Final Report on the Safety Assessment of Adipic Acid Dihydrazide

Abstract

Adipic Acid Dihydrazide has been used as a chemical additive in a variety of cosmetic products. The ingredient was previously reported to be used; however, there are no reported uses of Adipic Acid Dihydrazide during 1992. The available safety test data were insufficient to judge the safety of use of Adipic Acid Dihydrazide in cosmetic products. The types of data required before an evaluation on the safety of use of this cosmetic ingredient include: metabolism (stability of compound in vivo, with respect to hydrolysis to hydrazine); stability and impurities (specifically, data on hydrazine content is necessary); concentration of use in cosmetic formulations. If the interpretation of the preceding requested data indicates that this ingredient could be safely used in cosmetic formulations, the following additional safety test data must be available and evaluated before it can be determined whether this compound may be safely used in cosmetic products. The needed data include: chemistry (including pH, method of manufacture, and UV spectrum); ocular irritation; dermal irritation; dermal sensitization; dermal photosensitization (only if the compound absorbs in the UV spectrum); 28-day dermal toxicity; genotoxicity (at least two assays); carcinogenicity may be requested if genotoxicity assays are positive.