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

Api, A. M.; Belsito, D.; Botelho, D.; Bruze, M. LU ; Burton, G. A.; Buschmann, J.; Dagli, M. L.; Date, M.; Dekant, W. and Deodhar, C., et al. (2019) In Food and Chemical Toxicology
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... (More)

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.

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Food and Chemical Toxicology
publisher
Elsevier
external identifiers
  • scopus:85061098433
ISSN
0278-6915
DOI
10.1016/j.fct.2019.01.031
language
English
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no
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3b5d33ea-f945-4631-beb0-d11f3b61e896
date added to LUP
2019-02-14 08:27:51
date last changed
2019-03-12 04:21:13
@article{3b5d33ea-f945-4631-beb0-d11f3b61e896,
  abstract     = {<p>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 &gt;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 &lt;1.</p>},
  author       = {Api, A. M. and Belsito, D. and Botelho, D. and Bruze, M. and Burton, G. A. and Buschmann, J. and Dagli, M. L. and Date, M. and Dekant, W. and Deodhar, C. and Francis, M. and Fryer, A. D. and Jones, L. and Joshi, K. and La Cava, S. and Lapczynski, A. and Liebler, D. C. and O'Brien, D. and Patel, A. and Penning, T. M. and Ritacco, G. and Romine, J. and Sadekar, N. and Salvito, D. and Schultz, T. W. and Sipes, I. G. and Sullivan, G. and Thakkar, Y. and Tokura, Y. and Tsang, S.},
  issn         = {0278-6915},
  language     = {eng},
  month        = {02},
  publisher    = {Elsevier},
  series       = {Food and Chemical Toxicology},
  title        = {RIFM fragrance ingredient safety assessment, 2-ethyl-5-methoxybicyclo[2.2.1]heptane, CAS registry number 122795-41-9},
  url          = {http://dx.doi.org/10.1016/j.fct.2019.01.031},
  year         = {2019},
}