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euxyl® K 120

Preservative for cosmetics & toiletries


euxyl® K 120
Product description MIC values
euxyl® K 120 is a liquid cosmetic preservative, which can be used Determination of the minimum inhibitory concentration in serial
in leave-on as well as rinse-off products. dilution tests produced the following values:
euxyl® K 120 is not recommended for products that are intended
for mucous membranes, or for lipsticks or toothpastes. Species ATCC-No. MIC value [%]
euxyl® K 120 has a broad, balanced spectrum of effect against
bacteria, yeasts and mould fungi. Gram-negative:
It acts in low use-concentrations. Enterobacter gergoviae 33028 0.03
Escherichia coli 11229 0.1
EU-INCI-declaration (active ingredients)* Klebsiella pneumoniae 4352 0.1
Methylchloroisothiazolinone Pseudomonas aeruginosa 15442 0.03
Methylisothiazolinone Pseudomonas fluorescens 17397 0.01
Pseudomonas putida 12633 0.03
US-INCI-declaration
Water (and) Gram-positive:
Methylchloroisothiazolinone (and) Staphylococcus aureus 6538 0.05
Methylisothiazolinone Staphylococcus epidermidis 12228 0.05

*Individual ingredients without auxiliaries.


Mould fungi:
For full INCI-declaration kindly contact us.
Aspergillus niger 6275 0.05
Penicillium funiculosum 36839 0.01
Microbiological effectiveness
euxyl® K 120 is equally effective against bacteria, yeasts and Yeasts:
mould fungi. It is a typically biostatic product with the biocidal Candida albicans 10231 0.01
properties necessary for practical use.
For euxyl® K 120 to perform effectively in destroying organisms Germ count reduction test
in products already contaminated, a minimum contact time of Dilutions of euxyl® K 120 are prepared with sterile tap water.
48 hours is necessary. Since the effect of euxyl® K 120 takes place 50 ml portions of the end solutions are inoculated with 0.5 ml
through chemical reactions with the microorganisms, when it is microorga­nism suspension (initial microorganism count approx.
used in hea­vily contaminated products loss of active ingredient 108 cfu/ml) and stirred.
must be taken into account.
Good production hygiene, as well as the use of raw materials Test organisms ATCC-No.
with low microorganism levels as a result of correct raw mate-
rial control are of course vital prerequisites for the production of Staphylococcus aureus 6538
microbiologically faultless finished products. Escherichia coli 11229
Candida albicans 10231
Aspergillus niger 6275

The solutions are streaked out onto tryptone soya agar or


Sabouraud-dextrose 4 % agar after 3, 6, 24, 48, 72 and 168 hours,
depending on the test organism. The cultures are incubated for
48 hours at 37 °C, except for Aspergillus niger, which is incubated
for 72 hours at 25 – 27 °C.
The evaluation is made on the basis of semi-quantitative assess-
ment of the microbial growth of the streaks.

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euxyl® K 120
In the table below, the microorganism reduction achieved by Use-concentrations
euxyl® K 120 as a function of the contact time and use-concentra-
tion is presented for the various test organisms: acc. schülke - acc. EU and ASEAN acc. CIR
recommendation Cosmetics Directive (USA)

Use-con- Contact time (h) Leave-on


Test organism
centration [%] 3 6 24 48 72 168 (i.e. creams, max. 0.05 % max. 0.10 % max. 0.05 %
Pseudomonas 0.0 (blank value) C C C C C C lotions etc.)
aeruginosa 0.05 C C + – – – Rinse-off
0.1 C C – – – – (i.e. shampoos,
0.03 – 0.10 % max. 0.10 % max. 0.10 %
bath prepara-
0.15 C C – – – – tions etc.)
0.2 C C – – – –
Recommended use-concentration are based on average active content. Please pay attention
Escherichia 0.0 (blank value) C C C C C C
to the corresponding certificate.
coli 0.05 C C C – – –
0.1 C C ++++ – – –
0.15 C ++++ +++ – – – The schülke recommended percentages relate to the complete
0.2 C +++ ++ – – – formulation in each case. The values given are recommended
Candida 0.0 (blank value) C C C C C C guides. The individual use-concentration is dependent on the
albicans 0.05 +++ – – – – – sensitivity of the product to microbial contamination, the choice
0.1 – – – – – – of raw materials and production hygiene.
0.15 – – – – – – The efficacy and optimum use-concentration should always be
0.2 – – – – – – determined in the end product with the aid of a preservation
Aspergillus 0.0 (blank value) C C C C C C load test (i.e. Schülke & Mayr GmbH Technical Service Depart-
niger 0.05 C C +++ + + + ment and Microbiology).
0.1 +++ ++ – – – –
All responsibility for determining the most effective percentage
0.15 ++ + – – – –
for a given use remains with the final product manufacturer since
0.2 + + – – – –
the optimal use-concentration level will vary due to product-
specific variables such as choice of raw materials, production
Symbol Finding Germ count/ml hygiene etc.

– no growth < 100 Japan (Standards for Cosmetics)


+ slight growth approx. 102 euxyl® K 120 is approved as a cosmetic preservative up
++ moderate growth approx. 103 to 0,10 % for cosmetics not used for mucosa and to be
+++ heavy growth approx. 104 washed away.
++++ massive growth approx. 105
C surface covered approx. 106 Indications for use
General
Repeated challenge test (schülke KoKo test) Temperature stability:
This method is used to determine the preservative effect of euxyl® K 120 should in principle only be incorporated into the
chemical preservatives in cosmetic formulations, e.g. creams, pro­duct to be preserved in the cooling phase at a temperature
lotions and shampoos. For this, in various test series the preser­ lower than 40 °C. In practice, adding euxyl® K 120 together with
vative to be tested is added in different concentrations to unpre- the fragrance has proved effective.
served samples. A constant microorganism load is achieved by
means of periodic inoculation (inoculation cycles) of the test pH stability:
preparations. High pH values (> 8) should be avoided when incorporating
Immediately before inoculation, samples of the individual prepa- euxyl® K 120.
rations are streaked out onto nutrient media.
The preservative effect is evaluated on the basis of the micro- Emulsions
orga­nism growth on the nutrient media. The longer the time to In practice, emulsions are preserved with 0.05 % euxyl® K 120
occurrence of the first microbial growth, the more effective is (corresponding to 7.5 ppm isothiazolinones). Products which con-
the preservative. Experience has shown that a well preserved tain proteins, caseins, fresh cell extracts, repair complexes or simi-
product should remain growth-free for six inoculation cycles in lar must in principle contain a higher proportion of preservative.
order to ensure the shelf-life in the original packaging required
in practice (30 months). Solutions
Oil/water and water/oil systems, as well as shampoos and bath For shampoos, bath preparations and hand cleansing prepara-
additives preserved with use-concentrations of between 0.05 tions good preservation results are achieved with 0.03 – 0.10 %
and 0.10 % euxyl® K 120 proved to be well preserved even after euxyl® K 120.
three months storage at + 40 °C.

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euxyl® K 120
Sun protection preparations Product-specific properties
In sun protection preparations we recommend not Material compatibility
exceeding a use-concentration of 0.05 % euxyl® K 120, cor- Concentrate
responding to 7.5 ppm isothiazolinones. In the material compatibility tests with the concentrate
of euxyl® K 120 stainless steel, polyethylene (PE), polycar-
Wet wipes bonate, polystyrene and hard polyvinyl chloride (hard PVC)
For wet wipes good preservation results are achieved with proved to be suitable materials for handling the undiluted
0.05 % euxyl® K 120. euxyl® K 120 is not recommended for product. Non-metallic materials must be tested for their
products that are intended for mucous membranes. suitability, polyamide should not be used. As sealing mate-
rial when hand­ling undiluted euxyl® K 120 polytetrafluor-
For other uses please contact us. ethylene (PTFE) or polymethylsiloxane (SI) should be
preferred. Other sealing materials could lead to severe
Chemical compatibility swelling or to pronounced discolouration of euxyl® K 120.
In general it is possible for interactions to occur between
various active ingredients and auxiliary substances in cos- Dilutions
metic formulations. euxyl® K 120 in 0.1 % aqueous solution showed material
Thus, certain incompatibilities of euxyl® K 120 with other compatibility behaviour which was not significantly diffe­
ingredients have been established, and are listed below. rent from that of the water used for dilution. No incompa­
tibilities with plastics have been observed with products
General preserved with euxyl® K 120.
euxyl® K 120 is fully effective in anionic as well as cationic
and non-ionic systems. High pH values (> 8) should be Please check the compatibility in individual cases.
avoided. Acidic pH values have no negative influence on
the effectiveness. Effect on surface tension
The addition of 0.2 % euxyl® K 120 in water has no effect on
Compatibility with surfactants the surface tension.
euxyl® K 120 proved to have good compatibility with
anionic surfactants such as sulphates, ether sulphates Foaming behaviour
and sulphosuccinates, as well as with non-ionogenic In the foaming test in accordance with DIN 53 902, 0.2 %
surfactants. solution of euxyl® K 120 in demineralised water proved to
be non-foaming.
Compatibility with sulphite ions
euxyl® K 120 is inactivated by sulphite ions. Solubility
Excessive sulphite > 10 ppm must be avoided. euxyl® K 120 is fully soluble in water.
In polar solvents such as 1,2-propylene glycol, propanol or
acetone, euxyl® K 120 is readily soluble.
In polyalcohols such as glycerol and sorbitol euxyl® K 120 is
readily soluble.
In aliphates with hydrophilic groups such as 2-octyldecanol
and isopropyl myristate, euxyl® K 120 is slightly soluble.
In pure aliphatic solvents it is insoluble.

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euxyl® K 120
General information

Descriptions of the individual substances Physical-chemical data

(Active ingredients without auxiliaries. For full INCI- Appearance: clear, colourless – light green liquid
declaration kindly contact us.) Odour: characteristic
Refractive index n20
D: approx. 1.341
O Density (20 °C): approx. 1.024 g/ml
Vapour pressure (20 °C): approx. 25 hPa
CI N CH C4H4CINOS Flash point (ISO 2719): > 100 °C
S 3
149.60 g/mol Flow time (DIN 53 211/20 °C): < 15 DIN seconds
CAS no.: 26 172-55-4 Viscosity (20 °C): approx. 1.2 mPa s
INCI name: Methylchloroisothiazolinone Water solubility (20 °C): in all proportions
Name according to 76/768/EEC: 5-Chloro-2-methyl-3-(2H)-
isothiazolone Storage
No. according to 76/768/EEC: 39 We recommend storing in the original container at room
EINECS name: 5-Chloro-2-methyl-(2H)- temperature.
isothiazol-3-one
EINECS no.: 247-500-7 Environmental information
schülke has DIN EN ISO 9001,  DIN EN 13485 and DIN EN ISO
14001 certification and a validated environmental manage-
O ment system in accordance with the Eco Audit Regulation.
The canisters and drums used by schülke are made of poly-
N CH C4H5NOS ethylene (HDPE) and are labelled accordingly.
S 3 115.15 g/mol The 1000 kg containers are affiliated to a recycling system
CAS no.: 2 682-20-4 that guarantees free pick-up and sensible utilisation of used
INCI name: Methylisothiazolinone containers throughout Europe.
Name according to 76/768/EEC: 2-Methyl-3-(2H)-isothiazolone The labels are made of PE. Our packaging materials contain
No. according to 76/768/EEC: 39 no PVC and are recyclable.
EINECS name: 2-Methyl-(2H)-isothiazol-3-one
EINECS no.: 220-239-6 Expert opinions
The toxicology and tolerance of the preservative
euxyl® K 120,
Dr. Susanne Hendrich, Schülke & Mayr GmbH,
July 2008

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schülke subsidiaries in:

Belgium China France Italy


S. A. Schülke&Mayr Belgium N.V. Schülke & Mayr GmbH Schülke France SARL Schülke & Mayr Italia S.r.l.
1830 Machelen Shanghai Representative Office 94250 Gentilly 20148 Milano
Phone +32-2-479 73 35 Shanghai 200041 Phone +33-1-49 69 83 78 Phone +39-02-40 21 820
Fax +32-2-479 99 66 Phone +86-21- 62 17 29 95 Fax +33-1-49 69 83 85 Fax +39-02-40 21 829
Fax +86-21- 62 17 29 97

Netherlands Switzerland United Kingdom USA


Schülke&Mayr Benelux B.V. Schülke & Mayr AG Schülke & Mayr UK Ltd. schülke inc.
2032 HA-Haarlem 8003 Zurich Sheffield S9 1AT Mt. Arlington, NJ 07856
Phone +31-23-535 26 34 Phone +41-44-466 55 44 Phone +44-114-254 35 00 Phone +1-973-770-7300
Fax +31-23-536 79 70 Fax +41-44-466 55 33 Fax +44-114-254 35 01 Fax +1-973-770-7302

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Our recommendations regarding our products are based on in-depth scientific testing in our Research Department;
they are given in good faith, but no liability can be derived from them. It is the responsibility of the final product
manufacturer to assure that claims made for the final product are in conformance with all applicable local laws. In other
respect our Conditions of Sale and Supply apply.

Schülke&Mayr GmbH
22840 Norderstedt | Germany
Phone | Fax +49 40 521 00- 0 | -244
www.schuelke.com | sai@schuelke.com
A company of the
Air Liquide Group
SAI_PC_ GB v_03

189 | II | 06.10 | B | Rako |


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