RIFM fragrance ingredient safety assessment, 3-(m-tert-butylphenyl)-2-methylpropionaldehyde, CAS Registry Number 62518-65-4
2020
Api, A.M. | Belsito, D. | Biserta, S. | Botelho, D. | Bruze, M. | Burton, G.A. | Buschmann, J. | Cancellieri, M.A. | Dagli, M.L. | Date, M. | Dekant, W. | Deodhar, C. | Fryer, A.D. | Gadhia, S. | Jones, L. | Joshi, K. | Lapczynski, A. | Lavelle, M. | Liebler, D.C. | Na, M. | O’Brien, D. | Patel, A. | Penning, T.M. | Ritacco, G. | Rodriguez-Ropero, F. | Romine, J. | Sadekar, N. | Salvito, D. | Schultz, T.W. | Siddiqi, F. | Sipes, I.G. | Sullivan, G. | Thakkar, Y. | Tokura, Y. | Tsang, S.
The existing information supports the use of 3-(m-tert-butylphenyl)-2-methylpropionaldehyde as described in this safety assessment.3-(m-tert-Butylphenyl)-2-methylpropionaldehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog p-t-butyl-α-methylhydrocinnamic aldehyde (CAS # 80-54-6) show that 3-(m-tert-butylphenyl)-2-methylpropionaldehyde is not expected to be genotoxic. Data on 3-(m-tert-butylphenyl)-2-methylpropionaldehyde provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and developmental and reproductive toxicity endpoints. Data from read-across analog p-t-butyl-α-methylhydrocinnamic aldehyde (CAS # 80-54-6) provided 3-(m-tert-butylphenyl)-2-methylpropionaldehyde a No Expected Sensitization Induction Level (NESIL) of 4100 μg/cm² for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3-(m-tert-butylphenyl)-2-methylpropionaldehyde is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the threshold of toxicological concern (TTC) for a Cramer Class I material; the exposure to 3-(m-tert-butylphenyl)-2-methylpropionaldehyde is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 3-(m-tert-butylphenyl)-2-methylpropionaldehyde 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 in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.
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