4 Final Report on the Safety Assessment of Sodium Dehydroacetate and Dehydroacetic Acid

Abstract

Sodium Dehydroacetate and Dehydroacetic Acid are used as preservatives in cosmetic formulations at concentrations of 1.0 percent or less. Both compounds are rapidly absorbed when administered orally or on the skin of test animals. Acute toxicity studies indicate that Sodium Dehydroacetate and Dehydroacetic Acid are slightly toxic when administered orally to rats. Neither compound was an irritant when applied to rabbit skin. Sodium Dehydroacetate was found to exhibit minimal eye irritation. Subchronic and chronic studies reveal various toxic effects, primarily due to the incurred lack of appetite and weight loss. No evidence of mutagenicity was reported for either ingredient use. No evidence of tumor induction by Dehydroacetic Acid was detected in a 64-week study. Dehydroacetic Acid had an inhibitory effect on hepatoma induction in rats when fed 4-(dimethylamino)azobenzene. A teratogenicity study in mice revealed no significant findings when compared to untreated controls. Sodium Dehydroacetate, Dehydroacetic Acid, and cosmetics containing these ingredients were found practically nonirritating, nonsensitizing, nonphotosensitizing, and nonphototoxic in numerous clinical tests. On the basis of the available animal and clinical data, it is concluded that Sodium Dehydroacetate and Dehydroacetic Acid are safe as cosmetic ingredients in the present practices of use and concentration.