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RIFM fragrance ingredient safety assessment, methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate, CAS Registry Number 81752-87-6

Api, A. M. ; Belsito, D. ; Biserta, S. ; Botelho, D. ; Bruze, M. LU ; Burton, G. A. ; Buschmann, J. ; Cancellieri, M. A. ; Dagli, M. L. and Date, M. , et al. (2021) In Food and Chemical Toxicology 149.
Abstract

The existing information supports the use of this material as described in this safety assessment. Methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate is not genotoxic. Data on methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate provide a calculated Margin of Exposure (MOE) >100 for the repeated dose toxicity endpoint. The reproductive and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I... (More)

The existing information supports the use of this material as described in this safety assessment. Methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate is not genotoxic. Data on methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate provide a calculated Margin of Exposure (MOE) >100 for the repeated dose toxicity endpoint. The reproductive and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate is below the TTC (0.03 mg/kg/day and 1.4 mg/day, respectively). Data show that there are no safety concerns for methyl-2,2-dimethyl-6-methylene-1-yclohexanecarboxylate for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate 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.

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@article{c95eadbc-dee6-489d-909e-a2aabac1740a,
  abstract     = {{<p>The existing information supports the use of this material as described in this safety assessment. Methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate is not genotoxic. Data on methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate provide a calculated Margin of Exposure (MOE) &gt;100 for the repeated dose toxicity endpoint. The reproductive and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate is below the TTC (0.03 mg/kg/day and 1.4 mg/day, respectively). Data show that there are no safety concerns for methyl-2,2-dimethyl-6-methylene-1-yclohexanecarboxylate for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate 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 &lt;1.</p>}},
  author       = {{Api, A. M. and Belsito, D. and Biserta, S. and Botelho, D. and Bruze, M. and Burton, G. A. and Buschmann, J. and Cancellieri, M. A. and Dagli, M. L. and Date, M. and Dekant, W. and Deodhar, C. and Fryer, A. D. and Gadhia, S. and Jones, L. and Joshi, K. and Kumar, M. and Lapczynski, A. and Lavelle, M. and Lee, I. and Liebler, D. C. and Moustakas, H. and Na, M. and Penning, T. M. and Ritacco, G. and Romine, J. and Sadekar, N. and Schultz, T. W. and Selechnik, D. and Siddiqi, F. and Sipes, I. G. and Sullivan, G. and Thakkar, Y. and Tokura, Y.}},
  issn         = {{0278-6915}},
  keywords     = {{Environmental safety; Genotoxicity; Local respiratory toxicity; Phototoxicity/photoallergenicity; Repeated dose, developmental, and reproductive toxicity; Skin sensitization}},
  language     = {{eng}},
  publisher    = {{Elsevier}},
  series       = {{Food and Chemical Toxicology}},
  title        = {{RIFM fragrance ingredient safety assessment, methyl-2,2-dimethyl-6-methylene-1-cyclohexanecarboxylate, CAS Registry Number 81752-87-6}},
  url          = {{http://dx.doi.org/10.1016/j.fct.2020.111900}},
  doi          = {{10.1016/j.fct.2020.111900}},
  volume       = {{149}},
  year         = {{2021}},
}