RIFM fragrance ingredient safety assessment, 2-ethyl-5-methoxybicyclo[2.2.1]heptane, CAS registry number 122795-41-9

A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, M. Francis, A. D. Fryer, L. Jones, K. Joshi, S. La Cava, A. Lapczynski, D. C. Liebler, D. O'Brien, A. Patel, T. M. PenningG. Ritacco, J. Romine, N. Sadekar, D. Salvito, T. W. Schultz, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura, S. Tsang

Research output: Contribution to journalShort surveypeer-review

Abstract

4H-4a,9-Methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) (CAS # 211299-54-6) was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from 4H-4a,9-methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) show that it is not genotoxic, and that there are no safety concerns for skin sensitization under the current, declared levels of use. Data from 4H-4a,9-methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) provide a calculated MOE >100 for the repeated dose toxicity endpoint. The reproductive and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class III material, and the exposure to 4H-4a,9-methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) is below the TTC (0.0015 mg/kg/day and 0.47 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; 4H-4a,9-methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) is not expected to be phototoxic/photoallergenic. For the environmental endpoints, 4H-4a,9-methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) is not PBT as per the IFRA Environmental Standards, and its risk quotients (i.e., PEC/PNEC) for the aquatic environment based on its current volume of use in Europe and North America are <1.

Original languageEnglish (US)
Pages (from-to)S90-S99
JournalFood and Chemical Toxicology
Volume127
DOIs
StatePublished - May 15 2019

ASJC Scopus subject areas

  • Food Science
  • Toxicology

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