1. RIFM fragrance ingredient safety assessment, dihydrocarvyl acetate, CAS Registry Number 20777-49-5.
- Author
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Api AM, Belsito D, Botelho D, Bruze M, Burton GA Jr, Buschmann J, Cancellieri MA, Dagli ML, Date M, Dekant W, Deodhar C, Fryer AD, Jones L, Joshi K, Kumar M, Lapczynski A, Lavelle M, Lee I, Liebler DC, Moustakas H, Na M, Penning TM, Ritacco G, Romine J, Sadekar N, Schultz TW, Selechnik D, Siddiqi F, Sipes IG, Sullivan G, Thakkar Y, and Tokura Y
- Subjects
- Academies and Institutes, Acetates toxicity, Animals, Dermatitis, Photoallergic, Dermatitis, Phototoxic, Europe, Female, Fertility drug effects, Male, Mutagenicity Tests, North America, Quantitative Structure-Activity Relationship, Rats, Sprague-Dawley, Rats, Wistar, Reproduction drug effects, Respiratory System drug effects, Risk Assessment, Skin drug effects, Toxicity Tests, Rats, Odorants analysis, Perfume toxicity, Registries, Safety Management
- Abstract
The existing information supports the use of this material as described in this safety assessment. Dihydrocarvyl acetate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analogs dihydrocarveol (isomer unspecified) (CAS # 619-01-2) and acetic acid (CAS # 64-19-7) show that dihydrocarvyl acetate is not expected to be genotoxic. Data on read-across analogs isopulegol (CAS # 89-79-2) and acetic acid (CAS # 64-19-7 provide a calculated MOE >100 for the repeated dose toxicity endpoint. The reproductive and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class I material, and the exposure to dihydrocarvyl acetate is below the TTC (0.03 mg/kg/day and 1.4 mg/day, respectively). Data from read-across analog 4-methyl-8-methylenetricyclo [3.3.1.(3,7)]decan-2-yl acetate (CAS # 122,760-85-4) provided dihydrocarvyl acetate a NESIL of 2500 μg/cm
2 for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on UV/Vis spectra; dihydrocarvyl acetate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; dihydrocarvyl acetate 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., (Copyright © 2021 Elsevier Ltd. All rights reserved.)- Published
- 2021
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