1 Final Report on the Safety Assessment of Polysorbates 20, 21, 40, 60, 61, 65, 80, 81, and 85

Abstract

The Polysorbates are a series of polyoxyethylenated sorbitan esters that are used as hydrophilic, nonionic surfactants in a variety of cosmetic products. Polysorbates are hydrolyzed by pancreatic and blood lipases; the fatty acid moiety is released to be absorbed and metabolized, whereas the polyoxyethylene sorbitan moiety is very poorly absorbed and is excreted unchanged. Acute and long-term oral toxicity in animals indicates a low order of toxicity with oral ingestion of the Polysorbates. Polysorbate 80 was shown to be nonmutagenic in the Ames and micronucleus tests. The Polysorbates were noncarcinogenic in laboratory animals. Multiple studies have shown that the Polysorbates enhance the activity of known chemical carcinogens while not actually being carcinogenic themselves. Extensive clinical skin testing showed Polysorbates to have little potential for human skin irritation or evidence of skin sensitization or phototoxicity. The available data indicate that these ingredients are used in numerous preparations without clinical reports of significant adverse effects. It is concluded that they are safe for use in cosmetics at present concentrations of use.