Summary: The use of this material under current conditions is supported by existing information.
The material diethyl malonate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Target data show that diethyl malonate is not genotoxic. The repeated dose and reproductive toxicity endpoints were completed using dimethyl malonate (CAS# 108-59-8) as a read-across analog, which provided an MOE > 100. Data from target material and read-across analog, pentanedioic acid, 1,5-dimethyl ester (CAS# 1119-40-0) show that is material is not a concern for skin sensitization. The local respiratory toxicity endpoint was completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (1.4 mg/day). The phototoxicity/photoallergenicity endpoint was completed based on UV spectra. The environmental endpoints were evaluated; diethyl malonate was found not to be a PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC) are < 1.