RIFM fragrance ingredient safety assessment, ethyl palmitate, CAS Registry Number 628-97-7

Abstract

Ethyl palmitate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analogs methyl hexadecanoate (CAS # 112-39-0) and methyl decanoate (CAS # 110-42-9) show that ethyl palmitate is not expected to be genotoxic. Data on read-across analog ethyl octadecenoate (CAS # 111-61-5) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and reproductive toxicity endpoints. Data from read-across analog methyl hexadecanoate (CAS # 112-39-0) provided ethyl palmitate a No Expected Sensitization Induction Level (NESIL) of 2400 μg/cm2 for the skin sensitization endpoint. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; ethyl palmitate is not expected to be photoirritating/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to ethyl palmitate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; ethyl palmitate was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients (RQs), based on its current volume of use (VoU) in Europe (EU), North America (NA), Asia-Pacific (AP), and South America (SA) (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.