TY - JOUR
T1 - RIFM fragrance ingredient safety assessment, 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol, CAS Registry Number 526218-21-3
AU - Api, A. M.
AU - Belsito, D.
AU - Biserta, S.
AU - Botelho, D.
AU - Bruze, M.
AU - Burton, G. A.
AU - Buschmann, J.
AU - Cancellieri, M. A.
AU - Dagli, M. L.
AU - Date, M.
AU - Dekant, W.
AU - Deodhar, C.
AU - Fryer, A. D.
AU - Gadhia, S.
AU - Jones, L.
AU - Joshi, K.
AU - Lapczynski, A.
AU - Lavelle, M.
AU - Liebler, D. C.
AU - Na, M.
AU - O'Brien, D.
AU - Patel, A.
AU - Penning, T. M.
AU - Ritacco, G.
AU - Rodriguez-Ropero, F.
AU - Romine, J.
AU - Sadekar, N.
AU - Salvito, D.
AU - Schultz, T. W.
AU - Siddiqi, F.
AU - Sipes, I. G.
AU - Sullivan, G.
AU - Thakkar, Y.
AU - Tokura, Y.
AU - Tsang, S.
N1 - Publisher Copyright:
© 2020 Elsevier Ltd
PY - 2020/10/15
Y1 - 2020/10/15
N2 - The existing information supports the use of this material as described in this safety assessment. 1-(2-Methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is not genotoxic. Data on 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. The reproductive and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class III material, and the exposure to 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is below the TTC (0.0015 mg/kg/day and 0.47 mg/day, respectively). Data show that there are no safety concerns for 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; for the hazard assessment based on the screening data, 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is not persistent, bioaccumulative, and toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. For the risk assessment, 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol was not able to be risk screened as there were no reported volumes of use for either North America or Europe in the 2015 IFRA Survey.
AB - The existing information supports the use of this material as described in this safety assessment. 1-(2-Methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is not genotoxic. Data on 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity endpoint. The reproductive and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class III material, and the exposure to 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is below the TTC (0.0015 mg/kg/day and 0.47 mg/day, respectively). Data show that there are no safety concerns for 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; for the hazard assessment based on the screening data, 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol is not persistent, bioaccumulative, and toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. For the risk assessment, 1-(2-methylprop-2-enoloxy)-2,2,4-trimethylpentan-3-ol was not able to be risk screened as there were no reported volumes of use for either North America or Europe in the 2015 IFRA Survey.
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U2 - 10.1016/j.fct.2020.111492
DO - 10.1016/j.fct.2020.111492
M3 - Short survey
C2 - 32634508
AN - SCOPUS:85087949636
SN - 0278-6915
VL - 144
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
M1 - 111492
ER -