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2.
Regul Toxicol Pharmacol ; 97: 186-188, 2018 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-29964119

RESUMEN

For many endpoints in toxicology, an interspecies safety factor remains a standard requirement. However, for skin sensitization, the hazard and potency predictions, notably from the local lymph node assay (LLNA) have been shown to correlate well with human data. Despite this, there are always exceptions, both over and under predictions. For this reason it has been suggested that an interspecies factor of 15 would accommodate potential "errors". An alternative approach is suggested in which an evidence-based strategy is taken: the large majority of the information indicates a human:LLNA ratio of 1, therefore a corrective factor would best be applied where our knowledge of the underlying chemistry of sensitization indicates that it is necessary.


Asunto(s)
Ganglios Linfáticos/patología , Piel/patología , Animales , Humanos , Ensayo del Nódulo Linfático Local , Ganglios Linfáticos/efectos de los fármacos , Ratones , Medición de Riesgo , Piel/efectos de los fármacos
3.
Regul Toxicol Pharmacol ; 88: 144-156, 2017 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-28559157

RESUMEN

In order to accurately assess aggregate exposure to a fragrance material in consumers, data are needed on consumer habits and practices, as well as the concentration of the fragrance material in those products. The present study describes the development of Phase 2 Creme RIFM model by expanding the previously developed Phase 1 model to include an additional six product types. Using subject-matching algorithms, the subjects in the Phase 1 Creme RIFM database were paired with subjects in the SUPERB and BodyCare surveys based on age and gender. Consumption of the additional products was simulated to create a seven day diary allowing full data integration in a consistent format. The inhalation route was also included for air care and other products where a fraction of product used is inhaled, derived from the RIFM 2-box model. The expansion of the Phase 1 Creme RIFM model has resulted in a more extensive and refined model, which covers a broader range of product categories and now, includes all relevant routes of exposure. An evaluation of the performance of the model has been carried out in an accompanying publication to this one.


Asunto(s)
Algoritmos , Cosméticos , Hábitos , Adulto , Aerosoles , Seguridad de Productos para el Consumidor , Cosméticos/química , Femenino , Preparaciones para el Cabello/química , Humanos , Exposición por Inhalación , Masculino , Análisis por Apareamiento , Persona de Mediana Edad , Perfumes/química , Jabones/química
4.
Regul Toxicol Pharmacol ; 86: 148-156, 2017 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-28257852

RESUMEN

As part of a joint project between the Research Institute for Fragrance Materials (RIFM) and Creme Global, a Monte Carlo model (here named the Creme RIFM model) has been developed to estimate consumer exposure to ingredients in personal care products. Details of the model produced in Phase 1 of the project have already been published. Further data on habits and practises have been collected which enable the model to estimate consumer exposure from dermal, oral and inhalation routes for 25 product types. . In addition, more accurate concentration data have been obtained which allow levels of fragrance ingredients in these product types to be modelled. Described is the use of this expanded model to estimate aggregate systemic exposure for eight fragrance ingredients. Results are shown for simulated systemic exposure (expressed as µg/kg bw/day) for each fragrance ingredient in each product type, along with simulated aggregate exposure. Highest fragrance exposure generally occurred from use of body lotions, body sprays and hydroalcoholic products. For the fragrances investigated, aggregate exposure calculated using this model was 11.5-25 fold lower than that calculated using deterministic methodology. The Creme RIFM model offers a very comprehensive and powerful tool for estimating aggregate exposure to fragrance ingredients.


Asunto(s)
Aire/análisis , Cosméticos/química , Administración Cutánea , Exposición a Riesgos Ambientales , Modelos Teóricos , Método de Montecarlo , Perfumes/química
5.
Regul Toxicol Pharmacol ; 72(3): 660-72, 2015 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-26003515

RESUMEN

Exposure of fragrance ingredients in cosmetics and personal care products to the population can be determined by way of a detailed and robust survey. The frequency and combinations of products used at specific times during the day will allow the estimation of aggregate exposure for an individual consumer, and to the sample population. In the present study, habits and practices of personal care and cosmetic products have been obtained from market research data for 36,446 subjects across European countries and the United States in order to determine the exposure to fragrance ingredients. Each subject logged their product uses, time of day and body application sites in an online diary for seven consecutive days. The survey data did not contain information on the amount of product used per occasion or body measurements, such as weight and skin surface area. Nevertheless, this was found from the literature where the likely amount of product used per occasion or body measurement could be probabilistically chosen from distributions of data based on subject demographics. The daily aggregate applied consumer product exposure was estimated based on each subject's frequency of product use, and Monte Carlo simulations of their likely product amount per use and body measurements. Statistical analyses of the habits and practices and consumer product exposure are presented, which show the robustness of the data and the ability to estimate aggregate consumer product exposure. Consequently, the data and modelling methods presented show potential as a means of performing ingredient safety assessments for personal care and cosmetics products.


Asunto(s)
Cosméticos , Exposición a Riesgos Ambientales , Modelos Teóricos , Perfumes , Adolescente , Adulto , Anciano , Seguridad de Productos para el Consumidor , Bases de Datos Factuales , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estados Unidos , Adulto Joven
6.
Regul Toxicol Pharmacol ; 72(3): 673-82, 2015 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-26071898

RESUMEN

Ensuring the toxicological safety of fragrance ingredients used in personal care and cosmetic products is essential in product development and design, as well as in the regulatory compliance of the products. This requires an accurate estimation of consumer exposure which, in turn, requires an understanding of consumer habits and use of products. Where ingredients are used in multiple product types, it is important to take account of aggregate exposure in consumers using these products. This publication investigates the use of a newly developed probabilistic model, the Creme RIFM model, to estimate aggregate exposure to fragrance ingredients using the example of 2-phenylethanol (PEA). The output shown demonstrates the utility of the model in determining systemic and dermal exposure to fragrances from individual products, and aggregate exposure. The model provides valuable information not only for risk assessment, but also for risk management. It should be noted that data on the concentrations of PEA in products used in this article were obtained from limited sources and not the standard, industry wide surveys typically employed by the fragrance industry and are thus presented here to illustrate the output and utility of the newly developed model. They should not be considered an accurate representation of actual exposure to PEA.


Asunto(s)
Cosméticos , Exposición a Riesgos Ambientales/análisis , Modelos Teóricos , Perfumes , Adulto , Seguridad de Productos para el Consumidor , Europa (Continente) , Humanos , Alcohol Feniletílico , Estados Unidos
7.
Food Chem Toxicol ; 189 Suppl 1: 114765, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38810943

RESUMEN

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.


Asunto(s)
Perfumes , Animales , Humanos , Hexanoles/toxicidad , Hexanoles/química , Pruebas de Mutagenicidad , Odorantes , Perfumes/toxicidad , Perfumes/química , Medición de Riesgo , Pruebas de Toxicidad
8.
Food Chem Toxicol ; 192 Suppl 1: 114938, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-39151876

RESUMEN

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.


Asunto(s)
Perfumes , Pruebas de Toxicidad , Medición de Riesgo , Perfumes/toxicidad , Perfumes/química , Animales , Humanos , Odorantes , Pruebas de Mutagenicidad , Aldehídos/toxicidad , Aldehídos/química , Nivel sin Efectos Adversos Observados
9.
Cell Mol Life Sci ; 69(5): 763-81, 2012 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-21997384

RESUMEN

Contact allergies are complex diseases, and one of the important challenges for public health and immunology. The German 'Federal Institute for Risk Assessment' hosted an 'International Workshop on Contact Dermatitis'. The scope of the workshop was to discuss new discoveries and developments in the field of contact dermatitis. This included the epidemiology and molecular biology of contact allergy, as well as the development of new in vitro methods. Furthermore, it considered regulatory aspects aiming to reduce exposure to contact sensitisers. An estimated 15-20% of the general population suffers from contact allergy. Workplace exposure, age, sex, use of consumer products and genetic predispositions were identified as the most important risk factors. Research highlights included: advances in understanding of immune responses to contact sensitisers, the importance of autoxidation or enzyme-mediated oxidation for the activation of chemicals, the mechanisms through which hapten-protein conjugates are formed and the development of novel in vitro strategies for the identification of skin-sensitising chemicals. Dendritic cell cultures and structure-activity relationships are being developed to identify potential contact allergens. However, the local lymph node assay (LLNA) presently remains the validated method of choice for hazard identification and characterisation. At the workshop the use of the LLNA for regulatory purposes and for quantitative risk assessment was also discussed.


Asunto(s)
Dermatitis Alérgica por Contacto/metabolismo , Alérgenos/inmunología , Congresos como Asunto , Dermatitis Alérgica por Contacto/epidemiología , Dermatitis Alérgica por Contacto/prevención & control , Humanos , Inmunidad Innata , Queratinocitos/citología , Queratinocitos/fisiología , Ensayo del Nódulo Linfático Local , Células T Asesinas Naturales/citología , Células T Asesinas Naturales/fisiología , Factores de Riesgo
10.
Food Chem Toxicol ; 182 Suppl 1: 114205, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-38008280

RESUMEN

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.


Asunto(s)
Odorantes , Perfumes , Pruebas de Mutagenicidad , Perfumes/toxicidad , Bioacumulación , Clima , Medición de Riesgo
11.
Int J Pharm ; 622: 121826, 2022 Jun 25.
Artículo en Inglés | MEDLINE | ID: mdl-35609833

RESUMEN

In vitro human skin permeation and distribution of the fragrance material linalool (3,7-dimethyl-1,6-octadien-3-ol, CAS No. 78-70-6) following application in a range of single and mixed vehicles was determined, under unoccluded and occluded conditions, using human epidermal membranes. Vehicles were (70/30 v/v) ethanol[EtOH]/water, dipropyleneglycol [DPG], diethyl phthalate [DEP], (25/75 v/v) EtOH/DEP, (25/75 v/v) EtOH/DPG and petrolatum. Worst case absorbed dose values (% applied dose) for linalool under unoccluded conditions varied from 1.84% (DPG) to 4.08% (EtOH/water) and under occluded conditions from 5.9% (DEP) to 14.7% (EtOH/water). Occlusion always increased absorption but the magnitude of the effect varied with the vehicle from 2 to 6-fold. This study demonstrated that in vitro human skin permeation of linalool varied quite widely between test vehicles and that the magnitude of the effect of occlusion was also vehicle dependent. This was particularly significant in view of the reported variations in biological responses using different vehicles (Lalko et al., 2004; Politano et al., 2006).


Asunto(s)
Absorción Cutánea , Piel , Monoterpenos Acíclicos , Etanol , Excipientes/metabolismo , Humanos , Vehículos Farmacéuticos , Piel/metabolismo , Agua/metabolismo
12.
Food Chem Toxicol ; 167 Suppl 1: 113383, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-35998860

RESUMEN

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.


Asunto(s)
Odorantes , Perfumes , Ciclohexenos/toxicidad , Pruebas de Mutagenicidad , Perfumes/toxicidad , Sistema de Registros , Medición de Riesgo
13.
Food Chem Toxicol ; 167 Suppl 1: 113341, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-35940332

RESUMEN

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.


Asunto(s)
Odorantes , Perfumes , Monoterpenos Acíclicos , Pruebas de Mutagenicidad , Perfumes/toxicidad , Sistema de Registros , Medición de Riesgo
14.
Food Chem Toxicol ; 161 Suppl 1: 112912, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-35278499

RESUMEN

Therefore, the (-)-(R)-α-phellandrene MOE for the repeated dose toxicity endpoint can be calculated by dividing the (-)-(R)-α-phellandrene NOAEL in mg/kg/day by the total systemic exposure to (-)-(R)-α-phellandrene, 8.33/0.00040, or 20825.


Asunto(s)
Monoterpenos Ciclohexánicos/toxicidad , Odorantes , Humanos , Pruebas de Mutagenicidad , Pruebas de Toxicidad
15.
Food Chem Toxicol ; 161 Suppl 1: 112853, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-35150761

RESUMEN

The existing information supports the use of this material as described in this safety assessment. 5-Hydroxy-7-decenoic acid δ-lactone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across material tetrahydro-6-(3-pentenyl)-2H-pyran-2-one (CAS # 32764-98-0) show that 5-hydroxy-7-decenoic acid δ-lactone is not expected to be 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 5-hydroxy-7-decenoic acid δ-lactone is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data show that there are no safety concerns for 5-hydroxy-7-decenoic acid δ-lactone for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 5-hydroxy-7-decenoic acid δ-lactone is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 5-Hydroxy-7-decenoic acid δ-lactone 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.


Asunto(s)
Lactonas/toxicidad , Odorantes , Humanos , Pruebas de Mutagenicidad , Pruebas de Toxicidad
16.
Food Chem Toxicol ; 161 Suppl 1: 112870, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-35183650

RESUMEN

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.


Asunto(s)
Isobutiratos/toxicidad , Odorantes , Humanos , Pruebas de Mutagenicidad , Pruebas de Toxicidad
17.
Food Chem Toxicol ; 161 Suppl 1: 112876, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-35189309

RESUMEN

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.


Asunto(s)
Nitrilos/toxicidad , Odorantes , Humanos , Pruebas de Mutagenicidad , Pruebas de Toxicidad
18.
Food Chem Toxicol ; 161 Suppl 1: 112865, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-35176436

RESUMEN

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.


Asunto(s)
Aldehídos/toxicidad , Odorantes , Humanos , Pruebas de Mutagenicidad , Pruebas de Toxicidad
19.
Food Chem Toxicol ; 163 Suppl 1: 112975, 2022 May.
Artículo en Inglés | MEDLINE | ID: mdl-35364130

RESUMEN

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.


Asunto(s)
Dermatitis Fototóxica , Perfumes , Monoterpenos Ciclohexánicos , Humanos , Pruebas de Mutagenicidad , Odorantes , Perfumes/toxicidad , Sistema de Registros , Medición de Riesgo , Pruebas de Toxicidad
20.
Food Chem Toxicol ; 163 Suppl 1: 112959, 2022 May.
Artículo en Inglés | MEDLINE | ID: mdl-35341829

RESUMEN

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.


Asunto(s)
Odorantes , Perfumes , Pruebas de Mutagenicidad , Norisoprenoides , Perfumes/toxicidad , Sistema de Registros , Medición de Riesgo , Pruebas de Toxicidad
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