化妆品原料PEG-14 月桂酸酯的安全评估信息

ABSTRACT: PEGs Dilaurate and PEGs Laurate are the diesters and monoesters, respectively, of polyethylene glycol and lauric acid used in a wide variety of cosmetic formulations as surfactants emulsifying agents. PEG esters are produced by the ethoxylation of fatty acids. In general, ethoxylated fatty acids can contain 1,4-dioxane as a by product of ethoxylation. Traces of the reactants (fatty acid, ethy lene oxide, and any catalystst may remain in the finished product. Current concentration of use data were not available; the highest previously reported concentration was 25%. The PEGs Dilaurate and PEGs Laurate are similar to the PEGs Stearate and PEGs Dis tearate, and to the components (Polyethylene Glycol and Lauric Acid); all of which have been addressed in previous safety assessments. PEGs were readily absorbed through damaged skin. Fatty acids such as Lauric Acid are absorbed, digested, and transported in animals and humans. The acute oral LDs0 of PEG-12 Laurate was >25 g/kg in mice. In short-term feeding studies, PEGs Laurate were irritating to the gastrointestinal tract, but not necrotizing. In chronic oral toxicity studies, there was some evidence of liver damage and hyperplasia in several tissues. It is generally recognized that the PEG monomer, ethylene glycol, and certain of its monoalkyl ethers are reproductive and developmental toxins. These esters and diesters are chemically different from PEG alkyl ethers and are not expected to cause adverse reproductive or developmental effects. In actual studies, PEGs Stearate, and PEGs Distearate did not cause reproductive or developmental toxicity, and were not carcinogenic. Likewise, PEGs were not carcinogenic. Although sensitization and nephrotoxicity were observed in burn patients treated with a PEG-based cream, no evidence of systemic toxicity or sensitization was found in studies with intact skin. Be- cause of the possible presence of 1,4-dioxane reaction product and unreacted ethylene oxide residues, it was considered necessary to use appropriate procedures to remove these from PEGs Dilaurate and PEGs Laurate ingredients before blending them into cosmetic formulations. Based on the limited data on the PEGs Dilaurate and the PEGs Laurate, on the data available on the component ingre- dients, and on the data available on similar PEG fatty acid esters, it was concluded that PEG-2, -4, -6, -8, -12, -20, -32, -75, and -150 Dilaurate; PEG-2, -4, -8, -9, -10, -12, -14, -20, -32, -75, -150, and -200 Laurate; and PEG-2 Laurate SE are safe for use in cosmetics at concentrations up to 25%.olnjicgni

CONCLUSION: On the basis of the available data, the CIR Expert Panel concludes that PEG-2, -4, -6, -8, - 12, -20, -32, -75, and - 150 Dilaurate; PEG-2,-4,-6,-8,-9,-10, -12, -14,-20,-32, -75, -150, and -200 Laurate; and PEG-2 Laurate SE are safe for use in cosmetics at concentrations up to 25%.olnjicgni

CITE: Final Report on the Safety Assessment of PEG (Polyethylene Glycol)-2, -4, -6, -8, -12, -20, -32, -75, and -150 Dilaurate; PEG-2, -4, -6, -8, -9, -10, -12, -14, -20, -32, -75, -150, and -200 Laurate; and PEG-2 Laurate SE