RESUMO
The existing information supports the use of this material as described in this safety assessment. 2-Methyl-4-phenylbutyraldehyde was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog ß-methyl-benzenepentanal (CAS # 55,066-49-4) show that 2-methyl-4-phenylbutyraldehyde is not expected to be genotoxic and provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog phenylacetaldehyde (CAS # 122-78-1) provide a calculated MOE >100 for the reproductive toxicity endpoint. Data show that there are no safety concerns for 2-methyl-4-phenylbutyraldehyde for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 2-methyl-4-phenylbutyraldehyde is not expected to be photoirritating/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 2-methyl-4-phenylbutyraldehyde is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 2-methyl-4-phenylbutyraldehyde 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 (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.
RESUMO
4-Hexen-1-ol, 5-methyl-2-(1-methylethenyl)- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-hexen-1-ol, 5-methyl-2-(1-methylethenyl)- 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 I material, and the exposure to 4-hexen-1-ol, 5-methyl-2-(1-methylethenyl)- is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data from read-across analog 3-methylbut-3-en-1-ol (CAS # 763-32-6) show that there are no safety concerns for 4-hexen-1-ol, 5-methyl-2-(1-methylethenyl)- for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 4-hexen-1-ol, 5-methyl-2-(1-methylethenyl)- is not expected to be photoirritating/photoallergenic. The environmental endpoints were evaluated; 4-hexen-1-ol, 5-methyl-2-(1-methylethenyl)- 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 (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.
Assuntos
Perfumes , Animais , Humanos , Hexanóis/toxicidade , Hexanóis/química , Testes de Mutagenicidade , Odorantes , Perfumes/toxicidade , Perfumes/química , Medição de Risco , Testes de ToxicidadeRESUMO
The existing information supports the use of this material as described in this safety assessment. This material has not been fully evaluated for photoallergenic potential. 2,4,6-Cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that 2,4,6-cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- 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 I material, and the exposure to 2,4,6-cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The skin sensitization endpoint was completed using the Dermal Sensitization Threshold (DST) for reactive materials (64 µg/cm2); exposure is below the DST. Based on data, 2,4,6-cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- is a photoirritant but is not a concern under the current declared use levels. 2,4,6-Cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- was not evaluated for photoallergenicity. The environmental endpoints were evaluated; for the hazard assessment based on the screening data, 2,4,6-cycloheptatrien-1-one, 2-hydroxy-4-(1-methylethyl)- 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 (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.
Assuntos
Odorantes , Perfumes , Testes de Mutagenicidade , Perfumes/toxicidade , Bioacumulação , Clima , Medição de RiscoRESUMO
The existing information supports the use of this material as described in this safety assessment. 2-Tridecanone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 2-heptanone (CAS # 110-43-0) show that 2-tridecanone is not expected to be genotoxic and provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and reproductive toxicity endpoints. Data from read-across analog 2-heptanone (CAS # 110-43-0) show that there are no safety concerns for 2-tridecanone for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 2-tridecanone is not expected to be photoirritating/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class II material, and the exposure to 2-tridecanone is below the TTC (0.47 mg/day). The environmental endpoints were evaluated; 2-Tridecanone 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 , Perfumes , Testes de Toxicidade , Testes de Mutagenicidade , Perfumes/toxicidade , Sistema de Registros , Medição de RiscoRESUMO
The existing information supports the use of this material as described in this safety assessment. 5,8-Methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 5,8-methano-2H-1-benzopyran-2-one, 6- ethylideneoctahydro- (CAS # 69486-14-2) show that 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class III material, and the exposure to 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). Data provided 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- a NESIL of 8200 µg/cm2 for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on human study data and UV/Vis spectra; 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.
Assuntos
Benzopiranos/toxicidade , Cosméticos/química , Exposição Ambiental/efeitos adversos , Odorantes/análise , Perfumes/toxicidade , Segurança , Academias e Institutos/normas , Animais , Benzopiranos/análise , Dermatite Fotoalérgica , Dermatite Fototóxica , Poluentes Ambientais/análise , Poluentes Ambientais/toxicidade , Europa (Continente) , Produtos Domésticos , Humanos , Testes de Mutagenicidade , América do Norte , Perfumes/química , Sistema de Registros , Reprodução/efeitos dos fármacos , Sistema Respiratório/efeitos dos fármacos , Medição de Risco , Pele/efeitos dos fármacos , Testes de ToxicidadeRESUMO
The following paper presents the method of determination of the percolation threshold in cement composites with expanded graphite by impedance spectroscopy. Most of the applications of cement composites with conductive additives require exceeding the percolation threshold. The ionic conductivity of cement matrix below the percolation threshold has a major impact on the conductivity of the composite, as a result, it significantly hinders the exploitation of these composites. The electric properties of cement composites with expanded graphite were evaluated by DC measurements and impedance spectroscopy (IS). Based on Nyquist plots, two equivalent circuits were adopted for the composites. Next, the values of capacitance and inductance of cement composites with expanded graphite were calculated from the fitted equivalent circuits. The analysis of the results shows that the percolation threshold occurs when the reactance of the composite changes from captative to inductive. Comparison between the values of percolation threshold obtained from DC measurements and IS shows that the method is effective for cement composites with conductive additives.
Assuntos
Cosméticos/química , Exposição Ambiental/efeitos adversos , Formiatos/toxicidade , Odorantes/análise , Perfumes/toxicidade , Segurança , Academias e Institutos/normas , Animais , Dermatite Fotoalérgica , Dermatite Fototóxica , Condutividade Elétrica , Feminino , Formiatos/análise , Grafite , Produtos Domésticos/toxicidade , Humanos , Masculino , Testes de Mutagenicidade , Perfumes/química , Sistema de Registros , 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. ß-Caryophyllene was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that ß-caryophyllene is not genotoxic. Data on ß-caryophyllene provided a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and fertility endpoints. The developmental and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to ß-caryophyllene is below the TTC (0.03 mg/kg/day and 1.4 mg/day, respectively. Data show that there are no safety concerns for ß-caryophyllene for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet/visible (UV/Vis) spectra; ß-caryophyllene is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; ß-caryophyllene 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
Exposição Ambiental/efeitos adversos , Odorantes/análise , Perfumes/toxicidade , Plantas Comestíveis/química , Sesquiterpenos Policíclicos/toxicidade , Segurança , Academias e Institutos/normas , Animais , Dermatite Fotoalérgica , Dermatite Fototóxica , Determinação de Ponto Final , Europa (Continente) , Fertilidade/efeitos dos fármacos , Humanos , Testes de Mutagenicidade , América do Norte , Perfumes/química , Sesquiterpenos Policíclicos/análise , Relação Quantitativa Estrutura-Atividade , Sistema de Registros , Reprodução/efeitos dos fármacos , Sistema Respiratório/efeitos dos fármacos , Medição de Risco , Pele/efeitos dos fármacos , Testes de ToxicidadeRESUMO
The Research Institute for Fragrance Materials, Inc. (RIFM) has evaluated safety data for fragrance materials for 55 years. The safety assessment of Natural Complex Substances (NCS) is similar to that of discrete fragrance materials; all of the same endpoints are evaluated. A series of decision trees, reflecting advances in risk assessment approaches of mixtures and toxicological methodologies, follows a tiered approach for each endpoint using a 4-step process with testing only as a last resort: 1) evaluate available data on NCS; 2) verify whether the Threshold of Toxicological Concern (TTC) can be applied; 3) verify whether the NCS risk assessment can be achieved on a component basis; and 4) determine whether data must be generated. Using in silico tools, RIFM examined NCS similarities based on the plant part, processing, and composition of materials across 81 plant families to address data gaps. Data generated from the Creme RIFM Aggregate Exposure Model for over 900 fragrance NCS demonstrate that dermal exposure is the primary route of human exposure for NCS fragrance uses. Over a third of materials are below the most conservative TTC limits. This process aims to provide a comprehensive Safety Assessment of NCS used as a fragrance ingredient.
Assuntos
Exposição Ambiental/efeitos adversos , Odorantes/análise , Perfumes/toxicidade , Extratos Vegetais/efeitos adversos , Plantas/química , Segurança , Pele , Academias e Institutos , Administração Cutânea , Animais , Misturas Complexas , Árvores de Decisões , Dermatite Fototóxica , Determinação de Ponto Final , Humanos , Testes de Mutagenicidade , Perfumes/análise , Extratos Vegetais/química , Sistema de Registros , Medição de Risco , Pele/efeitos dos fármacosRESUMO
The existing information supports the use of this material as described in this safety assessment. Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that tetrahydro-6-(3-pentenyl)-2H-pyran-2-one 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 II material, and the exposure to tetrahydro-6-(3-pentenyl)-2H-pyran-2-one is below the TTC (0.009 mg/kg/day, 0.009 mg/kg/day, and 0.47 mg/day, respectively). Data and read-across to 5-hydroxy-7-decenoic acid δ-lactone (CAS # 25,524-95-2) show that there are no safety concerns for tetrahydro-6-(3-pentenyl)-2H-pyran-2-one for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet/visible (UV/Vis) spectra; tetrahydro-6-(3-pentenyl)-2H-pyran-2-one is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; tetrahydro-6-(3-pentenyl)-2H-pyran-2-one 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
Exposição Ambiental/efeitos adversos , Odorantes/análise , Perfumes/toxicidade , Piranos/toxicidade , Segurança , Academias e Institutos/normas , Animais , Dermatite Fotoalérgica , Dermatite Fototóxica , Europa (Continente) , Humanos , Testes de Mutagenicidade , América do Norte , Perfumes/química , Piranos/análise , Sistema de Registros , Reprodução/efeitos dos fármacos , Sistema Respiratório/efeitos dos fármacos , Medição de Risco , Pele/efeitos dos fármacos , Testes de ToxicidadeRESUMO
l-Carvone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that l-carvone is not genotoxic and provided a No Expected Sensitization Induction Level (NESIL) of 2600 µg/cm2 for the skin sensitization endpoint. Data on l-carvone provided a calculated Margin of Exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. The phototoxicity/photoallergenicity endpoint was completed based on data and ultraviolet/visible (UV/Vis) spectra; l-carvone is not phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class II material (0.47 mg/day); the exposure to l-carvone is below the TTC. The environmental endpoints were evaluated; l-carvone 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
Dermatite Fototóxica , Perfumes , Monoterpenos Cicloexânicos , Humanos , Testes de Mutagenicidade , Odorantes , Perfumes/toxicidade , Sistema de Registros , Medição de Risco , Testes de ToxicidadeRESUMO
The existing information supports the use of this material as described in this safety assessment. 4-(2,6,6-Trimethyl-2-cyclohexen)-2-methylbutanal was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal 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 I material, and the exposure to 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data provided 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal a No Expected Sensitization Induction Level (NESIL) of 1100 µg/cm2 for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet/visible (UV/Vis) spectra; 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4-(2,6,6-trimethyl-2-cyclohexen)-2-methylbutanal 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
Aldeídos/toxicidade , Odorantes , Humanos , Testes de Mutagenicidade , Testes de ToxicidadeRESUMO
No treatment-related effects at the low and mid doses were observed in gestation, viability and lactation indices, duration of gestation, parturition, sex ratio, maternal care, litter size, and early postnatal pup development consisting of mortality, clinical signs, anogenital distance, areola/nipple retention, T4 thyroid hormone levels, or macroscopic examination. However, the number of litters (N = 5) at the high dose was considered too low for toxicological evaluation. Thus, based on insufficient data at 120 mg/kg/day, the NOAEL for this study was considered to be 60 mg/kg/day (RIFM, 2020d).
Assuntos
Aldeídos/efeitos adversos , Cosméticos/química , Exposição Ambiental/efeitos adversos , Odorantes/análise , Perfumes/efeitos adversos , Resultado da Gravidez , Segurança , Academias e Institutos/normas , Aldeídos/análise , Animais , Dermatite Fotoalérgica , Dermatite Fototóxica , Feminino , Produtos Domésticos , Humanos , Lactação/efeitos dos fármacos , Tamanho da Ninhada de Vivíparos , Testes de Mutagenicidade , Nível de Efeito Adverso não Observado , Perfumes/química , Gravidez , Sistema de Registros , 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. Phenethyl phenylacetate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that phenethyl phenylacetate is not genotoxic. Data provide a calculated MOE >100 for the repeated dose toxicity endpoint. Data on read-across analog benzyl benzoate (CAS # 120-51-4) provide an MOE >100 for the developmental toxicity endpoint. The fertility and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class I material, and the exposure to phenethyl phenylacetate is below the TTC (0.03 mg/kg/day, and 1.4 mg/day, respectively). Data from analog benzyl phenylacetate (CAS # 102-16-9) show that there are no safety concerns for phenethyl phenylacetate for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on UV/Vis spectra; phenethyl phenylacetate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; phenethyl phenylacetate was found not to be PBT as per the IFRA Environmental Standards and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.
Assuntos
Acetatos/toxicidade , Exposição Ambiental/efeitos adversos , Odorantes/análise , Perfumes/toxicidade , Fenóis/toxicidade , Fenilacetatos/toxicidade , Segurança , Academias e Institutos/normas , Acetatos/análise , Animais , Dermatite Fotoalérgica , Dermatite Fototóxica , Determinação de Ponto Final , Europa (Continente) , Fertilidade/efeitos dos fármacos , Humanos , Testes de Mutagenicidade , América do Norte , Perfumes/química , Fenóis/análise , Fenilacetatos/análise , Sistema de Registros , Reprodução/efeitos dos fármacos , Sistema Respiratório/efeitos dos fármacos , Medição de Risco , Pele/efeitos dos fármacos , Testes de ToxicidadeRESUMO
Therefore, the phenethyl formate MOE for the fertility endpoint can be calculated by dividing the phenethyl alcohol NOAEL in mg/kg/day by the total systemic exposure to phenethyl formate, 1000/0.00062 or 1612903.
Assuntos
Odorantes , Perfumes , Qualidade de Produtos para o Consumidor , Formiatos , Perfumes/toxicidade , Fenilacetatos , Sistema de Registros , Medição de Risco , Testes de ToxicidadeRESUMO
In addition, the total systemic exposure to α-irone (1.1 µg/kg/day) is below the TTC (30 µg/kg/day; Kroes et al., 2007) for the repeated dose toxicity endpoint of a Cramer Class I material at the current level of use.
Assuntos
Odorantes , Perfumes , Testes de Mutagenicidade , Norisoprenoides , Perfumes/toxicidade , Sistema de Registros , Medição de Risco , Testes de ToxicidadeRESUMO
The MOE is greater than 100. Without adjustment for specific uncertainty factors related to inter-species and intra-species variation, the material exposure by inhalation at 0.0040 mg/day is deemed to be safe under the most conservative consumer exposure scenario.
Assuntos
Perfumes , Testes de Toxicidade , Acetatos , Compostos de Benzil , Qualidade de Produtos para o Consumidor , Dano ao DNA , Relação Dose-Resposta a Droga , Avaliação Pré-Clínica de Medicamentos , Determinação de Ponto Final , Nível de Efeito Adverso não Observado , Odorantes , Perfumes/toxicidade , Sistema de Registros , Medição de RiscoRESUMO
The existing information supports the use of this material as described in this safety assessment. Geraniol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that geraniol is not genotoxic. Data on geraniol provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and reproductive toxicity endpoints. Data provided geraniol a No Expected Sensitization Induction Level (NESIL) of 11000 µg/cm2 for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; geraniol 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 geraniol is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; geraniol 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 , Perfumes , Monoterpenos Acíclicos , Testes de Mutagenicidade , Perfumes/toxicidade , Sistema de Registros , Medição de RiscoRESUMO
The existing information supports the use of this material as described in this safety assessment. 3-Cyclohexene-1-carboxaldehyde, 1-ethenyl- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 3-cyclohexene-1-carboxaldehyde, 1-ethenyl- is not genotoxic. Data on 3-cyclohexene-1-carboxaldehyde, 1-ethenyl- provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity endpoint. The reproductive and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to 3-cyclohexene-1-carboxaldehyde, 1-ethenyl-is below the TTC (0.03 mg/kg/day and 1.4 mg/day, respectively). Data provided 3-cyclohexene-1-carboxaldehyde, 1-ethenyl- a No Expected Sensitization Induction Level (NESIL) of 1000 µg/cm2 for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 3-cyclohexene-1-carboxaldehyde, 1-ethenyl- is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 3-cyclohexene-1-carboxaldehyde, 1-ethenyl- 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 , Perfumes , Cicloexenos/toxicidade , Testes de Mutagenicidade , Perfumes/toxicidade , Sistema de Registros , Medição de RiscoRESUMO
The existing information supports the use of this material as described in this safety assessment. 2,6-Nonadienenitrile was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2,6-nonadienenitrile is not genotoxic. Data on read-across analog E- and Z-2(+3),12-tridecadiennitrile (CAS # 124071-40-5) provided 2,6-nonadienenitrile a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity endpoint. The 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 2,6-nonadienenitrile is below the TTC (0.0015 mg/kg/day and 0.47 mg/day, respectively). Data show that there are no safety concerns for 2,6-nonadienenitrile for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 2,6-nonadienenitrile is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 2,6-nonadienenitrile 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
Nitrilas/toxicidade , Odorantes , Humanos , Testes de Mutagenicidade , Testes de ToxicidadeRESUMO
The existing information supports the use of this material as described in this safety assessment. Octyl isobutyrate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog hexyl isobutyrate (CAS # 2349-07-7) show that octyl isobutyrate is not expected to be genotoxic. Data on analog propyl (2S)-2-(1,1-dimethylpropoxy)-propanoate (CAS # 319002-92-1) provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose and reproductive toxicity endpoints. Data from analog hexyl 2-methylbutyrate (CAS # 10032-15-2) provided octyl isobutyrate a No Expected Sensitization Induction Level (NESIL) of 7000 µg/cm2 for the skin sensitization endpoint. Octyl isobutyrate is not expected to be phototoxic/photoallergenic based on ultraviolet/visible (UV/Vis) spectra. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material; exposure to is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; octyl isobutyrate 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.