Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2026
Update to RIFM fragrance ingredient safety assessment, 2-tert-butylcyclohexanol, CAS Registry Number 13491-79-7.
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Api A M, Bartlett A, Belsito D, Botelho D, Bruze M, Bryant-Friedrich A, Burton G A, Cancellieri M A, Chon H, Cronin M, Crotty S, Dagli M L, Dekant W, Deodhar C, Farrell K, Fryer A D, Guttenberg M, Jones L, Joshi K, Lapczynski A, Laskin D L, Lavelle M, Lee I, Moustakas H, Muldoon J, Penning T M, Piersma A H, Ritacco G, Sadekar N, Schember I, Schultz T W, Siddiqi F, Sipes I G, Sullivan G, Thakkar Y
Аннотация
2-tert-Butylcyclohexanol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Target data show that 2-tert-butylcyclohexanol is not genotoxic. Data on read-across analogs l-menthol (CAS # 2216-51-5) and d,l-menthol (isomer unspecified; CAS # 1490-04-6) provide a calculated Margin of Exposure (MOE) >100 for the repeated dose toxicity endpoint. Data on read-across analogs menthol (CAS # 89-78-1) and d,l-menthol (isomer unspecified; CAS # 1490-04-6) provide a calculated MOE >100 for the reproductive toxicity endpoint. Target data show that there are no safety concerns for 2-tert-butylcyclohexanol for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 2-tert-butylcyclohexanol is not expected to be 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 2-tert-butylcyclohexanol is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 2-tert-butylcyclohexanol 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.