RESUMO
The existing information supports the use of these materials as described in this safety assessment. The 167 materials identified in this assessment were evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Target data, read-across analogs and TTC show that these materials are not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for their respective Cramer Classes (see Fig. 1 below) and the exposure to these materials is below the TTC. The skin sensitization endpoint was completed using the DST for non-reactive and reactive materials (900 µg/cm2 and 64 µg/cm2, respectively); exposures are below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; these materials are not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; the materials were found not to be PBT as per the IFRA Environmental Standards, and their risk quotients, based on their current volume of use in Europe and North America (i.e., 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 ToxicidadeAssuntos
Monoterpenos Acíclicos/toxicidade , Aldeídos/toxicidade , Odorantes , Monoterpenos Acíclicos/administração & dosagem , Monoterpenos Acíclicos/química , Aldeídos/administração & dosagem , Aldeídos/química , Animais , Poluentes Ambientais/toxicidade , Feminino , Humanos , Masculino , Nível de Efeito Adverso não Observado , Gravidez , 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. p-Tolualdehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, and environmental safety. Data from read-across analog benzaldehyde (CAS # 100-52-7) show that p-tolualdehyde is not expected to be genotoxic. Data from read-across analog cuminaldehyde (CAS # 122-03-2) provided p-tolualdehyde a No Expected Sensitization Induction Level (NESIL) of 1100 µg/cm2 for the skin sensitization endpoint. The repeated dose toxicity, developmental and reproductive toxicity, and local respiratory toxicity endpoints were completed using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to p-tolualdehyde is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on data from read-across analog 4-ethylbenzaldehyde (CAS # 4748-78-1); p-tolualdehyde is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; p-tolualdehyde 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
Benzaldeídos/toxicidade , Odorantes , Animais , Benzaldeídos/química , Relação Dose-Resposta a Droga , Humanos , Relação Quantitativa Estrutura-Atividade , Reprodução/efeitos dos fármacos , Medição de Risco , Testes de ToxicidadeAssuntos
Poluentes Ambientais/toxicidade , Farneseno Álcool/análogos & derivados , Odorantes , Animais , Farneseno Álcool/química , Farneseno Álcool/toxicidade , Feminino , Humanos , Exposição por Inalação , Pulmão/efeitos dos fármacos , Masculino , Reprodução/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. 3,7-Dimethyl-1,3,6-octatriene was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from 3,7-dimethyl-1,3,6-octatriene and read-across analog myrcene (ß-myrcene; CAS # 123-35-3) show that 3,7-dimethyl-1,3,6-octatriene is not expected to be genotoxic and provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and developmental and reproductive toxicity endpoints. The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for non-reactive materials (900 µg/cm 2 ); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3,7-dimethyl-1,3,6- octatriene 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 I material, and the exposure to 3,7-dimethyl-1,3,6-octatriene is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 3,7-dimethyl-1,3,6- octatriene 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 oncentration/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 ToxicidadeAssuntos
Cetonas/toxicidade , Odorantes , Animais , Poluentes Ambientais/toxicidade , Humanos , Cetonas/química , Mutagênicos/toxicidade , Nível de Efeito Adverso não Observado , 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. 2-Decanone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 2-heptanone (CAS # 110-43-0) show that 2-decanone is not expected to be genotoxic. Data on read-across analog 2-heptanone (CAS # 110-43-0) provide a calculated margin of exposure (MOE) > 100 for the repeated dose toxicity and reproductive toxicity endpoints. 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; 2-decanone is not expected to be phototoxic/photoallergenic. For the local respiratory endpoint, a calculated MOE >100 was provided by the read-across analog 4-methyl-2-pentanone (CAS # 108-10-1). The environmental endpoints were evaluated; for the hazard assessment based on the screening data, 2-decanone is not persistent, bioaccumulative, and toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. For the risk assessment, 2-decanone was not able to be risk screened as there were no reported volumes of use for either North America or Europe in the 2015 IFRA Survey.
Assuntos
Odorantes/análise , Perfumes/toxicidade , Animais , Bases de Dados de Compostos Químicos , Dermatite Fototóxica , Determinação de Ponto Final , Humanos , Testes de Mutagenicidade , Perfumes/química , Plantas/efeitos dos fármacos , Sistema de Registros , Reprodução/efeitos dos fármacos , Pele/efeitos dos fármacos , Testes de ToxicidadeRESUMO
Dodecane was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog nonane (CAS # 111-84-2) show that dodecane is not expected to be genotoxic. Data on read-across analog undecane (CAS # 1120-21-4) provide a calculated Margin of Exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. 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/visible (UV/vis) spectra; dodecane 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 I material, and the exposure to dodecane is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; dodecane 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.