euxyl® K 500 - Schülke & Mayr

euxyl ® K 500Preservative for cosmeticstoiletries

euxyl ® K 500Product descriptioneuxyl® K 500 is a liquid cosmetic preservative, which can be usedin leave-on as well as rinse-off products.euxyl® K 500 has a broad, balanced spectrum of effect againstbacteria, yeasts and mould fungi.As a result of the special preparation, the known tendency forsorbic acid to discolour can be reduced or prevented.EU INCI declarationAquaDiazolidinyl UreaSodium BenzoatePotassium SorbateUS INCI declarationDiazolidinyl Urea (and)Sodium Benzoate (and)Potassium SorbateMicrobiological effectivenesseuxyl® K 500 is equally effective against bacteria, yeasts andmould fungi. It is a typically biostatic product with the biocidalproperties necessary for practical use.For euxyl® K 500 to perform effectively in destroying organismsin products already contaminated, a minimum contact time of48 hours is necessary. Since the effect of euxyl® K 500 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:Burkholderia cepacia 17759 0.13Enterobacter gergoviae 33028 0.25Escherichia coli 11229 0.25Klebsiella pneumoniae 4352 0.25Pseudomonas aeruginosa 15442 0.25Pseudomonas fluorescens 17397 0.25Pseudomonas putida 12633 0.25Gram-positive:Staphylococcus aureus 6538 0.25Kocuria rhizophila 9341 0.25Mould fungi:Aspergillus niger 6275 1.0Yeasts:Candida albicans 10231 1.0Germ count reduction testDilutions of euxyl® K 500 are prepared with sterile tap water.50 ml portions of the end solutions are each inoculated with0.5 ml microorganism suspension (initial microorganism countapprox. 10 8 cfu/ml) and stirred.Test organismsATCC-No.Pseudomonas aeruginosa 15442Escherichia coli 11229Candida albicans 10231Aspergillus niger 6275These solutions are streaked out onto tryptone soya agar orSabouraud-dextrose 4 % agar after 3, 6, 24, 48, 72 and 168 hoursdepending 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 500In the table below, the microorganism reduction achieved byeuxyl® K 500 as a function of the contact time and use-concentrationis presented for the various test organisms at pH 6.0:Test organismPseudomonasaeruginosaEscherichiacoliCandidaalbicansAspergillusnigerUse-concentrationContact time [h][%] 3 6 24 48 72 1680.0 (blank value) C C C C C C0.5 C ++++ – – – –1.0 ++++ ++ – – – –1.5 +++ – – – – –0.0 (blank value) C C C C C C0.5 C C +++ + – –1.0 ++++ ++++ – – – –1.5 ++++ ++++ – – – –0.0 (blank value) C C C C C C0.5 C C C C C C1.0 +++ ++ – – – –1.5 – – – – – –0.0 (blank value) C C C C C C0.5 C C C +++ ++ ++1.0 ++++ +++ + – – –1.5 + – – – – –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 theunpreserved samples.A constant microorganism load is achieved by means of periodicinoculation (inoculation cycles) of the test preparations.Immediately before inoculation, samples of the individual preparationsare streaked out onto nutrient media. The preservativeeffect is evaluated on the basis of the microorganism growth onthe nutrient media. The longer the time to the occurrence of thefirst microbial growth, the more effective is the preservative.Experience has shown that a well preserved product shouldremain growth-free for six inocu lation cycles in order to ensurethe shelf-life in the original packaging required in practice(30 months).Oil/water and water/oil systems as well as shampoos and bathadditives preserved with use-concentrations of between 0.2 and1.5 % euxyl® K 500 proved to be well preserved even after threemonths storage at + 40 °C.Use-concentrationsLeave-on(i. e. creams,lotions etc.)Rinse-off(i. e. shampoos,bath preparationsetc.)acc. schülkerecommendationacc. EU andASEAN CosmeticsDirectiveRecommended use-concentration are based on average active content.Please pay attention to the corresponding certificate.acc. CIR(USA)0.50 – 1.50 % max. 2.50 % max. 2.50 %0.20 – 1.00 % max. 2.50 % max. 2.50 %The schülke recommended percentages relate to the completeformulation in each case. The values given are recommendedguides.The individual use-concentration is dependent on the sensitivityof the product to microbial contamination, the choice of rawmaterials 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 & Mayr GmbH Technical ServiceDepartment and Micro biology).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 useGeneralTemperature stabilityWhen using euxyl® K 500 prolonged heating periods (max.4 hours) > 80 °C should be avoided. It is advantageous to addeuxyl® K 500 in the cooling phase, e. g. with the parfume (t < 40 °C).pH stabilityeuxyl® K 500 is adapted for use in products with a pH-value upto 6.5. In some cases even up to pH 7 depending on the formulationof the cosmetic product. The efficacy of euxyl K® 500depends on the pH value. The efficiency is increased by reducingthe ph value.The alkalinity of euxyl® K 500 can lead to an increase in pH-value.If ph values exceeding 6.5 occur in the production process afterthe addition of euxyl K® 500, euxyl K® 500 is stable but ineffective.In all cases the pH value of the finished product must bechecked at the end of the production process, and if necessaryadjusted. The measure ment of a w/o emulsion is problematic.In this case the measurement must be performed in the waterphase.3

euxyl ® K 500EmulsionsIn practice, emulsions are preserved with 0.5 – 1.5 % euxyl®K 500.SolutionsFor shampoos, bath preparations and hand cleansing preparationsgood preservation results are achieved with 0.2 –1.0 % euxyl® K 500.Wet wipesFor wet wipes good preservation results are achieved with0.5 – 1.5 % euxyl® K 500.For other uses please contact us.Chemical compatibilityIn general, it is possible for interactions to occur betweenvarious active ingredients and auxiliary substances in cosmeticformulations.Thus, certain incompatibilities of euxyl® K 500 with otheringredients have been established and are listed below.Generaleuxyl® K 500 is fully effective in anionic as well as cationicand non-ionic systems. High pH values (> pH 7.5) shouldbe avoided. Acidic pH values have no negative influence onthe effectiveness.Compatibility with surfactantseuxyl® K 500 proved to have good compatibility withan ionic surfactants such as sulphates, ether sulphatesand sulphosuccinates, as well as with non-ionogenic surfactants.Compatibility with sulphite ionseuxyl® K 500 exhibits no interaction with sulphite ions.Compatibility with proteinsThe presence of proteins might decrease the efficacy ofeuxyl® K 500.Product-specific propertiesMaterial compatibilityConcentrateIn the material compatibility tests with the concentrate ofeuxyl® K 500, stainless steel, hard polyvinyl chloride (hardPVC), polyethylene (PE), polystyrene (PS) and polycarbonate(PC) proved to be suitable materials for handling theundiluted product. Other metallic materials should not beused.As sealing material when handling undiluted euxyl® K 500,fluorine rubber or ethylene-propylene terpolymers (EPDM)or polytetrafluorethylene (PTFE) should be preferred.Other sealing materials could lead to severe swelling or topronounced discolouration of euxyl® K 500.DilutionsThe behaviour of euxyl® K 500 in 1.5 % aqueous solutionwith regard to material compatibility was not significantlydifferent from that of the tap water used for the dilution.No incompatibilities with plastics have been observed withproducts preserved with euxyl® K 500.Please check the compatibility in individual cases.Effect on surface tensionThe surface tension of water is slightly reduced by the additionof euxyl® K 500. With a 1.5 % solution in water it is70 mN/m (water: 73 mN/m).Foaming behaviourIn the foaming test in accordance with DIN 53 902, a 1.5 %solution of euxyl® K 500 in demineralised water proved tobe non-foaming.SolubilityIn water as well as in Propylene glycol euxyl® K 500 isunlimitedly soluble. In other glycols such as Dipropyleneglycerol euxyl® K 500 is sparingly soluble.In non-polar solvents it is practically insoluble.Compatibility with pigmentsThe presence of pigments such as titanium dioxide andzinc oxide decreases the efficacy of euxyl® K 500.DiscolourationIn general euxyl® K 500 displays good compatibility withthe ingredients of cosmetics. Compared with sorbic acidand potassium sorbate discolouration occurs less frequentlywhen euxyl® K 500 is used.4

euxyl ® K 500General informationDescriptions of individual substancesPhysical-chemical dataHOOHONHNC 8H 14N 4O 7Odour:characteristicOOH20278.23 g/molRefractive index n D : approx. 1.44C 6H 7O 2KDr. Susanne Hendrich, Schülke & Mayr GmbH, July 2008H O -3C K + 150.22 g/molCAS no.: 78491-02-8Density (20 °C):approx. 1.21 g/mlINCI name:Diazolidinyl UreaVapour pressure (20 °C):approx. 25 hPaName according to 76/768/EEC: N-(Hydroxymethyl)-N-(dihydroxymethyl-1.3-dioxo-2.5-imidazolidinyl-4)-N‘-(hydroxymethyl)ureaFlash point (ISO 2719):Flow time (DIN 53 211/20 °C):Viscosity (Brookfield-RVT; 20 °C):> 100 °C< 15 DIN secondsUL-Adapter/100 r.p.m.:approx. 55 mPa sNo. according to 76/768/EEC: 46Water solubility (20 °C):unlimitedEINECS name:1-[1.3-Bis(hydroxymethyl)-2.5-dioxoimidazolidin-4-yl]- Storage1.3-bis(hydroxymethyl)urea We recommend storing in the original container at roomEINECS no.: 278-928-2temperature.Environmental informationOschülke has DIN EN ISO 9001, DIN EN 13485 and DIN EN ISOO - Na + C 7H 5O 2Na14001 certification and a validated environmental managementsystem in accordance with the Eco Audit Regulation.144.10 g/molCAS no.: 532-32-1The canisters and drums used by schülke are made ofINCI name:Sodium Benzoatepolyethylene (HDPE) and are labelled accordingly.Name according to 76/768/EEC: Benzoic acid, its saltsand estersThe 1000 kg containers are affiliated to a recycling systemthat guarantees free pick-up and sensible utilisation of usedNo. according to 76/768/EEC: 1containers throughout Europe. The labels are made of PE.EINECS name:Sodium BenzoateOur packaging materials contain no PVC and are recyclable.EINECS no.: 208-534-8Expert opinionOThe toxicology and tolerance of the preservative euxyl® K 500,CAS no.: 24634-61-5INCI-name:Name according to 76/768/EEC:No. according to 76/768/EEC: 4EINECS name:NNOHOPotassium SorbateSorbic acid (Hexa-2.4-dienoicacid) and its saltsEINECS no.: 246-376-1Potassium-(E,E)-hexa-2.4-dienoateAppearance:Colour index (Gardner): max. 2clear, nearly colourlessto yellow liquid5

schülke subsidiaries in:BelgiumS. A. Schülke&Mayr Belgium N.V.1830 MachelenPhone +32-2-479 73 35Fax +32-2-479 99 66ChinaSchülke&Mayr GmbHShanghai Representative OfficeShanghai 200041Phone +86-21-62 17 29 95Fax +86-21-62 17 29 97FranceSchülke France SARL94250 GentillyPhone +33-1-49 69 83 78Fax +33-1-49 69 83 85ItalySchülke&Mayr Italia S.r.l.20148 MilanoPhone +39-02-40 21 820Fax +39-02-40 21 829NetherlandsSchülke&Mayr Benelux B.V.2032 HA-HaarlemPhone +31-23-535 26 34Fax +31-23-536 79 70SwitzerlandSchülke&Mayr AG8003 ZurichPhone +41-44-466 55 44Fax +41-44-466 55 33United KingdomSchülke&Mayr 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&Mayr GmbH22840 Norderstedt | GermanyPhone | Fax +49 40 521 00- 0 | -244www.schuelke.com | sai@schuelke.comA company of theAir Liquide Group969 | V | 06.10 | C | RakoThis information is not automatically updated.SAI_PC_ GB v_03