A M Api, A Bartlett, D Belsito, D Botelho, M Bruze, A Bryant-Friedrich, G A Burton, M A Cancellieri, H Chon, M Cronin, S Crotty, M L Dagli, W Dekant, C Deodhar, K Farrell, A D Fryer, M Guttenberg, L Jones, K Joshi, A Lapczynski, D L Laskin, M Lavelle, I Lee, H Moustakas, J Muldoon, T M Penning, A H Piersma, G Ritacco, N Sadekar, I Schember, T W Schultz, F Siddiqi, I G Sipes, G Sullivan, Y Thakkar
Phenylethyl anthranilate 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 analogs phenethyl alcohol (CAS # 60-12-8) and benzoic acid, 2-amino- (CAS # 118-92-3) show that phenylethyl anthranilate is not expected to be genotoxic. Data from read-across analogs phenethyl alcohol (CAS # 60-12-8) and benzoic acid, 2-amino- (CAS # 118-92-3) provide a calculated Margin of Exposure (MOE) >100 for the repeated dose toxicity endpoint. The reproductive and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class II material, and the exposure to phenylethyl anthranilate is below the TTC (0.009 mg/kg/day and 0.47 mg/day, respectively). The skin sensitization endpoint was completed using the Dermal Sensitization Threshold (DST) for non-reactive materials (900 μg/cm2); exposure is below the DST. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; phenylethyl anthranilate is not expected to be photoirritating/photoallergenic. The environmental endpoints were evaluated; phenylethyl anthranilate was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotient (RQ), based on its current volume of use (VoU) in North America (NA) (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), is <1. Phenylethyl anthranilate was not able to be risk screened for Asia-Pacific (AP), Europe (EU), South America (SA), or Japan (JP) as there were no reported VoUs for these regions in the 2023 IFRA Survey.