Update to RIFM fragrance ingredient safety assessment, myristic acid, CAS Registry Number 544-63-8

Abstract

Myristic acid was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Target data and data from read-across analog palmitic acid (CAS # 57-10-3) show that myristic acid is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to myristic acid is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Target data and data from read-across analog nonanoic acid (CAS # 112-05-0) show that there are no safety concerns for myristic acid for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; myristic acid is not expected to be photoirritating/photoallergenic. The environmental endpoints were evaluated; myristic acid was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients, based on its current volume of use (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.