Final Report on the Safety Assessment of Formic Acid

Abstract

Formic Acid is a simple organic acid used as a p H adjustor in cosmetic products. It is a common metabolic intermediate that can be oxidized to carbon dioxide. The available data suggest that Formic Acid is an ocular and skin irritant and can be especially irritating to lung tissue. Both positive and negative results were noted in various mutagenicity studies (acidic experimental conditions were indicated in most cases of positive mutagenicity). In cosmetic formulations, Formic Acid is expected to be used at low concentrations and neutralized into various formate salts. Thus, the free Formic Acid level is expected to be very low. Using data from an inhalation toxicity study in which 64 ppm was found to be nonirritating, it was extrapolated that such a level of free Formic Acid in a cosmetic formulation should not produce adverse effects. Accordingly, it was concluded that Formic Acid is safe for use in cosmetics as a p H adjustor with a limit of 64 ppm for the free acid.