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1.
Food Chem Toxicol ; 182 Suppl 1: 114205, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38008280

ABSTRACT

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.


Subject(s)
Odorants , Perfume , Mutagenicity Tests , Perfume/toxicity , Bioaccumulation , Climate , Risk Assessment
2.
Food Chem Toxicol ; 165 Suppl 1: 113180, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35644446

ABSTRACT

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.


Subject(s)
Perfume , Toxicity Tests , Acetates , Benzyl Compounds , Consumer Product Safety , DNA Damage , Dose-Response Relationship, Drug , Drug Evaluation, Preclinical , Endpoint Determination , No-Observed-Adverse-Effect Level , Odorants , Perfume/toxicity , Registries , Risk Assessment
3.
Food Chem Toxicol ; 163 Suppl 1: 113055, 2022 May.
Article in English | MEDLINE | ID: mdl-35460830

ABSTRACT

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.


Subject(s)
Odorants , Perfume , Consumer Product Safety , Formates , Perfume/toxicity , Phenylacetates , Registries , Risk Assessment , Toxicity Tests
4.
Food Chem Toxicol ; 161 Suppl 1: 112912, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35278499

ABSTRACT

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.


Subject(s)
Cyclohexane Monoterpenes/toxicity , Odorants , Humans , Mutagenicity Tests , Toxicity Tests
5.
Food Chem Toxicol ; 161 Suppl 1: 112853, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35150761

ABSTRACT

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.


Subject(s)
Lactones/toxicity , Odorants , Humans , Mutagenicity Tests , Toxicity Tests
6.
Food Chem Toxicol ; 161 Suppl 1: 112870, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35183650

ABSTRACT

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.


Subject(s)
Isobutyrates/toxicity , Odorants , Humans , Mutagenicity Tests , Toxicity Tests
7.
Food Chem Toxicol ; 161 Suppl 1: 112876, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35189309

ABSTRACT

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.


Subject(s)
Nitriles/toxicity , Odorants , Humans , Mutagenicity Tests , Toxicity Tests
8.
Food Chem Toxicol ; 161 Suppl 1: 112865, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35176436

ABSTRACT

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.


Subject(s)
Aldehydes/toxicity , Odorants , Humans , Mutagenicity Tests , Toxicity Tests
9.
Food Chem Toxicol ; 163 Suppl 1: 112959, 2022 May.
Article in English | MEDLINE | ID: mdl-35341829

ABSTRACT

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.


Subject(s)
Odorants , Perfume , Mutagenicity Tests , Norisoprenoids , Perfume/toxicity , Registries , Risk Assessment , Toxicity Tests
10.
Food Chem Toxicol ; 163 Suppl 1: 112975, 2022 May.
Article in English | MEDLINE | ID: mdl-35364130

ABSTRACT

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.


Subject(s)
Dermatitis, Phototoxic , Perfume , Cyclohexane Monoterpenes , Humans , Mutagenicity Tests , Odorants , Perfume/toxicity , Registries , Risk Assessment , Toxicity Tests
11.
Food Chem Toxicol ; 159 Suppl 1: 112707, 2022 Jan 15.
Article in English | MEDLINE | ID: mdl-34848252

ABSTRACT

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.


Subject(s)
Environmental Exposure/adverse effects , Odorants/analysis , Perfume/toxicity , Plants, Edible/chemistry , Polycyclic Sesquiterpenes/toxicity , Safety , Academies and Institutes/standards , Animals , Dermatitis, Photoallergic , Dermatitis, Phototoxic , Endpoint Determination , Europe , Fertility/drug effects , Humans , Mutagenicity Tests , North America , Perfume/chemistry , Polycyclic Sesquiterpenes/analysis , Quantitative Structure-Activity Relationship , Registries , Reproduction/drug effects , Respiratory System/drug effects , Risk Assessment , Skin/drug effects , Toxicity Tests
12.
Food Chem Toxicol ; 159 Suppl 1: 112715, 2022 Jan 15.
Article in English | MEDLINE | ID: mdl-34848254

ABSTRACT

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.


Subject(s)
Environmental Exposure/adverse effects , Odorants/analysis , Perfume/toxicity , Plant Extracts/adverse effects , Plants/chemistry , Safety , Skin , Academies and Institutes , Administration, Cutaneous , Animals , Complex Mixtures , Decision Trees , Dermatitis, Phototoxic , Endpoint Determination , Humans , Mutagenicity Tests , Perfume/analysis , Plant Extracts/chemistry , Registries , Risk Assessment , Skin/drug effects
13.
Food Chem Toxicol ; 159 Suppl 1: 112711, 2022 Jan 15.
Article in English | MEDLINE | ID: mdl-34843869

ABSTRACT

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.


Subject(s)
Acetates/toxicity , Environmental Exposure/adverse effects , Odorants/analysis , Perfume/toxicity , Phenols/toxicity , Phenylacetates/toxicity , Safety , Academies and Institutes/standards , Acetates/analysis , Animals , Dermatitis, Photoallergic , Dermatitis, Phototoxic , Endpoint Determination , Europe , Fertility/drug effects , Humans , Mutagenicity Tests , North America , Perfume/chemistry , Phenols/analysis , Phenylacetates/analysis , Registries , Reproduction/drug effects , Respiratory System/drug effects , Risk Assessment , Skin/drug effects , Toxicity Tests
14.
Food Chem Toxicol ; 159 Suppl 1: 112734, 2022 Jan 15.
Article in English | MEDLINE | ID: mdl-34864142

ABSTRACT

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.


Subject(s)
Environmental Exposure/adverse effects , Odorants/analysis , Perfume/toxicity , Pyrans/toxicity , Safety , Academies and Institutes/standards , Animals , Dermatitis, Photoallergic , Dermatitis, Phototoxic , Europe , Humans , Mutagenicity Tests , North America , Perfume/chemistry , Pyrans/analysis , Registries , Reproduction/drug effects , Respiratory System/drug effects , Risk Assessment , Skin/drug effects , Toxicity Tests
15.
Food Chem Toxicol ; 159 Suppl 1: 112658, 2022 Jan 15.
Article in English | MEDLINE | ID: mdl-34742791

ABSTRACT

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).


Subject(s)
Aldehydes/adverse effects , Cosmetics/chemistry , Environmental Exposure/adverse effects , Odorants/analysis , Perfume/adverse effects , Pregnancy Outcome , Safety , Academies and Institutes/standards , Aldehydes/analysis , Animals , Dermatitis, Photoallergic , Dermatitis, Phototoxic , Female , Household Products , Humans , Lactation/drug effects , Litter Size , Mutagenicity Tests , No-Observed-Adverse-Effect Level , Perfume/chemistry , Pregnancy , Registries , Respiratory System/drug effects , Risk Assessment , Skin/drug effects , Toxicity Tests
16.
Food Chem Toxicol ; 159 Suppl 1: 112648, 2022 Jan 15.
Article in English | MEDLINE | ID: mdl-34757225

ABSTRACT

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.


Subject(s)
Cosmetics/chemistry , Environmental Exposure/adverse effects , Formates/toxicity , Odorants/analysis , Perfume/toxicity , Safety , Academies and Institutes/standards , Animals , Dermatitis, Photoallergic , Dermatitis, Phototoxic , Electric Conductivity , Female , Formates/analysis , Graphite , Household Products/toxicity , Humans , Male , Mutagenicity Tests , Perfume/chemistry , Registries , Reproduction/drug effects , Respiratory System/drug effects , Risk Assessment , Skin/drug effects , Toxicity Tests
17.
Food Chem Toxicol ; 159 Suppl 1: 112647, 2022 Jan 15.
Article in English | MEDLINE | ID: mdl-34756964

ABSTRACT

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.


Subject(s)
Benzopyrans/toxicity , Cosmetics/chemistry , Environmental Exposure/adverse effects , Odorants/analysis , Perfume/toxicity , Safety , Academies and Institutes/standards , Animals , Benzopyrans/analysis , Dermatitis, Photoallergic , Dermatitis, Phototoxic , Environmental Pollutants/analysis , Environmental Pollutants/toxicity , Europe , Household Products , Humans , Mutagenicity Tests , North America , Perfume/chemistry , Registries , Reproduction/drug effects , Respiratory System/drug effects , Risk Assessment , Skin/drug effects , Toxicity Tests
18.
Food Chem Toxicol ; 167 Suppl 1: 113383, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35998860

ABSTRACT

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.


Subject(s)
Odorants , Perfume , Cyclohexenes/toxicity , Mutagenicity Tests , Perfume/toxicity , Registries , Risk Assessment
19.
Food Chem Toxicol ; 167 Suppl 1: 113341, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35940332

ABSTRACT

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.


Subject(s)
Odorants , Perfume , Acyclic Monoterpenes , Mutagenicity Tests , Perfume/toxicity , Registries , Risk Assessment
20.
Food Chem Toxicol ; 169 Suppl 1: 113408, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36087617

ABSTRACT

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.


Subject(s)
Odorants , Perfume , Toxicity Tests , Mutagenicity Tests , Perfume/toxicity , Registries , Risk Assessment
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