Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2019
RIFM fragrance ingredient safety assessment, 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol, CAS registry number 63500-71-0.
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Api A M, Belsito D, Botelho D, Bruze M, Burton G A, Buschmann J, Dagli M L, Date M, Dekant W, Deodhar C, Francis M, Fryer A D, Jones L, Joshi K, La Cava S, Lapczynski A, Liebler D C, O'Brien D, Patel A, Penning T M, Ritacco G, Romine J, Sadekar N, Salvito D, Schultz T W, Sipes I G, Sullivan G, Thakkar Y, Tokura Y, Tsang S
Аннотация
2-Isobutyl-4-methyltetrahydro-2H-pyran-4-ol) was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol is not genotoxic, does not have skin sensitization potential, and provided an MOE >100 for the repeated dose, developmental, and reproductive toxicity endpoints. The local respiratory toxicity endpoint was completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class III material (0.47 mg/day). The phototoxicity/photoallergenicity endpoint was completed based on UV spectra and data on 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol. The environmental endpoints were evaluated; 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.