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

 
: 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.; Cava, S. La; 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.

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Food and Chemical Toxicology : FCT 130 (2019), Supplement 1, Art.110564
ISSN: 0278-6915
ISSN: 1873-6351
English
Journal Article
Fraunhofer ITEM ()

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.

: http://publica.fraunhofer.de/documents/N-558365.html