euxyl K 340 Preservative for cosmetics & toiletries

Transcription

1 Preservative for cosmetics & toiletries

2 Product description euxyl K 340 is a liquid cosmetic preservative, which can be used in leave-on as well as rinse-off products. euxyl K 340 has a broad, balanced spectrum of effect against bacteria, yeasts, and mould fungi and has good vapour phase effectiveness. KoKo test results Comparison test of euxyl K 340 with the standard paraben blend euxyl K 300 in an /W lotion. euxyl K 300 is a liquid preparation based on Phenoxyethanol, ethylparaben, Buthylparaben, Ethylparaben, and Isobutylparaben. EU-INCI-declaration Phenoxyethanol ethylparaben Butylparaben Ethylparaben US-INCI-declaration Phenoxyethanol (and) ethylparaben (and) Butylparaben (and) Ethylparaben (and) Formulation INCI Name Function % w/w Phase 1 Water (Aqua) 83.5 icrobiological effectiveness euxyl K 340 is equally effective against bacteria, yeasts and mould fungi. It is a typically biostatic product with the biocidal properties necessary for practical use. For euxyl K 340 to perform effectively in destroying organisms in products already contaminated, a minimum contact time of 48 hours is necessary. Since the effect of euxyl K 340 takes place through chemical reactions with the microorganisms, when it is used in heavily contaminated products loss of active ingredient must be taken into account. Good production hygiene, as well as the use of raw materials with low microorganism levels as a result of correct raw material control are of course vital prerequisites for the production of microbiologically faultless finished products. IC values Determination of the minimum inhibitory concentration in serial dilution tests is not possible due to the limited water solubility of propyl - and butylparaben. Repeated challenge tests (schülke KoKo test) This method is used to determine the preservative effect of chemical preservatives in cosmetic formulations, e.g. creams, lotions and shampoos. For this in various test series the preservative to be tested is added in different concentrations to unpreserved samples. A constant microorganism load is achieved by means of periodic inoculation (inoculation cycles) of the test preparations. Immediately before inoculation samples of the individual preparations are streaked out onto nutrient media. The preservative effect is evaluated on the basis of the microorganism growth on the nutrient media. The longer the time before the occurrence of the first microbial growth, the more effective is the preservative. Experience has shown that a well preserved product should remain growth-free for six inoculation cycles in order to ensure the shelf-life in the original packaging required in practice (30 months). Propylene Glycol 2.0 Phase 2 Paraffinum liquidum Emollient 9.5 CETEARYL ALCHL Emollient 3.0 CETEARETH-25 Emulsifier 1.5 Preservative Q.S.* Total Basic Lotion /W unpreserved, standard lotion o/w 0.75 % euxyl K 340 Inoculation B, Y B, Y./. 1.0 % euxyl K % euxyl K % euxyl K 300 Legend: 0 = Sterility control - = free of microbial growth B = Bacteria = slight growth = oulds = moderate growth Sp = Sporeforming bacteria = massive growth Y = Yeasts Comparison test proof the efficacy of euxyl K 340 is comparable to euxyl K

3 Use-concentrations Leave-on (i. e. creams, lotions etc.) Rinse-off (i. e. shampoos, bath preparations etc.) acc. schülkerecommendation acc. EU and ASEAN Cosmetics Directive acc. CIR (USA) % max % max % % max % max % Recommended use-concentration is based on average active content. Please pay attention to the corresponding certificate of analysis. The schülke recommended percentages relate to the complete formulation in each case. The values given are recommended guides. The individual use-concentration is dependent on the sensitivity of the product to microbial contamination, the choice of raw materials and production hygiene. The efficacy and optimum use-concentration should always be determined in the end product with the aid of a preservation load test (i. e. Schülke & ayr GmbH Technical Service Department and icrobiology). All responsibility for determining the most effective percentage for a given use remains with the final product manufacturer since the optimal use-concentration level will vary due to product-specific variables such as choice of raw materials, production hygiene, etc. Japan (Standards for Cosmetics) euxyl K 340 is approved as a cosmetic preservative up to 1.39 % for all types of cosmetics & toiletries. Cosmetics not used for mucosa and to be washed away Cosmetics not used for mucosa and not to be washed away Cosmetics that may be used for mucosa euxyl K 340 max % max % max % Indications for use General Particularly in formulations with a low water content, heating to C may be required for incorporation of a sufficient amount of euxyl K 340 into the aqueous phase. In formulations that contain surfactants, euxyl K 340 can be dissolved in the surfactants before the addition of water and other components. Temperature stability euxyl K 340 is stable at temperatures up to 80 C. n account of its limited solubility in water, in purely aqueous systems. euxyl K 340 can only be dissolved in low concentrations. ph stability Addition of euxyl K 340 at high ph-values (ph > 8.0) should be avoided. Emulsions Use concentrations of % euxyl K 340 are sufficient for emulsified systems of both the w/o and o/w types. Solutions For shampoos, bath preparations and hand cleansing preparations good preservation results are achieved with % euxyl K 340. Wet wipes For wet wipes good preservation results are achieved with % euxyl K 340. For other uses please contact us. Toxicology euxyl K 340 is a preservative concentrate, which is used in cosmetic preparations in a recommended use-concentrations of 0.5% %. All components of euxyl K 340 are listed in Appendix V of the EU Products Regulation 1223/2009/EC or in Appendix VI of EU Cosmetics Directive 76/768/EC respectively and approved for safe use throughout the EU. n the basis of the results with the given upper concentration limit euxyl K 340 can be considered safe for the preservation of cosmetics and toiletries from the toxicological point of view. 3

4 Chemical compatibility General In general, it is possible for interactions to occur between various active ingredients and auxiliary substances in cosmetic formulations. Thus certain incompatibilities of euxyl K 340 with other ingredients have been established and are listed below. euxyl K 340 is fully effective both in anionic as well as cationic systems. High ph values (> ph 8.0) should be avoided when using euxyl K 340. euxyl K 340 is fully effective in acidic media. Compatibility with surfactants euxyl K 340 proved to have good chemical compatibility with anionic surfactants such as sulphates and sulphosuccinates, as well as with non-ionogenic sur fac tants. Ethoxylated surfactants may lead to loss of effectiveness. Compatibility with sulphite ions euxyl K 340 exhibits no interaction with sulphite ions. Product-specific properties aterial compatibility Concentrate In the material compatibility tests with the concentrate of euxyl K 340, metals such as steel, brass, copper, zinc and aluminium as well as polyethylene (PE), and hard polyvinyl chloride (hard PVC) proved to be the most suitable materials for handling the undiluted product. Non-metallic materials must be tested for their suitability; in particular, polycarbonate (PC), polymethyl methacrylate (PA) and acrylonitrile butadiene styrene copolymer (ABS) should not be used. As sealing material when handling undiluted euxyl K 340, chloroprene rubber (CR/SBR), natural rubber/styrene-butadiene rubber (NR/SBR) and polytetrafluorethylene (PTFE) should be given preference. ther sealing materials could lead to severe swelling or to pronounced discolouration of euxyl K 340. Dilutions The 0.2 % aqueous solution of euxyl K 340 shows no discolouration on contact with non-ferrous metals. No incompatibilities with plastics have been observed with products preserved with euxyl K 340. Please check the compatibility in individual cases. Effect on surface tension The surface tension of water is clearly reduced by the addition of euxyl K 340. With a 0.2 % solution in water it is 53 mn/m (water: 73 mn/m). Foaming behaviour In the foaming test in accordance with DIN , a 0.2 % solution of euxyl K 340 in demineralised water proved to be non-foaming. Solubility In water euxyl K 340 is only limitedly soluble. 100 g water at 20 C dissolves 0.2 g euxyl K g euxyl K 340 dissolve approx. 7 g water. To dissolve euxyl K 340 in water, an agitator with good turbulence is necessary. The dissolution of euxyl K 340 in finished formulated aqueous products such as shampoos proved in practice to be unproblematic. euxyl K 340 is readily soluble in polar solvents such as 1,2-propylene glycol, propanol and acetone. 4

5 General information Descriptions of individual substances Phenoxyethanol H C 8 H g/mol CAS no.: Phenoxyethanol Name acc. to 76/768/EEC: 2-Phenoxyethanol No. acc. to 76/768/EEC: 29 2-Phenoxyethanol EINECS no.: ethylparaben H e C 8 H g/mol CAS no.: ethylparaben Name acc. to 76/768/EEC: 4-Hydroxybenzoic acid and its salts and esters ethyl-4-hydroxybenzoate EINECS no.: Butylparaben H Bu C 11 H g/mol CAS no.: Butylparaben Name acc. to 76/768/EEC: 4-Hydroxybenzoic acid and its salts and esters Butyl-4-hydroxybenzoate EINECS no.: Ethylparaben H Et C 9 H g/mol CAS no.: Ethylparaben Name acc. to 76/768/EEC: 4-Hydroxybenzoic acid and its salts and esters Ethyl-4-hydroxybenzoate EINECS no.: H Pr C 10 H g/mol CAS no.: Name acc. to 76/768/EEC: 4-Hydroxybenzoic acid and its salts and esters Propyl-4-hydroxybenzoate EINECS no.: Physical-chemical Data Appearance: Colour index (Hazen): max. 100 dour: clear colourless liquid - yellow characteristic Refractive Index n 20 D : Density (20 C): g/ml Vapour pressure (20 C) < 1 hpa Flash point (IS 2719): > 100 C Flow time (DIN /20 C): Viscosity Water solubility (20 C): approx. 20 DIN seconds approx. 65 mpa s approx. 2 g/l Storage We recommend storing in the original container at room temperature. Shelf life 36 months at recommended storage conditions. Product specification is valid for the whole shelf life. Environmental information schülke has DIN EN IS 9001, DIN EN and DIN EN IS certification and a validated environmental management system 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 system that guarantees free pick-up and sensible utilisation of used containers throughout Europe. The labels are made of PE. ur packaging materials contain no PVC and are recycable. Expert opinions The Toxicology and Tolerance of the Preservative euxyl K 340, Dr. Susanne Hendrich, Schülke & ayr GmbH, arch

6 schülke subsidiaries in: Belgium S. A. Schülke&ayr Belgium N.V Brussels Phone Fax China Schülke&ayr GmbH Shanghai Representative ffice Shanghai Phone Fax France Schülke France SARL Gentilly Phone Fax Italy Schülke&ayr Italia S.r.l ilano Phone Fax Netherlands Schülke&ayr Benelux B.V HA-Haarlem Phone Fax Switzerland Schülke&ayr AG 8003 Zurich Phone Fax United Kingdom Schulke&ayr UK Ltd. Sheffield S9 1AT Phone Fax USA schülke inc. t. Arlington, NJ Phone Fax ther 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 alaysia alta acedonia exico iddle East ontenegro 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 Vietnam ur 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& ayr GmbH Norderstedt Germany Phone Fax A company of the Air Liquide Group 2576 I A Rako This product information is not automatically updated. SAI GB V03