Final Report on the Safety Assessment of Arachidonic Acid

Abstract

Arachidonic Acid is an essential, polyunsaturated, fatty acid that is used as a surfactant-cleansing agent and a surfactant-emulsifying agent in cosmetic formulations. Arachidonic Acid is well absorbed from the gastrointestinal tract and the circulatory system; it distributes rapidly into the lipid compartment of the body and is rapidly converted to phospholipid by the liver. Arachidonic Acid may alter the cutaneous immune response; in one study, the effect was more pronounced at lower test concentrations than at higher. Application of Arachidonic Acid to mouse skin produced edema and inflammation, with high dosages possibly causing ulceration of the skin. Arachidonic Acid has mutagenic potential. In a 24 h single insult patch test, a formulation containing 0.04% Arachidonic Acid was not a skin irritant. The safety of use of this ingredient in cosmetic products has not been documented and substantiated. It cannot be concluded that Arachidonic Acid is safe for use in cosmetic products until the needed additional safety test data have been obtained and evaluated. If the requested skin absorption data indicate that absorption occurs, immunomodulatory data, carcinogenicity and photocarcinogenicity data, human irritation, sensitization, and photosensitization data may also be required.