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euxyl® K 100

Preservative for cosmetics toiletries


euxyl® K 100
Product description MIC values
euxyl® K 100 is a liquid cosmetic preservative with a broad, Determination of the minimum inhibitory concentration in the
balanced spectrum of effect against bacteria, yeasts and mould serial dilution test produced the following values:
fungi. It acts even in very low use-concentrations and has good
vapour phase effectiveness. Species ATCC-No. MIC value [%]

EU INCI declaration (active ingredients)* Gram-negative:


Benzyl Alcohol Burkholderia cepacia
17759 0.06
Methylchloroisothiazolinone Enterobacter cloacae 13047 0.02
Methylisothiazolinone Escherichia coli 11229 0.03
Klebsiella pneumoniae 4352 0.02
US INCI declaration Proteus mirabilis 14153 0.03
Benzyl Alcohol (and) Pseudomonas aeruginosa 15442 0.06
Methylchloroisothiazolinone (and) Pseudomonas fluorescens 17397 0.02
Methylisothiazolinone Pseudomonas maltophilia 17444 0.03
* Individual ingredients without auxiliaries. Pseudomonas putida 12633 0.03
For full INCI-declaration kindly contact us.
Pseudomonas stutzeri 11607 0.03

Microbiological effectiveness Gram-positive:


euxyl® K 100 is equally effective against bacteria, yeasts and Bacillus subtilis 6633 0.25
mould fungi. It is a typically biostatic product with the biocidal Brevibacterium ammoniagenes 6871 0.13
properties necessary for practical use. Staphylococcus aureus 6538 0.25
For euxyl® K 100 to perform effectively in destroying or­ganisms Streptococcus lactis 19435 0.06
in products already contaminated, a minimum contact time of
48 hours is necessary. Mould fungi:
Since the effect of euxyl® K 100 takes place through chemical Aspergillus niger 6275 0.03
reactions with the microorganisms, when it is used in heavily Aspergillus oryzae (IAM 2961) 0.03
contaminated products loss of active ingredient must be taken Microsporum gypseum 16428 0.03
into account. Penicillium expansum (IMB 11203) 0.03
Good production hygiene, as well as the use of raw materials Penicillium funiculosum 36839 0.02
with low microorganism levels as a result of correct raw material Trichoderma viride (IMB 12098) 0.06
control are of course vital prerequisites for the production of Trichophyton mentagrophytes (CBS 11065) 0.06
microbiologically faultless finished products.
Yeasts:
Candida albicans 10231 0.03
Saccharomyces cerevisiae 9763 0.13

Germ count reduction test


Dilutions of euxyl® K 100 are prepared with sterile tap water.
50 ml portions of the end solutions are each inoculated with
0.5 ml microorganism suspension (initial microorganism count
approx. 108 cfu/ml) and stirred.

Test organisms ATCC-No.

Pseudomonas aeruginosa 15442


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 assessment of the microbial growth of
the streaks.

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euxyl® K 100
In the table below, the microorganism reduction achieved by Use-concentrations
euxyl® K 100 as a function of the contact time and use-concen- acc. EU acc. ASEAN
Use acc. schülke - acc. CIR
tration is presented for the various test organisms: concentrations recommendation
Cosmetics Cosmetics
(USA)
Regulation Directive
Use-con- Contact time [h] Leave-on
Test organism
centration [%] 3 6 24 48 72 168 (i.e. creams, – – max. 0.21 % max. 0.10 %
Pseudomonas 0.0 (blank value) C C C C C C lotions etc.)
aeruginosa 0.05 C C C + – – Rinse-off
0.10 C C ++++ – – – (i.e. shampoos,
0.05 – 0.15 % max. 0.21 % max. 0.21 % max. 0.21 %
bath preparations
0.15 C C ++++ – – –
etc.)
Escherichia 0.0 (blank value) C C C C C C
coli Recommended use-concentration are based on average active content. Please pay attention to
0.05 C C C +++ +++ – the corresponding certificate.
0.10 C C ++++ ++ + –
0.15 C C ++++ ++ – – The schülke recommended percentages relate to the complete for-
Candida 0.0 (blank value) ++++ ++++ ++++ C C C mulation in each case. The values given are recommended guides.
albicans 0.05 +++ – – – – – The individual use-concentration is dependent on the sensiti­vity of
0.10 + – – – – – the product to microbial contamination, the choice of raw materi-
0.15 – – – – – – als and production hygiene.
Aspergillus 0.0 (blank value) ++++ ++++ ++++ ++++ ++++ ++++ The efficacy and optimum use-concentration should always be
niger 0.05 ++++ ++++ ++++ ++++ ++++ + determined in the end product with the aid of a preservation
0.10 ++++ ++++ ++ – – – load test (i.e. Schülke & Mayr GmbH Technical Service Department
0.15 ++++ ++ – – – –
and Microbiology).
All responsibility for determining the most effective percentage for
Symbol Finding Germ count/ml a given use remains with the final product manufacturer since the
optimal use-concentration level will vary due to product-specific
– no growth < 100 variables such as choice of raw materials, production hygiene, etc.
+ slight growth approx. 102
++ moderate growth approx. 103 Japan (Standards for Cosmetics)
+++ heavy growth approx. 104 euxyl® K 100 is approved as a cosmetic preservative up to 0.24 %
++++ massive growth approx. 105 for cosmetics not used for mucosa and to be washed away.
C surface covered > 106
Indications for use
Repeated challenge test (schülke KoKo test) General
This method is used to determine the preservative effect of Temperature stability
chemical preservatives in cosmetic formulations, e.g. creams, euxyl® K 100 should in principle only be incorporated into the
lotions and shampoos. For this, in various test series, the pre- product to be preserved in the cooling phase at a temperature
servative to be tested is added in different concentrations to the lower than 40 °C. In practice, adding euxyl® K 100 together with
unpreserved samples. the fragrance has proved effective.
A constant microorganism load is achieved by means of periodic
inoculation (inoculation cycles) of the test preparations. Immedi- pH stability
ately before inoculation, samples of the individual preparations High pH values (> 8.0) should be avoided when incorporating
are streaked out onto nutrient media. euxyl® K 100.
The preservative effect is evaluated on the basis of the microor-
ganism growth on the nutrient media. The longer the time to the Emulsions
occurrence of the first microbial growth, the more effective is the In practice, emulsions are preserved with 0.10 % euxyl® K 100
preservative. Experience has shown that a well preserved product (corresponding to 7.5 ppm isothiazolinones).
should remain growth-free for six inoculation cycles in order to Products which contain proteins, caseins, fresh cell extracts, repair
ensure the shelf-life in the original packaging required in practice complexes, or similar, must in principle contain a higher proportion
(30 months). of preservative. On account of its special formulation the distribution
Shampoos and bath additives preserved with use-concentrations of euxyl® K 100 in water/oil systems is better than pure water-based
of be­tween 0.05 and 0.15 % euxyl® K 100 proved to be well pre- preservatives.
served even after three months storage at + 40 °C. The products good effectiveness in w/o systems is attributable to this.

Solutions
For shampoos, bath preparations and hand cleansing prepa-
rations good preservation results are achieved with 0.05 – 0.15 %
euxyl® K 100.

For other uses please contact us.

3
euxyl® K 100
Chemical compatibility Product-specific properties
In general, it is possible for interactions to occur between Material compatibility
various active ingredients and auxiliary substances in Concentrate
cosmetic formulations. In the material compatibility tests with the concentrate of
Thus certain incompatibilities of euxyl® K 100 with other euxyl® K 100 stainless steel, hard polyvinyl chloride (hard
ingredients have been established and are listed below. PVC), polyethylene (PE), polystyrene (PS) and polycarbo-
nate (PC) proved to be suitable materials for handling the
General undiluted product.
euxyl® K 100 is fully effective both in anionic as well as Other metallic materials and especially polymethylmeth­
cationic and non-ionic systems. High pH values (> pH 8.0) acrylate (PMMA) should not be used. Soft polyvinyl chlo-
should be avoided. Acidic pH values have no negative ride (soft PVC) – e.g. tubing – proved unsui­table.
influence on the effectiveness. As sealing material when handling undiluted euxyl® K 100,
fluorine rubber or ethylene-propylene terpolymers (EPDM)
Compatibility with surfactants or polytetrafluor-ethylene (PTFE) should be preferred.
euxyl® K 100 proved to have good compatibility with an­ionic Other sealing materials could lead to severe swelling or to
surfactants such as sulphates, ether sulphates and sulpho- pronounced discolouration of euxyl® K 100.
succinates, as well as with non-ionogenic surfactants.
Dilutions
Compatibility with sulphite ions The behaviour of euxyl® K 100 in 0.15 % aqueous solution
euxyl® K 100 is inactivated by sulphite ions. with regard to material compatibility was not significantly
Excessive sulphite > 10 ppm must be avoided. different from that of the tap water used for the dilution.
No incompatibilities with plastics have been observed with
products preserved with euxyl® K 100.

Please check the compatibility in individual cases.

Effect on surface tension


The surface tension of water is slightly reduced by the
addition of euxyl® K 100. With a 0.1 % solution in water it is
67 mN/m, with a 0.2 % solution it is 65 mN/m
(water: 73 mN/m).

Foaming behaviour
In the foaming test in accordance with DIN 53 902, a 0.15 %
solution of euxyl® K 100 in demineralised water proved to
be non-foaming.

Solubility
In water euxyl® K 100 is only limitedly soluble.
100 g water at 20 °C dissolve approx. 25 g euxyl® K 100.
100 g euxyl® K 100 dissolve approx. 45 g water.
In the polar solvents such as 1,2-propylene glycol, glycerol,
triethylene glycol, 2-phenoxyethanol euxyl® K 100 is
unlimitedly soluble. In non-polar solvents it is only limitedly
soluble, in pure hydrocarbons it is practically insoluble.

4
euxyl® K 100
General information

Descriptions of individual substances Storage


We recommend storing in the original container at room
(active ingredients) temperature.

OH Environmental information
C7H8O schülke has DIN EN ISO 9001 and DIN EN 14 001 certifica-
108.13 g/mol tion and a validated environmental management system
CAS no.: 100-51-6 in accordance with the Eco Audit Regulation. The canisters
INCI name: Benzyl Alcohol and drums used by schülke are made of polyethylene
Name according to EC 1223/2009: Benzyl Alcohol (HDPE) and are labelled accordingly. The 1000 kg containers
No. according to EC 1223/2009: 34 are affiliated to a recycling system that guarantees free pick-
EINECS name: Benzyl Alcohol up and sensible utilisation of used containers throughout
EINECS no.: 202-859-9 Europe. The labels are made of PE. Our packaging materials
contain no PVC and are recyclable.

Expert opinions
O Akute Toxizitätsprüfung von DFL 387 (= euxyl® K 100) nach

CI
N
CH3
C4H4CINOS oraler Applikation an der Ratte, International Bio-Research,
S
149.60 g/mol Hannover, May 1978
CAS no.: 26 172-55-4
INCI name: Methylchloroisothiazolinone Akute dermale Toxizitätsprüfung von DFL 387 (= euxyl® K 100)
Name according to EC 1223/2009: 5-Chloro-2-methyl-3-(2H)- an der Ratte, International Bio-Research, Hannover,
isothiazolone July 1978
No. according to EC 1223/2009: 39
EINECS name: 5-Chloro-2-methyl-(2H)- Prüfung der Hautverträglichkeit des Konservierungsmittels
isothiazol-3-one DFL 387 (= euxyl® K 100) als Zusatz zu Sagrolind sowie in
EINECS no.: 247-500-7 wässriger Lösung, A. Winkler, Hamburg, August 1978

euxyl® K 100 – Ocular Irritation Tests in the Rabbit,


Consultox Laboratories Ltd., London, March 1979
O

N CH C4H5NOS Untersuchung von euxyl® K 100 auf sensibilisierende


S 3
115.15 g/mol Wirkung am Meerschweinchen, Bühler-Test, Reprotox,
CAS no.: 2 682-20-4 Münster, July 1982
INCI-name: Methylisothiazolinone
Name according to EC 1223/2009: 2-Methyl-3-(2H)-isothiazolone Sechs-Wochen-Anwendungstest mit Hautschutzlotion
No. according to EC 1223/2009: 39 Sagromedal TPH-5811 (nach Angabe des Herstellers mit
EINECS name: 2-Methyl-(2H)-isothiazol-3-one 0,2 % euxyl® K 100 konserviert), H. Ippen, Göttingen,
EINECS no.: 220-239-6 May 1983

Untersuchung zur Hemmung der mikrobiellen Atmungsrate


nach OECD 209, Dr. Andreas Berg, Schülke & Mayr GmbH,
Physical-chemical data January 1990

Appearance: clear, nearly colourless – Bestimmung der biologischen Abbaubarkeit der


light yellow liquid Prüfsubstanz euxyl® K 100 (OECD-No. 301D), NATEC,
Colour Index (Gardner) max. 2 Hamburg, January 1990
20
Odour: characteristic
Refractive index n20
D: 1.426-1.431 The Toxicology and Tolerance of the Preservative
Density (20 °C): 1.069-1.075 g/ml euxyl® K 100, Dr. Susanne Hendrich, Schülke & Mayr GmbH,
Vapour pressure (20 °C): approx. 25 hPa January 2015
Flash point (ISO 2719): > 100 °C
Flow time (DIN 53 211/20 °C): < 15 DIN seconds
Viscosity (Brookfield RVT, 20 °C): UL-Adapter/100 r.p.m.:
approx. 7 mPa s
Water solubility (20 °C): > 20 g/l

5
schülke worldwide:
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Schülke & Mayr GmbH Schülke France SARL Schülke & Mayr UK Ltd. Schülke & Mayr Italia S.r.l.
Shanghai Representative Office 92800 Puteaux Paris La Defense Sheffield S9 1AT 20158 Milano
Shanghai 200041 Phone +33-1- 42 91 42 42 Phone +44-114-254 35 00 Phone +39-02-40 26 590
Phone +86-21-62 17 29 95 Fax +33-1- 42 91 42 88 Fax +44-114-254 35 01 Fax +39-02-40 26 609
Fax +86-21-62 17 29 97

Benelux Switzerland Turkey USA


Schülke & Mayr Benelux B.V. Schülke & Mayr AG Schülke & Mayr GmbH schülke inc.
2031 CC Haarlem 8003 Zurich Fulya, Sisli, Istanbul Fairfield, NJ 07004
Phone +31-23-535 26 34 Phone +41-44-466 55 44 Phone +90-212-356-72-03 Phone +1-973-770-7300
Fax +31-23-536 79 70 Fax +41-44-466 55 33 Fax +90-212-356-73-37 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.

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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 -T | GB | 06.15

736 | X | 06.15 | E | Rako


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