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RIFM fragrance ingredient safety assessment, hydroxycitronellal dimethyl acetal, CAS Registry Number 141-92-4

Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association | 10 Dec 2019

AM Api, F Belmonte, D Belsito, S Biserta, D Botelho, M Bruze, GA Burton, J Buschmann, MA Cancellieri, ML Dagli, M Date, W Dekant, C Deodhar, AD Fryer, S Gadhia, L Jones, K Joshi, A Lapczynski, M Lavelle, DC Liebler, M Na, D O'Brien, A Patel, TM Penning, G Ritacco, F Rodriguez-Ropero, J Romine, N Sadekar, D Salvito, TW Schultz, IG Sipes, G Sullivan, Y Thakkar, Y Tokura and S Tsang
Abstract
Hydroxycitronellal dimethyl acetal was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog hydroxycitronellal diethyl acetal (CAS # 7779-94-4) show that hydroxycitronellal dimethyl acetal is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class I material and the exposure to hydroxycitronellal dimethyl acetal is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data from hydroxycitronellal dimethyl acetal and from read-across material hydroxycitronellal diethyl acetal (CAS # 7779-94-4) show that there are no safety concerns for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; hydroxycitronellal dimethyl acetal is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; hydroxycitronellal dimethyl acetal 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.
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