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  4. RIFM fragrance ingredient safety assessment, 2-ethyl-5-methoxybicyclo[2.2.1]heptane, CAS registry number 122795-41-9
 
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2019
Journal Article
Title

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

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.
Author(s)
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.
Cava, S. La
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.
Journal
Food and Chemical Toxicology : FCT  
Open Access
DOI
10.1016/j.fct.2019.01.031
Additional full text version
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Language
English
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM  
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