Final Report on the Safety Assessment of Polyethylene Glycols (PEGs)-6,-8,-32,-75,-150,-14M,-20M

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Abstract
PEGs-6,-8,-32,-75,-150,-14M, and 20M are polymers of ethylene oxide used as humectants, solvents, binders, emulsion stabilizers, and viscosity-increasing agents in cosmetics. In metabolism studies with rats, rabbits, dogs, and humans, the lower molecular weight PEGs were absorbed by the digestive track and excreted in the urine and feces. PEGs have low oral and dermal toxicity, and are not irritating to the skin of rabbits or guinea pigs; PEG-75 was not a sensitizer. PEGs caused mild, transient ocular irritation in rabbits. PEG-8 was negative in the Chinese hamster ovary cell mutation test, the sister chromatid exchange test, and the unscheduled DNA synthesis assay. PEG-150 was not mutagenic in the mouse TK+/TK-/- forward mutation assay. PEG-8 was not carcinogenic when administered orally, intraperitoneally, or subcutaneously to various test animals. No adverse reproductive effects occurred during subchronic and chronic oral toxicity studies of PEG-6–32 and PEG-75. In clinical studies, PEG-8, PEG-6–32, and PEG-75 were not sensitizers. On the basis of the individual and combined data on PEGs-6,-8,-32,-75,-150,-14M, and-20M, it is concluded that these ingredients are safe for use at the concentrations reflected in the Cosmetic Use section and in the product formulation safety test data included in this report. However, cosmetic formulations containing these PEGs should not be used on damaged skin.