Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2020
RIFM fragrance ingredient safety assessment, 1-nonanol, 2,4,6,8-tetramethyl-,acetate, CAS Registry Number 68922-14-5.
СтатьяОбзорНазвание и аннотация: Перевод в очереди
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Api A M, Belsito D, Biserta S, Botelho D, Bruze M, Burton G A, Buschmann J, Cancellieri M A, Dagli M L, Date M, Dekant W, Deodhar C, Fryer A D, Gadhia S, Jones L, Joshi K, Lapczynski A, Lavelle M, Liebler D C, Na M, O'Brien D, Patel A, Penning T M, Ritacco G, Rodriguez-Ropero F, Romine J, Sadekar N, Salvito D, Schultz T W, Siddiqi F, Sipes I G, Sullivan G, Thakkar Y, Tokura Y, Tsang S
Аннотация
The existing information supports the use of this material as described in this safety assessment. 1-Nonanol, 2,4,6,8-tetramethyl-,acetate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from 1-nonanol, 2,4,6,8-tetramethyl-,acetate and read-across analog isotridecyl acetate (CAS # 69103-23-7) show that this material is not expected to be genotoxic. Data on read-across material 3,5,5-trimethylhexyl acetate (CAS # 58430-94-7) provide a calculated MOE >100 for the repeated dose and reproductive toxicity endpoints. Based on the existing data and the additional material acetic acid, C11-14-isoalkyl esters, C13-rich (CAS # 84712-50-5), 1-nonanol, 2,4,6,8-tetramethyl-,acetate does not present a concern for skin sensitization under the current, declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and UV spectra; 1-nonanol, 2,4,6,8-tetramethyl-,acetate is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the TTC for a Cramer Class I material and the exposure to 1-nonanol, 2,4,6,8-tetramethyl-,acetate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 1-nonanol, 2,4,6,8-tetramethyl-,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.