2 Final Report on the Safety Assessment of PEG-2, 6, 8,-12, 20, 32, 40, 50, 100, and 150 Stearates

Abstract

The PEG Stearates are the polyethylene glycol esters of stearic acid. These nonionic surfactants are used mainly in cosmetic products as surfactants and emollients at concentrations up to 25%. The PEG Stearates, whose average number of ethylene oxide monomers range from 2 to 150, were nonlethal to test animals up to 10 g/kg. They gave evidence of only low-level skin irritation and minimal eye irritation when tested at 100% concentrations in test animals. PEG-8, 40, and 100 Stearates produced no significant changes in growth mortality rates, histopathologic observations or hematologic values in long-term feeding studies. Multiple generation studies of PEG-8 and 40 Stearates were negative for effects on reproduction; the presence or absence of a carcinogenic effect was not reported. Clinical studies on the PEG Stearates indicated that these ingredients are neither irritants nor sensitizers at concentrations of ≥ 25%. There was no evidence of phototoxicity or photosensitization of PEG-2 or 8 Stearates. It is concluded that PEG-2, 6, 8, 12, 20, 32, 40, 50, 100, and 150 Stearates are safe as cosmetic ingredients in the present practices of concentration and use.