RIFM fragrance ingredient safety assessment, 2-isobutyl-4-methyltetrahydro-2H-pyran-4-ol, CAS registry number 63500-71-0. (August 2019)

• Record Type: Journal Article
• Authors: 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.
• Is Part Of: Food and chemical toxicology. Volume 130(2019)Supplement 1
• Publication Date: 2019-08
• Subjects: Toxicology -- Periodicals; Food poisoning -- Periodicals; Food Poisoning -- Periodicals; Toxicology -- Periodicals; Toxicologie -- Périodiques; Intoxications alimentaires -- Périodiques; Food poisoning; Toxicology; Periodicals; Electronic journals; 615.9
• DOI: 10.1016/j.fct.2019.110564
• Languages: English
• ISSNs: 0278-6915

Abstract

Abstract: 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. Highlights: 2-Isobutyl-4-methyltetrahydro-2H-pyran-4-ol, safety assessment based on RIFM's criteria. Safety assessment based on 7 human health endpoints plus environmental. All endpoints were cleared using target data, read-across, and/or TTC.