1,3-Dimethylol-5,5-dimethylhydantoin 3-Iodo-2-propynyl butyl carbamate

Transcription

1 Product Information Glydant Plus Liquid The liquid high performance preservative system. Synergistic, broad spectrum mode of action: no need for auxiliary preservatives. ighly cost-effective use level. Stable in sunlight and over a wide range of temperatures and p. Water soluble. Low free formaldehyde and improved toxicology profile. ompatible with virtually all raw materials used in personal care formulations. 1. Active matter Equilibrium mixture in water of: 1,3-Dimethylol-5,5-dimethylhydantoin 3-Iodo-2-propynyl butyl carbamate 3 3 O O O 2 N N 2 O l O N O 1.1 AS No.: not applicable (mixture) 1.2 EINES No.: all the components of the mixture are listed in EINES 1.3 UN No.: not applicable 1.4 INI-Name: DMDM ydantoin (and) Iodopropynyl Butylcarbamate 2. Typical Specifications Iodo-2-Propynyl Butyl arbamate % 2.2 Water % 2.3 free O 0.09 % Max. 2.4 Total O 13.0 % Min. 2.5 p olor, APA 50 Max. 2.7 Butylene glycol 3.00% Min. The seller makes no warranty, expressed or implied, concerning the accuracy of any results to be obtained from the use of this information and no warranty is expressed or implied concerning the use of these products other than indicated within. The buyer assumes all risks of use and/or handling. No statement is intended or should be construed as a recommendation to infringe any patent. Printed in the USA Revised 21-Sep-10 Supercedes 25-Mar-09 Page 1 of 7

2 3. Properties 3.1 Appearance water white to light yellow liquid 3.2 ydantoin 70.0 % (patent pending, proprietary equilibrium mixture of hydantoin species) 3.3 Specific gravity at Flash point > Solubility see ompatibility see larity lear 4. Registrations 4.1 IPB-Registration North America IPB was reviewed in 1996 by the Expert Panel of the osmetic Ingredient Review (IR) and their recommendations were adopted by TFA. Their approval states that IPB can be used at a level up to 0.1 % of the formulation in both rinse-off and leave-on products. The only restriction is that IPB is not to be used in aerosol products. Europe On April 17, 2007 the European ommission put into force an amendment to the existing entry 56 to Annex VI allowing the following for IPB: 0.02 % in rinse off and 0.01% in leave-on products, except in deodorants/antiperspirants where the maximum concentration is limited to %. IPB may not be used in oral and lip products and there are additional restrictions for children's products and required warnings. Not to be used in preparations for children under three years of age, except in bath products/shower gels and shampoo o Please also note labeling requirements listed on the directive regarding use on children under the age of three: Rinse-off products: Solely for products other than bath products/shower gels and shampoo which might be used on children under three years of age: Not to be used for children under three years old Leave-on products: Solely for products which might be used on children under three years of age: Not to be used for children under three years of age Not to be used in body lotion and body cream. oncerns any products aimed to be applied on a large part of the body The commission requires that all products in the cosmetic markets comply with this directive by October 18, Page 2 of 7

3 Japan Lonza has received approval from Japan MLW for IPB preservatives in osmetics and Personal care products under Pharmaceutical and Food Safety Bureau Notification N The approved usage level of IPB for both rinse-off and leave-on products is 0.02% which includes lip care, oral care and baby care products, with the exception of aerosolized formulations 4.2 DMDM-Registration Europe Listed as a preservative for cosmetics on the EE positive list EE max. accepted concentration: 0.6 % (100% active) USA DMDM ydantoin is recognized by the osmetic,toiletry and Fragrance association (TFA) for use in cosmetic and personal care products. Japan DMDM ydantoin can be used at a level up to 0.3% only in products that are rinsed after use. Listed in the positive list owever, the following warning must be labelled: should not be used by infants or by people who are hypersensitive to formaldehyde 4.3 Glydant-Plus Liquid - Registration Max use level in Europe: 0.4 % in leave-on products 0.8% in rinse-off products 0.3 % in deodorants and antiperspirants Not to be used in body lotion and body cream. oncerns any products aimed to be applied on a large part of the body. annot be used in oral hygiene or lip care products. Additional restrictions for children's products and required warnings. Not to be used in preparations for children less than three years of age, except in bath products/shower gels and shampoo. See European labelling requirements in section Antimicrobial efficacy Efficacy in hallenge Tests Glydant Plus Liquid was incorporated into a shampoo formula and a glyceryl monostearate cream (GMS), both standard media used for efficacy studies. Shampoo formula Ingredients (unpreserved) % wt/wt. GMS cream Ingredients (unpreserved) % wt/wt. Sodium lauryl ether sulfate 35.0 Glyceryl monostearate 6.0 Triethanolamine lauryl 25.0 POE 20 glyceryl monostearate 4.0 sulfate ocamide DEA 3.0 etearyl alcohol 1.5 Anhydrous protein 1.0 Myristyl propionate 8.0 Sterile DI water 36.0 Glycerin 5.0 Total weight Sterile DI water 75.5 Page 3 of 7

4 Total weight % preservatives (as supplied) required to achieve < 10 cfu/g of mix inocula in the GMS cream Glydant Plus Liquid ompetitor A ompetitor B ompetitor ompetitor D BATERIA 1 Day > 0.6 > 0.8 Day > 0.6 < 0.8 Day > 0.6 < 0.8 Day > 0.6 < 0.8 FUNGI 2 Day > 0.8 > 0.8 > 0.6 > 1.0 Day > 0.8 > 0.6 > 0.8 Day > 0.8 > 0.6 > 0.8 Day > 0.8 > 0.6 > 0.8 % preservatives (as supplied) required to achieve < 10 cfu/g of mix inocula in the Shampoo Glydant Plus Liquid ompetitor ompetitor D BATERIA 1 Day NT NT Day NT NT Day NT NT Day NT NT FUNGI 2 Day > 0.6 > 0.8 Day > 0.6 > 0.8 Day > 0.6 > 0.8 Day > 0.6 > Mix inoculum of bacteria consists of E.coli, P.aeruginosa and S.aureus. 2 Mix inoculum of fungi consists of.albicans and A.niger. NT = Not Tested ompetitor A : commercially available blend containing 60% Propylene Glycol % Diazolidinyl Urea + 0.4% IPB. ompetitor B :commercially available blend containing 56% Propylene Glycol + 30% Diazolidinyl Urea + 11% Methylparaben + 3% Propylparaben. ompetitor : 0.4% Methylparaben + 0.2% Propylparaben. ompetitor D : commercially available blend containing 70% Phenoxyethanol + 15% Methylparaben + 5% Isopropylparaben + 5% Isobutylparaben + 5% Butylparaben. Page 4 of 7

5 5.1 BATERIA MI values Micro-organisms ppm Glydant Plus Liquid as supplied Acinetobacter baumannii 125 Pseudomonas cepacia 188 Klebsiella pneumoniae 188 Staphylococcus epidermidis 188 Escherichia coli 250 Staphylococcus aureus 375 Enterobacter gergoviae Pseudomonas aeruginosa FUNGI + YEAST MI values Micro-organisms ppm Glydant Plus Liquid as supplied Aspergillus niger 48 Trychophyton mentagrophytes 48 andida albicans 250 Saccharomyces cerevisiae Stability 6.1 Recovery % of actives vs. Temperature Time, months % total O % IPB > > 95 NT > 90 > 95 NT 12 > 95 NT NT > 95 NT NT 18 > 95 NT NT > 90 NT NT NT: not tested 6.2 Typical % Free O level % Free O Glydant Plus Liquid < 0.1 ompetitor A > 1.0 ompetitor B > olor stability Water-white to light yellow color of Glydant Plus Liquid is stable when stored at omogeneity stability Glydant Plus Liquid homogeneous phase is stable when stored at 23. After storage of three months at 40, one month at 50 and three months exposure to sunlight, Glydant Plus Liquid maintains its homogeneity. Page 5 of 7

6 6.5 Use areas air are Baby Products Shaving Eye makeup Sun Products Lotions reams Raw Materials Shampoos, onditioners, Rinses Shampoos, Lotions, Suncreams Lotions, reams, Gels Mascara, Eye Shadow, Eye Liner Screens, Lotions, Oils Body Lotions, leansing Lotions, Moisturizing Lotions old reams, Moisturizers, and and Foot Surfactants, Shampoos and onditioner Blends Glydant Plus Liquid is not recommended for use in aerosol products. 7 Formulation Recommendations Glydant Plus Liquid can be added at both room and elevated temperatures as high as 60 for 2-3 hours. owever, at high temperatures, mixing should be carried out in a closed vessel. Glydant Plus Liquid is stable over a wide range of p (3-10) 7.1 Solubility Glydant Plus Liquid is readily soluble in any aqueous phase, as well as in polar organic solvents like alcohols, glycols, glycol esters, alkyl sulfates, amphoterics, alkanolamides ompatibility Glydant Plus Liquid is compatible with virtually all raw materials used in personal care formulations including anionic, cationic and nonionic surfactants, thickening agents, chelating agents, colors and fragrances. A stability study has been conducted by adding 0.3% Glydant Plus Liquid in a broad variety of personal care products, and by checking viscosity, p, color and homogeneity of the end products after one month at room temperature and 50. Glydant Plus Liquid proved to be compatible with all of the tested products. No major change was observed for either criteria. 8. Analytical procedure Analytical methods to determine free and total formaldehyde of Glydant Plus liquid and formulated products are available upon request. PL to determine IPB in Glydant Plus Liquid. 9. Packaging / Storage Product is supplied in polyethylene pails or polyethylene drums. It can be stored 18 months in the sealed original packaging, at a temperature between 60 and 75 F (15 and 24.) The product must be kept protected from light and freezing. 10. Regulatory information Refer to MSDS 11. Toxicological information Refer to MSDS 12. Ecological and Ecotoxicological Information Refer to MSDS Page 6 of 7

7 13. Safety evaluation DMDM ydantoin 3-Iodo-2-propynyl butylcarbamate Sensitizer no no Nitrosamines no no Teratogenic no no Mutagenic no no Genotoxic no no Evaluations of DMDM ydantoin and 3-Iodo-2-propynyl butylcarbamate clearly show that there are no adverse toxicological effects associated with either component. Page 7 of 7