RIFM fragrance ingredient safety assessment, 3-methoxy-5-cresol, CAS Registry Number 3209-13-0

The existing information supports the use of this material as described in this safety assessment. 3-Methoxy-5-cresol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from 3-methoxy-5-cresol and read-across analogs 3,5-dimethoxytoluene (CAS # 4179-19-5) and resorcinol (CAS # 108-46-3) show that 3-methoxy-5-cresol 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 3-methoxy-5-cresol is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data from the target material and readacross analog 2-methoxy-4-methylphenol (CAS # 93-51-6) provided 3-methoxy-5-cresol a No Expected Sensitization Induction Level (NESIL) of 110 mu g/cm(2) for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet/visible (UV/Vis) spectra; 3-methoxy-5-cresol is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 3-methoxy-5-cresol 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.

Automated summary

The safety assessment supports the use of this material. Evaluations on various aspects of 3-methoxy-5-cresol indicate low risks in terms of genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety.