Assuntos
Odorantes , Floroglucinol/análogos & derivados , Animais , Poluentes Ambientais/toxicidade , Humanos , Mutagênicos/toxicidade , Nível de Efeito Adverso não Observado , Floroglucinol/química , Floroglucinol/toxicidade , Reprodução/efeitos dos fármacos , Sistema Respiratório/efeitos dos fármacos , Medição de Risco , Pele/efeitos dos fármacos , Testes de ToxicidadeRESUMO
The existing information supports the use of this material as described in this safety assessment. 3,4,4a,5,8,8a (Or 3,4,4a,7,8,8a)-Hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class III material, and the exposure to 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for non-reactive materials (900 µg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3,4,4a, 5,8,8a (Or 3,4,4a,7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran 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.
Assuntos
Odorantes , Animais , Relação Dose-Resposta a Droga , Humanos , Relação Quantitativa Estrutura-Atividade , Reprodução/efeitos dos fármacos , Medição de Risco , Testes de ToxicidadeRESUMO
The existing information supports the use of this material as described in this safety assessment.2-Propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from the target material and read-across analog 1,1',1''-nitrilotripropan-2-ol (CAS # 122-20-3) show that 2-propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- is not expected to be genotoxic. Data on 2-propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints and show that there are no safety concerns for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 2-propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the threshold of toxicological concern (TTC) for a Cramer Class III material, and the exposure to 2-propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- is below the TTC (0.47 mg/day). The environmental endpoints were evaluated; 2-propanol, 1,1',1',1'-(1,2-ethanediyldinitrilo)tetrakis- 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.