euxyl® K 510 - Schülke & Mayr
euxyl® K 510 - Schülke & Mayr
euxyl® K 510 - Schülke & Mayr
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
euxyl ® K <strong>510</strong>Preservative for cosmeticstoiletries
euxyl ® K <strong>510</strong>Product descriptioneuxyl® K <strong>510</strong> is a liquid cosmetic preservative, which can be usedin leave-on as well as rinse-off products.euxyl® K <strong>510</strong> is not recommended for products that are intendedfor mucous membranes or for lipsticks or toothpastes.euxyl® K <strong>510</strong> has a broad, balanced spectrum of effect againstbacteria, yeasts and mould fungi. It acts even in low use-concentrationsand has good vapour phase effectiveness.EU-INCI-declaration (active ingredients)*DMDM-HydantoinMethylchloroisothiazolinoneMethylisothiazolinoneUS-INCI-declaration*DMDM-Hydantoin (and)Methylchloroisothiazolinone (and)Methylisothiazolinone (and)* Individual ingredients without auxiliaries.For full INCI-declaration kindly contact us.Microbiological effectivenesseuxyl® K <strong>510</strong> is equally effective against bacteria, yeasts andmould fungi. It is a typically biostatic product with the biocidalproperties necessary for practical use.For euxyl® K <strong>510</strong> to perform effectively in destroying organismsin products already contaminated, a minimum contact time of48 hours is necessary. Since the effect of euxyl® K <strong>510</strong> takes placethrough chemical reactions with the microorganisms, when it isused in heavily contaminated products loss of active ingredientmust be taken into account.Good production hygiene, as well as the use of raw materialswith low microorganism levels as a result of correct raw materialcontrol, are of course vital prerequisites for the production ofmicrobiologically faultless finished products.MIC valuesDetermination of the minimum inhibitory concentration in serialdilution tests produced the following values:Species ATCC-No. MIC-Value [%]Gram-negative:Enterobacter gergoviae 33028 0.20Escherichia coli 11229 0.20Klebsiella pneumonite 4352 0.20Pseudomonas aeruginosa 15442 0.20Pseudomonas fluorescens 17397 0.10Pseudomonas putida 12633 0.10Gram-positive:Staphylococcus aureus 6538 0.20Staphylococcus epidermidis 12228 0.30Mould fungi:Aspergillus niger 6275 0.05Penicillium funiculosum 36839 0.025Yeasts:Candida albicans 10231 0.05Germ count reduction testDilutions of euxyl® K <strong>510</strong> are prepared with sterile tap water.50 ml portions of the end solutions are inoculated with 0.5 mlmicroorganism suspension (initial microorganism count approx.10 8 cfu/ml) and stirred.Test organismsATCC-No.Pseudomonas aeruginosa 15442Escherichia coli 11229Candida albicans 10231Aspergillus niger 6275The solutions are streaked out onto tryptone soya agar orSabouraud-dextrose 4 % agar after 3, 6, 24, 48, 72 and 168 hours,depending on the test organism. The cultures are incubated for48 hours at 37 °C, except for Aspergillus niger, which is incubatedfor 72 hours at 25 – 27 °C.The evaluation is made on the basis of semi-quantitative assessmentof the microbial growth of the streaks.2
euxyl ® K <strong>510</strong>In the table below, the microorganism reduction achieved byeuxyl® K <strong>510</strong> as a function of the contact time and use-concentrationis presented for the various test organisms:Test organismPseudomonasaeruginosaEscherichiacoliCandidaalbicansAspergillusnigerUse-concentrationContact time [h][%] 3 6 24 48 72 1680.0 (blank value) C C C C C C0.025 C C – – – –0.05 C C – – – –0.1 C +++ – – – –0.2 +++ ++ – – – –0.0 (blank value) C C C C C C0.025 C C + – – –0.05 C C – – – –0.1 C +++ – – – –0.2 +++ +++ – – – –0.0 (blank value) C C C C C C0.025 C C C C C +++0.05 C C C C +++ –0.1 C C – – – –0.2 – – – – – –0.0 (blank value) C C C C C C0.025 C C C C C C0.05 C C C C C +0.1 C C – – – –0.2 C C – – – –Symbol Finding Germ count/ml– = no growth < 100+ = slight growth approx. 10 2++ = moderate growth approx. 10 3+++ = heavy growth approx. 10 4++++ = massive growth approx. 10 5C = surface covered approx. 10 6Repeated challenge test (schülke KoKo test)This method is used to determine the preservative effect ofchemical preservatives in cosmetic formulations, e. g. creams,lotions and shampoos. For this, in various test series, the preservativeto be tested is added in different concentrations to unpreservedsamples. A constant microorganism load is achieved bymeans of periodic inoculation (inoculation cycles) of the testpreparations. Immediately before inoculation, samples of theindividual preparations are streaked out onto nutrient media.The preservative effect is evaluated on the basis of the microorganismgrowth on the nutrient media. The longer the timebefore the occurrence of the first microbial growth, the moreeffective is the preservative. Experience has shown that a wellpreserved product should remain growth-free for six inoculationcycles in order to ensure the shelf-life in the original packagingrequired in practice (30 months).Oil/water and water/oil systems, as well as shampoos and bathadditives preserved with use-concentrations of between 0.05and 0.15 % euxyl® K <strong>510</strong> proved to be well preserved even afterthree months storage at +40 °C.Use-concentrationsLeave-on(i. e. creams,lotions etc.)Rinse-off(i. e. shampoos,bath preparationsetc.)acc. schülkerecommendationRecommended use-concentration are based on average active content. Please pay attention tothe corresponding certificate.The schülke recommended percentages relate to the completeformulation in each case. The values given are recommendedguides. The individual use-concentration is dependent on thesensitivity of the product to microbial contamination, the choiceof raw materials, and production hygiene.The efficacy and optimum use-concentration should always bedetermined in the end product with the aid of a preservationload test (i. e. Schülke & <strong>Mayr</strong> GmbH Technical Service Departmentand Microbiology).All responsibility for determining the most effective percentagefor a given use remains with the final product manufacturer sincethe optimal use-concentration level will vary due to productspecificvariables such as choice of raw materials, productionhygiene, etc.Indications for useGeneraleuxyl® K <strong>510</strong> should in principle only be incorporated into theproduct to be preserved in the cooling phase at a temperaturelower than 40 °C. In practice, adding euxyl® K <strong>510</strong> together withthe fragrance has proved effective. High pH values (> 8) shouldbe avoided when incorporating euxyl® K <strong>510</strong>.EmulsionsIn practice, emulsions are preserved with 0.05 – 0.15 %euxyl® K <strong>510</strong>. Products which contain proteins, caseins, fresh cellextracts, repair complexes or similar must in principle containa higher proportion of preservative, but not exceeding 0.27 %(corresponding to 7.5 ppm isothiazolinones).SolutionsFor shampoos, bath preparations and hand cleansing preparationsgood preservation results are achieved with 0.05 – 0.15 %euxyl® K <strong>510</strong>.Wet wipesFor wet wipes good preservation results are achieved with0.05 – 0.15 % euxyl® K <strong>510</strong>. euxyl® K <strong>510</strong> is not recommendedfor products that are intended for mucous membranes.For other uses please contact us.acc. EU andASEAN CosmeticsDirectiveacc. CIR(USA)0.05 – 0.15 % max. 0.55 % max. 0.27 %0.05 – 0.15 % max. 0.55 % max. 0.55 %3
euxyl ® K <strong>510</strong>Chemical compatibilityIn general, it is possible for interactions to occur betweenvarious active ingredients and auxiliary substances in cosmeticformulations.Thus, certain incompatibilities of euxyl® K <strong>510</strong> with otheringredients have been established and are listed below.Generaleuxyl® K <strong>510</strong> is fully effective in anionic as well as cationicand non-ionic systems. High pH values (> 8) should beavoided.Acidic pH values have no negative influence on the effectiveness.Compatibility with surfactantseuxyl® K <strong>510</strong> proved to have good compatibility with anionicsurfactants such as sulphates, ether sulphates and sulphosuccinates,as well as with non-ionogenic surfactants.Compatibility with sulphite ionseuxyl® K <strong>510</strong> is inactivated by sulphite ions.Product-specific propertiesMaterial compatibilityConcentrateIn the material compatibility tests with the concentrateof euxyl® K <strong>510</strong> stainless steel, polyethylene (PE), polycarbonate,polystyrene and hard polyvinyl chloride (hard PVC)proved to be suitable materials for handling the undilutedproduct. Non-metallic materials must be tested for theirsuitability, polyamide and polymethyl methacrylate shouldnot be used. As sealing material when handling undilutedeuxyl® K <strong>510</strong> polytetrafluor-ethylene (PTFE) or polymethylsiloxane(SI) should be preferred. Other sealing materialscould lead to severe swelling or to pronounced discolourationof euxyl® K <strong>510</strong>.Dilutionseuxyl® K <strong>510</strong> in 0,1% aqueous solution showed materialcompatibility behaviour which was not significantlydifferent from that of the water used for dilution. Noincompatibilities with plastics have been observed withproducts preserved with euxyl® K <strong>510</strong>.Please check the compatibility in individual casesFoaming behaviourIn the foaming test in accordance with DIN 53 902, euxyl®K <strong>510</strong> in demineralised water proved to be non-foaming.Solubilityeuxyl® K <strong>510</strong> is fully soluble in water.In polar solvents such as 1,2-propylene glycol, propanol oracetone, euxyl® K <strong>510</strong> is readily soluble.In polyalcohols such as glycerol and sorbitol euxyl® K <strong>510</strong> isreadily soluble.In aliphates with hydrophilic groups such as 2-octyldecanoland isopropyl myristate, euxyl® K <strong>510</strong> is limitedly soluble.In pure aliphatic solvents it is slightly soluble.4
euxyl ® K <strong>510</strong>General informationDescriptions of the individual substances(active ingredients)H 3CH 3COC 7H 12N 2O 4188.18 g/molCAS no.: 6440-58-0INCI name:Name according to 76/768/EEC:No. according to 76/768/EEC: 33EINECS name:DMDM HydantoinEINECS no: 229-222-81.3-Bis-(hydroxymethyl)-5.5-di-methylimidazolidine-2.4-dione1.3-Bis-(hydroxymethyl)-5.5-di-methylimidazolidine-2.4-dioneS N C 4H 5NOSCH 3115.15 g/molOC 4H 4CINOSCICHSN3149.60 g/molCAS no.: 26 172-55-4INCI name:MethylchloroisothiazolinoneName according to 76/768/EEC: 5-Chloro-2-methyl-3-(2H)-isothiazoloneNo. according to 76/768/EEC: 39EINECS name:5-Chloro-2-methyl-(2H)-isothiazol-3-oneEINECS no: 247-500-7OCAS no.: 2 682-20-4INCI name:NName according to 76/768/EEC:No. according to 76/768/EEC: 39EINECS name:OHNOOHEINECS no.: 220-239-6Methylisothiazolinone2-Methyl-3-(2H)-isothiazolone2-Methyl-(2H)-isothiazol-3-onePhysical-chemical dataAppearance:Odour:clear, colourless – light blue liquidcharacteristicRefractive index n D20: approx. 1.375Density (20 °C):Flash point (ISO 2719): > 100 °CFlow time (DIN 53 211/20 °C):Viscosity (20 °C )Water solubility (20 °C):approx. 1.07 g/ml< 15 DIN secondsapprox. 2,1 mPa sfully solubleStorageWe recommend storing in the original container at roomtemperature.Environmental informationSchülke & <strong>Mayr</strong> GmbH has DIN EN ISO 9001 and DIN EN 14001certification and a validated environmental managementsystem in accordance with the Eco Audit Regulation.The canisters and drums used by schülke are made of polyethylene(HDPE) and are labelled accordingly.The 1000 kg containers are affiliated to a recycling systemthat guarantees free pick-up and sensible utilisation of usedcontainers throughout Europe. The labels are made of PE.Our packaging materials contain no PVC and are recyclable.Expert opinionsThe toxicology and tolerance of the preservative euxyl® K <strong>510</strong>,Dr. Susanne Hendrich, Schülke & <strong>Mayr</strong> GmbH, July 20085
schülke subsidiaries in:BelgiumS. A. Schülke&<strong>Mayr</strong>Belgium N.V.1830 MachelenPhone +32-2-479 73 35Fax +32-2-479 99 66ChinaSchülke&<strong>Mayr</strong> GmbHShanghai Representative OfficeShanghai 200041Phone +86-21-62 17 29 95Fax +86-21-62 17 29 97FranceS&M France75341 Paris Cedex 07Phone +33-1- 44 11 00 81Fax +33-1- 44 11 02 41ItalySchülke&<strong>Mayr</strong> Italia S.r.l.20148 MilanoPhone +39-02-40 21 820Fax +39-02-40 21 829NetherlandsSchülke&<strong>Mayr</strong> Benelux B.V.2003 LM-HaarlemPhone +31-23-535 26 34Fax +31-23-536 79 70SwitzerlandSchülke&<strong>Mayr</strong> AG8003 ZurichPhone +41-44-466 55 44Fax +41-44-466 55 33United KingdomSchülke&<strong>Mayr</strong> UK Ltd.Sheffield S9 1ATPhone +44-114-254 35 00Fax +44-114-254 35 01USAschülke inc.Mt. Arlington, NJ 07856Phone +1-973-770-7300Fax +1-973-770-7302Other Distributors in:Africa (north) · Albania · Argentina · Australia · Austria · Belarus · Bosnia-Herzegovina · Brazil · Bulgaria · Canada · Croatia · Cyprus · Czech Republic ·Denmark · Egypt · Estonia · Finland · Ghana · Greece · Hong Kong · Hungary · India · Indonesia · Iran · Israel · Japan · Jordan · Kazakhstan · Korea · Kuwait ·Latin America · Latvia · Lebanon · Lithuania · Malaysia · Malta · Macedonia · Mexico · Middle East · Montenegro · New Zealand · Nigeria · Norway · Pakistan ·Philippines · Poland · Portugal · Puerto Rico · Romania · Russia · Serbia · Singapore · Slovakia · Slovenia · Spain · South Africa · Sweden · Syria · Taiwan ·Thailand · Turkey · Ukraine · VietnamOur 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 productmanufacturer to assure that claims made for the final product are in conformance with all applicable local laws. In otherrespect our Conditions of Sale and Supply apply.Schülke&<strong>Mayr</strong> GmbH22840 Norderstedt | GermanyPhone | Fax +49 40 521 00- 0 | -244www.schuelke.com | sai@schuelke.comA company of theAir Liquide Group184 | II | 10.08 | B | westwerk |This information is not automatically updated.SAI_PC_ GB v_02