The existing information supports the use of this material as described in this safety assessment. 4H-1,3-Benzodioxin, hexahydro-4-methyl-2-(phenylmethyl)- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 4-methyl-2-(1-phenylethyl)-1,3-dioxolane ( CAS # 67634-23-5) show that 4H-1,3-benzodioxin, hexahydro-4-methyl-2-(phenylmethyl)- is not expected to be genotoxic. The repeated dose, 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 4H-1,3-benzodioxin, hexahydro-4-methyl-2-(phenylmethyl)-is below the TTC(0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). Data from read-across analog phenylacetaldehyde 2,4-dihydroxy-2-methylpentane acetal (CAS # 67633-94-7) show that there are no safety concerns for 4H-1,3-benzodioxin, hexahydro-4-methyl-2-(phenylmethyl)- for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 4H-1,3-benzodioxin, hexahydro-4-methyl-2- (phenylmethyl)-is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4H-1,3-benzodioxin, hexahydro-4- methyl-2-(phenylmethyl)-was found not to be persistent, bioaccumulative, and toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., Predicted EnvironmentalConcentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.
Authors: Api AM, Belmonte F, Belsito D, Biserta S, Botelho D, Bruze M, Burton GA Jr, Buschmann J, Cancellieri MA, Dagli ML, Date M, Dekant W, Deodhar C, Fryer AD, Gadhia S, Jones L, Joshi K, Lapczynski A, Lavelle M, Liebler DC, Na M, OBrien D, Patel A, Penning TM, Ritacco G, Rodriguez-Ropero F, Romine J, Sadekar N, Salvito D, Schultz TW, Saddiqi F, Sipes IG, Sullivan G, Thakkar Y, Tokura Y, Tsang S
; Full Source: Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association. 2020 Apr 28:111379. doi: 10.1016/j.fct.2020.111379. [Epub ahead of print]