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Cosmetic Toxi

Cosmetic Toxi

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CHAPTER
37
Cosmetic Toxicology
JOHN F. CORBETT, RAJ K. SHARMA, WILLIAM E. DRESSLER
Bristol-Myers Squibb Worldwide Beauty Care, Stamford, Connecticut
INTRODUCTIONCOSMETIC SAFETY REGULATIONDecorative cosmetics and fragrances have beenpart of almost every culture for many thousands ofyears but a formal approach to the toxicological eval-uation of cosmetic products has only evolved duringthe 20th century. Initially; the evaluation involvedonly dermal, ocular, and, in some cases, mucousmembrane irritation toxicity and allergenicity via theDraize eye and skin tests in rabbits and guinea pigs.This was sometimes followed by clinical studies inhumans.The recognition that the skin was not an imperme-able barrier to topically applied materials requiredthat systemic toxicity, including both acute andchronic effects, also be taken into account. For themost part, and for obvious reasons, ingredients usedin products subject to incidental ingestion, such aslipstick, have received particular attention, followedby those used in the eye area and products applied toand left on the skin, while rinse-off products, exceptfor hair dyes, have been of least concern.This chapter will consider the scope of testing thatis generally accepted as desirable for cosmetic prod-ucts, together with the chemical nature of the activeingredients used in selected specialized hair productssuch as dyes, bleaches, permanent waves, andstraighteners. For other varied types of cosmetic prod-ucts, use experience and some general principles re-garding safety evaluation and risk assessment will bediscussed. In addition, reference will be made to theparticular requirements for and methods of reviewsof safety data in the European Union, the UnitedStates and Japan.
The United States
In the U.S., the Food, Drug and Cosmetic Act des-ignates the Food and Drug Administration as theagency responsible for cosmetic safety.For this purpose, the FDA has defined cosmetics as"articles to be rubbed, poured, sprinkled, or sprayedon or introduced into, or otherwise applied to thehuman body or any part thereof for cleansing, beau-tifying, promoting attractiveness, or altering the ap-pearance, and articles intended for use as a compo-nent of any such articles; except that such term shallnot include soap." The exemption for soap appliesonly to a composition consisting of an alkali metal saltof a fatty acid that is intended only for cleansing.Certain cosmetic products that are "intended foruse in the diagnosis, cure, mitigation, treatment orprevention of disease" are classified by FDA as drugs.This category includes sunscreen products, anticavitytoothpastes, antiperspirants (as opposed to deodor-ants, which are "cosmetics"), antidandruff prepara-tions, "medicated" skin lotions and liquids, skin pro-tectants, and hair restorers.Under the regulations, the active ingredients in cos-metic drug products must be safe and effective ac-cording to the appropriate monograph covering theclaimed indication.The only category of cosmetic ingredient subject toFDA approval is colors used for purposes other thandyeing the hair. There are only 36 "certified colors"and 23 "permitted" colors available for general use incosmetics, and a further 7 that are permitted only for
TOXICOLOGY
899
Copyright 9 1999 Academic Press.All rights of reproduction in any form reserved.
 
900 Corbett
et al.
specific uses. In addition, a number of lakes of thesoluble certified colors are available.For all other cosmetic ingredients, the safety eval-uation is the responsibility of the manufacturer. Inorder to assist its members in this, the Cosmetic, Toi-letry, and Fragrance Association (CTFA) establishedin 1976 the Cosmetic Ingredient Review (CIR) to re-view all the available data on an ingredient and todecide whether the ingredient is safe under the con-ditions of use. The CIR expert panel comprises sixindependent scientists as voting members and a non-voting member representing each of the CTFA, theFDA, and the consumer. By 1996, the CIR had re-viewed over 600 ingredients, finding 64% to be safeas used, 27% to be safe for use under defined condi-tions, 8% to have insufficient data, and five ingredi-ents to be unsafe.The CIR expert panel currently requests the follow-ing as a minimum data requirement for reviewing thesafety of the cosmetic ingredients that are on its pri-ority list:1. Current concentration of use data.2. Chemistry data, including method of manufactureand impurities.3. UV-absorption data; if absorption occurs in theUVA or UVB range, photosensitization data areneeded.4. Skin-irritation and -sensitization data at concentra-tions of use in humans.5. Dermal-absorption data; if significant dermal ab-sorption occurs, 28-day dermal-toxicity and devel-opment-toxicity data are needed.6. Two genotoxicity studies, one using a mammaliansystem; if positive, a 2-year dermal carcinogenicityassay performed using NTP methods is needed.Additional studies may be requested based on thenature and use of the ingredient.
The European Union
In the European Union, cosmetics are regulated un-der the Cosmetics Directive (76/768/EEC) of 1976 andamendments thereto. For the purpose of regulation,cosmetics are more broadly defined than in the UnitedStates, viz. "any substance or preparation intended tobe placed in contact with various external parts of thehuman body (epidermis, hair system, nails, lips andexternal genitalia) and with the teeth or mucous mem-branes of the oral cavity with a view exclusively ormainly to cleaning them, perfuming them, changingtheir appearance and/or correcting body odors and/or protecting them or keeping them in good condi-tion." This definition covers many of the product cat-egories that are considered to be over-the-counterdrugs in the U.S.In common with the United States, cosmetics donot require premarket clearance in Europe. However,certain ingredients, notably colorants (other than hairdyes), preservatives, and sunscreens, do require ap-proval before they can be used in cosmetic products.The list of permitted colorants (Annex IV) is broaderthan the U.S. list, comprising 157 materials.The approval process involves the submission ofdata via COLIPA, the European trade association, tothe European Commission. The data is evaluated by agroup of independent experts who make up the Sci-entific Committee for Cosmetology and Non-FoodProducts (SCCNFP) and who decide whether the in-gredient can be accepted for listing in the appropriateAnnex. Data requirements are similar to those listedabove for the CIR.The General Toxicological Requirements for Cos-metic Ingredients (1996 revision) state:When requested, the manufacturer shall provide the Com-mission with the information set out below:1. Acute toxicity2. Dermal absorption3. Dermal rritation4. Mucous membrane irritation5. Skin sensitization6. Sub-chronic toxicity7. Mutagenicity8. Phototoxicity and Photomutagenciny (in case of UV-fight absorbing substances)9. Human data (if available)When considerable oral intake can be expected or when thedata or dermal absorption do indicate a considerable pene-tration of the ingredients through the skin, taking into ac-count the toxicological profile of the substance and its chem-ical structure, the following further information may benecessary:10. Toxicokinetics11. Teratogenicity, Reproduction toxicity, Carcinogenicity,and additional Genotoxicity.Additionally, there is now a legal requirement, for-realized in Article 7a of the sixth amendment to theCosmetics Directive, that cosmetic companies hold atechnical dossier of information on each of their prod-ucts. This requirement applies to every cosmetic prod-uct, both retail and professional, including importedproducts.This dossier must include information or productcomposition, specifications, and method of manufac-ture, as well as an assessment of product safety car-fled out by an appropriately qualified expert. Theassessment must take account of the general toxico-
 
Cosmetic Toxicology 901logical profile of the ingredients, their chemical struc-tures, and the potential levels of exposure.The SCC is also responsible for recommending thelisting of substances prohibited for use in cosmetics(Annex II) and substances that can be used with cer-tain limitations with regard to product category, con-centration, and/or special labeling requirements (An-nex III).In addition to these requirements, the EU regula-tion for the Notification of New Substances must befollowed by companies introducing new chemicals.These regulations state that "a material is consideredto be a new substahce within the EU if it is not listedin EINECS (European Inventory of Existing ChemicalSubstances)." EINECS is a closed list (closed in 1981),that is, no new substances can now be added.Substances not in EINECS must be notified accord-ing to Council Directive 92/32/EEC (seventh amend-ment to the EC Dangerous Substances Directive) priorto marketing in the EU. Notified substances are issuedin ELINCS (European List of New Chemical Sub-stances). ELINCS is an open list, that is, new sub-stances may be added once notified according to theDirective.The precise contents of a notification depend on thequantity of the substance to be placed or alreadyplaced on the market. The notification system isbanded, the information required increasing as thequantity of a substance placed on the market in-creases.
Japan
The Japanese regulation of cosmetics is the mostrestrictive. While the definition of a cosmetic is similarto that in the U.S., the number of product types con-sidered to be "quasi-drugs" (analogous to cosmeticdrugs or O.T.C. products) is much greater. Thus, inaddition to the U.S. categories, products to combatbad breath, bath preparations, hair dyes, permanentwaves, talcum powder, depilatories, shaving lotions,and skin packs are considered "quasi-drugs."In Japan, all cosmetic products are subject to pre-market approval by the Ministry of Health and Wel-fare and can contain only those ingredients includedin the Comprehensive Licensing Standards of Cosmet-ics by Category (CLS) and these must conform to cer-tain defined specifications. New ingredients can beadded to the list on the basis of the submission ofappropriate toxicological data.For quasi-drugs, there are lists of permitted activeingredients for use in hair dyes, permanent waves,and medicated toothpastes. Lists for other categoriesare being developed.For countries other than those discussed here, in-gredients acceptable in the United States and/or Eu-rope would usually be acceptable.
HAIR COSMETICSPermanent Waves
The conformational integrity of the hair fiber ismaintained by various interactions between proteinchains making up the cortex. These comprise polar(electrostatic) and nonpolar interactions between theside chains of the amino acids, hydrogen bonding,and covalent bonding--in particular the interchaindisulfide bonds of the amino acid cystine.A temporary set can be imparted to hair simply bywetting the hair, restraining it in the desired newconformation, and drying it while still constrained.On the release of the constraint, the hair will retainthe new conformation until it is again exposed to wa-ter or even to high humidity.If a more permanent effect is desired, it is necessaryto break and reform covalent bonds, as is done in theprocess of permanent waving. For this purpose, thiols(compounds containing the-SH group) have beenfound to be the most effective at reducing the disul-fide bond.Essentially the permanent wave process involvesabout six or seven steps:1. Rolling, in which a section of hair is wound onto aperm rod. In this step the hair may be first damp-ened with water or with the waving lotion.2. The application of waving lotion, if the hair wasdry-rolled or water-rolled, to the hair on the rodsin such a way as to saturate each hair mass.3. The creep step, in which the reduced hair is left onthe rods for about 20 minutes to allow movementof segments within the individual cortex.4. Water rinsing, which is then carried out with thehair still on the rods.5. Neutralization, in which the disulfide bonds arerebuilt. This step can be performed on or off therods depending on the desired end result.6. Rinsing to remove the excess neutralizer and otherchemicals, which is performed after removal of therods.7. Styling and drying.Because of the complexity of the process and theskill required to obtain satisfactory results, the market

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