Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2020
RIFM fragrance ingredient safety assessment, 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile, CAS registry number 68084-04-8.
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Api A M, Belsito D, Botelho D, Bruze M, Burton G A, Buschmann J, Dagli M L, Date M, Dekant W, Deodhar C, Francis M, Fryer A D, Jones L, Joshi K, La Cava S, Lapczynski A, Liebler D C, O'Brien D, Patel A, Penning T M, Ritacco G, Romine J, Sadekar N, Salvito D, Schultz T W, 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. 3-(4-Methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile is not genotoxic. Data show that there are no safety concerns for 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile for skin sensitization under the current declared levels of use. 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 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated, 3-(4-methyl-3-pentenyl)-3-cyclohexene-1-carbonitrile 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 Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]) are <1.