Update to RIFM fragrance ingredient safety assessment, isopropylphenylbutanal, CAS Registry Number 125109-85-5

Abstract

SummaryThe existing information supports the use of this material as described in this safety assessment.Isopropylphenylbutanal was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Target data show that isopropylphenylbutanal is not genotoxic and provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog 2-methyl-3-(p-isopropylphenyl)propionaldehyde (CAS # 103-95-7) provide a calculated MOE >100 for the reproductive toxicity endpoint and a No Expected Sensitization Induction Level (NESIL) of 5900 μg/cm2 for the skin sensitization endpoint. The photoirritation/photoallergenicity endpoints were evaluated based on data and ultraviolet (UV) spectra; isopropylphenylbutanal is not 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 isopropylphenylbutanal is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; isopropylphenylbutanal 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 (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.