Final report on the safety assessment of PEG-6, -8, and -20 sorbitan beeswax.

Polyethylene Glycol (PEG)-6, -8, and -20 Sorbitan Beeswax are ethoxylated derivatives of Beeswax that function as surfactants in cosmetic formulations. Only PEG-20 Sorbitan Beeswax is currently reported to be used, at concentrations up to 11%. Few data on the PEGs Sorbitan Beeswax ingredients were available. This safety assessment relied upon the available data from previous safety assessments of Beeswax, Synthetic Beeswax, Sorbitan Esters, PEGs, and PEG Sorbitan fatty acid esters, also known as Polysorbates. The ester linkage of PEG Sorbitan fatty acid esters was hydrolyzed after oral administration, and the PEG Sorbitan moiety was poorly absorbed from the gastrointestinal tract. Sorbitan Stearate was hydrolyzed to stearic acid and anhydrides of sorbitol in the rat. PEGs are readily absorbed through damaged skin and are associated with contact dermatitis and systemic toxicity in burn patients. PEGs were not sensitizing to normal skin. PEGs did not cause reproductive toxicity, nor were tested PEGs mutagenic or carcinogenic. Sorbitol was not a reproductive or developmental toxin in multigenerational studies in rats. Neither Beeswax nor Synthetic Beeswax produced significant acute animal toxicity, ocular irritation, skin irritation, or skin sensitization. Polysorbates produced no acute or long-term effects, were generally not irritating or sensitizing, and were noncarcinogenic, although studies did demonstrate enhancement of the activity of chemical carcinogens. Sorbitan fatty acid esters were relatively nontoxic via ingestion, generally were not skin irritants or sensitizers, and were not mutagenic or carcinogenic. Sorbitan Laurate was a cocarcinogen in a mouse skin-painting study. PEG-6 Sorbitan Beeswax delivered via a stomach tube was nontoxic in rats in acute studies. Undiluted PEG-6 Sorbitan Beeswax was nonirritating to the eyes of rabbits and was non-irritating to intact and abraded skin of rabbits. PEG-20 Sorbitan Beeswax was only minimally irritating to rabbit eyes at concentrations as high as 30%, and was not a significant skin irritant in rabbits exposed to a product with PEG-20 Sorbitan Beeswax at 2%. In clinical tests, PEG-6 and -20 Sorbitan Beeswax at concentrations up to 3% were only minimally irritating and were nonsensitizers. Careful consideration was made of the data on the cocarcinogenesis, but the high exposure levels, high frequency of exposure, and absence of a dose-response led to the conclusion that there was not a cocarcinogenesis risk with the use of these ingredients in cosmetic formulations. Accordingly, these ingredients were considered safe for use in cosmetic formulations under the present practices of use.