Api, A.M.A.M.ApiBelsito, D.D.BelsitoBotelho, D.D.BotelhoBruze, M.M.BruzeBurton, G.A.G.A.BurtonBuschmann, J.J.BuschmannDagli, M.L.M.L.DagliDate, M.M.DateDekant, W.W.DekantDeodhar, C.C.DeodharFrancis, M.M.FrancisFryer, A.D.A.D.FryerJones, L.L.JonesJoshi, K.K.JoshiCava, S. LaS. LaCavaLapczynski, A.A.LapczynskiLiebler, D.C.D.C.LieblerO'Brien, D.D.O'BrienPatel, A.A.PatelPenning, T.M.T.M.PenningRitacco, G.G.RitaccoRomine, J.J.RomineSadekar, N.N.SadekarSalvito, D.D.SalvitoSchultz, T.W.T.W.SchultzSipes, I.G.I.G.SipesSullivan, G.G.SullivanThakkar, Y.Y.ThakkarTokura, Y.Y.TokuraTsang, S.S.Tsang2022-03-062022-03-062019https://publica.fraunhofer.de/handle/publica/25915410.1016/j.fct.2019.01.0314H-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.en610615620journal article