RIFM fragrance ingredient safety assessment, ethyl octadecanoate, CAS Registry Number 111-61-5

Abstract

Ethyl octadecanoate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that ethyl octadecanoate is not genotoxic. Data on ethyl octadecanoate 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 octadecanoate 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 octadecanoate 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 octadecanoate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; ethyl octadecanoate 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.