A - Bath Soaps and Detergents
10B - Deodorants (underarm)
10E - Other Personal Cleanliness Products
11E - Shaving Cream
12A - Cleansing
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12E - Foot Powders and Sprays
12F - Moisturizing
12H - Paste Masks (mud packs)
12J - Other Skin Care Preps
13B - Indoor Tanning Preparations
2
2
1
10
2
1
9
1
5
1
2
4
3
3
14
1
10
1
8
3
8
32
87
18
1
2
15
3
1
1
168
13
9
1
1
2
1
1
6
1
10
1
3
1
6
13
4
1
10
11
3
1
17
2
2
3
39
9
1
9
22
50
1
88
11
5
34
1
1
3
1
2
4
1
1
3
11
5
4
2
3
2
3
2
2
4
1
5
1
1
12
3
16
10
1
17
11
52
23
1
5
2
2
3
20
8
3
1
1
4
16
24
76
74
12G - Night
12H - Paste Masks (mud packs)
12J - Other Skin Care Preps
13A - Suntan Gels, Creams, and Liquids
13B - Indoor Tanning Preparations
13C - Other Suntan Preparations
14
5
41
6
3
2
07E - Lipstick
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12F - Moisturizing
11
4
1
1
3
1
4
1
1
1
2
1
9
6
4
16
3
1
7
2
23
1
1
2
3
1
12
1
2
3
7
58
4
10
1
26
33
57
2
4
60
23
14
1
2
1
1
1
1
30
13
2
4
2
2
37
1
35
95
1
199
20
14
2
46
5
8
3
1
6
2
1
FROM:
DATE:
SUBJECT:
202.331.1770
www.personcilcarecouncil.org
Ingredient
Product Category
Concentration of Use
Vegetable Oil
0002-0.02%
Vegetable Oil
Eyebrow pencil
0.02-0.05%
Vegetable Oil
Eye shadow
0.01-11%
Vegetable Oil
Eye lotion
0.05-2%
Vegetable Oil
Mascara
2%
Vegetable Oil
Perfumes
0.0005-0.02%
Vegetable Oil
Hair conditioners
2%
Vegetable Oil
Pennanent waves
0.02%
Vegetable Oil
0.07%
Vegetable Oil
0.02%
Vegetable Oil
Foundations
0.04-5%
Vegetable Oil
Lipstick
0.03-11%
Vegetable Oil
0.005-0.09%
Vegetable Oil
Cuticle softeners
2%
Vegetable Oil
0.03-2%
Vegetable Oil
0.1%
Vegetable Oil
Depilatories
31%
Vegetable Oil
0.3-2%
Vegetable Oil
0.2-5%
Vegetable Oil
0.05%
Vegetable Oil
0.05-2%
Vegetable Oil
0.0005-8%
Vegetable Oil
0.03-1%
0.5%
Eyebrow pencil
7-31%
Eyeliner
10-49%
Eye shadow
0.4-25%
Eye lotion
0.2-1 1%
Mascara
0.008-8%
Page 1 of 2
Hair conditioners
0.0007%
Shampoos (noncoloring)
0.0005%
0.09%
0.0004%
Hair tints
1%
2-6%
Face powders
1%
Foundations
0.2-57%
Lipstick
0.8-60%
0.02-31%
Cuticle softeners
0.2%
2%
4%
0.002%
8%
Depilatories
6%
3-20%
0.01-14%
3%
0.0005-0.2%
8%
2-8%
3%
12%
Information collected in 2010
Table prepared May 12, 2010
Page 2 of 2
Product Category
Concentration of Use
Shampoos (noncoloring)
0.1%
Lipstick
9%
1%
0.01-10%
2-17%
0.0 1-9%
3%
3%
1%
0.07%
0,007%
Mascara
2%
Foundations
0.3%
4%
0.8%
Canola Oil
1-33%
Canola Oil
Eye shadow
0.03%
Canola Oil
Eye lotion
0.002%
Canola Oil
0.02%
Canola Oil
Perfumes
17%
Canola Oil
0.0002%
Canola Oil
Hair conditioners
0.9-24%
Canola Oil
0.006%
Canola Oil
Shampoos (noncoloring)
0.06%
Canola Oil
0.1-1 1%
Page 1 of 9
Canola Oil
Foundations
0.02%
Canola Oil
Lipstick
0.3-70%
Canola Oil
Canola Oil
02-1%
Canola Oil
0.02%
Canola Oil
2%
Canola Oil
Depilatories
002-0.06%
Canola Oil
1-5%
Canola Oil
28-73%
Canola Oil
3%
Canola Oil
0.03-5%
Canola Oil
0.09%
Hair conditioners
0.00 1%
Shampoos (noncoloring)
0.001%
2%
0,1-78%
Eyebrow pencil
0.1-1%
Eyeliner
0.1-1%
Eye shadow
0.005-0.8%
Eye lotion
0.2-2%
Mascara
0.04 2%
Perfumes
0.03-0.5%
0.04%
Hair conditioners
0.0002-30%
Permanent waves
95%
Rinses (noncoloring)
0.02%
Shampoos (noncoloring)
0.0 1-0.2%
0.2-66%
0.005-0.7%
Face powders
0.005%
Foundations
0.0 1-1%
Page 2 of 9
0.3%
Lipstick
0.06-4%
NIakeup has
0.0
2-95%
0.02%
0.02%
0.0 1-52%
Deodorants (underarm)
0.0 1-0.5%
8%
93%
0.2-9%
Depilatories
0.5%
0.0005-4%
0.1-75%
0.05%
0.1-94%
0.008-4%
0.008-1%
0.04-49%
1%
1%
0.2-0.3%
Foundations
0.03-0.1%
0,2%
0.0001%
42%
Bubble baths
5%
Eyebrow pencil
7%
Eyeliner
5%
Page 3 of 9
Eye shadow
0.03-2%
Hair conditioners
0.1%
Bliislicrs (all
I 1
Face powders
0.07%
Foundations
0.09-15%
Lipstick
0.1-39%
Makeup bases
4%
0.01%
0.001%
Cuticle softeners
0.05-2%
25%
0.00 1-2%
0.05%
6%
0.2-15%
Depilatories
0.1%
2%
0.1-5%
0.4-5%
0.5-0.8%
7%
4-21%
1-2%
0.5%
0.2%
0.05-75%
Bubble baths
0.2%
Eyebrow pencil
0.1%
Eyeliner
0.01-19%
Eye Shadow
0.002-0.3%
Eye lotion
0.0 1-5%
ps)
Page 4 of 9
0.0005-2%
Mascara
0.1%
0.027
Perfumes
0.03%
0.1-85%
Hair conditioners
0.000007-92%
0.06-0.07%
Rinses (noncoloring)
0.1%
Shampoos (noncoloring)
0.00007- 0.3%
0.1-83%
0.3-15%
0.8%
Hair tints
20-35%
Hair bleaches
0.03%
2%
0.1-10%
Face powders
0.0 1-0.5%
Foundations
0.1-16%
Lipstick
0.08-41%
Makeup bases
0.1%
2%
Cuticle softeners
30%
0.05%
0.4%
0.003-10%
Deodorants (underarm)
0.0003-4%
0.02-6%
0.2%
0.1-0.5%
0.03-35%
Depilatories
0.07-2%
1lelianiluis Aiinuns
(Suniio\ver)
Seed Oil
Page 5 of 9
0.0 1-28%
0.00 1-96%
00002I %
0.1-3%
0.05-48%
0.3-16%
Skin fresheners
0.1%
0.02-80%
1-23%
0.002%
0.1%
Eyeliner
0.02%
0.1%
0.02%
2%
0.02%
0.01-2%
0.005%
Eyeliner
7%
Hair tints
15-35%
Lipstick
6%
15-35%
0.2%
2%
Bubble baths
0.9%
17%
Page 6 of 9
Eyeliner
0.1-17%
Eye shadow
0.1-2%
E.
0.0 1-10%
Mascara
0.004-0.8%
Perfumes
0.2-5%
Hair conditioners
0.03-94%
3%
Hair straighteners
0.01-0.5%
Rinses (noncoloring)
0.01%
Shampoos (noncoloring)
0.006-0.5%
0.01-15%
1%
0.2%
Hair bleaches
0.2%
0.5%
0.1-26%
Face powders
0.08-2%
Foundations
0.1-44%
32%
Lipstick
0.7-26%
Makeup bases
49%
Rouges
0.5%
0.4%
0.00 1%
Cuticle softeners
1-2%
3%
40%
0.0005-3%
Deodorants (underarm)
0.02-0.1%
0.00 1-0.05%
lotion
Page 7 of 9
1-3%
Aftershave lotions
0.5%
0.007-0.1%
QILa
ropnca
creams.
clennsing
lotions.
0.0110%
Depilatories
0.1%
0.03-50%
0.03-100%
3%
0.05-3%
0.005-1%
0.0005-3%
0.05-33%
0.1%
1%
20%
0.04%
Eye shadow
0.02-0.4%
Eye lotion
0.3%
Mascara
0.2%
3%
Hair conditioners
0.07-0.3%
Shampoos (noncoloring)
0.2%
0.02%
Foundations
2%
Lipstick
0.08%
0.3%
0.01-0.04%
0.0001%
0.4%
Eye Shadow
0.1-3%
Eye lotion
0.1%
Mascara
2%
Page 8 of 9
Hair conditioners
0.01%
Shampoos (noncoloring)
0.1%
Face po\\ders
12%
Foundations
0.1-7%
Lipstick
0.1-12%
0.1%
0.0005%
1-2%
0.1-1%
0.2%
0.1-0.5%
0.1%
1%
0.1%
0.1%
Eye shadow
2%
Eye lotion
0.3%
Foundations
0.05-3%
5%
3%
2%
2%
Sodium Olivate
Bath soaps and detergents
4-18%
*Ingredients included in the title of the table, but not found in the table were included in the survey, but no uses were reported
Information collected in 2010
Table prepared May 13, 2010
The following ingredients will be included in a later concentration of use survey: Hydrogenated Safflower Oil, Potassium
Safflowerate, Safflower Acid, Sodium Safflowerate, Elaeis Guineensis (Palm)Oil, Elaeis Guineensis (Palm) Kernel Oil,
Hydrogenated Palm Oil, Hydrogenated Palm Kernel Oil, Palm Kernel Acid, Elaeis Guineensis (Palm) Butter, Elaeis Oleifera
Kernel Oil, Elaies (Palm) Oil, Palm Acid, Hydrogenated Palm Acid, Potassium Palmate, Potassium Hydrogentaed Pamlate,
Potassium Hydrogenated Palmate, Potassium Palm Kernelate, Sodium Hydrogenated Palmate, Sodium Palmate, Sodium Palm
Kernelate, Gossypium Herbaceum (Cotton) Seed Oil, Cottonseed Acid, Hydrogenated Cottonseed Oil, Oryza Sativa (Rice) Bran
Oil, Oryza Sativa (Rice) Germ Oil, Rice Bran Acid, Hydrogenated Rice Bran Oil, Oryza Sativa (Rice) Seed Oil, Sesamum
Indicum (Sesame) Seed Butter
Page 9 of 9
Product Category
Concentration
of Use
Hair conditioners
0.1%
Shampoos (noncoloring)
0.1%
Lipstick
0.01%
0.05%
Eyebrow pencil
0.1%
Eyeliner
0.1%
Eye shadow
0.2%
Eye lotion
1%
Mascara
0.1%
Hair conditioners
1%
0.0 1%
Shampoos (noncoloring)
0.1%
0.1%
Page 1 of 15
0.07%
0.1%
Lipstick
0.1-1%
0.001-0.1%
0.00 1-2%
Deodorants (underarm)
0.001%
0.5%
Aftershave lotions
0.005%
0.002%
0.5-3%
4-10%
0.04%
0.04-0.1%
2-3%
Eyeliner
0.06%
Eye shadow
0.2%
Eye lotion
0.5%
Hair conditioners
0.00 1-0.2%
Shampoos (noncoloring)
0.09%
0.2%
Foundations
1%
Lipstick
1-7%
0.001%
1%
0.1-0.2%
0.2%
0.1%
0.2%
0.002%
0.005%
0.002%
Page2of 15
0.1%
0.1%
Eye lotion
0.2%
Shampoos (noncoloring)
0.1%
Lipstick
2%
0.01-0.1%
0.5%
0.1-3%
0.1%
0.1-0.5%
Eye lotion
0.001-0.5%
0.1%
Lipstick
0.0 1%
0.00 1%
0.01%
0.04%
0.5%
0.1%
1%
0.05-1%
0.1%
1%
0.5%
0.5%
0.5%
Hair conditioners
0.5%
Shampoos (noncoloring)
0.00 1%
3%
Eye lotion
0.05%
Hair conditioners
1%
Page 3 of 15
Lipstick
0.05-0.5%
0.002%
0.05-1%
0.1-0.9%
0.04%
0.04%
0.05%
Eye lotions
2%
2%
1%
Lipstick
3%
0.01-0.1%
0.003%
0.0 1-1%
0.08%
0.08%
0.01%
Shampoos (noncoloring)
0.1%
Lipstick
0.1%
0.1%
Deodorants (underarm)
0.1%
0.1%
0.1%
0.1%
0.1%
0.1%
Lipstick
0.2%
0.0005%
0.3%
2%
Page4of 15
Hair conditioners
0.1%
Shampoos (noncoloring)
0.1%
0.1%
0.1%
0.1%
0.1%
0.1%
0.1%
Eye lotion
0.003%
0.1%
0.1%
0.05%
Eye lotion
0.5%
Lipstick
0.002%
0.00001%
0.001%
Lipstick
0.003-0.3%
0.2-0.4%
0.03%
0.9%
Bubble baths
0.5%
Eyeliner
6-20%
Eye lotion
0.1-0.4%
3%
Hair conditioners
0.1-1%
0.5%
0.2-2%
Foundations
0.01-5%
Lipstick
0.6-26%
Cuticle softeners
0.5%
0.01%
PageS of 15
0.6%
0.05%
0.002%
Depilatories
2%
0.08-72%
0.005-27%
0.1%
0.04- 74%
0.04-3%
0.1-1%
0.02%
Bubble baths
0.2%
Eye lotion
0.01%
Mascara
10%
Hair conditioners
0.00 1-0.01%
Shampoos (noncoloring)
0.00 1-0.1%
0.01%
Lipstick
0.0 1%
Cuticle softeners
0.05%
0.002%
0.003-0.4%
Deodorants (underarm)
0.05-0.1%
Aftershave lotions
4%
0.01-1%
0.0 1-0.5%
0.1-0.2%
0.01-0.1%
0.1%
Eyeliner
5%
Hair conditioners
0.2%
Hair straighteners
0.05%
Page6of 15
Shampoos (noncoloring)
0.1%
0.01%
0.05%
Lipstick
0.03-6%
0.1%
0.003-0.5%
0.2-3%
0.1-0.9%
0.08%
0.08%
1%
0.1%
Eye shadow
0.02%
0.02%
Shampoos (noncoloring)
0.1-0.5%
0.5%
0.02%
Face powders
0.02%
Foundations
0.02-5%
Lipstick
1-5%
Makeup bases
0.0 1%
Cuticle softeners
0.5%
0.0005-0.1%
0.5%
0.1%
Depilatories
0.05%
1-3%
0.1-3%
0.1%
0.1%
0.04-2%
Page7of 15
0.0 1%
Eye lotion
3%
0.02%
0.003%
0.004%
Bubble baths
0.2%
Eye lotion
0.00002-0.5%
0.002%
Shampoos (noncoloring)
0.05-0.1%
0.1%
0.08%
Foundations
58%
Lipstick
0.1-15%
Cuticle softeners
3%
0.00 1-0.3%
0.00 1%
0.1-0.2%
Deodorants (underarm)
0.2%
0.001-0.5%
0.08-2%
0.1-2%
0.04-0.1%
0.008-3%
0.1%
0.002-0.1%
0.003%
0.5%
Bath capsules
0.1%
0.0 1%
Eye shadow
0.5-0.6%
Hair conditioners
0.3-2%
Page8of 15
0.02%
0.1-1%
Foundations
0.5%
Lipstick
0.001-2%
27%
0.05%
0.005-1%
2%
0.1%
0.1%
4%
0.0009%
Sodium Babassuate
8%
4%
7%
Eye shadow
0.002-2%
Eye lotion
0.2-9%
18%
Mascara
0.002-0.05%
0.1%
0.02-1%
Hair conditioners
0.003-89%
0.0009%
Hair straighteners
0.0001%
Rinses (noncoloring)
0.05%
Shampoos (noncoloring)
0.1-0.5%
0.00 1-0.1%
0.1%
0.2%
Face powders
0.1-0.6%
Foundations
0.1-1%
Page9of 15
0.001%
Lipstick
0.00 1-5%
0.2%
0.05%
Cuticle softeners
0.05-5%
2-40%
0.05%
0.002-0.01%
0.1-9%
Deodorants (underarm)
0.003-0.1%
0.0 1-0.5%
Aftershave lotions
0.5%
0.1%
0.00 1-3%
Depilatories
0.00001-2%
0.05-17%
0.03-12%
0.1-3%
0.1-8%
2%
Skin fresheners
0.01%
0.0001-0.5%
0.0 1-0.05%
0.01-1%
0.0005%
0.0 1-0.02%
0.04%
0.1%
1%
2%
0.1%
Page lOof 15
Lipstick
0.04-22%
0.003-6%
0.2-0.4%
0.8-3%
0.08%
0.08%
0.05%
Eye lotion
0.08%
Lipstick
0.03-0.1%
0.2%
0.05%
0.01%.
0.1-0.3%
0.1%
0.000001%
5%
0.1%
Hair conditioners
1%
Shampoos (noncoloring)
1%
1%
1%
Foundations
Eye shadow
0.0 1%
0.0 1%
Face powders
0.05%
Lipstick
0.00 1%
1%
0.0 1%
Page 11 of 15
0.5%
0.0 1%
0.1%
1%
Eyebrow pencil
0.02%
Eyeliner
0.02-9%
Eye lotion
0.9-4%
Mascara
0.0002%
Hair conditioners
1%
Hair straighteners
0.01%
Shampoos (noncoloring)
0.0 1-0.1%
0.1-2%
0.1%
0.4%
Foundations
0.2-2%
Lipstick
0.3-37%
Makeup bases
0.02%
Makeup fixatives
0.00004%
9%
Cuticle softeners
0.1%
1%
0.02-2%
Deodorants (underarm)
0.00 1-1%
0.1%
Aftershave lotions
1%
0.0 1-0.1%
0.0001-1%
Depilatories
0.05-1%
0.08-3%
0.000002-6%
0.4%
2%
Page l2of 15
2%
0.1-25%
5%
0.1-0.5%
0.5%
Eyeliner
2%
Eye shadow
0.1%
Eye lotion
2%
Hair conditioners
0.001-1%
Shampoos (noncoloring)
0.001-0.1%
0.01%
1%
Foundations
5%
Lipstick
7%
0.1%
Deodorants (underarm)
0.1%
0.05%
Aftershave lotions
0. t %
0.1%
0.003%
2-5%
0.1-5%
0.1%
0.1-3%
0.00005%
Hair conditioners
0.1%
Shampoos (noncoloring)
0.0 1%
0.1%
Foundations
0.1%
Page 13 of 15
Lipstick
0.3%
0.002%
0.003-0.1%
2%
0.1%
0.1%
0.1%
0.1-0.5%
Bubble baths
2%
0.01%
Eye lotion
5%
0.01%
Perfumes
1%
0.00 1-7%
Hair conditioners
0.01-0.3%
Shampoos (noncoloring)
0.05-0.1%
0.01-0.1%
43%
Foundations
0.2%
Lipstick
0.03-7%
Cuticle softeners
35%
1%
0.00 1%
0.0 1-7%
Deodorants (underarm)
0.00 1-0.2%
0.001-1%
Aftershave lotions
0.1-1%
Page l4of 15
16-39%
2%
0.1%
0.004-20%
Depilatories
0.5%
0.1-8%
0.0141%
1%
0.0 1-5%
0.0 1-5%
0.01%
0.01-13%
0.00 1%
15%
0.5%
Lipstick
0.5%
Cuticle softeners
0.3%
Ingredients included in the title of the table, out not found in the table were included in the survey, but no uses were reported
Information collected in 2010
Table prepared May 13, 2010
The following ingredients will be included in a later concentration of use survey: Camellia Japonica Seed Oil, Citrus Aurantifolia
(Lime) Seed Oil Unsaponifiables, Persea Gratissima (Avocado) Oil, Hydrogenated Avocado Oil, Persea Gratissima (Avocado)
Butter, Persea Gratissima (Avocado) Oil Unsaponifiables, Sodium Avocadoate, Triticum Vulgare (Wheat) Germ Oil,
Hydrogenated Wheat Germ Oil, Hydrogenated Wheat Germ Oil Unsaponifiables, Triticum Aestivum (Wheat) Germ Oil, Triticum
Vulgare (Wheat) Germ Oil Unsaponifiables and Wheat Germ Acid.
Page 15 of 15
Personal Care
Products Council
Committed to Safety,
ua if y nnovaf ion
Memorandum
TO:
FROM:
DATE:
Product Category
Concentration of
Use
Eyeliner
0.1-11%
Eye shadow
0.1%
Eye lotion
0.5%
Foundations
0.5%
Lipstick
0.2-1%
30-32%
0.5%
0.1%
Deodorants (underarm)
0.2%
0.004-0.01%
29%
1%
0.5%
0.5%
0.3-2%
0.2%
0.08%
0.08-2%
Page 1 of 9
5%
Eyebrow pencil
1 1-24%
Eyeliner
8-15%
Mascara
0.5%
8%
Hair conditioners
0.0 1%
Shampoos (noncoloring)
0.01%
0.1%
Foundations
5%
Lipstick
8-12%
0.002-1 1%
0.005-5%
0.00 1%
Eye lotion
0.04-2%
Hair conditioners
2%
13%
34%
Foundations
5%
Lipstick
2%
48%
0.002%
Aftershave lotions
0.5%
0.002-8%
0.008-4%
4-6%
0.4-3%
3-4%
4-5%
Page 2 of 9
0.9-2%
Eye lotion
0.8%
Shampoos (noncoloring)
0.9-23%
3%
0.05%
0.05%
0.8%
2%
Eyebrow pencil
3-5%
Eyeliner
2-30%
Eye lotion
0.9%
Mascara
0.2%
1%
Face powders
0.4%
Foundations
8%
Lipstick
2-30%
Makeup bases
1%
Makeup fixatives
0.5%
25%
2%
2%
10%
3%
2%
3%
1%
Eyebrow pencil
2%
Eyeliner
7-10%
Foundations
0.4%
Page 3 of 9
Lipstick
3-13%
0.9-2%
1-5%
0.6-3%
2%
3%
0.6-1%
0.6%
Palm Acid
1-4%
Palm Acid
17%
0.2-3%
12%
0.3-3%
0.3-30%
Sodium Palmate
3-68%
Sodium Palmate
63%
Sodium Palmate
28%
16-44%
15%
12%
0.6-6%
Eyeliner
0.1-1%
Eye shadow
0.1%
Eye lotion
0.05-2%
2%
Mascara
0.2%
Perfumes
8%
Potassium Palmate
Potassium Palm Kernelate
I
I
Page 4 of 9
02%
1%
Hair conditioners
0.0001-15%
0.05%
Shampoos (noncoloring)
0.01-1%
41%
0.3%
0.3%
0.2-0.5%
Face powders
0.1-0.3%
Foundations
0.0 1-3%
Lipstick
0.05-26%
Makeup bases
2%
0.1%
Cuticle softeners
18-19%
2-5%
0.00 1%
34%
0.02-0.5%
Deodorants (underarm)
0.1%
1-3%
Aftershave lotions
0.5%
0.00 1%
0.05%
0.8-2%
0.003-3%
Depilatories
0. 1%
Page 5 of 9
0.01-98%
0.01-6%
0.0 1%
0.1-2%
0.02-1%
0.3-2%
0.1-31%
0.02-2%
0.0005-0.5%
0.5%
Eye shadow
0.5%
6%
Lipstick
3%
0.2%
0.2%
Eyeliner
0.8%
Eye shadow
0.5%
Eye lotion
0.5-0.6%
Hair conditioners
0.2-0.3%
0.1%
Shampoos (noncoloring)
0.005-0.3%
0.02-0.5%
0.3%
0.3%
Face powders
0.3%
Foundations
0.1-1%
Lipstick
0.1-8%
Page 6 of 9
Makeup bases
0.4%
3-78%
0.02%
0.1%
1%
Deodorants (underarm)
0.5%
0.0006-6%
Aftershave lotions
0.5%
1%
0.2-0.6%
Depilatories
0.5%
0.1-27%
0.5-5%
0.0003%
8%
4-5%
0.5-27%
3%
Bubble baths
0.03%
Eyebrow pencil
0.1%
Eyeliner
0.1%
Eye shadow
0.01%
0.01-0.1%
Mascara
0.1-1%
0.1%
Face powders
0.01%
Foundations
0.1%
Lipstick
0.1-3%
Makeup bases
0.1%
Page 7 of 9
0.5%
Deodorants (underarm)
0.003%
0.003-0.005%
0.003-0.01%
0.2-3%
0.02-2%
0.01-0.1%
0.08%
0.0 1%
0.1%
0.01%
0.5%
Eye shadow
0.02%
Eye lotion
0.1-0.5%
0.01%
Mascara
0.05-0.1%
Hair conditioners
0.00 1-0.5%
0.0001-00005%
Shampoos (noncoloring)
0.00 1-0.5%
0.00 1-0.5%
0.1%
0.0 1-0.2%
Face powders
0.1%
Foundations
0.00 1-2%
Lipstick
0.3-5%
Makeup bases
0.1%
Cuticle softeners
1%
3%
Page 8 of 9
0.1-28%
0.0 1-0.5%
0.2%
0.0 1-2%
Depilatories
0.6%
0.001-20%
0.3-1%
0.5%
0.08-0.5%
2%
0.1-23%
0.04%
0.0005%
0.2%
Hair conditioners
<1%
Hair straighteners
<1%
<1%
Eye shadow
0.01%
Rinses (noncoloring)
0.1%
0.01%
Lipstick
0.1%
Deodorants (underarm)
0.0 1%
0.1%
Page 9 of 9
Persona Care
Products Council
Committed to Safety,
Quality & Innovation
Memorandum
TO:
FROM:
DATE:
July2l,2010
SUBJECT:
202.331.1770
202.331.1969 (fax)
www.personalcarecouncil.org
Product Category
Concentration of
Use
Eyeliner
0.1-11%
Eye shadow
0.1%
Eye lotion
0.5%
Foundations
0.5%
Lipstick
0.2-1%
30-32%
0.5%
0.1%
Deodorants (underarm)
0.2%
0.004-0.01%
29%
1%
0.5%
0.5%
0.3-2%
0.2%
0.08%
0.08-2%
Page 1 of 9
5%
Eyebrow pencil
11-24%
Eyeliner
8-15%
Mascara
0.5%
8%
Hair conditioners
0.01%
Shampoos (noncoloring)
0.01%
0.1%
Foundations
5%
Lipstick
8-12%
0.002-11%
0.005-5%
0.00 1%
Eye lotion
0.04-2%
Hair conditioners
2%
13%
34%
Foundations
5%
Lipstick
2%
48%
0.002%
Aftershave lotions
0.5%
0.002-8%
0.008-4%
4-6%
0.4-3%
3-4%
4-5%
Page 2 of 9
0.9-2%
Eye lotion
0.8%
Shampoos (noncoloring)
0.9-23%
3%
0.05%
0.05%
0.8%
2%
Eyebrow pencil
3-5%
Eyeliner
2-30%
Eye lotion
0.9%
Mascara
0.2%
1%
Face powders
0.4%
Foundations
8%
Lipstick
2-30%
Makeup bases
1%
Makeup fixatives
0.5%
25%
2%
2%
10%
3%
2%
3%
1%
Eyebrow pencil
2%
Eyeliner
7-10%
Foundations
0.4%
Page 3 of 9
Lipstick
3-13%
0.9-2%
1-5%
0.6-3%
2%
3%
0.6-1%
0.6%
Palm Acid
1-4%
Palm Acid
17%
0.2-3%
12%
Potassium Palmate
0.3-3%
0.3-30%
Sodium Palmate
3-68%
Sodium Palmate
63%
Sodium Palmate
28%
16-44%
15%
12%
0.6-6%
Eyeliner
0.1-1%
Eye shadow
0.1%
Eye lotion
0.05-2%
2%
Mascara
0.2%
Perfumes
8%
Page 4 of 9
0.2%
1%
Hair conditioners
0.0001-15%
0.05%
Shampoos (noncoloring)
0.01-1%
41%
0.3%
0.3%
0.2-0.5%
Face powders
0.1-0.3%
Foundations
0.01-3%
Lipstick
0.05-26%
Makeup bases
2%
0.1%
Cuticle softeners
18-19%
2-5%
0.00 1%
34%
0.02-0.5%
Deodorants (underarm)
0.1%
1-3%
Aftershave lotions
0.5%
0.00 1%
0.05%
0.8-2%
0.003-3%
Depilatories
0.1%
Page 5 of 9
0.01-98%
0.01-6%
0.0 1%
0.1-2%
0.02-1%
0.3-2%
0.1-31%
0.02-2%
0.0005-0.5%
0.5%
Eye shadow
0.5%
6%
Lipstick
3%
0.2%
0.2%
Eyeliner
0.8%
Eye shadow
0.5%
Eye lotion
0.5-0.6%
Hair conditioners
0.2-0.3%
0.1%
Shampoos (noncoloring)
0.005-0.3%
0.02-0.5%
0.3%
0.3%
Face powders
0.3%
Foundations
0.1-1%
Lipstick
0.1-8%
Page 6 of 9
Makeup bases
0.4%
3-78%
0.02%
0.1%
1%
Deodorants (underarm)
0.5%
0.0006-6%
Aftershave lotions
0.5%
1%
0.2-0.6%
Depilatories
0.5%
0.1-27%
0.5-5%
0.0003%
8%
4-5%
0.5-27%
3%
Bubble baths
0.03%
Eyebrow pencil
0.1%
Eyeliner
0.1%
Eye shadow
0.0 1%
0.01-0.1%
Mascara
0.1-1%
0.1%
Face powders
0.0 1%
Foundations
0.1%
Lipstick
0.1-3%
Makeup bases
0.1%
Page 7 of 9
05%
Deodorants (underarm)
0.003%
0.003-0.005%
0.003-0.01%
0.2-3%
0.02-2%
0.01-0.1%
0.08%
0.01%
0.1%
0.01%
0.5%
Eye shadow
0.02%
Eye lotion
0.1-0.5%
0.0 1%
Mascara
0.05-0.1%
Hair conditioners
0.00 1-0.5%
0.0001-00005%
Hair straighteners
<1%
Shampoos (noncoloring)
0.00 1-0.5%
0.00 1-0.5%
0.1%
0.0 1-0.2%
Face powders
0.1%
Foundations
0.001-2%
Lipstick
0.3-5%
Makeup bases
0.1%
Cuticle softeners
1%
Page 8 of 9
3%
0.1-28%
0.01-0.5%
0.2%
0.0 1-2%
Depilatories
0.6%
0.00 1-20%
0.3-1%
0.5-1%
0.08-0.5%
2%
0.1-23%
0.04%
0.0005%
0.2%
Eye shadow
0.0 1%
Rinses (noncoloring)
0.1%
0.01%
Lipstick
0.1%
Deodorants (underarm)
0.0 1%
0.1%
Page 9 of 9
Personal Care
Products Council
Committed to Safety,
Quality & Innovation
Memorandum
TO:
FROM:
DATE:
SUBJECT:
Comments on the Scientific Literature Review on Vegetable Oil and Related Edible
Oils and Derivatives as Used in Cosmetics
A Subcommittee of the CW Science and Support Committee (CIR SSC) reviewed the Scientific
Literature Review (SLR) on Vegetable Oil and Related Edible Oils and Derivatives as Used in
Cosmetics. The subcommittee is concerned that the SLR contains incorrect information about
the chemistry of plant oils, and that the composition information on the oils is still very
incomplete. The subcommittee recommends that the Vegetable Oil and Related Edible Oils
and Derivatives report be revised based on these comments before the CW Expert Panel is
given the opportunity to review the report. This delay will also allow industry to work on
identifying additional dermal safety data on the ingredients in the report before the report is
provided to the Cifi Expert Panel
In the introduction, please provide a rational as to why the ingredients listed in Table 1 are included in
the report. Please consider including only triglyceride oils (oils, butters and hydrogenated oils)
in this report, removing the fatty acids, salts of fatty acids and unsaponifiables. If the
unsaponifiable ingredients are left in the report, please provide a rational as to why it is
appropriate to include these ingredients in the report, as they generally are neither triglycerides
nor fatty acids.
Dictionary
The
has misclassified at least three of the ingredients listed in Table 1. Angelica
Archangelica Seed Oil, Apium Graveolens (Celery) Seed Oil, and Daucus Carota Sativa
(Carrot) Seed Oil are all essential oils rather than in the chemical class fats and oils. The
chemical class for these ingredients listed in the Dictionary has now been changed to essential
oil. These three ingredients need to be removed from the report. Food Chemical Codex says
these ingredients are obtained by steam distillation. This is how essential oils are obtained, not
triglyceride oils.
Please consider moving Sclerocarya Birrea Seed Oil, Mangifera Indica (Mango) Seed Oil and
Mangifera Indica (Mango) Seed Butter to the nut oil report. These two species are in the family
Anacardiaceae, along with other nuts such as cashews and pistachios.
If composition information on an oil cannot be identified in either published or unpublished reports,
please consider removing the oil from the report.
202.331.1770
202.331.1969 (fax)
www.personalcarecouncil.org
Title The title of the report should be changed. Edible is not an appropriate descriptor for all of these
oils. Vegetable oils may be a better term to describe them. If the fatty acids and
unsaponifiables are left in the report these classes of ingredients should be specifically
mentioned in the title.
p.1 Although common names may be easier, the full INCI names including genus species name
should be used to avoid confusion (see blackberry seed oil example below).
p.1 If the fatty acids are left in the report, it should be made clear that acid refers to fatty acid.
p.1 It is not correct to state the oils are mixtures of fatty acids. The oils are mixtures of glyceryl
esters of fatty acids.
p.1, 14, Table 2 It should also be noted that the glyceryl triesters have been reviewed by Cifi and
found safe as used (report published in 2001).
p.1 The Chemistry section needs to be rewritten. These oils are not a varying assortment of fatty
acids. As indicated in the fats and oils chemical class definition in the Dictionary, Fats and
Oils, as a group, are the glyceryl esters of Fatty Acids (triglycerides) a general structure as
shown in the Dictionary definition of the fats and oils chemical class would also be helpful.
The Chemistry section should note how the hydrogenated oil differs from the oil
(hydrogenation reduces or eliminates unsaturation) and define butter (solid triglyceride
without any modification). If the fatty acid and unsaponifiable ingredients are left in the
report, these terms should also be defined. The Dictionary says unsaponifiables refers to lipid
components of natural Fats and Oils which are not hydrolyzed and remain soluble in lipid
solvents after alkaline hydrolysis. More information about oil chemistry basics can be found
in AAK AarhusKarlshamn Handbook Vegetable Fats and Oils at
http://www.annaochanna.se/pdf/Vegetabilisk%20Handbok.pdf (this is large file that may take a
long time to open).
p.1, 15-18, Table 3 Please provide a reason as to why fatty acid composition for some oils are
included in Table 3 but others are not included. For example the fatty acid composition of
Oenothera Biennis (Evening Primrose) Oil is readily available on the internet, e.g.,
http://www.vitaplant.ch/plant-oils.pdf and is also found in the PDR for Herbal Medicines (a
copy can be found in CJEs office). Why is the composition of Oenothera Biennis (Evening
Primrose) Oil missing from Table 3? If it has not been done already, please search the
AGRICOLA AGRICultural On Line Access http://www.nal.usda.gov/ag98/ database which
may have additional information about composition of the plant oils included in this report.
Were there criteria for the types of references that were included for composition information
compared to the types of references that were not included? If only specific references were
considered acceptable, the acceptance criteria should be stated.
p.1 It should be noted that Table 4 includes Food Chemical Codex specifications for oils where
available.
p.1 Please be consistent when talking about vitamin E. In the last paragraph, both vitamin E and
tocopherol are used.
p.2 As nut oils are not included in this report, nut should be removed from the first paragraph of the
Processing section.
-
Page 2 of 5
p.2, 22-28, Table 5 The members of the Cifi Expert Panel are accustomed to seeing the cosmetic use
information by FDA product category. It would be helpful if the CIR Expert Panel members
were provided with an explanation about which FDA categories fit in each of the categories
presented in Table 5. For example, From the categories provided in Table 5, it is not clear
which category includes the FDA bath product categories. Bath products are highly diluted
before use. Including them with rinse-off products would be misleading, as the concentrations
of some ingredients in bath products may be higher than in rinse-off products, although actual
exposure concentrations will be lower. As FDA uses the term baby please continue to use
baby rather than infant the use of infant suggests you mean something different than
what is meant by the FDA product category terms. Use information as provided in Table 5 is
not sufficient to complete as risk assessment. A specific product category is needed to estimate
exposure.
p.3 In the second paragraph of this page, please change particle diameters to aerodynamic
diameters or da as used in the previous paragraph.
p.3 Please add the concentrations of Elaeis Guineensis (Palm) Oil that were practically non- to
minimally irritating to rabbit skin. What concentration was non-allergenic in a maximization
study? What protocol was used for the in vitro phototoxicity study?
p.4 In the Olea Europaea (Olive) Fruit Oil section, it would be helpful to note that acetone/olive oil is
the recommended vehicle in murine local lymph node assays (see
http://iccvam.niehs.nih.gov/docs/immunotox docs/llna/LLNAProt .pdf).
p.4 What protocol was used in the guinea pig sensitization study by Grover (1962) (reference 20) (it
should be briefly mentioned each time this study is discussed)? Was the composition of the 10year old oil olive oil measured?
p.4 What concentrations of Oryza Sativa (Rice) Bran Oil were not irritating or sensitizing to animals?
p.4 What were the concentrations of Triticum Vulgare (Wheat) Germ Oil tested in formulations?
p.5 Please provide a reference that indicates that limonene is a main component of citrus seed oils.
Limonene is a major component of citrus essential oils (from the peel and fruit), but those oils
are not the subject of this report. If the citrus seed oils are not triglycerides they should be
removed from the report. Please see the following reference at
http://www .fshs .org/Proceedings/Password%20Protectedl 1963 %2OVol. %2076/249-253 %20(H
ENDRICKSON).pdf for information on the composition of lemon seed oil.
Hendrickson H, Kesterson. 1963. Florida lemon seed oil. Florida Agricultural Experimental
Station Journal Series No. 1726. Florida State Horticultural Society.
The following references may also be helpful in determining the composition of the citrus seed
oils.
Ranganna S, Govindarajan VS, Ramana Ky. 1983. Citrus Fruits Part II Chemistry, technology
and quality evaluation Part A. Chemistry Crit Rev Food Sci Nutr 18(4): 3 13-386
Part B. Technology Crit Rev Food Sci Nutr 19(1) 1-98.
p.6 What concentrations of Oryza Sativa (Rice) Bran Oil and Oryza Sativa (Rice) Germ Oil were
non- to minimally irritating to rabbit eyes? As two oils are mentioned, they should both be in
the subheading.
p.6 What concentration of Triticum Vulgare (Wheat) Germ Oil was not an ocular irritant?
-
Page 3 of 5
p.6-7 IARC states that glycidol is not known to occur as a natural product. IARC did not assess
glycidol fatty esters in refined vegetable oils, they assessed glycidyl stearate and glycidyl
oleate and put them in Group 3. If the Cifi Expert Panel determines that the carcinogenicity of
glycidol is important to assessing the safety of the plant oils, tL NTP study (found at
http://ntp.ni ehs.ni h. gov/ntp/htdocs/LT rpts/tr3 74.pdf) should be cited.
p.6-7 The English summary of the BdR report is at
http://www.bfr.bund.de/cm1245/initial evaluation of the assessment of levels of glycidol f
atty acid esters.pdf. They also state At the present time, the detection of glycidol fatty acid
esters in refined vegetable fats has no impact on the fundamental statements on the risk
assessment of 3-MCPD fatty acid esters which also occur in these fats.
p.7 If the conversion of glycidol to 3-chloropropanediol was presented as an artifact of the analytical
method, why is this information in the report? Please identify the crude oil discussed in the
presentation by Weisshour.
p.7 If the CIR Expert Panel believes that carcinogenicity is an issue for the oils reviewed in the report,
literature searches on carcinogenicity and each oil need to be completed and studies on the
carcinogenicity of the oils need to be added to the report.
p.7 Aflatoxins are a toxicity issue and not an allergy issue.
p.8 The paragraph concerning protein impurities in oils should be in an impurities section.
p.9 What concentrations of Olea Europea (Olive) Fruit Oil were used in the patch tests (references 4249)?
p.10, Item 3 It would helpful if CJR staff would do a more complete job of finding published
information regarding the composition of the oils proposed for inclusion in this report.
p.10 In item 4 of Information Sought, what is meant by specified concentrations?
p.10, Item 5 As the oils are triglycerides not mixtures of fatty acids, having irritation and sensitization
testing of individual fatty acids is not necessary if the fatty acids are removed from the report.
If the fatty acids are left in the report, Cifi staff should look for published information regarding
irritation and sensitization of individual fatty acids. Searching PubMed for Linolenic Acid and
sensitization the following was the first reference identified.
Kreilling R, Hollnagal HM, Hareng L, et al. 2008. Comparison of the skin sensitization
potential of unsaturated compounds as assessed by the murine local lymph node
assay (LLNA) and the guinea pig maximization test (GPMT). Food Chemical
Toxicology 46(6): 1896-1904.
p.10 Request 6 is not clear. If this review is focused only on the composition of the ingredients and
the dermal effects of the ingredients, why is any other information that pertains to the safety of
use in cosmetics necessary? Requests to industry should reflect the same criteria Cifi staff
used for identifying information in the published literature. If all types of safety information are
needed from industry, CIR staff need to go back and identify all the relevant published safety
information on these oils. Two examples (identified using the NTP website and ToxNet):
there is an NTP study on corn oil and safflower oil that is not mentioned in this report, there is a
developmental study on perilla oil not in the report (Naito et al. 1990. Shokuhin Eiseigaku
Zasshi 3 1(3): 25 1-254).
p.11 Please provide a reference for Figure 1.
-
Page 4 of 5
p.15-18, Table 3 What is meant by Araquidic?? As no oil in the table appears to contain it, it can
be deleted.
p.15-18, Table3, p.1
!, Table 4 Rather than arranging these tables in alphabetical order by common
2
9
name, these tables should be wTangecl in the same order as tha ingredients are arranged in Table
1, alphabetical order by genus species name. Arranging by genus species name will result in
species of the same genus being presented near each other so similarities among species of the
same genus will be easier to see.
p.16, Table 3, p.20, Table 4 Reference 60 is for Blackberry Seed Oil (Rubus Fruticosus (Blackberry)
Seed Oil) it is incorrectly called Black Currant Oil in Table 3. Although the company says
this is an INCI name, it has not been officially assigned and it is not in the Dictionary, nor is it
on the list of ingredients included in the report (Table 1). Therefore, the information about this
ingredient should be deleted from the report (Tables 3 and 4).
p.18, Table 3, p. 21, Table 4 As there are several species of strawberries in the Dictionary, the species
needs to be identified. Reference 69 indicates that this is Fragaria Ananassa (Strawberry) Seed
Oil.
p.19-21, Table 4 Please delete Carrot Seed Oil, Celery Seed Oil and Wild Celery Seed Oil from this
table (and from this report). As discussed above, these essential oils were incorrectly classified
as fats and oils in the Dictionary. What is the meaning of
with murumuru butter and
strawberry seed oil, and
with peach kernel oil?
p.Z2-28, Table 5 The font used for this table makes it difficult to read.
, Table 6 Please provide references for this table. As ingredients derived from the shea nut are
9
p.2
not included in this report, please delete shea from this table. It would be helpful if
information about the dietary supplement use for some of these oils, e.g,. Oenothera Biennis
(Evening Primrose) Oil, were also provided in this table. If this table is supposed to include
only non-food, non-cosmetic uses, substitute for cocoa butter in food needs to be deleted
from this table.
-
Page 5 of 5
GREEN BOOK 3
Nut Oils
Memorandum
To:
From:
Date:
Subject:
The Scientific Literature Review (SLR) for this group of edible nut oils was announced June 23, 2010. A related
SLR on an expansive group of edible plant oils was announced in April of this year, and is to be reviewed by the
Panel at this meeting as well. Both reports are taking a slightly new approach to reviewing multiple related
ingredients at one time and are including oil ingredients that have previously been reviewed by the CIR Expert
Panel, which are designated in italic print.
At the time that the SLR was announced, CIR sought the following additional information:
1.
Manufacturing information about oils used in cosmetic formulation, particularly on methods used
to remove non-fatty acid components (e.g., glycidol fatty acid esters);
2.
Cosmetic grade specifications, if such exist, for oils used in cosmetic formulations.
3.
Fatty acid composition for those oils covered in this report (where such information has not been
provided or differs from what is presented).
4.
5.
Irritation and sensitization testing on those fatty acids present in the oils covered in this report that
have previously not been reviewed by CIR.
6.
Any other information that pertains to the safety of the use in cosmetics of the oils covered in this
report.
Data on cosmetic grade specifications and fatty acid compositions, as well as an HRIPT study on Plukenetia
Volubilis Seed Oil have been received from the Personal Care Products Council and are incorporated in this draft
report.
Please note that the new use table is being employed in this report. The raw data from which the table was created
can be found with the unpublished data.
If the data provided are sufficient for the Panel to assess the safety of these ingredients, a tentative conclusion should
be developed regarding their safety in cosmetics, along with a rationale for that conclusion. The report will then be
issued as a Tentative Safety Assessment. If additional data are needed, these should be identified and an Insufficient
Data Announcement should be issued.
For your convenience, the materials for this report can also be found at http://www.cir-safety.org/aug10.shtml.
Toxline
PubMed
5/25/2010
ChemIDplus
HSDB
CAplus
NTIS
HPV
Merck USP
5/26/2010
5/26/2010
5/26/2010
5/27/2010
5/27/2010
5/27/2010
Ingredients All Searched with Chemical Composition, Dermal Toxicity, Irritation and Sensitization qualifiers
CoconutOil (Limited from Panels last review to present day) Coconut Oil; 8001-31-8; Cocos Nucifera Oil; 61788-47-4 Coconut Acid; 6893815-8; Hydrog Coco Acid; 84836-98-6; Hydrog Coco Oil; 61789-30-8; Potassium (Hydrog) Cocoate; 61789-31-9; Sodium (Hydrog) Cocoate;
Magnesium Cocoate; Cocos Nucifera Seed OR Coconut Butter
PeanutOil (Limited from Panels last review to present day) Arachis Hypogaea Oil; 8002-03-7; Peanut Oil; 68425-36-5; Hydrog Peanut Oil;
91051-35-3; Peanut Acid; Potassium OR Sodium Peanutate
SachaInchiSdOil Plukenetia Volubilis Seed Oil; Sacha Inchi Oil
SheaOil Shea Oil; 68920-03-6; 194043-92-0; Shea Butter; 225234-14-0; Shea Butter Unsap; Butyrospermum Parkii; Vitellaria paradoxa
ChileanHzlOil Gevuina Avellana Oil; Chilean Hazel Nut Oil
GalipSdOil Canarium Indicum Seed Oil; Galip Oil
BrazilSdOil Bertholletia Excelsa Seed Oil; Brazil Nut Oil
KukuiSdOil Kukui Nut Oil; 8015-80-3;Aleurites Moluccana Seed Oil; Aleurites Moluccanus Bakoly Seed Oil; Hydrogenated Kukui Nut Oil
WalnutSdOil Walnut Oil; Juglans Regia Seed Oil; 8024-09-7
PistachioSdOil Pistachio Nut Oil; Pistacia Vera Seed Oil; 90082-81-8; 129871-01-8
PecanSdOil Pecan Oil; Carya Illinoensis Seed Oil
MongongoKrnlOil Mongongo Oil; Schinziophyton Rautanenii Kernel Oil
MacadamiaSdOil Macadamia Nut Oil; Macadamia Integrifolia Seed Oil; Macadamia Ternifolia Seed Oil; 128497-20-1; 129811-19-4; Hydrog.
Macadamia Nut Oil; Sodium Macadamiaseedate
HazelSdOil (Limited from Panels last review to present day) Hazelnut Oil; Corylus Americana Seed Oil; Corylus Avellana Seed Oil; Hydrog
Hazelnut Oil
CashewSdOil Cashew Nut Oil; Anacardium Occidentale Seed Oil; 8007-24-7
SwtAlmondOil (Limited from Panels last review to present day) (Sweet) Almond Oil; Prunus Amygdalus (Dulcis) Oil; 8007-69-0; 90320-379; Hydrog Sweet Almond Oil (Unsapon.); Sodium Sweet Almondate
1
CIR Panel Book Page 149
Report
Draft Report
The 2010 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.;
Donald V. Belsito, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; Ronald A Hill, Ph.D. James G.
Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR
Director is F. Alan Andersen, Ph.D. This report was prepared by Christina L. Burnett and Monice Fiume, Scientific
Analyst/Writers.
TABLE OF CONTENTS
INTRODUCTION ............................................................................................................................................................................... 1
Chemistry ............................................................................................................................................................................................. 1
Processing .......................................................................................................................................................................... 2
Analytical Methods ............................................................................................................................................................ 2
Impurities ........................................................................................................................................................................... 3
Use ....................................................................................................................................................................................................... 4
Cosmetic ............................................................................................................................................................................ 4
Non-Cosmetic .................................................................................................................................................................... 5
ANIMAL TOXICOLOGY .................................................................................................................................................................. 5
Acute Dermal Toxicity ...................................................................................................................................................... 5
Acute Subcutaneous Toxicity ............................................................................................................................................ 6
Dermal Irritation ................................................................................................................................................................ 6
Arachis Hypogaea (Peanut) Oil..................................................................................................................................... 6
Cocos Nucifera (Coconut) Oil ....................................................................................................................................... 6
Corylus Avellana (Hazel) Seed Oil ................................................................................................................................ 6
Prunus Amygdalus Dulcis (Sweet Almond) Oil ............................................................................................................. 6
Dermal Sensitization .......................................................................................................................................................... 7
Arachis Hypogaea (Peanut) Oil..................................................................................................................................... 7
Cocos Nucifera (Coconut) Oil ....................................................................................................................................... 7
Prunus Amygdalus Dulcis (Sweet Almond) Oil ............................................................................................................. 7
Ocular Irritation ................................................................................................................................................................. 8
Aleurites Moluccana Seed Oil ....................................................................................................................................... 8
Cocos Nucifera (Coconut) Oil, Hydrogenated Coconut Oil, Coconut Acid .................................................................. 8
Prunus Amygdalus Dulcis (Sweet Almond) Oil ............................................................................................................. 8
CARCINOGENICITY ......................................................................................................................................................................... 8
Anacardium Occidentale (Cashew) Seed Oil................................................................................................................. 9
CLINICAL ASSESSMENT OF SAFETY .......................................................................................................................................... 9
Irritation/Sensitization/Allergenicity ................................................................................................................................. 9
Arachis Hypogaea (Peanut) Oil................................................................................................................................... 10
Butyrospermum Parkii (Shea) Butter and Unsaponifiables......................................................................................... 10
Cocos Nucifera (Coconut) Oil and Potassium Cocoate .............................................................................................. 11
Hazel Nut Oil ............................................................................................................................................................... 12
Plukenetia Volubilis ..................................................................................................................................................... 12
Prunus Amygdalus Dulcis (Sweet Almond) Oil ........................................................................................................... 12
Phototoxicity/Photosensitization...................................................................................................................................... 13
Cocos Nucifera (Coconut) Oil and Sodium Cocoate ................................................................................................... 13
Prunus Amygdalus Dulcis (Sweet Almond) Oil ........................................................................................................... 13
Clinical Trials/Case Studies ............................................................................................................................................. 13
Aleurites Moluccana Seed Oil ..................................................................................................................................... 13
Anacardium Occidentale (Cashew) Seed Oil............................................................................................................... 13
Cocos Nucifera (Coconut) Oil ..................................................................................................................................... 14
Macadamia Nut Oil ..................................................................................................................................................... 14
SUMMARY ....................................................................................................................................................................................... 14
FIGURES AND TABLES ................................................................................................................................................................. 17
ii
CIR Panel Book Page 152
INTRODUCTION
Oils derived from edible tree and ground nuts have been safely consumed by humans for millennia. While nuts
themselves may cause allergic reactions in certain individuals, the refined oils derived from the nuts generally pose no
significant safety concern following oral exposure, and their general biology is well characterized due to extensive use in
food materials. Various oils have been used on the skin since antiquity. Initially used for anointing in religious ceremonies,
oils and their components have long been used on the skin for cosmetic purposes. This safety assessment will focus solely on
the basic chemistry, manufacturing/production, uses, and irritation and sensitization data available on these oils as they are
used in cosmetic products. The full list of ingredients this report covers, which includes oils, hydrogenated oils,
unsaponifiables, acids, and simple salts, is found in Table 1. For the sake of brevity, the common name of the oil, when
available, will be used throughout this report. While a large number of oils derived from plants are included in this literature
review, there is a commonality in their structure and composition; they all are triglycerides containing various fatty acids and
fatty acid derivatives, the safety of which in cosmetics have been established.
This report includes the macadamia nut ingredients, Macadamia Integrifolia Seed Oil and Macadamia Ternifolia
Seed Oil, which are described in the International Cosmetic Ingredient Dictionary and Handbook.1 The species M.
integrifolia is currently the only species of macadamia nut that is used for oil production. The name M. ternifolia is an old
naming convention for the edible nut that is currently used to describe a non-cultivated, inedible species.2;3 Macadamia
Integrifolia Seed Oil and Macadamia Ternifolia Seed Oil are the same ingredient. The shea plant also has two species names,
Butyrospermum parkii and Vitellaria paradoxa. Only B. parkii (as Butyrospermum Parkii [Shea] Oil or Butter) is the current
naming convention described by the cosmetics industry.
This report includes cosmetic ingredients that have been previously reviewed by the Cosmetic Ingredient Review
Expert Panel. The ingredients, their conclusion, and published citations are found in Table 2. Previously reviewed fatty
acids and glyceryl triesters are also found in Table 2. A report on the safety of vegetable oils and related ingredients is
currently in CIRs review process.
CHEMISTRY
This group of cosmetic ingredients characterized as fats and oils are the glyceryl esters of fatty acids (triglycerides)
normally found in plant tissues, including those which have been hydrogenated to reduce or eliminate unsaturation.1 Figure 1
provides the general structure of fats and oils. In additions to triglycerides, tree nut oils are also composed of diglycerides,
monoglycerides, free fatty acids, and other minor components, including natural antioxidants and fat-soluble vitamins.4 The
extent to which these components are removed during processing varies. The available information on chemical properties
1
CIR Panel Book Page 153
and chemical constituents are found in Tables 3 and 4, respectively. The available fatty acid compositions for the oils in this
report are found in Table 5. The percentage of chemical constituents in individual oil types is dependent on region where the
nut plant is grown, individual cultivars, and plant genetics.5 The nutritional content of these oils varies with oil type, also.
In a study by Lodn and Andersson, shea butter liquid contained 9% unsaponifiable lipids, mainly triterpene esters
and sterol esters with cinnamic acid (as determined by high performance liquid chromatography). 6 The unsaponifiable
fraction in this study contained 22% unsaponifiable lipids, out of which 40% consisted of triterpene and sterol esters with
cinnamic acid.
Processing
Oils used in cosmetics are probably produced using the same process used in the food industry. Depending on the
source, oil may be directly expressed from the source (seed or pulp) followed by solvent extraction. Bailey states that the
removal of pigments and polar materials is mandatory for most cosmetic applications.7 The process used for oil refining for
foods may be adequate for this purpose, or additional steps may be required. Special refining methods to yield colorless and
odorless oils are used by the cosmetic industry and include proprietary adsorption chromatography and supercritical fluid
extractions.
The majority of the oils presented in this report are produced either from mechanical extraction or solvent extraction
or a hybrid of both methods, known as prepress solvent extraction.5 In solvent extraction, hexane is the most commonly used
solvent as it is economical and has low toxicity potential when compared to other solvents.
After the initial extraction by methods such as solvent extraction, the crude (degummed) oil is often refined.5 The
first step is treating the oil with caustic soda to neutralize free fatty acids, hydrolyze phosphatides, and remove some colored
pigments and unsaponifiable materials. Soap stock is usually a by-product of this step. The next step involves bleaching the
neutralized oil with activated earth to further absorb pigments. The last major step in refining oil is deodorizing, which
removes all oxidative cleavage products that impart odor or flavor to the oil. Deodorization also removes tocopherols,
sterols, and other minor constituents of free fatty acids and undesirable foreign materials. Figure 2 is a flowchart of the basic
refinement process.
After deodorization, oils can be further processed by hydrogenation, which makes oil more resistant to oxidative and
thermal damage, and by winterization, where oil is slowly cooled to promote formation of crystals that cause cloudiness and
filtered to remove the crystals.
Analytical Methods
Near infrared spectroscopy and gas chromatography have been used, respectively, to phenotype and analyze fatty
acid profiles in shea fat (described as Vitellaria paradoxa, not Butyrospermum parkii).8 The fatty acid composition of
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hazelnut oil (Corylus avellana, in crude form) has also been analyzed by gas chromatography.9 The triacylglycerol and
diacylglycerol composition oils from hazelnut, pistachio, almond, Brazil nut, and macadamia nuts have been characterized
with high-performance liquid chromatography with atmospheric pressure chemical ionization and UV detection.10 The
triacylglycerol profile of Brazil nut oil has also been quantified using dry matrix-assisted laser desorption/ionization time-of
flight mass spectrometry.11 According to Crevel et al., a validated analytical methodology for establishing the protein content
of oil is needed.12
Impurities
Proteins
Many edible oils are derived from foods that are recognized as potent food allergens. It has been shown that often
an individual that is allergic to a food will generally not react to the refined oil, especially if the oil has been hot-pressed or
has undergone more processing.12;13 It should be noted that while the Panel has found a general lack of clinical effects for nut
oils that they have already reviewed,14;15 other researchers have raised concerns about the presence of residual proteins in nut
oils. Olszewski et al. found 0.1-0.2 g protein per g of peanut oil,16 while Ramazzotti et al. reported finding IgE responsive
residual proteins in peanut oil extracts. 17 The European Medicines Agency (EMEA) Working Party on Herbal Medicinal
Products concluded that peanut products should be treated as allergenic unless they have an analytically-monitored nonallergenic specification and a safe maximum daily dose.18 The EMEA found that threshold concentrations for induction of a
protein contact dermatitis were not available and recommended that all medications for topical use containing peanut
products should be treated as allergenic.
Aflatoxin
Aflatoxins are metabolic products of the molds Aspergillus flavus and Aspergillus parasiticus. They are most often
produced in stored agricultural crops (such as peanuts and other nut crops) when growth conditions and genetic requirements
are favorable.19-21 Aflatoxins are identified as B1, B2, G1, G2, M1 and M2 (milk toxins), B2a, and G2a based on fluorescent
color (B = blue, G = green) when separated chromatographically. Aflatoxins B3, R0, P1, Q1, RB1, RB2 and D1 have also been
isolated.20
The International Agency for Research on Cancer (IARC) categorized aflatoxins as group 1 agents, carcinogenic to
humans.22;23 Epidemiological studies noted positive correlation between estimated aflatoxin intake or level of aflatoxin
contamination of market food samples and cooked food and incidence of hepatocellular cancer. The observations were
supported by positive results in laboratory carcinogenicity and mutagenicity studies. Aflatoxin B1 specifically is recognized
as one of the most potent environmental mutagens and carcinogens known.20 Aflatoxin B1 and B2 are the most common
aflatoxins found in peanuts.24
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The United States government places the following limitations on peanuts to be considered negative for aflatoxin:
< 15 ppb for peanuts which have been certified as meeting edible quality grade requirements and < 25 ppb for non-edible
quality categories (7 CFR Sections 997.30 and 998.200). The FDA has defined the action levels for aflatoxin content in
foods at 20 ppb.25
A study reported that crude peanut oil (obtained by solvent extraction or hydraulic pressing) has reduced aflatoxin
concentration compared to peanut kernels, and that subsequent processing (alkali refining and bleaching) reduces the
concentration still further.14 In one example, processed peanut oil from moldy peanuts (contaminated with 5500 ppb
aflatoxin) had an aflatoxin concentration of < 1ppb. [From CIR assessment on peanut oil, 2001.]
In 50 samples of hazel nuts from Spain, all samples showed fungal contamination, but no aflatoxin contamination.26
Of the 50 fungal strains identified, 25 were aflatoxigenic strains. In 20 hazel nut samples collected in Egypt, however,
aflatoxin (25-175 g/kg) was reported as a contaminant in 90% of samples. [From CIR assessment on hazel seed oil, 2001.]
Aflatoxin contamination of raw and dried coconut copra has been reported.15 Improper drying, handling, and
storage greatly increase the possibility of contamination by aflatoxins growing on copra. Smoke drying of copra inhibited
aflatoxin formation. [From CIR assessment on coconut oil, 2008.]
USE
Cosmetic
The available use information supplied to the Food and Drug Administration (FDA) by industry as part of the
Voluntary Cosmetic Registration Program (VCRP) on these oil ingredients can be found in Table 6.27 Shea butter has the
most reported uses in cosmetic and personal care products with a total of 1950. A recent survey of use concentrations for shea
butter reports a maximum use concentration of 60% in leave-on products as a cuticle softener, a manicuring application.28 A
survey of use concentrations in the remaining ingredients discussed in this report is currently being conducted by the Personal
Care Products Council (Council). The use concentrations that were reported in previous CIR safety assessments of oils are
also found in Table 5.14;15;26;29 (The year the data were reported is included in parentheses; if no date is available, the data is
current.) Although hazel nut oil (Corylus Americana and Corylus Avellana) were previously reviewed, specific
concentration of use data were not available. One source reported Corylus Avellana seed oil was used up to 100%. Nonspecific hazel nut oil concentration of use ranged from <5% to 50% according to historical FDA data.26
Oils are used in a wide variety of cosmetic products for their skin conditioning, occlusive, emollient, moisturizing
and other properties. The oil ingredients described in this report may be used in hair sprays, and effects on the lungs that may
be induced by aerosolized products containing these ingredients are of concern.
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The aerosol properties that determine deposition in the respiratory system are particle size and density. The
parameter most closely associated with deposition is the aerodynamic diameter, da, defined as the diameter of a sphere of unit
density possessing the same terminal settling velocity as the particle in question. In humans, particles with an aerodynamic
diameter of 10m are respirable. Particles with a da from 0.1 - 10m settle in the upper respiratory tract and particles with
a da < 0.1 m settle in the lower respiratory tract.30;31
Particle diameters of 60-80 m and 80 m have been reported for anhydrous hair sprays and pump hairsprays,
respectively.32 In practice, aerosols should have at least 99% of their particle diameters in the 10 110 m range and the
mean particle diameter in a typical aerosol spray has been reported as ~38 m.33 Therefore, most aerosol particles are
deposited in the nasopharyngeal region and are not respirable.
None of the oils or their related counterparts described in this report were restricted from use in any way under the
rules governing cosmetic products in the European Union.34
Non-Cosmetic
The primary uses for nut oils are for cooking. Of the nut oils, peanut oil and coconut oil are the world's most widely
consumed.5;35 Non-food, non-cosmetic uses for edible nut oils are found in Table 7.
ANIMAL TOXICOLOGY
Irritation, sensitization and phototoxicity information were not found for all the oils listed in this report. The data
available were reviewed and are summarized below. Information from previous CIR reports on nut oils is identified by
italics.
Acute Dermal Toxicity
Cocos Nucifera (Coconut) Oil
Undiluted hydrogenated coconut oil was applied as a single dose of 3 g/kg to the skin of 12 guinea pigs.15 No
deaths occurred during the 7-d observation period.
Prunus Amygdalus Dulcis (Sweet Almond) Oil
Undiluted sweet almond oil was tested for acute dermal toxicity in guinea pigs.36 The test material was applied
under occlusion to the clipped abraded and intact skin of 12 animals (6 male/6 female) at a dose of 3 g/kg. At 24 hours,
excess material was rinsed off. Observations were made daily for seven days; animals were then killed and necropsied. The
acute dermal LD50 was > 3 g/kg.
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sweet almond oil was nonirritating (PII = 0; maximum score = 4); whereas, the formulations containing 25% sweet almond
oil were minimally irritating (PIIs = 0.28 and 0.72, respectively).
A 60-day cumulative irritation test was used to evaluate the subchronic irritancy of sweet almond oil in rabbits.36
The test material, at concentrations of 10% or 100%, was applied daily to the clipped dorsal skin of groups of 3 albino
rabbits. Sites were scored daily. When tested in 7 separate trials, 100% sweet almond oil produced mean maximum
irritation indices (MMIIs) ranging from 0.34 to 1.34 (maximum score = 8). At a concentration of 10%, MMIIs for this
ingredient ranged from 0 to 0.66. Results indicated that, when applied to the skin over a long period of time, undiluted sweet
almond oil is slightly irritating; whereas, at 10% it is practically nonirritating.
Dermal Sensitization
Arachis Hypogaea (Peanut) Oil
Hartley and/or Himalayan guinea pigs were used to determine the sensitization potential of peanut oil. Single drops
of a store-bought peanut oil were applied to an area clipped free of hair on the backs of 4 guinea pigs. Applications were
made at 2-6 wk intervals, for a total of 7 applications over a 5-mo period. It appears that the test sites were not covered. The
test sites were scored 24 h after application. Well-defined erythema was considered a positive reaction. None of the animals
had a positive reaction following the initial application. Two animals had positive reactions following application at wks 6
and 12, while one animal had a positive reaction following dosing at wk 12 only.14
Cocos Nucifera (Coconut) Oil
In guinea pigs, neither undiluted coconut oil or hydrogenated coconut oil were sensitizers.15
Prunus Amygdalus Dulcis (Sweet Almond) Oil
A maximization assay was used to determine the sensitizing potential of sweet almond oil.36 Hartley-strain female
guinea pigs were divided into groups of 10 animals. Each animal received intradermal injections of 50% aqueous Freunds
complete adjuvant (FCA), 5% sweet almond oil in propylene glycol, and 5% sweet almond oil in 50% FCA into different sites
on epilated dorsal skin. Vehicle control animals were also used. In the dose-range phase of the experiment, each of 50
animals received a single dermal application of 5%, 10%, or 100% sweet almond oil to determine subirritating and
slightly irritating concentrations to be used for the challenge and booster phases. One week after the induction injection,
100% sweet almond oil was applied occlusively to the treated sites for 48 hours as a topical booster. Animals were
challenged 2 weeks later with 5% sweet almond oil in petrolatum applied topically under occlusion for 24 h. Patches were
then removed and sites were scored 24 and 48 h later. Sweet almond oil was nonsensitizing under these test procedures.
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Ocular Irritation
Aleurites Moluccana Seed Oil
In in vitro human conjunctival cell assays and in vivo guinea pig Draize tests, Aleurites Moluccana oil was not
cytotoxic and was not an ocular irritant.37 The same authors tested the efficacy of Aleurites Moluccana oil in ocular burn
treatment in vitro and in vivo and did not observe any adverse effects.38
Cocos Nucifera (Coconut) Oil, Hydrogenated Coconut Oil, Coconut Acid
Undiluted coconut oil was instilled into the conjunctival sac of the eyes of each of 2 groups of rabbits (6
rabbits/group). Without subsequent water rinsing of the eyes, maximum irritation scores of 2 and 1 were reported for the 2
treatment groups (max = 110). These results were indicative of minimal eye irritation.15
Undiluted hydrogenated coconut oil was instilled into the eyes of 10 groups of 6 rabbits each in a single dose. The
treated eyes received no subsequent water rinse. In 1 test, mild irritation (6/110) was observed. The eyes appeared normal by
the fourth day. In another study, minimal irritation (2/110) was observed, and the eyes appeared normal by the third day. In
eight tests, negligible or minimal irritation was observed. The eyes were clinically normal by the second day.15
Tests of 2 lipstick formulations containing 10% hydrogenated coconut oil were conducted with 6 albino rabbits
each. Slight conjunctivitis was observed from both formulations (no score provided), but the reaction disappeared by 48 and
24 h, respectively. Undiluted coconut acid was assayed for ocular toxicity in 3 groups of 6 rabbits each. In 2 tests, mild
irritation (8/110 and 9/110) was observed. The eyes were considered normal by the fourth day. In 1 test, minimal irritation
(1/110) was observed, with the eyes returning to normal by the third day.15
Prunus Amygdalus Dulcis (Sweet Almond) Oil
The Draize method or a modification of it was used to test the eye irritancy of undiluted sweet almond oil and
cosmetic formulations containing up to 25% sweet almond oil.36 The test material was instilled into one eye of each of 3 to
6 rabbits; the other eye served as an untreated control. Irritation was evaluated 1 h, as well as 1, 2, 3, 4, and 7 days later.
Undiluted sweet almond oil was practically nonirritating or minimally irritating. Formulations containing up to 25% sweet
almond oil were nonirritating to minimally irritating. In most instances, reactions that occurred were limited to conjunctival
irritation, which cleared by the third day of observation.
CARCINOGENICITY
The safety of glycidol fatty acid esters in refined vegetable oils was assessed by IARC. Glycidol was determined to
be a Group2A (probably carcinogenic to humans) chemical while Glycidol Fatty Acid Esters was determined to be a Group 3
(not classifiable as to carcinogenicity to humans) chemical.39;40
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The Federal Institute for Risk Assessment in Germany released a summary of their initial evaluation of the
assessment of levels of glycidol fatty acid esters detected in refined vegetable fats.41 While acknowledging that the levels of
glycidol that may be released from glycidol fatty acid esters are not known, the evaluation noted that glycidol is classified as
probably carcinogenic to humans. The evaluation was based on findings of the German Chemical and Veterinary Test
Agency (CVUA).
In a presentation by Weisshauer from the CVUA, the conversion of glycidol to 3-chloropropanediol was presented
as an artifact of the analytical method, and it appeared to be the 3-chloropropanediol that was detected its indicative of the
presence of glycidol.42 The levels of 3-chloropropanediol were negligible at the crude oil, degummed, neutralized, and
bleached stages, but levels were significant at the deodorized stage.
Anacardium Occidentale (Cashew) Seed Oil
Singh et al. investigated the modulatory effect of cashew nut oil on antioxidant potential in female Swiss albino
mice in a 120 day skin papillomagenesis study.43 The mice were divided into 4 groups of 15 and 1 group of 10 (vehicle
control). Test groups were as follows: Group I was the vehicle control, receiving 0.1 ml acetone; Group II was the positive
control, receiving a single dose of 7,12-dimethylbenz(a)anthracene (DMBA) (0.005 mg/0.05 ml acetone ) followed by
applications of 2% croton oil 3 times a week until study termination; Group III received a single dose of DMBA followed by
applications of 2.5% cashew nut kernel oil 3 times a week until study termination; Group IV received a single dose of DMBA
followed by applications of 5% cashew nut kernel oil 3 times a week until study termination; and Group V was 5% cashew
nut kernel oil applied until study termination. The oil was applied to the clipped dorsal scapular region that was 2 cm in
diameter. Body weights were recorded at regular intervals. Skin papillomas greater than 1 mm in diameter at the application
sites were recorded weekly and included in the data analysis if they persisted for more than 2 weeks. The positive control
group yielded expected results (86% tumor incidence). No tumors were observed in the vehicle control or the other test
groups. The authors concluded that cashew nut kernel oil did not exhibit any solitary carcinogenic activity.
but reaction to the oil is rare. In the original safety assessment on peanut (Arachis hypogaea) oil, the Expert Panel noted that
the major concern associated with allergic reactions to peanuts is the protein.14 The protein does not partition into the refined
oil, and therefore, oil does not raise the same type of safety concerns as the food containing oil and protein. Crevel et al. also
concluded that chemically refined peanut oil is safe for the majority of peanut allergic individuals.12 They stated that as
peanut is acknowledged to be one of the most potent food allergens, it is reasonable to extrapolate the conclusions drawn up
for peanut oil to other edible oils. However, they concede that validated analytical methodology for establishing the protein
content of oil is needed.
In support of the conclusions stated earlier, Crevel et al. also examined the allergenicity of some other oils. Very
few instances of allergic reactions to other major edible oils have been reported. Even sesame oil, which differs from the
other oils in that it is used as a flavorant and therefore is not as refined and expected to contain significantly more protein that
the other edible oils, has had very few reports of allergic reaction.
The preceding paragraphs addressed general allergenicity issues of edible oils. Specific information, where
available, follows and is either summarized from previous CIR reports on edible oils, and is identified by italics, or is new
data and identified by normal text.
Arachis Hypogaea (Peanut) Oil
The sensitization potential of a topical dermatologic product containing 0.01% fluocinolone and refined peanut oil
was studied in peanut-sensitive children and adults.45 The volunteers for the study included 8 children and 6 adults. The
subjects first underwent a prick skin test with peanut extracts, a solution of 50% glycerin (negative control), a solution o f 1.8
mg.ml histamine phosphate in 50% glycerin (positive control) the complete test product, the products vehicle only (without
fluocinolone), and refined peanut oil. Wheals that appeared were measured and recorded after 15 minutes. The subjects
were also patch tested with the complete test product, the products vehicle only, and the refined peanut oil. The materials
were applied with Finn chambers on the mid-back, were left in place for 48 h, removed, and observed immediately and after
24 h. Only 1 child had a trace positive reaction to refined peanut oil in the prick skin test. There were no reactions in any of
the subjects to the test product, product vehicle, or the negative control; positive results were observed to the positive control
and the peanut extracts. All subjects had negative patch tests at 48 and 72 h.
Butyrospermum Parkii (Shea) Butter and Unsaponifiables
The effect of a single application of 9 different lipids, including shea butter and fractions of unsaponifiable lipids
from shea butter, on normal skin and sodium lauryl sulfate (SLS)-irritated skin was studied in 21 healthy subjects.6 The
shea butter liquid sample was obtained from a supplier and the unsaponifiable fraction was obtained through low
temperature crystallization of the supplied sample. The right volar forearm was treated with 50 l of each test material in 12
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mm Finn chambers for 48 h. The left volar forearm was treated with 50 l of 14% aq. SLS for 7 h, rinsed, dried, and then
treated with 50 l of each test material for 17 h. The treated areas were then washed with mild soap solution, dried, and
examined after 24 h. Visible signs of irritation were assessed and cutaneous blood flow and transepidermal water loss
(TEWL) were measured.
In the normal skin treated with shea butter, barely perceptible erythema was observed in a small number of subjects
(number not reported) 24 h after patching. No irritation from the shea unsaponifiable fraction was observed in any of the
subjects. In the SLS-irritated skin treated with shea butter, 7 subjects had no irritation reaction, 6 had barely perceptible
erythema, 7 had slight erythema, and 1 had moderate erythema. In the SLS-irritated skin treated with shea unsaponifiable
fraction, 9 subjects had no irritation reaction, 8 had barely perceptible erythema, and 2 subjects each had slight and moderate
erythema. No significant differences in cutaneous blood flow or TEWL were observed in shea butter and shea unsaponifiable
fraction when compared to water (control) in either normal or SLS-irritated skin.6
Cocos Nucifera (Coconut) Oil and Potassium Cocoate
A bar soap containing 13% coconut oil was evaluated for skin irritation using standard Draize procedures. One
percent aqueous solutions of the product were applied with occlusive patches to the forearms of 106 panelists over a 3-wk
period. Very minimal skin reactions were recorded, and the researchers concluded the material was not hazardous under
conditions of normal use.15
Bar soaps containing 13% coconut oil were evaluated in a 2-week normal use test. The investigators reported no
unusual irritation response under normal use conditions in 72 panelists.15
Soap chamber tests employing Duhring chambers applied to the forearm were conducted with 8% aqueous
suspension of bar soaps containing 13% coconut oil. One 24-h patch and four 6-h patches were applied over a 5-d period.
In one test with 10 panelists the soap was moderately irritating, and the researchers concluded it was safe under conditions
of normal use. In a second soap chamber test, minimal irritation was observed in a panel of 10 individuals.15
The skin of 40 healthy volunteers and 480 subjects with active skin diseases were patch tested with 15 L of 5%
aqueous potassium cocoate. Positive responses were observed in 5 subjects (0.9%). Intensities of the positive responses
were not reported; however, 2 subjects had active psoriasis and 3 had active eczema.15
A tanning butter containing 2.5% coconut oil was evaluated using a repeat insult predictive patch test. Nine 24-h
induction patches were applied over a 3-week period. No erythematous reactions were observed in 103 panelists after a
single challenge in the sixth wk of the study.15
Four lipstick formulations containing 10% hydrogenated coconut oil were tested with a single 48-h application on
204 white females. There was no evidence of primary irritation and no indication of sensitization on retests performed 14 d
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later. 15
Coconut oil was not an allergen at 100% concentration in 12 subjects in a double-blind randomized controlled pilot
study.15
Hazel Nut Oil
A patch testing reference book by de Groot noted that the published literature does not contain recommended test
concentrations concerning hazel nut oil.26 To serve as a guide to the reader, de Groot reported that an unpublished (and at
the time, ongoing) study found no irritant reaction in 1 to 20 patients suffering from or suspected to suffer from cosmetic
product contact allergy who had been patch tested with 30% hazel nut oil in petrolatum.
Plukenetia Volubilis
A human repeat insult patch test (HRIPT) was performed on a lipstick containing 0.51% Plukenetia Volubilis seed
oil in 108 subjects.46 The test material (0.2 g) was applied to the upper back with a inch square absorbent pad and
occluded. A total of 9 applications were applied for 24 h over a 3-week period during the induction phase. After a 2-week
resting period, a challenge patch was applied to a virgin site for 24 h and the test site was scored at 24 and 72 h postapplication. No reactions were observed and it was concluded that the lipstick containing 0.51% Plukenetia Volubilis seed
oil was not a dermal irritant or sensitizer.
Prunus Amygdalus Dulcis (Sweet Almond) Oil
A single insult patch test (SIPT) was used to determine the irritancy of undiluted sweet almond oil.36 The test
material was applied under occlusion to the backs of 101 subjects; 48 h later, the patches were removed and the sites scored.
Sweet almond oil produced no reactions in the test subjects and was determined to be nonirritating.
A HRIPT was used to study the irritancy and sensitizing potential of undiluted sweet almond oil in 52 subjects.36
The test material was applied under occlusion to the back of each subject for 48 h; sites were then read and the compound
reapplied. This procedure was repeated 3 days per week for 3 weeks (9 applications). Following a 2-week rest, 1 or 2
challenge patches were applied to previously untreated skin of each subject. Sites were scored 48 and/or 96 h later.
Undiluted sweet almond oil produced no reactions in any of the 52 subjects and was concluded to be nonirritating and
nonsensitizing.
Repeated insult patch tests were used to study the effects of cosmetic formulations containing 0.1%-25% sweet
almond oil in a total of 6906 subjects.36 Results indicate that these products are practically nonirritating and nonsensitizing
to human skin. Additionally, the Lanman-Maibach 21-day Cumulative Irritancy Assay was used to test the subchronjc
irritancy of a moisturizer containing 25% sweet almond oil. The test material was applied under occlusion to the backs of 10
subjects for 23 hours. Patches were then removed, the site rinsed and scored 1 h later, and the compound reapplied. This
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procedure was repeated for 21 consecutive days. Of the 10 subjects tested, 7 reacted to 1 or more patches. The total
irritancy score was 14 out of a maximum possible 630.
Phototoxicity/Photosensitization
Cocos Nucifera (Coconut) Oil and Sodium Cocoate
Bar soaps made with 13% coconut oil were tested as a 3% aqueous solution. Patches containing 0.2 ml were
applied 3 times a week for 24 h for a 3-wk period to stripped skin. Sites were exposed to a Wood's lamp for 40 min and a sun
lamp for 15 min following each application. Following a 2-week nontreatment period, duplicate challenge patches were
applied. No evidence of photosensitization was observed in any of the 10 panelists.15
A similar soap prepared as 1 or 3% aqueous solutions was tested on 52 panelists. Occlusive patches containing 0.4
ml of the test solution were applied to the arms 3 times a week for a 3-week period. Sites were exposed to sunlight for 30 min,
24 h after application. Following a 2-week nontreatment period, duplicate challenge patches were applied. Sun exposures
were made 24 h following the challenge application. No evidence of photosensitization was noted.15
Bar soaps made with 13% sodium cocoate were prepared as a 3% aqueous solution. Occlusive patches containing
0.2 ml of the test solution were applied to the tape-stripped backs of 10 volunteers over a 6-week period. After each
application, the treated sites were exposed to an inspectrolamp for 45 min. After UVA exposure, the area was exposed to
about 2/3 of the minimal erythemal dose (MED) from an air-cooled Kromayer lamp. No evidence of phototoxicity was
observed.15
Prunus Amygdalus Dulcis (Sweet Almond) Oil
Formulations containing 0.1% - 2.0% sweet almond oil were tested for photosensitization in a total of 764 subjects.
The test material was applied under occlusion to each subjects back.36 Twenty-four hours later, the patch was removed and
the site scored and irradiated with ultraviolet light from a 150W Xenon Arc Solar Simulator (290-400 nm) at a dose equal to
3 times the individuals minimal erythema dose (MED). The site was again graded at 72 h and the procedure repeated once.
The products containing 0.1% - 2% sweet almond oil did not manifest photosensitivity in any of the test subjects.
Clinical Trials/Case Studies
Aleurites Moluccana Seed Oil
In an efficacy study of Aleurites Moluccana oil as a topical treatment for psoriasis, 15 patients with mild, stable
plaque psoriasis (less than 15% total body surface area) applied just enough (oil) to moisten the plaque 3 times daily for 12
weeks. No side effects or adverse events were reported.47
Anacardium Occidentale (Cashew) Seed Oil
A 37-year-old male resin researcher presented with painful, edematous erythema with bullae on his right leg after
dropping pure cashew nut oil from a bottle on his right thigh.48 He had removed his clothes immediately and thoroughly
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washed the skin. The erythema developed 10 days after exposure. Patch testing was performed with cashew nut oil 3%
alcohol, cashew nut oil 0.3% alcohol, cashew nut oil 0.03% alcohol, and urushiol 0.01% petrolatum. The patients had a +
reaction on day 2 and ++ reactions on days 3 and 4 to the 3% dilution, and + reactions to the 0.3% dilution and urushiol
on days 2-4. A ?+ reaction was observed on days 2 and 3 and a + reaction was observed on day 4 to the 0.03% dilution.
Cocos Nucifera (Coconut) Oil
Coconut oil did not produce adverse effects in several therapeutic studies.15
Macadamia Nut Oil
A case of cheilitis was reported in a 28-year-old woman that had used a lipstick that contained macadamia nut oil
(no species description or concentration of oil were reported).49 When patch tested with the ingredients contained in the
lipstick, the patient had positive reactions to di-isostearyl malate and macadamia nut oil. The patient was told to discontinue
use of lipsticks containing these 2 ingredients and her condition improved with steroid ointment.
SUMMARY
The oils derived from edible nuts are composed of mono-, di-, and triglycerides, free fatty acids and other minor
components, including natural antioxidants and fat-soluble vitamins. The percentage of chemical constituents and nutritional
content of individual oil types is dependent on region where the nut plant is grown, individual cultivars, and plant genetics.
Oils used in cosmetics are likely produced in the same manner as those used in the food industry. Oils may be expressed
through mechanical or solvent extraction. The oils may undergo further refining to remove pigments, odors, unsaponifiable
materials, and other undesirables.
It has been shown that often an individual that is allergic to a food will generally not react to the refined oil. The
CIR Expert Panel has found a general lack of clinical effects for edible nut oils that they have already reviewed; however,
other researchers have raised concerns about the presence of residual proteins in oils, such as peanut and soy. These
ingredients may also contain aflatoxins, a metabolic products of certain molds that are carcinogenic to humans. The FDA
action level for aflatoxin in foods is 20 ppb.
Of the nut oils described in this report, shea butter has the most reported uses in cosmetic and personal care products
with a total of 1950 and is used at a maximum concentration of 60% in leave-on products with manicuring applications. Nut
oils are used in a wide variety of cosmetic products for their skin conditioning, occlusive, emollient, moisturizing, and other
properties. These ingredients may be used in hair spray and other aerosolized products. None of the oils or the related
counterparts described in this report were restricted from use in the European Union.
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In acute animal studies, undiluted hydrogenated coconut oil and undiluted sweet almond oil were not dermal
toxicants in dermal toxicity studies in guinea pigs at doses of 3 g/kg. In a subcutaneous toxicity study, 10% sweet almond oil
produced nonallergic eosinophilia reactions in guinea pigs.
Undiluted peanut oil was moderately irritating to rabbits and guinea pig skin, mildly irritating in rat skin, and nonirritating in miniature swine in dermal studies. Undiluted coconut oil, hydrogenated coconut oil, and coconut acid were nonto minimally irritating in rabbit skin. Corylus Avellana (hazel) nut oil was not irritating to rabbit skin. Sweet almond oil at
25% in formulations was minimally irritating; at 10%, it was practically non-irritating, and at undiluted concentrations, it was
practically non-irritating to slightly irritating.
In animal sensitization studies, store-bought peanut oil produced well-defined erythema only at 12 weeks in a 5
month guinea pig study. Undiluted coconut oil and hydrogenated coconut oil were not sensitizers in guinea pig studies.
Sweet almond oil up to 100% was not sensitizing in a guinea pig study.
Aleurites Moluccana seed oil was not cytoxic or irritating in in vitro and in vivo ocular efficacy studies. Undiluted
coconut oil and undiluted hydrogenated coconut oil were minimal to mild eye irritants in rabbit eyes, while formulations
containing 10% hydrogenated coconut oil produced slight conjunctivitis in rabbit eyes that disappears after 24-48 h.
Undiluted sweet almond oil and formulations containing up to 25% sweet almond oil were nonirritating to minimally
irritating in Draize studies.
Glycidol and glycidol fatty acid esters, possible constituents in refined vegetable and nut oils, were determined to be
Group 2A (probably carcinogenic to humans) and Group 3 (not classifiable as to carcinogenicity to humans) chemicals,
respectively, by IARC. Cashew nut oil did not exhibit solitary carcinogenic activity in a study of the modulatory effect on
the antioxidant potential of this nut oil.
Edible nut oils are believed to be safe for use on the skin and very few reports of adverse reactions have been
reported. While the nuts that these oils are derived from are recognized food allergens, the proteins that are responsible for
allergenic responses do not partition into refined oils.
In 14 peanut-sensitive subjects, only one trace positive reaction was observed to refined peanut oil in a prick skin
test, but no reactions were observed in patch tests. Barely perceptible erythema was observed after exposure to shea butter on
normal skin while no irritation was observed following exposure to shea unsaponifiable fractions.
Bar soaps containing 13% coconut oil, when tested using standard Draize procedures, produced very minimal skin
reactions. In a 2-week normal use test, the bar soaps caused no unusual irritation response. The results of soap chamber tests
of bar soaps were minimal irritation in one study and mild irritation in another. A tanning butter containing 2.5% coconut
oil did not cause erythematous reactions in a 6-week repeat insult predictive patch test. Lipstick containing 10%
15
CIR Panel Book Page 167
hydrogenated coconut oil caused no evidence of primary irritation after a single patch application and no indication of
sensitization in retests performed 14 days later. Coconut oil was not an allergen at 100% concentration in 12 subjects in a
double-blind randomized controlled pilot study.
No irritation was observed in patients that were patch tested with 30% hazel nut oil. Irritation and sensitization was
not observed in subjects tested with 0.51% Plukenetia Volubilis seed oil in a HIPT. Undiluted sweet almond oil was nonirritating and nonsensitizing in SIPT and RIPT studies, and formulations containing 0.1%-25% sweet almond oil were
practically nonirritating and nonsensitizing to human skin.
Bar soaps containing up to 13% coconut oil or sodium cocoate were not photosensitizers in human subjects, nor
were formulations containing 0.1%-2% sweet almond oil.
Aleurites Moluccana seed oil and coconut oil did not produce adverse effects in efficacy studies. Cashew nut oil
and macadamia nut oil caused allergic response in separate case studies.
16
CIR Panel Book Page 168
H2 C
OCR
O
OCR'
HC
O
OCR"
H2 C
-OCR, -OCR', and -OCR" may be the same or dif ferent fatty acid radicals.
17
CIR Panel Book Page 169
Crude Oil
Water
Degummed Oil
Lecithin Sludge
Alkali
Deodorization
Salad Oil
Soap Stock
Activated Earth
Deodorization
Salad Oil
Bleached Oil
H2, Catalyst
Deodorization
Cooking Oil
Partially
Hydrogenated Oil
Winterization &
Deodorization
Deodorization
Deodorization
Shortening
Stock
Blended Oils
Deodorization
Margarine Stock
18
CIR Panel Book Page 170
Salad and
Cooking Oil
19
CIR Panel Book Page 171
Ingredients
Table 2. Previously reviewed nut oils, fatty acids, and glyceryl triesters.
Publication Date
Oil Ingredients
Arachis Hypogaea (Peanut) Oil (CAS No. 8002-03-7)
Hydrogenated Peanut Oil (CAS No. 68425-36-5)
Peanut Acid (CAS No. 91051-35-3)
Cocos Nucifera (Coconut) Oil (CAS No. 8001-31-8)
Coconut Acid (CAS No. 61788-47-4)
Hydrogenated Coconut Acid (CAS No. 68938-15-8)
Hydrogenated Coconut Oil (CAS No. 84836-98-6)
Magnesium Cocoate
Potassium Cocoate (CAS No. 61789-30-8)
Potassium Hydrogenated Cocoate
Sodium Cocoate (CAS No. 61789-31-9)
Sodium Hydrogenated Cocoate
Corylus Americana (Hazel) Seed Oil
Corylus Avellana (Hazel) Seed Oil
Prunus Amygdalus Dulcis (Sweet Almond) Oil
(CAS No. 8007-69-0)
Fatty Acids
Arachidonic Acid (CAS No. 506-32-1)
Hydroxystearic Acid (CAS No. 106-14-9)
Lauric Acid (CAS No. 143-07-7)
Myristic Acid (CAS No. 544-63-8)
Oleic Acid (CAS No. 112-80-1)
Palmitic Acid (CAS No. 57-10-3)
Stearic Acid (CAS No. 57-11-4)
Conclusion
Safe
Safe
Insufficient data
Safe
Insufficient data
Safe
Safe
Safe
Glyceryl Triesters
Trilaurin (CAS No. 538-24-9)
Triarachidin (CAS No. 620-64-4)
Tribehenin (CAS No. 18641-57-1)
Tricaprin (CAS No. 621-71-6)
Tricaprylin (CAS No. 538-23-8)
Trierucin (CAS No. 2752-99-0)
Triheptanoin (CAS No. 620-67-7)
Triheptylundecanoin (CAS No. 105214-66-2)
Triisononanoin
Triisopalmitin (CAS No. 68957-79-9)
Triisostearin (CAS No. 26942-95-0)
Trilinolenin (CAS No. 14465-68-0)
Trimyristin (CAS No. 555-45-3)
Trioctanoin (CAS No. 7360-38-5)
Triolein (CAS No. 122-32-7)
Tripalmitin (CAS No. 555-44-2)
Tripalmitolein (CAS No. 20246-55-3)
Triricinolein (CAS No. 2540-54-7)
Tristearin (CAS No. 555-43-1)
Triundecanoin (CAS No. 13552-80-2)
Glyceryl Triacetyl Hydroxystearate (CAS No. 27233-00-7)
Glyceryl Triacetyl Ricinoleate (CAS No. 101-34-8)
Glyceryl Stearate Diacetate
20
CIR Panel Book Page 172
Appearance
5.0 max
0.920-0.940
(15.5C); 0.9200.930 (20C)
Specific gravity
Refractive index
Iodine value
Saponification value
0.1 - 4; 2 max
(refined)
-15
1.473 - 1.479
(25C); 1.470-1.480
(20C)
1.0 max
146 - 166; 130-175
Solidification point
(C)
Aleurites
Molucanna Seed
Oil [Kukui]50-53
0.22
Anacardium
Occidentale
(Cashew) Seed
Oil54
21
0.914 (25C)
0.16
192.4
74.2
74-107; 80-106
180-208; 185-195
1.473
Bertholletia
Excelsa Seed Oil
[Brazil]54;58
Arachis Hypogaea
(Peanut) Oil5;50;55-57
0.918 (15C)
5.0 max
178-190; 165-190
1.468 (25C)
1.5 max
50-67; 45-73
Butyrospermum
Parkii (Shea)
Butter5;50;59;60
< 10
185-195
28 - 43
Butyrospermum
Parkii (Shea) Oil61
0.924 (25C)
0.15
190
100 - 105
1.472
Carya Illinoensis
(Pecan) Seed
Oil50;54;58
Appearance
0.917 - 0.919
(25/15.5C)
187-197
1.467-1.474 (20C)
0.6 max (refined)
83-97
Hazel Seed
Oil55;62;63
< 10
248 - 265
Specific gravity
6.0 - 11
Refractive index
Iodine value
Saponification value
Solidification point
(C)
Cocos Nucifiera
(Coconut) Oil5;50;61
22
0.917 (25C)
0.37
190 - 197
150 - 162
1.475 (25C)
0.2 - 2.5
Juglans Regia
(Walnut) Seed
Oil50;55;58
0.915 (25C);
0.911-0.918 (20C)
193.7; 190-200
78.3; 62-82
1.469; 1.466-1.470
(20C)
Macadamia Nut
Oil55;58;64;65
0.22
Table 3. Average chemical properties for crude and refined nut oils (continued).
0.19
0.913 - 0.916
(25C); 0.911-0.920
(20C)
93 - 106
9.0 - 12.0
1.462 - 1.466
(40C); 1.467-1.473
(20C)
1.0 max
Prunus Amygdalus
(Sweet Almond)
Oil5;50;55;66;67
0.31
0.0612
0.186
0.991
0.0667
0.0381
-Tocopherol
(mg/g)
Squalene (mg/g)
-Sitosterol (mg/g)
Campesterol (mg/g)
Stigmasterol
< 0.5
-Tocohpherol
(mg/g)
Unsaponifiable
matters (%)
Hazel Seed
Oil55;62;63
57.2
89.4
1768
105.3
116.7
Cocos Nucifiera
(Coconut) Oil5;50;61
3.6
-Tocopherol
(mg/g)
Squalene (mg/g)
-Sitosterol (mg/g)
Campesterol (mg/g)
Stigmasterol
Anacardium
Occidentale
(Cashew) Seed
Oil54
-Tocohpherol
(mg/g)
Unsaponifiable
matters (%)
Aleurites
Molucanna Seed
Oil [Kukui]50-53
0.301
0.0094
1.13
0.051
0.0555
0.021
0.5
Juglans Regia
(Walnut) Seed
Oil50;55;58
0.0603
0.0983
1.36
0.198
0.163
0.0879
< 1.0
Arachis Hypogaea
(Peanut) Oil5;50;55-57
23
Trace
0.185
1.51
0.0733
0.0383
0.122
Macadamia Nut
Oil55;58;64;65
116.2
1377.8
1325.4
26.9
577.5
82.9
Bertholletia
Excelsa Seed Oil
[Brazil]54;58
275.4
91.4
4685.9
236.8
663.3
15.6
3.0 - 10.0
Butyrospermum
Parkii (Shea)
Butter5;50;59;60
0.0125
0.095
2.07
0.055
0.0517
0.4395
0.4 - 1.0
Prunus Amygdalus
(Sweet Almond)
Oil5;50;55;66;67
< 1.5
Butyrospermum
Parkii (Shea) Oil61
168.5
151.7
1572.4
52.2
340.4
12.2
0.35 - 40
Carya Illinoensis
(Pecan) Seed
Oil50;54;58
Arachis Hypogaea
(Peanut) Oil5;56;57
Fatty Acids
Caproic (C6)
Caprylic (C8)
Capric (C10)
Lauric (C12)
Myristic (C14)
(C15)
Palmitic (C16)
8-11
7.2-14.2; 7.0-16.0
Palmitoleic (C16:1)
0-1
Heptadecanoic
(C17)
(C17:1)
Stearic (C18)
1-3
1.1-5; 1.3-6.5
Oleic (C18:1)
5-8
33.3-71.2; 35.0-72.0
Linoleic (C18:2)
Trace - 2.5
12-47.5; 13.0-43.0
Linolenic (C18:3)
0-0.04; 0.6
Arachidic (C20)
0.17-2.7; 0.5-3.0
Eicosenoic (C20:1)
0.33-2.3; 0.5-2.1
Eicosadienoic
(C20:2)
Behenic (C22)
0.7-4.1; 1.0-5.0
Erucic (C22:1)
0.5
(C23)
Lignoceric (C24)
0.2-2.8; 0.5-3.0
*Shadowing identifies previously reviewed ingredients.
Cocos Nucifiera
(Coconut) Oil15
0-1
5-9
6-10
44-52
13-19
30-41; 34.0-50.0
45-50; 38.0-50.0
4.0-5; 3.0-8.0
0.5 max
3
41.2-56.8
34.0-46.9
3.7-6.5
24
5.0-9.0; 3.0-9.0
3.8-4.1
1.0-2.0
Butyrospermum
Parkii (Shea)
Butter5;59;60
Butyrospermum
Parkii (Shea) Oil61
0.5 - 3
9.0 - 30
57 - 76
2.0 - 16
3.0 - 7
Juglans Regia
(Walnut) Seed
Oil68
0.3 - 0.7
2.0-3.0
70-77; 69
17 - 20
0.4
5.5-6.5; 6
0.1 - 1.4
0.7 - 0.8
8.0 - 9.2; 6.0-12.0
15.6 - 24.6; 12-25
Prunus Amygdalus
(Sweet Almond)
Oil5;50;66;67;69
Macadamia Nut
Oil2;64;65
1.8 - 2
40.6 - 79
16 - 50.3
0.7
Trace
1.2
0.1
3 - 4.3
0.1
Trace
6.7; 0.1-5
10.5; 10-35
48.5; 35-50
28.5; 24-40
1.5
1.0
5.5; 5-8
0.5
Aleurites
Molucanna Seed
Oil [Kukui]50;52;53
Eicosadienoic (C20:2)
Behenic (C22)
0.2
Erucic (C22:1)
0.3
(C23)
Lignoceric (C24)
*Shadowing identifies previously reviewed ingredients.
Fatty Acids
Caproic (C6)
Caprylic (C8)
Capric (C10)
Lauric (C12)
Myristic (C14)
(C15)
Palmitic (C16)
Palmitoleic (C16:1)
Heptadecanoic
(C17)
(C17:1)
Stearic (C18)
Oleic (C18:1)
Linoleic (C18:2)
Linolenic (C18:3)
Arachidic (C20)
Eicosenoic (C20:1)
Carya Illinoensis
(Pecan) Seed
Oil50;54
0.02
0.01
0.01
0.01
25
0.04 - 0.05
0.07 - 0.08
1.7 - 1.9; 1.0-6.0
80.7 - 82.6; 66-85
9.8 - 11.3; 7-25
0.2; 0.5-0.6
0.1
0.1 - 0.2
0.03 - 0.04
0.01
4.96 - 5.8; 5-9
0.2; 0.5-1.0
Corylus Avellana
(Hazel) Seed
Oil9;62;63
0.1
0.3
11.8
29.1
42.8
0.2
0.5
0.2
0.2
13.5
0.3
0.06
Bertholletia
Excelsa Seed Oil
[Brazil]54
0.3
0.6
0.9
58.2
30.3
0.4
0.6
0.6
7.4
0.7
0.09
0.4
0.3
8.7
57.2
20.8
0.2
1
0.3
0.1
9.9
0.4
0.07
Anacardium
Occidentale
(Cashew) Seed
Oil54
Frequency of Use
Leave-On
Rinse Off
Eye
Possible Ingestion
Inhalation
Dermal
Deodorant
(underarm)
Hair - Noncoloring
Hair - Coloring
Nail
Mucous
Membrane
Baby
Frequency of Use
Leave-On
Rinse Off
Eye
Possible Ingestion
Inhalation
Dermal
Deodorant
(underarm)
Hair - Noncoloring
Hair - Coloring
Nail
Mucous
Membrane
Baby
0.01 - 0.1
(2002 conc.)
0.3 - 3
0.1
1 - 76
0.004
0.4
0.5
1-3
0.004 - 11
0.004 - 76
0.004 - 76
0.01 - 2
0
0
11
0
0
1
1
(2001 conc.)
41
25
16
4
4
0
36
0
up to 100
0
0
21
13
8
0
1
0
15
26
0
28
208
191
17
22
11
2
170
0
0
4
4
0
0
0
0
4
14
3
1
33
533
471
62
16
33
12
493
0
0
10
9
1
0
0
0
9
150
130
20
9
2
0
147
18
134
2
13
117
1127
801
326
28
55
18
986
0
0
Schinziophyton Rautanenii
Kernel Oil
6
3
3
0
0
0
3
0
0
10
9
1
0
0
0
10
No. of Uses
Conc. of Use (%)
Hazel Nut Oil (C. Americana)
Frequency of Use
Leave-On
Rinse Off
Eye
Possible Ingestion
Inhalation
Dermal
Deodorant
(underarm)
Hair - Noncoloring
Hair - Coloring
Nail
Mucous
Membrane
Baby
Frequency of Use
Leave-On
Rinse Off
Eye
Possible Ingestion
Inhalation
Dermal
Deodorant
(underarm)
Hair - Noncoloring
Hair - Coloring
Nail
Mucous
Membrane
Baby
18
0
2
27
3
0
0
18
0
0
105
79
26
7
10
0
102
0.5 - 39
2 - 50
(2008 conc.)
0.001 - 2
0.5 - 0.6
0.8 - 25
0.001 - 50
0.001 - 50
0.001 - 39
0.2 - 22
0.7 - 29
0.3 - 0.7
0.06 - 50
101
0
0
141
17
124
1
0
0
140
0.04 - 14
(2008 conc.)
0.03 - 0.3
-
0.04 - 14
0.03 - 14
0.03 - 14
Coconut Acid
158
105
53
7
6
0
133
8
7
1
1
0
0
8
27
0
0
0
0
0
0
0
0
0
(2008 conc.)
6 - 10
6 - 10
6
10
0
0
13
12
1
1
3
0
13
0
0
9
0
9
0
0
0
9
(2008 conc.)
Magnesium Cocoate
0
0
15
12
3
1
0
0
14
Table 6. Frequency and concentration of use according to duration and exposure (continued).14;15;26-29
Conc. of Use
No. of Uses
No. of Uses Conc. of Use (%)
No. of Uses
Conc. of Use (%)
No. of Uses Conc. of Use(%)
(%)
Pecan Nut Oil
Pistachio Nut Oil
Plukenetia Volubilis Seed Oil
Walnut Oil
0.0005 - 41
0.01 - 0.3
(2008 conc.)
0.0001 - 13
0.005 - 2
0.1 - 16
0.01 - 80
0.2 - 51
0.1 - 26
0.0005 - 80
0.0001 - 80
0.005 - 80
0.0001 - 41
26
0
0
40
0
40
0
0
0
38
0.2 - 40
(2008 conc.)
15
0.003
-
0.3
0.3 - 40
0.003 - 40
0.3
0.003 - 40
Potassium Cocoate
15
176
69
5
176
798
372
426
25
44
10
548
Coconut Oil
No. of Uses
Frequency of Use
Leave-On
Rinse Off
Eye
Possible Ingestion
Inhalation
Dermal
Deodorant
(underarm)
Hair - Non-coloring
Hair - Coloring
Nail
Mucous Membrane
Baby
Frequency of Use
Leave-On
Rinse Off
Eye
Possible Ingestion
Inhalation
Dermal
Deodorant
(underarm)
Hair - Non-coloring
Hair - Coloring
Nail
Mucous Membrane
Baby
2
1 - 52
(2008 conc.)
1 - 52
1 - 52
1 - 52
0
0
0
2
0
4
2
2
0
0
0
4
2010 conc.
1
1
1
71
0
0
241
5
340
12
328
0
0
0
269
(2001 conc.)
<25 - >50
5
0
0
0
1
38
33
5
7
2
0
33
2
2010 conc.
0.2 0.7
13
0.06 3
0.06 3
0.06 3
2
21
0
0
2
0
74
53
21
4
0
2
53
28
58
0
4
11
0
0
0
0
0
0
12
12
0
0
0
0
12
0.0005 - 5
0.01 - 60
0.003 - 5
0.01 - 5
2010 conc.
0.1 - 8
0.5 - 26
0.001 - 3
0.001 - 45
0.0005 60
0.001 - 60
0.0005 - 30
12
14
0
10
0
55
18
37
1
0
1
29
210
4
7
114
24
1950
1596
354
108
128
17
1724
Table 6. Frequency and concentration of use according to duration and exposure (continued).14;15;26-29
Conc. of Use
Conc. of Use
Conc. of Use
Conc. of Use
No. of Uses
No. of Uses
No. of Uses
No. of Uses
(%)
(%)
(%)
(%)
Sodium Cocoate
Peanut Oil
Hydrog. Peanut Oil
Shea Butter
0.01 1
0.6 1
2010 conc.
15
0.6 15
0.01 15
0.01 15
0.6 1
0
0
0
0
0
0
5
5
0
0
0
0
5
0
0
0
6
0
22
16
6
1
0
0
22
Conc. of Use
(%)
Shea Butter Oil
No. of Uses
Use
Almond
Cashew
Folk remedies
Coconut
Kukui
Peanut
Shea
Walnut
Illumination
29
CIR Panel Book Page 181
Reference List
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Ref Type: Edited Book
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Johnson. NewCROP . 1-7-1998. Department of Horticulture and Landscape Architecture, 625 Agriculture Mall
Drive, West Lafayette, IN 47907-2010, Purdue University. 5-20-2010.
Ref Type: Online Source
(3) Storey W. The Ternifolia group of Macadamia species. Pacific Science 1965;19:507-514.
(4) Miraliakbari H, Shahidi F. Oxidative stability of tree nut oils. J Agric Food Chem 2008;56:4751-4759.
(5) Salunkhe D, Chavan J, Adsule R, Kadam S. World Oilseeds: Chemistry, Technology, and Utilization. New York:
Van Nostrand Reinhold, 1992.
(6) Loden M, Andersson A. Effect of topically applied lipids on surfactant-irritated skin. Br J Dermatol 1996;134:215220.
(7) Bailey's Industrial Oil & Fat Products. John Wiley & Sons., 1996.
(8) Davrieux F, Allal F, Piombo G et al. Near infrared spectroscopy for high-throughput characaterization shea tree
(Vitellaria paradoxa) nut fat profiles. J Agric Food Chem 2010.
(9) Oliveira I, Sousa A, Morais J et al. Chemical composition, and antioxidant and antimicrobial activities of three
hazelnut (Corylus avellana L.) cultivars. Food Chem Toxicol 2008;46:1801-1807.
(10) Holcapek M, Jandera P, Zderadicka P, Hruba L. Characterization of triacylglycerol and diacylglycerol composition
of plant oils using high-performance liquid chromatography-atmospheric pressure chemical ionization mass
spectrometry. J Chromatogr A 2003;1010:195-215.
(11) Saraiva S, Cabral E, Eberlin M, Catharino R. Amazonian vegetable oils and fats: Fast typification and quality
control via triacylglycerol (TAG) profiles from dry matrix-assisted laser desorption/ionization time-of-flight
(MALDI-TOF) mass spectrometry fingerprinting. J Agric Food Chem 2009;57:4030-4034.
(12) Crevel RW, Kerkhoff MA, Koning MM. Allergenicity of refined vegetable oils. Food Chem Toxicol 2000;38:385393.
(13) Teuber S, Brown R, Haapanen L. Allergenicity of gourmet nut oils processed by different methods. J Allergy Clin
Immunol 1997;99:502-507.
(14) Andersen,F.A.(ed). Final report on the safety assessment of peanut (arachis hypogaea) oil, hydrogenated peanut oil,
peanut acid, peanut glycerides, and peanut (arachis hypogaea) flour. Int J Toxicol 2001;20:65-77.
(15) Burnett C, Cosmetic Ingredient Review Expert Panel, Andersen F. Final Report of the Cosmetic Ingredient Review
Expert Panel. Amended Safety Assessment of Cocos Nucifera (Coconut) Oil, Coconut Acid, Hydrogenated Coconut
Oil, Ammonium Cocomonoglyceride Sulfate, Butylene Glycol Cocoate, Caprylic/Capric/Coco Glycerides,
Cocoglycerides, Coconut Alcohol, Coconut Oil Decyl Esters, Decyl Cocoate, Ethylhexyl Cocoate, Hydrogenated
Coco-Glycerides, Isodecyl Cocoate, Lauryl Cocoate, Magnesium Cocoate, Methyl Cocoate, Octyldodecyl Cocoate,
Pentaerythrityl Cocoate, Potassium Cocoate, Potassium Hydrogenated Cocoate, Sodium Cocoate, Sodium
Cocomonoglyceride Sulfate, Sodium Hydrogenated Cocoate, and Tridecyl Cocoate. Available from CIR 2008.
(16) Olszewski A, Pons L, Moutt F et al. Isolation and characterization of proteic allergens in refined peanut oil. Clin
Exp Allergy 1998;28:850-859.
30
CIR Panel Book Page 182
(17) Ramazzotti M, Mulinacci N, Pazzagli L et al. Analytic investigations on protein content in refined seed oils:
implications in food allergy. Food Chem Toxicol 2008;46:3383-3388.
(18) European Medicines Agency (EMEA). Working party on herbal medicinal products. Final position paper on the
allergenic potency of herbal medicinal products containing soya or peanut protein. EMEA/HMPWP/37/04.
http://www ema europa eu/pdfs/human/hmpc/003704en pdf [serial online] 2004; Accessed April 12, 10 A.D.
(19) Pease RW. Webster's Medical Desk Dictionary. 1986. Springfield, MA, Merriam-Webster, Inc.
Ref Type: Edited Book
(20) Budavari S. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. 10th. 1989. Rahway, NJ,
Merck and Co.
Ref Type: Edited Book
(21) Wood GE. Aflatoxins in domestic and imported foods and feeds. J Assoc Anal Chem 1989;72:543-548.
(22) IARC. IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans. [10], 51-72. 1976.
Lyon, France, IARC.
Ref Type: Serial (Book,Monograph)
(23) IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans. Overall evaluations of
carcinogenicity: An updating of IARC Monographs volumes 1 to 42. [Supplement 7], 83-87. 1987. Lyon, France,
IARC.
Ref Type: Serial (Book,Monograph)
(24) Wilson DM. Analytical methods for aflatoxins in corn and peanuts. Arch Environ Contam Toxicol 1989;18:308-314.
(25) Food and Drug Administration (FDA). CPG Sec. 555.400 Foods - Adulteration with Alfatoxin. 12-9-2009. 6-212010.
Ref Type: Online Source
(26) Andersen F. Final Report on the Safety Assessment of Corylus Avellana (Hazel) Seed Oil, Corylus Americana
(Hazel) Seed Oil, Corylus Avellana (Hazel) Seed Extract, Corylus Americana (Hazel) Seed Extract, Corylus
Rostrata (Hazel) Seed Extract, Corylus Avellana (Hazel) Leaf Extract, Corylus Americana (Hazel) Leaf Extract, and
Corylus Rostrata (Hazel) Leaf Extract. IJT 2001;20:15-20.
(27) Food and Drug Administration (FDA). Frequency of use of cosmetic ingredients. FDA database 2010.
(28) Personal Care Products Council. Updated Concentration of Use - Butyrospermum Parkii (Shea) Butter, et al.
Unpublished data. 7-26-2010.
Ref Type: Generic
(29) Andersen F. Annual Review of Cosmetic Ingredient Safety Assessments - 2002/2003. IJT 2005;24:1-102.
(30) James AC, Stahlhofen W, Rudolf G et al. Annexe D. Deposition of inhaled particles. Annals of the ICRP
1994;24:231-2.
(31) Oberdorster G, Oberdorster E, Oberdorster J. Nanotoxicology: An Emerging Discipline Evolving from Studies of
Ultrafine Particles. Environmental Health Perspectives 2005;113:823-839.
(32) Bower D. Unpublished information on hair spray particle sizes provided at the September 9, 1999 CIR Expert Panel
meeting. 1999.
(33) Johnson MA. The Influence of Particle Size. Spray Technology and Marketing 2004;November:24-27.
(34)
1976, Council Directive 1976/768/EEC of 27 July 1976 on the Approximation of the Laws of the Member States
Relating to Cosmetic Products, as amended through Commission Directive 2008/42/EC.: 2008.
31
CIR Panel Book Page 183
(35) American Soybean Association. Soy Stats 2010 - World Vegetable Oil Consumption 2009. 2010. 4-14-2010.
Ref Type: Online Source
(36) Elder R. Final Report on the Safety Assessment of Sweet Almond Oil and Almond Meal. JACT 1983;2:85-99.
(37) Said T, Dutot M, Christon R et al. Benefits and side effects of different vegetable oil vectors on apoptosis, oxidative
stress, and P2X7 cell death receptor activation. Invest Ophthalmol Vis Sci 2007;48:5000-5006.
(38) Said T, Dutot M, Labbe A, Warnet J-M, Rat P. Ocular burn: Rinsing and healing with ionic marine solutions and
vegetable oils. Ophthalmologica 2009;223:52-59.
(39) IARC. Glycidol. IARC Monographs[77], 469-486. 2000. 4-20-2010.
Ref Type: Serial (Book,Monograph)
(40) IARC. Epoxides. IARC Monographs[11], 125-209. 1976. 4-20-2010.
Ref Type: Serial (Book,Monograph)
(41) Federal Institute for Risk Assessment. Initial evaluation ofhte assessment of levels of glycidol fatty acid esters
detected in refined vegetable fats--B&R opinion no. 007/2009. 2009. 3-10-2009.
Ref Type: Report
(42) Weisshauer R. Fatty acid esters of 3-MCPD: overview of occurences in different types of foods. 2009. Chemisches
und Veterinaruntersuchungsaut (CUUA).
Ref Type: Report
(43) Singh B, Kale R, Rao A. Modulation of antioxidant potential in liver of mice by kernel oil of cashew nut
(Anacardium occidentale) and its lack of tumour promoting ability in DMBA induced skin papillomagenesis. Indian
J Exp Biol 2004;42:373-377.
(44) de Groot AC. Adverse Reactions to Cosmetics. Port Washington, NY: Scholium International, Inc, 1988.
(45) Yunginger J, Calobrisi S. Investigation of the allergenicity of a refined peanut oil-containing topical dermatologic
agent in persons who are sensitive to peanuts. Cutis 2001;68:153-155.
(46) Consumer Product Testing Co. Repeated insult patch test of a lipstick containing 0.509847% Plukentia Volubilis
Seed Oil. Experiment reference number: C08-5394.06. Unpublished data. 2008. Consumer Product Testing Co.
Ref Type: Generic
(47) Brown A, Koett J, Johnson D et al. Effectiveness of kukui nut oil as a topical treatment for psoriasis. Int J Toxicol
2005;44:684-687.
(48) Hirao A, Oiso N, Matsuda H, Kawara S, Kawada A. Occupational allergic contact dermatitis due to cashew nut oil.
Contact Dermatitis 2008;59:131-132.
(49) Sugiura K, Sugiura M. Di-isostearyl malate and macademia nut oil in lipstick caused cheilitis. J Eur Acad Dermatol
Venereol 2009;23:606-607.
(50) Swern, D (ed). Bailey's Industrial Oil and Fat Products. 4th ed. John Wiley & Sons, Inc., 1979.
(51) Center for New Crops & Plant Products. Aleurites moluccana (L.) Willd. NewCROP . 1997. Department of
Horticulture and Landscape Architecture, 625 Agriculture Mall Drive, West Lafayette, IN 47907-2010, Purdue
University. 5-20-2010.
Ref Type: Online Source
(52) John L. Seaton & Co., Ltd. Seatons Kukui Nut Oil. 2006. John L. Seaton & Co. Limited.
Ref Type: Generic
(53) John L. Seaton & Co., Ltd. Seatons Refined Kukui Nut Oil Specification. 2006. John L. Seaton & Co. Limited.
32
CIR Panel Book Page 184
33
CIR Panel Book Page 185
(70) Center for New Crops & Plant Products. Anacardium occidentale L. NewCROP . 12-22-1997. Department of
Horticulture and Landscape Architecture, 625 Agriculture Mall Drive, West Lafayette, IN 47907-2010, Purdue
University. 5-20-2010.
Ref Type: Online Source
(71) Center for New Crops & Plant Products. Arachis hypogaea L. NewCROP . 1997. Department of Horticulture and
Landscape Architecture, 625 Agriculture Mall Drive, West Lafayette, IN 47907-2010, Purdue University. 5-202010.
Ref Type: Online Source
(72) Center for New Crops & Plant Products. Cocos nucifera L. NewCROP . 1996. Department of Horticulture and
Landscape Architecture, 625 Agriculture Mall Drive, West Lafayette, IN 47907-2010, Purdue University. 5-202010.
Ref Type: Online Source
34
CIR Panel Book Page 186
Data
1
13
4
25
10
6
1
2
1
5
3
9
7
2
4
40
8
27
29
12
2
1
3
55
1
9
9
1
1
2
64
2
29
5
1
7
1
3
59
11
45
200
4
266
22
25
7
72
5
5
1
2
8
5
1
2
1
3
4
1
1
3
1
1
3
2
1
1
1
1
2
7
1
1
3
4
2
1
4
2
1
1
1
1
2
1
8
1
1
1
2
1
1
5
41
30
22
7
10
14
1
1
1
3
1
1
1
4
1
9
4
7
8
1
03B - Eyeliner
03C - Eye Shadow
03D - Eye Lotion
03F - Mascara
03G - Other Eye Makeup Preparations
04E - Other Fragrance Preparation
05A - Hair Conditioner
05F - Shampoos (non-coloring)
05G - Tonics, Dressings, and Other Hair Grooming Aids
05I - Other Hair Preparations
07A - Blushers (all types)
07B - Face Powders
07E - Lipstick
07F - Makeup Bases
07G - Rouges
07I - Other Makeup Preparations
08A - Basecoats and Undercoats
08E - Nail Polish and Enamel
12A - Cleansing
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12F - Moisturizing
12G - Night
12H - Paste Masks (mud packs)
12I - Skin Fresheners
12J - Other Skin Care Preps
13A - Suntan Gels, Creams, and Liquids
13B - Indoor Tanning Preparations
8
9
1
1
3
2
3
4
1
1
7
3
11
11
5
6
1
27
5
24
18
31
7
3
1
6
3
5
1
1
1
1
1
1
1
1
1
2
1
2
2
1
3
4
1
2
1
1
1
2
3
7
4
2
1
1
2
1
2
1
1
4
2
4
8
3
1
5
7
5
6
8
7
3
1
3
1
33
1
4
7
1
6
6
1
1
17
32
90
2
195
17
6
1
41
1
3
09A - Dentifrices
09B - Mouthwashes and Breath Fresheners
10A - Bath Soaps and Detergents
10E - Other Personal Cleanliness Products
11A - Aftershave Lotion
11F - Shaving Soap
12A - Cleansing
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12F - Moisturizing
12G - Night
12H - Paste Masks (mud packs)
12I - Skin Fresheners
12J - Other Skin Care Preps
2
2
13
2
1
1
5
28
14
28
1
5
6
7
1
3
4
2
2
1
2
1
1
2
7
1
1
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
COCONUT ACID
1
1
1
2
8
99
2
1
15
1
5
1
1
1
1
1
8
7
3
1
11
7
3
4
3
8
3
1
5
50
21
28
40
37
65
1
3
3
3
4
1
44
12
2
3
147
14
6
9
20
4
13
65
1
82
3
3
3
24
13
8
2
1
2
3
1
1
2
1
3
4
07E - Lipstick
07I - Other Makeup Preparations
10A - Bath Soaps and Detergents
10E - Other Personal Cleanliness Products
11E - Shaving Cream
11F - Shaving Soap
12A - Cleansing
12C - Face and Neck (exc shave)
12D - Body and Hand (exc shave)
12F - Moisturizing
12H - Paste Masks (mud packs)
12J - Other Skin Care Preps
13B - Indoor Tanning Preparations
10
4
16
2
1
1
3
10
7
21
1
9
2
MAGNESIUM COCOATE
POTASSIUM COCOATE
POTASSIUM COCOATE
POTASSIUM COCOATE
POTASSIUM COCOATE
POTASSIUM COCOATE
POTASSIUM COCOATE
2
18
8
3
1
8
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
SODIUM COCOATE
5
3
1
65
1
4
226
12
1
2
2
12
1
5
1
3
8
7
6
1
2
5
16
6
2
7
3
5
1
1
3
5
3
1
19
5
9
1
3
3
9
10
52
1
5
28
7
64
2
23
2
32
50
37
1
3
9
1
15
128
4
1
41
4
2
1
59
2
42
17
1
7
2
45
2
153
269
8
516
84
21
4
107
11
21
7
1
2
1
3
12
2
1
1
3
4
1
2
2
3
4
1
2
5
1
8
1
2
2
5
1
2
3
1
8
15
7
1
15
12
1
7
1
1
2
1
2
3
1
3
2
14
23
1
5
1
1
2
3
1
5
5
2
14
1
3
4
2
1
1
11
1
1
2
2
1
Personal Carei
Products Council
Committed to Safety,
Quality & Innovation
Memorandum
TO:
[i to
FROM:
DATE:
SUBJECT:
Consumer Product Testing Co. 2008. Repeated insult patch test of a lipstick containing 0.509847%
Plukenetia Volubilis Seed Oil. Experiment Reference Number C08-5394.06.
202.331.1770
202.331.1969 (fax)
www.personalcarecouncil.org
Personal Care
Products Counci
Committed to Safety,
Quality & Innovation
Memorandum
TO:
FROM:
John Bailey,
Industry Liaison to the CIR Expert Panel
DATE:
SUBJECT:
John L Seaton & Co Ltd. 2005. Seatons Arachis Oil Data sheet.
John L Seaton & Co Ltd. 2010. Arachis Oil BP/EP Specification.
John L Seaton & Co Ltd. 2005. Seatons Shea Nut Butter Data sheet.
John L Seaton & Co Ltd. 2009. Seatons Refined Shea Nut Butter Specification.
John L Seaton & Co Ltd. 2005. Seatons Hazelnut Oil Data sheet.
John L Seaton & Co Ltd. 2010. Seatons Refined Hazelnut Oil Specification.
John L Seaton & Co Ltd. 2005. Seatons Macadamia Oil Data sheet.
John L Seaton & Co Ltd. 2010. Seatons Refined Macadamia Oil Specification.
John L Seaton & Co Ltd. 2006. Seatons Kukui Nut Oil Data sheet.
John L Seaton & Co Ltd. 2006. Seatons Refined Kukui Nut Oil Specification.
John L Seaton & Co Ltd. 2005. Seatons Sweet Almond Oil Data sheet.
John L Seaton & Co Ltd. 2009. Seatons Refined Sweet Almond Oil Cosmetic Blend Specification.
202.331.1770
202.331.1969 (fax)
www.personalcarecouncil.org
Typical properties
Free fatty acids
Iodine value
Saponification value
Relative density @ 20C
Refractive index @ 40C
Colour, Lovibond 5.25 cell
Required HLB value
0.5 max
80- 106
185 195
0.9 12 0.920
1.462 1.464
20 yellow, 2.5 red max
6
7- 16%
1 6%
35 72%
13 43%
0.6% max
Registration information
INCI name
CAS number
EINECS number
Non-warranty
Information in this leaflet is given in good faith. John L Seaton & Co Ltd and its associate companies cannot assume
any liability expressed or implied in the presentation of this data, nor should information contained herein be construed
as granting licence to practise any methods or compositions of matter covered by British or other patents. Details are
correct at the date of issue (April 2005).
John L Seaton & Co Ltd
First Floor 7 Waterside Business Park Livingstone Road
Hessle East Yorkshire HU13 OEG United Kingdom
Tel + 44 (0)1482 579700 Fax + 44 (0)1482 647313
Website www.croda.com/seatons
Email cosmetic@seatons-uk.co.uk
CIR Panel Book Page 212
Specification
Product
Definition
Arachis oil is the fixed oil obtained from the shelled seeds of Arachis hypogaea
(L) and further refined. It conforms to the monograph contained in the British
Pharmacopoeia 2010 and European Pharmacopoeia 6.0.
Characteristics
P9046
Test
Range
Mm
Acid value
Peroxide value
Unsaponifiable matter
Alkaline impurities
Max
0.5
5.0
British Pharmacopoeia
1.0% w/w
Method
Mm
-
0.3%
Max
0.4%
7.0%
16.0%
1.3%
6.5%
35.0%
72.0%
13.0%
43.0%
0.6%
0.5%
3.0%
0.5%
2.1%
1.0%
5.0%
0.5%
0.5%
3.0%
Storage conditions
Arachis oil should be kept in a well filled, well closed container and protected
from light.
Issued by
PA Bentley
Date of issue
Confirmed
August2009
January 2010
Typical properties
Acid value
Iodine value
Saponification value
Colour, Lovibond 5.25 cell
Slip melting point
Required HLB value
1.5 max
45-73
165-190
20 yellow, 3 red max
28 42CC
8
3-9%
34-48%
38-50%
3-8%
0.5% max
45%
47%
6%
0
Registration information
INCI name
CAS number
EINECS number
Non-warranty
Information in this leaflet is given in good faith. John L Seaton & Co Ltd and its associate companies cannot assume
any liability expressed or implied in the presentation of this data, nor should information contained herein be construed
as granting licence to practise any methods or compositions of matter covered by British or other patents. Details are
correct at the date of issue (April 2005),
John L Seaton & Co Ltd
First Floor 7 Waterside Business Park Livingstone Road
Hessle East Yorkshire HU13 OEG United Kingdom
Tel + 44 (0)1482 579700 Fax + 44(0)1482647313
Website www.croda.com/seatons
Email cosmetics@seatons-uk.co.uk
CIR Panel Book Page 214
Specification
Product
Description
Speciality vegetable oil obtained from the kernels of the Shea tree
(Butyrospermum parkii)
P9010
Test
Range
Mm
Method
Max
Physical Properties
Appearance
Visual
Chemical Properties
Free fatty Acid content (% as oleic)
Iodine Value (gI
JlOOg oil)
2
Peroxide value 2
(meqO
l
kg)
45
-
1.0
73
5.0
GLC
2.0
8.0%
36.0
50.0%
40.0
50.0%
4.0
8.0%
3.0%
Typical properties
Acid value
Iodine value
Saponification value
Relative density @ 15.5C
Refractive index @ 20C
5 9%
0.5% max
1 -4%
66 83%
8 25%
0.6% max
Registration information
INCI name
CAS number
EINECS number
Non-warranty
Information in this leaflet is given in good faith. John L Seaton & Co Ltd and its associate companies cannot assume
any liability expressed or implied in the presentation of this data, nor should information contained herein be construed
as granting licence to practise any methods or compositions of matter covered by British or other patents. Details are
correct at the date of issue (April 2005).
Specification
Product
Description
P9062
Test
Range
Mm
Colour
187
-
Method
Max
25 Yellow 2.5 Red
197
10.0
0.2
83
90
5.0
9.0%
GLC
C16:0
Palmitic acid
C16:1
Palmitoleic acid
018:0
Stearic acid
2.0
6.0%
018:1
Oleic acid
68
85%
C18:2
Linoleic acid
7.0
15.0%
018:3
Linolenic acid
1.0%
0.5%
Non-warranty
The information in this publication in belieued to be accurate and is given in good faith but no representation or warranty as to its completeness or accuracy is made.
Suggestions for uses or applications are only opinions. Users are responsible for determining the suitability of these products for their own particular purpose.
No representation or warranty, eupress or implied, is made with respect to information or products including without limitation warranties of merchantability or fitness
for a particular purpose or non-infringement of any third party patent or other intellectual property rights including without limit copyright, trademark and designs.
Any trademarks identified herein are trademarks of the Croda group of companies.
Typical properties
Free fatty acids
Iodine value
Saponification value
Relative density20C
0.5 Max
70 80
190 -200
0.911 -0.918
1.466
7
7.5 10%
1624%
2-4%
53-67%
1.5-4%
0.5% max
1.5 3%
1.5 3%
7% max
82%
14%
4%
0
Registration information
INCI name
CAS number
EINECS number
1.470
Non-warranty
Information in this leaflet is given in good faith. John L Seaton & Co Ltd and its associate companies cannot assume
any liability expressed or implied in the presentation of this data, nor should information contained herein be construed
as granting licence to practise any methods or compositions of matter covered by British or other patents. Details are
correct at the date of issue (April 2005).
John L Seaton & Co Ltd
First Floor 7 Waterside Business Park Livingstone Road
Hessle East Yorkshire HU13 OEG United Kingdom
Tel + 44(0)1482 579700 Fax + 44(0)1482647313
Website www.croda.com/seatons
CIR Panel Book Page 218
Email cosmetics@seatons-uk.co.uk
Specification
Product
Description
P9014
Test
Range
Mm
Appearance
Peroxide (meqO
lkg)
2
10.0
Method
Max
62
Visual
BS 684 : Section 2.14
1.0
82
GLC
C16:0
Palmitic acid
6.0
12.0%
C16:1
Palmitoleic acid
12.0
25.0%
C18:0
Stearicacid
0.5
8.0%
C18:1
Oleic acid
50.0
67.0%
C18:2
Linoleic acid
C20:0
Arachidic acid
5.0%
5.0%
Non-warranty
The informahon in this publication is believed to be accurate and is given in good faith but no representation or warranty as to its completeness or accuracy is made.
Suggestions for uses or applications are only opinions. Users are responsible for determining the suitability of these products for their own particular purpose.
No representation or warranty, eopress or implied, is made with respect to information or products including without limitation warranties of merchantability or fitness
for a particular purpose or noninfringenient of any third party patent or other intellectual property rights including without limit copyright, trademark and designs.
Any trademarks identified herein are trademarks of the Crude group of companies,
Typical properties
Appearance
Free fatty acids
Iodine value
Saponification value
Relative density @ 15.5C
Refractive index @ 20C
5-8%
2 5%
15- 30%
35 45%
24 34%
Registration information
INCI name
CAS number
EINECS number
Non-warranty
Information in this leaflet is given in good faith. John L Seaton & Co Ltd and its associate companies cannot assume
any liability expressed or implied in the presentation of this data, nor should information contained herein be construed
as granting licence to practise any methods or compositions of matter covered by British or other patents. Details are
correct at the date of issue (June 2006).
Specification
Product
Description
J9073-00
Test
Range
Mm
Physical status
25C
Colour
Method
Max
Liquid
Visual
Light yellow
Visual
5.0
Acid value
1.0
Unsaponifiable matter
Density
AOCS Cd3a-63
1.0%
@ 20C
0.920
0.930
ASTM D1298-85
Refractive Index
1.470
1.480
ASTM D1248-92
Iodine value g1
/100g
2
130
175
AOCS Tg2a-64
185
210
6.0%
7.0%
0.5%
C18:0 Stearic
0.1%
C18:1 Oleic
10.0%
C18:2 Linoleic
35%
50%
C18:3 x-Linolenic
25.0%
40.0%
35.0%
C20:0 Arachidic
1.5%
C20:1 Eicosenoic
1.0%
Issued by
Authorised by
S M Pritchard
P A Bentley
Non-warranty
Information in this leaflet is given in good faith. John L Seaton & Co Ltd and its associate companies cannot assume any
liability expressed or implied in the presentation of this data, nor should information contained herein be construed as
granting licence to practise any methods or compositions of matter covered by British or other patents. Specification
details are correct at the date of issue.
Updated April 2006
John L Seaton & Co limited
First Floor, 7 Waterside Business Park. Livingstone Road
Hessle, East Yorkshire, HU 13 OEG, United Kingdom
Tel + 44(0)1482579700 Fax + 44(0)1482647313
Website: www.croda.com/seatons
Email: cosmetics@seatons-uk.co.uk
Typical properties
Free fatty acids
Iodine value
Saponification value
Relative density @ 20C
Refractive index @ 20C
Colour, Lovibond 5.25 cell
Required HLB value
1% max
93-105
185-195
0.911-0.920
1.467-1.473
3.5R max
7
6%
3%
69%
17%
0.4%
Registration information
INCI name
CAS number
EINECS number
Non-warranty
Information in this leaflet is given in good faith. John L Seaton & co Ltd and its associate companies cannot assume
any liability expressed or implied in the presentation of this data, nor should information contained herein be construed
as granting licence to practise any methods or compositions of matter covered by British or other patents. Details are
correct at the date of issue (April 2005).
Specification
Product
Description
A blend of refined sweet almond oil and other refined vegetable oils
P9053
Test
Range
Max
Mm
Appearance
Specific gravity
Refractive
Method
@
Index @ 20C
20C
0.910
BS 718
1.465
1.475
185
200
10.0
lkg)
2
Peroxide (meqO
Acid value (mgKOH/g)
Iodine value gl
/lOOg
2
95
0.5
109
Palmitic acid
C16:1
Palmitoleic acid
C18:0
Stearic acid
Visual
0.930
GLC
3.0
9.0%
2.0%
1.0
3.0%
75.0%
C18:1
Oleic acid
60.0
C18:2
Linoleic acid
20.0
C18:3
Linolenic acid
30.0%
0.5%
C20:0
Arachidic acid
0.3%
C20:1
Gadoleic acid
0.3%
C22:0
Behenic acid
0.8%
C24:0
Lignoceric acid
0.5%
Non-warranty
The information In this publication is believed to be accurate and is given in good faith but no representation or warranty as to its completeness or accuracy is macfe
Suggestions for uses or applications are only opinions. Users are responsible for determining the suitability of these products for their own particular purpose.
No representation or warranty, express or implied, is made with respect to information or products including without limitation warranties of merchantability or fitness
for a particular purpose or non-infringement of any third party patent or other intellectual property rights induding without limit copyright, trademark and designs.
My trademarks identified herein are trademarks of the Croda group of companies.
Personal Care
Products Council
Committed to Safety,
Quality & Innovation
Memorandum
TO:
FROM:
DATE:
SUBJECT:
The 80% face product in the original table is actually a mask that is diluted to 30% Butyrospermum
Parkii (Shea) Butter before use. The attached updated table reflects this change.
202.331.1770
202.331.1969 (fax)
www.personalcarecouncil.org
Ingredient
Product Category
Concentration
of Use
0.1-5%
0.0 1-0.3%
1%
Eyebrow pencil
0.1-6%
Eyeliner
0.1-8%
Eye shadow
0.5-6%
Eye lotion
0.5-7%
Mascara
0.5%
Perfumes
0.2-0.8%
0.00 1-1%
Hair conditioners
0.0005-1%
Hair straighteners
0.1-1%
Shampoos (noncoloring)
0.001-1%
0.1-2%
0.5-3%
0.1-1%
Face powders
0.2-2%
Foundations
0.4-20%
Page 1 of 6
6%
Lipstick
0.5-26%
1-6%
Cuticle softener
18-60%
2-25%
0.05%
3%
0.01%
0.003-3%
Deodorants (underarm)
1%
0.1-5%
Aftershave lotions
0.2-4%
0.0 1-2%
0.03-10%
Depilatories
0.3%
0.04-19%
0.4-45%
1%
1-3%
0.003-11%
0.03-6%
0.1-30%
0.01-16%
0.5-8%
2%
Page 2 of 6
0.03%
Bubble baths
1%
0.03-1%
Eyebrow pencil
0.2%
Eye lotion
0.5-2%
Hair conditioners
0.0 1%
1%
1%
Foundations
0.009%
Lipstick
0.1-6%
0.0 1%
0.03-1%
Deodorants (underarm)
0.03%
0.03%
0.006-1%
Depilatories
0.0 1-0.3%
2%
0.02-5%
0.5-1%
0.3%
0.1%
0.5%
Eyebrow pencil
0.2%
Eyeliner
0.7%
Page 3 of 6
]_1%
Unsaponifiables
Butyrospermum Parkii (Shea) Butter
Unsaponifiables
Eye shadow
0.4%
2%
0.06%
Face powders
0.2-1%
Lipstick
1-3%
Rouges
0.06%
3%
1%
2%
2%
1%
Bubble baths
1%
Lipstick
15%
0.01-1%
0.6%
Aftershave lotions
1%
1%
1%
1%
1%
Page 4 of 6
powders
Hydrogenated Shea Butter
1%
0.1%
2%
Hair conditioners
0.00 1%
Shampoos (noncoloring)
0.001%
0.001%
3%
3%
0.1%
0.1-1%
0.1 %
Skin fresheners
2%
Bubble baths
1%
0.5%
Hair conditioners
0.1%
Shampoos (noncoloring)
0.3%
0.02%
0.1-3%
Douches
0.1%
1%
0.1%
0.002-1%
Page 5 of 6
Lipstick
*Ingredients included in the title of the table, but not found in the table were included in the survey, but
no uses were reported.
11% in a face highlighter
21% in a shower gel
O. 1% in a rinse-off product
43%
in a hand scrub
Information collected in 2009
Table prepared September 17, 2009
Updated July 26, 2010
Page 6 of 6
Personal Care
Products Council
Committed to Safety,
Quality & Innovation
Memorandum
F. Alan Andersen, Ph.D.
Director COSMETIC INGREDIENT REVIEW (CIR)
TO:
3-(ri Ii
FROM:
DATE:
SUBJECT:
pA In the Introduction, please change as they are used in cosmetic ingredients. to as they are used
in cosmetic products.
p.4 In the Introduction, please change triglycerides composed of mixtures of fatty acids to
triglycerides containing various fatty acids.
p.4- At the start of the Chemistry section, please clarify what is meant by The group. Fats and oils
are not just derived from plants as this paragraph seems to imply.
p.8 Is it correct to call all the oils in this report edible?
p.8 Unless there was evidence of dermal absorption of Prunus Amygdalus Dulcis (Sweet Almond)
Oil, please change percutaneous absorption to percutaneous exposure.
p.10 Please indicate the number guinea pigs and types of assays, e.g., maximization, in which the
sensitization potential of Cocos Nucifera (Coconut) Oil and Hydrogenated Coconut Oil was
studied. If studies were done on both substances, both substances should be in the subsection
heading.
p.10 Please provide the type of in vitro studies that were used to study the potential ocular effects of
Aleurites Moluccana Seed Oil. What species was used in the in vivo study?
p.12 As Singh et al. (2004) (reference 41) completed a tumor promotion study, did they include a
conclusion regarding the tumor promoting potential of Anacardium Ocidentale (Cashew) Seed
Oil?
p.14- The following is not a complete sentence. A bar soap contining 13% coconut oil evaluated for
skin irritation using standard Draize procedures.
p.15 It would be helpful to indicate the number of subjects treated with cosmetic formulations
containing 25% Prunus Amygdalus Dulcis (Sweet Almond) Oil.
p.17, Item 5 As the oils are triglycerides not mixtures of fatty acids, having irritation and sensitization
testing of individual fatty acids is not necessary. If irritation and sensitization data on the fatty
acids is needed, CIR staff should look for published information. Searching PubMed for
Linolenic Acid and sensitization the following was the first reference identified.
Kreilling R, Hollnagal HM, Hareng L, et al. 2008. Comparison of the skin sensitization
potential of unsaturated compounds as assessed by the murine local lymph node
-
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www.personalcarecouncil.org
assay (LLNA) and the guinea pig maximization test (GPMT). Food Chemical
Toxicology 46(6): 1896-1904.
p.17 Request 6 is not clear. If this review is focused only on the composition of the ingredients and
the dermal effects of the ingredients, why is any other information that pertains to the safety of
use in cosmetics necessary? Requests to industry should reflect the same criteria CIR staff
used for identifying information in the published literature. If all types of safety information are
needed from industry, CIR staff need to go back and identify all the relevant published safety
information on these oils.
-