Glydant Plus Liquid The liquid high performance preservative system.

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 N N 2 l N 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. Specifications Iodo-2-Propynyl Butyl arbamate % 2.2 Water % 2.3 free 0.09 % max. 2.4 Total 13.0 % min. 2.5 p olor, APA 50 max. 2.7 larity clear 3. Properties 3.1 Appearance water white liquid 3.2 ydantoin 70.0 % (patent pending, proprietary equilibrium mixture of hydantoin species) 3.3 Butylene glycol 4.5 % 3.4 Specific gravity at Flash point > Solubility see ompatibility see Registration 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. lonza ltd t münchensteinerstrasse 38 f ch 4002 basel, switzerland 37-Glydant-Plus-Liquid.doc 1 (5) Muriel Girault LP-Basel ST Version: ctober 23, 2002

2 Europe IPB was placed on the Positive List in 2000 by the SNFP. The approval allows for the use of IPB as a preservative in both leave-on and rinse-off products at an incorporation rate of up to 0.05%. If IPB is used in leave-on products at a rate between 0.02 % and 0.05 %. the finished product must carry a label statement that it contains Iodine. Finished leave-on products containing less than 0.02 % do not require the label statement. IPB cannot be used in oral hygiene or lip care products. Japan urrently, IPB cannot be used in cosmetics though it continues to be widely used in household and industrial products. Lonzagroup is working to gain approval for the use of IPB in personal care products in Japan. 4.2 DMDM-Registration Europe USA Japan listed as a preservative for cosmetics on the EE positive list EE max. accepted concentration: 0.6 % (100% active) DMDM ydantoin is recognized by the osmetic,toiletry and Fragrance association (TFA) for use in cosmetic and personal care products. 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 labeled: 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: 0.85 % Finished product must carry a label statement that it contains iodine if Glydant Plus liquid is used in leave-on products at a rate between 0.8 % and 0.85 %. annot be used in oral hygiene or lip care products. 5. 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 sulfate 25.0 PE 20 glyceryl monostearate 4.0 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 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 > Glydant-Plus-Liquid.doc 2 (5) Muriel Girault LP-Basel ST Version: ctober 23, 2002

3 % 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. 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 ther investigations Typical formulations containing Glydant Plus Liquid and other preservatives have been undergoing comparative tests (28 days challenge tests and MI determinations). Information with results available upon request. 37-Glydant-Plus-Liquid.doc 3 (5) Muriel Girault LP-Basel ST Version: ctober 23, 2002

4 7. Stability 7.1 Recovery % of actives vs. Temperature Time, months % total % IPB > > 95 NT > 90 > 95 NT 12 > 95 NT NT > 95 NT NT 18 > 95 NT NT > 90 NT NT NT: not tested 7.2 Typical % Free level % Free Glydant Plus Liquid < 0.1 ompetitor A > 1.0 ompetitor B > olor stability Water-white 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. 8. 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, ils Body Lotions, leansing Lotions, Moisturizing Lotions old reams, Moisturizers, and and Foot Surfactants, Shampoos and onditioner Blends We do not recommend the use of Glydant Plus Liquid in aerosol products. 9. Recommendations to formulate It 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) 9.1 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 Glydant-Plus-Liquid.doc 4 (5) Muriel Girault LP-Basel ST Version: ctober 23, 2002

5 9.2 ompatibility It 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 1 month at room temperature and 50. Glydant Plus Liquid proved to be compatible with all the tested products : no major change was observed for either criteria. 10. 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. 11. Packaging / Storage Product is supplied in polyethylene pails holding 30 kg net or polyethylene drums holding kg net. It can be stored three years in the sealed original packaging, at a temperature between 15 and 24. The product must be kept protected from light and freezing. At a temperature of lower than 15 cristallization of the product is possible. In such a case product should be heated up to in a closed vessel under continuous stirring until the product is completely solubilized. 12. Regulatory information 13. Toxicological information 14. Ecological and Ecotoxicological Information 15. 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. Additional tox data are available upon request The information contained herein is believed to be correct as to the date hereof. owever, no warranty is made, either expressed or implied, regarding its accuracy or the result to be obtained from the use of such information. 37-Glydant-Plus-Liquid.doc 5 (5) Muriel Girault LP-Basel ST Version: ctober 23, 2002