RESUMEN
A toxicologic and dermatologic review of alpha-iso-methylionone when used as a fragrance ingredient is presented.
Asunto(s)
Norisoprenoides/toxicidad , Perfumes/toxicidad , Alérgenos/clasificación , Alérgenos/farmacocinética , Alérgenos/toxicidad , Animales , Seguridad de Productos para el Consumidor , Relación Dosis-Respuesta a Droga , Humanos , Norisoprenoides/clasificación , Norisoprenoides/farmacocinética , Noxas/clasificación , Noxas/farmacocinética , Noxas/toxicidad , Perfumes/clasificación , Perfumes/farmacocinética , Reproducción/efectos de los fármacos , Medición de Riesgo , Piel/efectos de los fármacos , Piel/metabolismo , Absorción Cutánea , Pruebas de Irritación de la Piel , Pruebas Cutáneas , Pruebas de ToxicidadRESUMEN
A toxicologic and dermatologic review of alpha-ionone when used as a fragrance ingredient is presented.
Asunto(s)
Norisoprenoides/toxicidad , Perfumes/toxicidad , Animales , Seguridad de Productos para el Consumidor , Relación Dosis-Respuesta a Droga , Humanos , Irritantes/clasificación , Irritantes/farmacocinética , Irritantes/toxicidad , Pruebas de Mutagenicidad , Mutágenos/clasificación , Mutágenos/farmacocinética , Mutágenos/toxicidad , Norisoprenoides/farmacocinética , Perfumes/farmacocinética , Medición de Riesgo , Piel/efectos de los fármacos , Piel/metabolismo , Piel/patología , Absorción Cutánea , Pruebas de Irritación de la Piel , Pruebas CutáneasRESUMEN
This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization potential, as well as, environmental safety. Data from the suitable read across analog isobornyl acetate (CAS # 125-12-2) show that this material is not genotoxic, provided a MOE > 100 for the repeated dose, developmental and reproductive endpoints, and does not have skin sensitization potential. The local respiratory toxicity endpoint was completed using the TTC (threshold of Toxicological Concern) for a Cramer Class II material (0.47 mg/day). The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.
Asunto(s)
Canfanos/análisis , Perfumes/análisis , Valeratos/análisis , Animales , Canfanos/toxicidad , Química/organización & administración , Seguridad de Productos para el Consumidor , Bases de Datos de Compuestos Químicos , Humanos , Perfumes/toxicidad , Sistema de Registros , Pruebas de Toxicidad , Valeratos/toxicidadRESUMEN
The use of this material under current conditions is supported by existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic nor does it have skin sensitization potential. The reproductive and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03 and 1.4 mg/day, respectively). The developmental toxicity endpoint was completed using linalool (CAS # 78-70-6), dehydrolinalool (CAS # 29171-20-8) and cinnamic acid (CAS # 621-82-9) as suitable read across analogs, which provided a MOE > 100. The repeated dose toxicity endpoint was completed using data on the target material which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.
Asunto(s)
Cinamatos/toxicidad , Monoterpenos/toxicidad , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Animales , Cinamatos/química , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Monoterpenos/química , Nivel sin Efectos Adversos Observados , Perfumes/química , Ratas , Medición de RiesgoRESUMEN
This material was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data from the suitable read across analogs 2-butyloctan-1-ol (CAS # 3913-02-8) and 2-ethyl-1-hexanol (CAS # 104-76-7) show that this material is not genotoxic nor does it have skin sensitization potential. The reproductive and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03 and 1.4 mg/day, respectively). The repeated dose toxicity endpoint was completed using 2-ethyl-1-hexanol (CAS # 104-76-7) and 1-heptanol, 2-propyl (CAS # 10042-59-8) as suitable read across analogs, which provided a MOE > 100. The developmental toxicity endpoint was completed using 2-ethyl-1-hexanol (CAS # 104-76-7) as a suitable read across analog, which provided a MOE > 100 The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.
Asunto(s)
Alcoholes Grasos/toxicidad , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Animales , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Alcoholes Grasos/química , Nivel sin Efectos Adversos Observados , Perfumes/química , Ratas , Medición de RiesgoRESUMEN
The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data from the target material and the suitable read across analog 6-acetyl-1,1,2,4,4,7-hexamethyltetraline (CAS # 21145-77-7) show that this material is not genotoxic. Data from the suitable read across analog 6-acetyl-1,1,2,4,4,7-hexamethyltetraline (CAS # 21145-77-7) provided a MOE > 100 for the repeat dose and developmental toxicity endpoints. The reproductive and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class II material (0.009 mg/kg/day and 0.47 mg/day, respectively). Data on the target material showed that this material is below the non-reactive DST for skin sensitization and did not have the potential for phototoxicity or photoallergenicity. The environmental endpoint was completed as described in the RIFM Framework.
Asunto(s)
Cetonas/toxicidad , Naftalenos/química , Perfumes/toxicidad , Propano/química , Propano/toxicidad , Tetrahidronaftalenos/toxicidad , Pruebas de Toxicidad/métodos , Animales , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Cetonas/química , Nivel sin Efectos Adversos Observados , Perfumes/química , Propanoles , Ratas , Medición de Riesgo , Tetrahidronaftalenos/químicaRESUMEN
The use of this material under current conditions is supported by existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic. Data from the suitable read across analog 2-butyloctan-1-ol (CAS # 3913-02-8) show that this material does not have skin sensitization potential. The reproductive and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03 and 1.4 mg/day, respectively). The developmental and repeat dose toxicity endpoints were completed data on the target material which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.
Asunto(s)
Hexanoles/toxicidad , Perfumes/toxicidad , Plastificantes/toxicidad , Pruebas de Toxicidad/métodos , Animales , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Hexanoles/química , Nivel sin Efectos Adversos Observados , Perfumes/química , Plastificantes/química , Ratas , Medición de RiesgoRESUMEN
The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data from the suitable read across analog benzyl acetate (CAS # 140-11-4) show that this material is not genotoxic nor does it have skin sensitization potential and also provided a MOE > 100 for the repeated dose, developmental and reproductive, and local respiratory toxicity endpoints. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.
Asunto(s)
Compuestos de Bencilo/toxicidad , Butiratos/toxicidad , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Animales , Compuestos de Bencilo/química , Butiratos/química , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Nivel sin Efectos Adversos Observados , Perfumes/química , Ratas , Medición de RiesgoRESUMEN
The use of this material under current conditions is supported by existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data from the suitable read across analog 2-ethylhexanol (CAS # 104-76-7) show that this material is not genotoxic. Data from the suitable read across analog isopropyl alcohol (CAS # 67-63-0) show that this material does not have skin sensitization potential. The local respiratory toxicity endpoint was completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (1.4 mg/day). The repeated dose toxicity endpoint was completed using 2-ethylhexanol (CAS # 104-76-7) and 1-heptanol, 2-propyl (CAS # 10042-59-8) as suitable read across analogs, which provided a MOE > 100. The developmental and reproductive toxicity endpoint was completed using 2-ethyl-hexanol (CAS # 104-76-7) and isobutyl alcohol (CAS # 78-83-1) as suitable read across analogs, which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.
Asunto(s)
Hexanoles/toxicidad , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Animales , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Hexanoles/química , Nivel sin Efectos Adversos Observados , Perfumes/química , Ratas , Medición de RiesgoRESUMEN
The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, as well as, environmental safety. Repeated dose toxicity was determined using a suitable read across analog to have the most conservative systemic exposure derived NO[A]EL of 36 mg/kg/day. A dermal 90-day subchronic toxicity study conducted in rats resulted in a MOE of 2250 while considering 14.4% absorption from skin contact and 100% from inhalation. A MOE of >100 is deemed acceptable.
Asunto(s)
Insecticidas/toxicidad , Monoterpenos/toxicidad , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Monoterpenos Acíclicos , Animales , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Insecticidas/química , Monoterpenos/química , Nivel sin Efectos Adversos Observados , Perfumes/química , Ratas , Medición de RiesgoRESUMEN
The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, as well as, environmental safety. Reproductive toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 230 mg/kg/day. A gavage multigenerational continuous breeding study conducted in rats on a suitable read across analog resulted in a MOE of 12,105 while considering 22.6% absorption from skin contact and 100% from inhalation. A MOE of >100 is deemed acceptable.
Asunto(s)
Antiinfecciosos/toxicidad , Eugenol/toxicidad , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Animales , Antiinfecciosos/química , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Eugenol/química , Nivel sin Efectos Adversos Observados , Perfumes/química , Ratas , Medición de RiesgoRESUMEN
The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, as well as, environmental safety. Repeated dose toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 14.5 mg/kg/day. A dietary 2-year chronic toxicity study conducted in rats on a suitable read across analog resulted in a MOE of 1318 while considering 78.7% absorption from skin contact and 100% from inhalation. A MOE of >100 is deemed acceptable.
Asunto(s)
Compuestos de Bencilo/toxicidad , Perfumes/toxicidad , Propionatos/toxicidad , Pruebas de Toxicidad/métodos , Animales , Compuestos de Bencilo/química , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Nivel sin Efectos Adversos Observados , Perfumes/química , Propionatos/química , Ratas , Medición de RiesgoRESUMEN
The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, as well as, environmental safety. Repeated dose toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 10 mg/kg/day. A dietary 90-day subchronic toxicity study conducted in rats resulted in a MOE of 182 while assuming 100% absorption from skin contact and inhalation. A MOE of >100 is deemed acceptable.
Asunto(s)
Norisoprenoides/toxicidad , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Animales , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Nivel sin Efectos Adversos Observados , Norisoprenoides/química , Perfumes/química , Ratas , Medición de RiesgoRESUMEN
The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, as well as, environmental safety. Developmental toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 100 mg/kg/day. A gavage developmental toxicity study conducted in rats on a suitable read across analog resulted in aMOE of 3571 while considering 78.7% absorption from skin contact and 100% from inhalation. A MOE of >100 is deemed acceptable.
Asunto(s)
Acetatos/toxicidad , Compuestos de Bencilo/toxicidad , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Acetatos/química , Animales , Compuestos de Bencilo/química , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Nivel sin Efectos Adversos Observados , Perfumes/química , Ratas , Medición de RiesgoRESUMEN
The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, as well as, environmental safety. Repeated dose toxicity was determined to have the most conservative systemic exposure derived NO[A]EL of 37.5 mg/kg/day. A gavage 13-week subchronic toxicity study conducted in mice resulted in a MOE of 5769 while considering 38.4% absorption from skin contact and 100% from inhalation. A MOE of >100 is deemed acceptable.
Asunto(s)
Eugenol/análogos & derivados , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Animales , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Eugenol/química , Eugenol/toxicidad , Ratones , Nivel sin Efectos Adversos Observados , Perfumes/química , Medición de RiesgoRESUMEN
The use of this material under current use conditions is supported by the existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization, as well as environmental safety. Data from the suitable read across analog, benzyl acetate (CAS # 140-11-4), show that this material is not genotoxic nor does it have skin sensitization potential. The repeated dose, developmental and reproductive, and local respiratory toxicity endpoints were completed using benzyl acetate (CAS # 140-11-4) as a suitable read across analog, which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.
Asunto(s)
Acetatos/toxicidad , Compuestos de Bencilo/toxicidad , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Acetatos/química , Animales , Compuestos de Bencilo/química , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Nivel sin Efectos Adversos Observados , Perfumes/química , Ratas , Medición de RiesgoRESUMEN
: The use of this material under current conditions is supported by existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic nor does it have skin sensitization potential. The local respiratory toxicity endpoint was completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (1.4 mg/day). The repeated dose toxicity endpoint was completed using ethylene dodecanedioate (CAS # 54982-83-1) as a suitable read across analog, which provided a MOE > 100. The developmental and reproductive toxicity endpoint was completed using oxacyclohexadec-12-en-2-one, (12E)- (CAS # 111879-80-2) as a suitable read across analog, which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra along with data on the target material. The environmental endpoint was completed as described in the RIFM Framework along with data on the suitable read across analog oxacyclohexadec-12-en-2-one, (12E)- (CAS # 111879-80-2).
Asunto(s)
Éteres Cíclicos/toxicidad , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Animales , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Éteres Cíclicos/química , Nivel sin Efectos Adversos Observados , Perfumes/química , Ratas , Medición de RiesgoRESUMEN
This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic nor does it have skin sensitization potential. The repeated dose, developmental and reproductive, and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03, 0.03 mg/kg/day and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.
Asunto(s)
Perfumes/toxicidad , Terpenos/toxicidad , Pruebas de Toxicidad/métodos , Animales , Seguridad de Productos para el Consumidor , Monoterpenos Ciclohexánicos , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Nivel sin Efectos Adversos Observados , Perfumes/química , Ratas , Medición de Riesgo , Terpenos/químicaRESUMEN
The use of this material under current conditions is supported by existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data from the suitable read across analog linalool (CAS # 78-70-6) show that this material is not genotoxic nor does it have skin sensitization potential and also provided a MOE > 100 for the local respiratory endpoint. The repeated dose, developmental and reproductive toxicity endpoints were completed using nerolidol (isomer unspecified, CAS # 7212-44-4) as a suitable read across analog, which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.
Asunto(s)
Alcoholes Grasos/toxicidad , Perfumes/toxicidad , Pruebas de Toxicidad/métodos , Animales , Seguridad de Productos para el Consumidor , Daño del ADN/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Determinación de Punto Final , Alcoholes Grasos/química , Nivel sin Efectos Adversos Observados , Perfumes/química , Ratas , Medición de RiesgoRESUMEN
The use of this material under current conditions is supported by existing information. This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic. Data from the suitable read across analog linalyl phenylacetate (CAS # 7143-69-3) show that this material does not have skin sensitization potential. The repeated dose toxicity endpoint was completed using linalyl cinnamate (CAS # 78-37-5) as a suitable read across analog, which provided a MOE > 100. The developmental and reproductive toxicity endpoint was completed using linalool (CAS # 78-70-6), dehydrolinalool (CAS # 29171-20-8), benzoic acid (CAS # 65-85-0) and sodium benzoate (CAS # 532-32-1) as suitable read across analogs, which provided a MOE > 100. The local respiratory toxicity endpoint was completed using linalool (CAS # 78-70-6) and benzoic acid (CAS # 65-85-0) as suitable read across analogs, which provided a MOE > 100. The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework along with data from the suitable read across analog linalyl cinnamate (CAS # 78-375).