Final Report on the Safety Assessment of PEG-2, -3, -4, -6, -8, -9, -12, -20, -32, -50, -75, -120, -150, and -175 Distearate’

Abstract

PEG Distearate compounds are the polyethylene glycol (PEG) diesters of Stearic Acid. They are manufactured by the esterification of Stearic Acid with a the number of moles of ethylene oxide corresponding to the average polyethylene glycol chain length desired. PEGs Distearate are used as emulsifying, cleansing, and solubilizing agents in a wide variety of cosmetic formulations. Not all of the polymer chain lengths covered in this assessment are currently reported to be used, but all are listed as cosmetic ingredients and may have been used in the past and could be used in the future. Very little toxicity data are available for the PEGs Distearate. Related compounds including PEGs, PEGs Stearate, Steareths, and Stearic Acid, have previously been reviewed. In general, PEGs have a low level of toxicity whether the exposure is oral or dermal. Minimal ocular irritation is seen with PEGs, PEGs Stearate, Steareths, and Stearic Acid. No evidence of mutagenicity, carcinogenicity, or reproductive and developmental toxicity of these related compounds was found. Based on clinical data in bum patients, PEGs were mild irritant/sensitizers and there was evidence of nephrotoxicity. Cosmetic manufacturers should continue to adjust product formulations to minimize any untoward effects when products are used on damaged skin. PEGs Stearate, Steareths, and Stearic Acid were not irritants, sensitizers, or phototoxins. Because of the possibility of residual ethylene oxide and/or 1,4-dioxane impurities in PEGs Distearate, cosmetic formulators are urged to continue efforts to remove these impurities before blending PEGs Distearate into cosmetic formulations. Although metabolites of ethylene glycol monoalkyl ethers are reproductive and developmental toxins, it was considered unlikely that the relevant metabolites would be found in or produced from the use of PEGs Distearate in cosmetic formulations. Based on the available data on related compounds, and current industry practices in the use and manufacture of PEGs Distearate, it was concluded that PEG-2, -3, -4, -6, -8, -9, -12, -20, -32, -50, -75, -120, -150, and -175 Distearate are safe for use in cosmetic formulations under the present practices of use.