RIFM fragrance ingredient safety assessment, methyl linoleate, CAS Registry Number 112-63-0

Methyl linoleate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog methyl linoleate (48%) methyl linolenate (52%) mixture (CAS # 301-00-8) show that methyl linoleate 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 methyl linoleate is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data from read-across analog linoleic acid (CAS # 60-33-3) provided methyl linoleate a No Expected Sensitization Induction Level (NESIL) of 1300 μg/cm² for the skin sensitization endpoint. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; methyl linoleate is not expected to be photoirritating/photoallergenic. The environmental endpoints were evaluated; methyl linoleate 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), Japan (JP), and South America (SA) (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.