NOAEL Studies
Cosmetic Ingredient
m-Phenylenediamine NOAEL Studies
INCI: M-PHENYLENEDIAMINE
CAS: 108-45-2
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =6 | mg/kg | rat | dermal | Subchronic | repeated dose toxicity | {"citation":"2; 0; 6","dose":"Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine.","effect":"test substance-related effect could be made based on necropsy findings in animals that survived to the end of the study. Necropsy results included isolated evidence of various spontaneous alterations, such as congenital fissurations of the spleen and liver nodules or testicular atrophy. Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine. It was concluded that the highest daily dose that could be administered to a group without cumulative damage and/or substance-related changes (no-effect-level) was 6 mg m- Phenylenediamine/kg body weight. Subchronic Dermal Toxicity The subchronic dermal toxicity of an oxidative dye formulation contain- ing 1.5% m-Phenylenediamine was evaluated using 12 adult New Zealand white rabbits (six males, six females; weights not stated). Three groups of 12 untreated rabbits served as controls. The dye was mixed with an equal volume of 6% hydrogen peroxide and applied (dose = 1 mL/kg) to the dorsolateral aspects of the thoracic-lumbar area (one on each side of the midline). The test sites were alternated in order to minim...","page":18,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_001"} |
| CIR_vision_codex | NOAEL | =5 | mg/kg | rat | - | - | developmental toxicity | {"citation":"5; 7; (99","dose":"It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992).","effect":"ons were not considered neurotoxic effects but were considered indicative of general malaise in experimental animals. The general malaise was supported by concurrent clinical observations of lethargy. In female rats, the test substance did not induce changes in horizontal or vertical motor activity counts at any of the doses tested. Neuropathologic exam- inations did not indicate any abnormalities within the nervous system or skeletal muscle. It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992). Reproductive Toxicity The results of six reproductive toxicity studies are summarized in Table 7. In the first study, the fetal toxicity of m-Phenylenediamine (99% pure) in water was evaluated using 125 female rats (weights = 200-250 g) that had been mated for the first time. The test substance was administered orally to three groups of 25 rats in doses of 10, 30, and 90 mg/kg/day, respectively, on gestation days 5 to 16. The doses were administered once daily at a dose volu...","page":25,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_002"} |
| CIR_vision_codex | NOAEL | =134 | mg/kg/day | rat | oral | 2-week | repeated dose toxicity | {"citation":"250; 500; (3","dose":"ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg.","effect":"ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg. Minimal nephrosis was the only pathologic change noted in six rats dosed orally with m-Phenylenediamine (3% suspension in peanut oil; dose = 90 mg/kg/day) over a 2-week period. There were not test sub- stance-related pathologic changes in six rats dosed (intragastric intu- bation) with 0.8% m-Phenylenediamine (in mixture; 134 mg/kg/day) over a 2-week period. In a subchronic (90-day) oral toxicity study involving groups of 20 rats, the no-effect level was 6 mg m-Phenylenediamine/kg body weight. At histopathologic examination, degenerative lesions in the liver were observed only in the 18-mg/kg/day dose group. There was no indication of toxic injury to the kidneys.","page":48,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_003"} |
| CIR_vision_codex | NOAEL | =6 | mg/kg | rat | dermal | Subchronic | repeated dose toxicity | {"citation":"2; 0; 6","dose":"Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine.","effect":"test substance-related effect could be made based on necropsy findings in animals that survived to the end of the study. Necropsy results included isolated evidence of various spontaneous alterations, such as congenital fissurations of the spleen and liver nodules or testicular atrophy. Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine. It was concluded that the highest daily dose that could be administered to a group without cumulative damage and/or substance-related changes (no-effect-level) was 6 mg m- Phenylenediamine/kg body weight. Subchronic Dermal Toxicity The subchronic dermal toxicity of an oxidative dye formulation contain- ing 1.5% m-Phenylenediamine was evaluated using 12 adult New Zealand white rabbits (six males, six females; weights not stated). Three groups of 12 untreated rabbits served as controls. The dye was mixed with an equal volume of 6% hydrogen peroxide and applied (dose = 1 mL/kg) to the dorsolateral aspects of the thoracic-lumbar area (one on each side of the midline). The test sites were alternated in order to minim...","page":18,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_001"} |
| CIR_vision_codex | NOAEL | =5 | mg/kg | rat | - | - | developmental toxicity | {"citation":"5; 7; (99","dose":"It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992).","effect":"ons were not considered neurotoxic effects but were considered indicative of general malaise in experimental animals. The general malaise was supported by concurrent clinical observations of lethargy. In female rats, the test substance did not induce changes in horizontal or vertical motor activity counts at any of the doses tested. Neuropathologic exam- inations did not indicate any abnormalities within the nervous system or skeletal muscle. It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992). Reproductive Toxicity The results of six reproductive toxicity studies are summarized in Table 7. In the first study, the fetal toxicity of m-Phenylenediamine (99% pure) in water was evaluated using 125 female rats (weights = 200-250 g) that had been mated for the first time. The test substance was administered orally to three groups of 25 rats in doses of 10, 30, and 90 mg/kg/day, respectively, on gestation days 5 to 16. The doses were administered once daily at a dose volu...","page":25,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_002"} |
| CIR_vision_codex | NOAEL | =134 | mg/kg/day | rat | oral | 2-week | repeated dose toxicity | {"citation":"250; 500; (3","dose":"ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg.","effect":"ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg. Minimal nephrosis was the only pathologic change noted in six rats dosed orally with m-Phenylenediamine (3% suspension in peanut oil; dose = 90 mg/kg/day) over a 2-week period. There were not test sub- stance-related pathologic changes in six rats dosed (intragastric intu- bation) with 0.8% m-Phenylenediamine (in mixture; 134 mg/kg/day) over a 2-week period. In a subchronic (90-day) oral toxicity study involving groups of 20 rats, the no-effect level was 6 mg m-Phenylenediamine/kg body weight. At histopathologic examination, degenerative lesions in the liver were observed only in the 18-mg/kg/day dose group. There was no indication of toxic injury to the kidneys.","page":48,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_003"} |
| CIR_vision_codex | NOAEL | =6 | mg/kg | rat | dermal | Subchronic | repeated dose toxicity | {"citation":"2; 0; 6","dose":"Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine.","effect":"test substance-related effect could be made based on necropsy findings in animals that survived to the end of the study. Necropsy results included isolated evidence of various spontaneous alterations, such as congenital fissurations of the spleen and liver nodules or testicular atrophy. Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine. It was concluded that the highest daily dose that could be administered to a group without cumulative damage and/or substance-related changes (no-effect-level) was 6 mg m- Phenylenediamine/kg body weight. Subchronic Dermal Toxicity The subchronic dermal toxicity of an oxidative dye formulation contain- ing 1.5% m-Phenylenediamine was evaluated using 12 adult New Zealand white rabbits (six males, six females; weights not stated). Three groups of 12 untreated rabbits served as controls. The dye was mixed with an equal volume of 6% hydrogen peroxide and applied (dose = 1 mL/kg) to the dorsolateral aspects of the thoracic-lumbar area (one on each side of the midline). The test sites were alternated in order to minim...","page":18,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_001"} |
| CIR_vision_codex | NOAEL | =5 | mg/kg | rat | - | - | developmental toxicity | {"citation":"5; 7; (99","dose":"It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992).","effect":"ons were not considered neurotoxic effects but were considered indicative of general malaise in experimental animals. The general malaise was supported by concurrent clinical observations of lethargy. In female rats, the test substance did not induce changes in horizontal or vertical motor activity counts at any of the doses tested. Neuropathologic exam- inations did not indicate any abnormalities within the nervous system or skeletal muscle. It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992). Reproductive Toxicity The results of six reproductive toxicity studies are summarized in Table 7. In the first study, the fetal toxicity of m-Phenylenediamine (99% pure) in water was evaluated using 125 female rats (weights = 200-250 g) that had been mated for the first time. The test substance was administered orally to three groups of 25 rats in doses of 10, 30, and 90 mg/kg/day, respectively, on gestation days 5 to 16. The doses were administered once daily at a dose volu...","page":25,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_002"} |
| CIR_vision_codex | NOAEL | =134 | mg/kg/day | rat | oral | 2-week | repeated dose toxicity | {"citation":"250; 500; (3","dose":"ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg.","effect":"ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg. Minimal nephrosis was the only pathologic change noted in six rats dosed orally with m-Phenylenediamine (3% suspension in peanut oil; dose = 90 mg/kg/day) over a 2-week period. There were not test sub- stance-related pathologic changes in six rats dosed (intragastric intu- bation) with 0.8% m-Phenylenediamine (in mixture; 134 mg/kg/day) over a 2-week period. In a subchronic (90-day) oral toxicity study involving groups of 20 rats, the no-effect level was 6 mg m-Phenylenediamine/kg body weight. At histopathologic examination, degenerative lesions in the liver were observed only in the 18-mg/kg/day dose group. There was no indication of toxic injury to the kidneys.","page":48,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_003"} |
| CIR_vision_codex | NOAEL | =6 | mg/kg | rat | dermal | Subchronic | repeated dose toxicity | {"citation":"2; 0; 6","dose":"Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine.","effect":"test substance-related effect could be made based on necropsy findings in animals that survived to the end of the study. Necropsy results included isolated evidence of various spontaneous alterations, such as congenital fissurations of the spleen and liver nodules or testicular atrophy. Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine. It was concluded that the highest daily dose that could be administered to a group without cumulative damage and/or substance-related changes (no-effect-level) was 6 mg m- Phenylenediamine/kg body weight. Subchronic Dermal Toxicity The subchronic dermal toxicity of an oxidative dye formulation contain- ing 1.5% m-Phenylenediamine was evaluated using 12 adult New Zealand white rabbits (six males, six females; weights not stated). Three groups of 12 untreated rabbits served as controls. The dye was mixed with an equal volume of 6% hydrogen peroxide and applied (dose = 1 mL/kg) to the dorsolateral aspects of the thoracic-lumbar area (one on each side of the midline). The test sites were alternated in order to minim...","page":18,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_001"} |
| CIR_vision_codex | NOAEL | =5 | mg/kg | rat | - | - | developmental toxicity | {"citation":"5; 7; (99","dose":"It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992).","effect":"ons were not considered neurotoxic effects but were considered indicative of general malaise in experimental animals. The general malaise was supported by concurrent clinical observations of lethargy. In female rats, the test substance did not induce changes in horizontal or vertical motor activity counts at any of the doses tested. Neuropathologic exam- inations did not indicate any abnormalities within the nervous system or skeletal muscle. It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992). Reproductive Toxicity The results of six reproductive toxicity studies are summarized in Table 7. In the first study, the fetal toxicity of m-Phenylenediamine (99% pure) in water was evaluated using 125 female rats (weights = 200-250 g) that had been mated for the first time. The test substance was administered orally to three groups of 25 rats in doses of 10, 30, and 90 mg/kg/day, respectively, on gestation days 5 to 16. The doses were administered once daily at a dose volu...","page":25,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_002"} |
| CIR_vision_codex | NOAEL | =134 | mg/kg/day | rat | oral | 2-week | repeated dose toxicity | {"citation":"250; 500; (3","dose":"ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg.","effect":"ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg. Minimal nephrosis was the only pathologic change noted in six rats dosed orally with m-Phenylenediamine (3% suspension in peanut oil; dose = 90 mg/kg/day) over a 2-week period. There were not test sub- stance-related pathologic changes in six rats dosed (intragastric intu- bation) with 0.8% m-Phenylenediamine (in mixture; 134 mg/kg/day) over a 2-week period. In a subchronic (90-day) oral toxicity study involving groups of 20 rats, the no-effect level was 6 mg m-Phenylenediamine/kg body weight. At histopathologic examination, degenerative lesions in the liver were observed only in the 18-mg/kg/day dose group. There was no indication of toxic injury to the kidneys.","page":48,"pdf":"PRS62.pdf","row_type":"noael_study","study_id":"PRS62_noael_003"} |
EPA_IRIS_iris_rfd_systems.csv 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EPA_IRIS_iris_rfd_systems.csv | NOEL | =6 | mg/kg/day | - | oral | chronic | IRIS chronic oral RfD system PoD | row_hash=bfcae381f66e6e79; file=iris_rfd_systems.csv; kind=point_of_departure; raw_column=point_of_departure; raw_value=NOEL : 6.0 mg/kg-day; system=Hepatic; basis=Increased relative and absolute liver weights and degenerative liver lesions; point_of_departure=NOEL : 6.0 mg/kg-day; composite_uf=1000; confidence=Low; dtxsid=DTXSID4021137; detail_url=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=87; rfd_last_updated=01/31/1987; rfd_pdf_url=https://iris.epa.gov/static/pdfs/0087_summary.pdf |
| EPA_IRIS_iris_rfd_systems.csv | RfD | =0.006 | mg/kg/day | - | oral | chronic | IRIS chronic oral RfD system | row_hash=991c4dbb3102b104; file=iris_rfd_systems.csv; kind=reference_value; raw_column=rfd_mg_per_kg_day; raw_value=6e-3; system=Hepatic; basis=Increased relative and absolute liver weights and degenerative liver lesions; point_of_departure=NOEL : 6.0 mg/kg-day; composite_uf=1000; confidence=Low; dtxsid=DTXSID4021137; detail_url=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=87; rfd_last_updated=01/31/1987; rfd_pdf_url=https://iris.epa.gov/static/pdfs/0087_summary.pdf |
IARC Monographs 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| IARC Monographs | IARC carcinogenicity classification | 3 | IARC group | - | - | 1987 | IARC Monographs | {"additional_info":"volume_publication_year=1987","evaluation_year":1987,"source_table":"iarc_classifications","volume":"16, Sup 7"} |
| IARC Monographs | IARC carcinogenicity classification | 3 | IARC group | - | - | 1987 | IARC Monographs | {"additional_info":"volume_publication_year=1987","evaluation_year":1987,"source_table":"iarc_classifications","volume":"16, Sup 7"} |
| IARC Monographs | IARC carcinogenicity classification | 3 | IARC group | - | - | 1987 | IARC Monographs | {"additional_info":"volume_publication_year=1987","evaluation_year":1987,"source_table":"iarc_classifications","volume":"16, Sup 7"} |
NTP_ICE_acute_oral 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | =280 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM ChemIDplus TEST (undated); record_id=acute_oral_736; row=6983; data_type=In Vivo; mixture=Chemical; chemical_name=1,3-Benzenediamine; preferred_name=1,3-Benzenediamine; dtxsid=DTXSID4021137; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID4021137; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =650 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_737; row=6984; data_type=In Vivo; mixture=Chemical; chemical_name=1,3-Benzenediamine; preferred_name=1,3-Benzenediamine; dtxsid=DTXSID4021137; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID4021137; source_file=acute_oral.xlsx |
NTP_ICE_adme_parameters 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_adme_parameters | Clint | 0 | uL/min/10^6 cells | Human | - | - | Measured; httk, Human Hepatic Intrinsic Clearance | sheet=Data; excel_row=1584; Record_ID=adme_parameters_806; Data_Type=Measured; DTXSID=DTXSID4021137; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=0.0; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021137 |
NTP_ICE_cancer 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_cancer | IARC group | 3 | unitless | - | - | - | WOE; IARC Carcinogenicity | sheet=Data; excel_row=4565; Record_ID=cancer_4704; Data_Type=WOE; Formulation_Name=1,3-Benzenediamine; Mixture=Chemical; DTXSID=DTXSID4021137; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/34; http://publications.iarc.fr/139; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021137 |
NTP_ICE_endocrine 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=628; RecordID=ARPathway2016_511; DatasetName=ARPathway2016; DTXSID=DTXSID4021137; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021137 |
NTP_ICE_eye_irritation 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_eye_irritation | GHS Classification | 1 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=1187; Record_ID=eye_irritation_218; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID4021137; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=GHS Classification; Response=1; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021137 |
| NTP_ICE_eye_irritation | Intensity | 0.35 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1189; Record_ID=eye_irritation_1324; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID4021137; Assay=Vitrigel; Endpoint=Intensity; Response=0.35; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021137 |
| NTP_ICE_eye_irritation | Lag time | 10 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1188; Record_ID=eye_irritation_1324; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID4021137; Assay=Vitrigel; Endpoint=Lag time; Response=10; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021137 |
| NTP_ICE_eye_irritation | Plateau level | 62 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1190; Record_ID=eye_irritation_1324; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID4021137; Assay=Vitrigel; Endpoint=Plateau level; Response=62; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021137 |
NTP_ICE_skin_sensitization 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | EC3 | 0.49 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13546; Record_ID=skin_sensitization_invivo_3754; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID4021137; Assay=LLNA; Endpoint=EC3; Response=0.49; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021137 |
| NTP_ICE_skin_sensitization | EC3 | 0.49 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13546; Record_ID=skin_sensitization_invivo_3754; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID4021137; Assay=LLNA; Endpoint=EC3; Response=0.49; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021137 |
| NTP_ICE_skin_sensitization | EC3 | 0.49 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13546; Record_ID=skin_sensitization_invivo_3754; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID4021137; Assay=LLNA; Endpoint=EC3; Response=0.49; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021137 |
| NTP_ICE_skin_sensitization | EC3 | 0.49 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13546; Record_ID=skin_sensitization_invivo_3754; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID4021137; Assay=LLNA; Endpoint=EC3; Response=0.49; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4021137; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4021137 |
ToxValDB_ECHA_IUCLID 18 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LEL | =720 | mg/m3 | Rat | inhalation | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059759e4b063812d6fa6de; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/3/3?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Inhalation_15799165_15799166:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6539c6ee33c5de22efe17e843f50d1f6 |
| ToxValDB_ECHA_IUCLID | LEL | =1000 | mg/kg bw/day | Rat | oral | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61bb0e4b096bca876f187; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/3/2?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Oral_15799724_15801029_15805452:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7596e54c928d1dfe36be148df33911d3 |
| ToxValDB_ECHA_IUCLID | LEL | =450 | mg/kg bw/day | Rat | oral | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/3/2?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Oral_15799724_15801029_15805452:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e1bbf396d54ad6ec198950810467ca7a |
| ToxValDB_ECHA_IUCLID | LEL | =25 | mg/kg bw/day | Cat | oral | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/3/2?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID:15812401:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8827c155942f37a3b5f84ed3a3ab8ba2 |
| ToxValDB_ECHA_IUCLID | LEL | =400 | mg/kg bw/day | Mouse | injection | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61bf1e4b096bca8770079; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/3/5?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID:15815110:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_fd5b5db047af25bd69c06185419a72c9 |
| ToxValDB_ECHA_IUCLID | LEL | =370 | mg/kg bw/day | Rabbit | injection | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61c45e4b096bca877148b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/3/5?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Other Routes_15815317_15816037_15816038:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6b96791b88ae985d47d54ec4e1379597 |
| ToxValDB_ECHA_IUCLID | LEL | =460 | mg/kg bw/day | Rat | injection | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61c89e4b096bca8772637; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/3/5?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID:15815510:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_996b0d81ab1b44b0291a3b627bee8ef5 |
| ToxValDB_ECHA_IUCLID | LEL | >=200 | mg/kg bw/day | Cat | injection | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61d0de4b096bca87747e2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/3/5?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Other Routes_15816031_15816032:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_324bdf3407dcb906b15e364eaa522af2 |
| ToxValDB_ECHA_IUCLID | LEL | <=435 | mg/kg bw/day | Cat | injection | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61d0de4b096bca87747e2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/3/5?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Other Routes_15816031_15816032:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_262e5d09b7648a2856a703f2d3d70979 |
| ToxValDB_ECHA_IUCLID | LEL | <=440 | mg/kg bw/day | Rabbit | injection | - | acute | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61d2ae4b096bca8774e00; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/3/5?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Other Routes_15815317_15816037_15816038:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_62f305c170e65247ffc001d294c6332a |
| ToxValDB_ECHA_IUCLID | LEL | >100 | mg/kg bw/day | Rat | oral | short-term; 4 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaccce4b0a7c65d1c0e4d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/6/2?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID:15831863:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0c0f4ea26b8be33751e092107096ceca |
| ToxValDB_ECHA_IUCLID | NOAEL | =38.2 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9cee4b0a7c65d1b2ce8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/8?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID:15819543:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a44b7db88ee525151117f319b2a1a17d |
| ToxValDB_ECHA_IUCLID | NOAEL | =41.8 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9cee4b0a7c65d1b2ce8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/8?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID:15819544:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_656189ddde8f3b034ab36ff1ec9608a8 |
| ToxValDB_ECHA_IUCLID | NOAEL | =30 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabb9e4b0a7c65d1bb707; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/9/3?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID:15821078:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_253f32af249f3404a1a60f3b611461bd |
| ToxValDB_ECHA_IUCLID | NOAEL | =20 | mg/kg bw/day | Rat | oral | - | repeat dose other | GUIDELINE=EPA OTS 798.6050 (Neurotoxicity Screening Battery); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c85ae4b0a7c65d2180e9; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/10/1?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID_dup_Neurotoxicity_15825726_15825727_15825796:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_f3d104ac276b1cb3907a4f8772eaf037 |
| ToxValDB_ECHA_IUCLID | NOAEL | >=300 | mg/kg bw/day | Rat | oral | - | repeat dose other | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa3ee4b0a7c65d1b4ec5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/10/1?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID_dup_Neurotoxicity_15825726_15825727_15825796:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_78199babda421d27ade45cc18a10699d |
| ToxValDB_ECHA_IUCLID | NOAEL | =6 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaccce4b0a7c65d1c0e4f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/6/2?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=ECHA IUCLID:15846192:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_b48c7ed7ee2ea074c7ad4fbf3889f0de |
| ToxValDB_ECHA_IUCLID | NOEL | =5 | mg/kg bw/day | Rat | oral | - | repeat dose other | GUIDELINE=EPA OTS 798.6050 (Neurotoxicity Screening Battery); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c85ae4b0a7c65d2180e9; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24112/7/10/1?documentUUID=2c44e6c1-a585-4f9e-8cec-c2b81d39768b; YEAR=1988; ORIGINAL_YEAR=1988; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical signs|food efficiency; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|other; STUDY_GROUP=ECHA IUCLID_dup_Neurotoxicity_15825726_15825727_15825796:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_fc5a9178233e18e718162b08cfb6d5d8 |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =0.24 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15634098:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_978e764e922bebdc2f1f25dd566abf3a |
ToxValDB_IRIS 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_IRIS | LOAEL | =18 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | LONG_REF=Hofer, H., R. Hruby, E Hruby, et al. 1982. Ninety-day toxicity study with m- phenylenediamine on rats. Oestrr. Forschungszent. Seibersdorf (Ber.) OEFZS Ber. No. 4155. p. 1-46.; TITLE=p; AUTHOR=Hofer, H., R. Hruby, E Hruby, et al; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a2ce4b045b9ff7a4d5e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=87; TOXICOLOGICAL_EFFECT=increased relative and absolute liver weight and degenerative liver lesions; TOXICOLOGICAL_EFFECT_CATEGORY=multiple; STUDY_GROUP=IRIS_dup_IRIS Summary_15645393_15645394:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_57e1dffbe556b4a3fe38ac40762b8842 |
| ToxValDB_IRIS | RfD | =0.006 | mg/kg bw/day | Human | oral | - | Toxicity Value | LONG_REF=Hofer, H., R. Hruby, E Hruby, et al. 1982. Ninety-day toxicity study with m- phenylenediamine on rats. Oestrr. Forschungszent. Seibersdorf (Ber.) OEFZS Ber. No. 4155. p. 1-46.; TITLE=p; AUTHOR=Hofer, H., R. Hruby, E Hruby, et al; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a2ce4b045b9ff7a4d5e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=87; TOXICOLOGICAL_EFFECT=Increased relative and absolute liver weights and degenerative liver lesions in male/female rats; STUDY_GROUP=IRIS:15645141:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_4c40d7c3351d53557765d5616655c21f |
ToxValDB_RSL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_RSL | RfD | =0.06 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759b87ce4b0a7c65d37b4e2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/risk/regional-screening-levels-rsls-generic-tables; STUDY_GROUP=RSL:15663670:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_365ac5accfd4553e3ca2ca1ff8456aa1 |
UnifiedCodex:CIR:beta.noael_studies 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 5 | mg/kg | rat | - | - | developmental toxicity | SOURCE_SUBDIR=PRS62; REPORT_TITLE=FINAL REPORT ON THE SAFETY ASSESSMENT OF m-PHENYLENEDIAMINE AND m-PHENYLENEDIAMINE SULFATE; OPINION_NUMBER=PRS62; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=1101; VALUE_TEXT=5; DOSE=It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992).; EFFECT=ons were not considered neurotoxic effects but were considered indicative of general malaise in experimental animals. The general malaise was supported by concurrent clinical observations of lethargy. In female rats, the test substance did not induce changes in horizontal or vertical motor activity counts at any of the doses tested. Neuropathologic exam- inations did not indicate any abnormalities within the nervous system or skeletal muscle. It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992). Reproductive Toxicity The results of six reproductive toxicity studies are summarized in Table 7. In the first study, the fetal toxicity of m-Phenylenediamine (99% pure) in water was evaluated using 125 female rats (weights = 200-250 g) that had been mated for the first time. The test substance was administered orally to three groups of 25 rats in doses of 10, 30, and 90 mg/kg/day, respectively, on gestation days 5 to 16. The doses were administered once daily at a dose volu...; CITATION=5; 7; (99; CITATION_NUMBERS=[5,7,99]; REFERENCE=5; 7; (99; DETAILS_JSON={"cas_number":"108-45-2","citation":"5; 7; (99","dose":"It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992).","duration":"","effect":"ons were not considered neurotoxic effects but were considered indicative of general malaise in experimental animals. The general malaise was supported by concurrent clinical observations of lethargy. In female rats, the test substance did not induce changes in horizontal or vertical motor activity counts at any of the doses tested. Neuropathologic exam- inations did not indicate any abnormalities within the nervous system or skeletal muscle. It was concluded that m-Phenylenediamine was not neurotoxic and that the no observable effect level for this chemical in male and female rats was 5 mg/kg (Du Pont, 1992). Reproductive Toxicity The results of six reproductive toxicity studies are summarized in Table 7. In the first study, the fetal toxicity of m-Phenylenediamine (99% pure) in water was evaluated using 125 female rats (weights = 200-250 g) that had been mated for the first time. The test substance was administered orally to three groups of 25 rats in doses of 10, 30, and 90 mg/kg/day, respectively, on gestation days 5 to 16. The doses were administered once daily at a dose volu...","endpoint":"developmental toxicity","ingredient":"THE SAFETY ASSESSMENT OF m-PHENYLENEDIAMINE AND m-PHENYLENEDIAMINE SULFATE","loael_value":"","noael_unit":"mg/kg","noael_value":"5","page":25,"route":"","species":"rat","study_id":"PRS62_noael_002"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 6 | mg/kg | rat | dermal | Subchronic | repeated dose toxicity | SOURCE_SUBDIR=PRS62; REPORT_TITLE=FINAL REPORT ON THE SAFETY ASSESSMENT OF m-PHENYLENEDIAMINE AND m-PHENYLENEDIAMINE SULFATE; OPINION_NUMBER=PRS62; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=1101; VALUE_TEXT=6.0; DOSE=Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine.; EFFECT=test substance-related effect could be made based on necropsy findings in animals that survived to the end of the study. Necropsy results included isolated evidence of various spontaneous alterations, such as congenital fissurations of the spleen and liver nodules or testicular atrophy. Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine. It was concluded that the highest daily dose that could be administered to a group without cumulative damage and/or substance-related changes (no-effect-level) was 6 mg m- Phenylenediamine/kg body weight. Subchronic Dermal Toxicity The subchronic dermal toxicity of an oxidative dye formulation contain- ing 1.5% m-Phenylenediamine was evaluated using 12 adult New Zealand white rabbits (six males, six females; weights not stated). Three groups of 12 untreated rabbits served as controls. The dye was mixed with an equal volume of 6% hydrogen peroxide and applied (dose = 1 mL/kg) to the dorsolateral aspects of the thoracic-lumbar area (one on each side of the midline). The test sites were alternated in order to minim...; CITATION=2; 0; 6; CITATION_NUMBERS=[2,6]; REFERENCE=2; 0; 6; DETAILS_JSON={"cas_number":"108-45-2","citation":"2; 0; 6","dose":"Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine.","duration":"Subchronic","effect":"test substance-related effect could be made based on necropsy findings in animals that survived to the end of the study. Necropsy results included isolated evidence of various spontaneous alterations, such as congenital fissurations of the spleen and liver nodules or testicular atrophy. Toxic effects were not observed in rats dosed with 2.0 or 6.0 mg/kg m-Phenylenediamine. It was concluded that the highest daily dose that could be administered to a group without cumulative damage and/or substance-related changes (no-effect-level) was 6 mg m- Phenylenediamine/kg body weight. Subchronic Dermal Toxicity The subchronic dermal toxicity of an oxidative dye formulation contain- ing 1.5% m-Phenylenediamine was evaluated using 12 adult New Zealand white rabbits (six males, six females; weights not stated). Three groups of 12 untreated rabbits served as controls. The dye was mixed with an equal volume of 6% hydrogen peroxide and applied (dose = 1 mL/kg) to the dorsolateral aspects of the thoracic-lumbar area (one on each side of the midline). The test sites were alternated in order to minim...","endpoint":"repeated dose toxicity","ingredient":"THE SAFETY ASSESSMENT OF m-PHENYLENEDIAMINE AND m-PHENYLENEDIAMINE SULFATE","loael_value":"","noael_unit":"mg/kg","noael_value":"6.0","page":18,"route":"dermal","species":"rat","study_id":"PRS62_noael_001"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 134 | mg/kg/day | rat | oral | 2-week | repeated dose toxicity | SOURCE_SUBDIR=PRS62; REPORT_TITLE=FINAL REPORT ON THE SAFETY ASSESSMENT OF m-PHENYLENEDIAMINE AND m-PHENYLENEDIAMINE SULFATE; OPINION_NUMBER=PRS62; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=1101; VALUE_TEXT=134; DOSE=ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg.; EFFECT=ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg. Minimal nephrosis was the only pathologic change noted in six rats dosed orally with m-Phenylenediamine (3% suspension in peanut oil; dose = 90 mg/kg/day) over a 2-week period. There were not test sub- stance-related pathologic changes in six rats dosed (intragastric intu- bation) with 0.8% m-Phenylenediamine (in mixture; 134 mg/kg/day) over a 2-week period. In a subchronic (90-day) oral toxicity study involving groups of 20 rats, the no-effect level was 6 mg m-Phenylenediamine/kg body weight. At histopathologic examination, degenerative lesions in the liver were observed only in the 18-mg/kg/day dose group. There was no indication of toxic injury to the kidneys.; CITATION=250; 500; (3; CITATION_NUMBERS=[250,500,3]; REFERENCE=250; 500; (3; DETAILS_JSON={"cas_number":"108-45-2","citation":"250; 500; (3","dose":"ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg.","duration":"2-week","effect":"ethal dose in a group of six rabbits was in the range of 250 mg/kg to 500 mg/kg. Minimal nephrosis was the only pathologic change noted in six rats dosed orally with m-Phenylenediamine (3% suspension in peanut oil; dose = 90 mg/kg/day) over a 2-week period. There were not test sub- stance-related pathologic changes in six rats dosed (intragastric intu- bation) with 0.8% m-Phenylenediamine (in mixture; 134 mg/kg/day) over a 2-week period. In a subchronic (90-day) oral toxicity study involving groups of 20 rats, the no-effect level was 6 mg m-Phenylenediamine/kg body weight. At histopathologic examination, degenerative lesions in the liver were observed only in the 18-mg/kg/day dose group. There was no indication of toxic injury to the kidneys.","endpoint":"repeated dose toxicity","ingredient":"THE SAFETY ASSESSMENT OF m-PHENYLENEDIAMINE AND m-PHENYLENEDIAMINE SULFATE","loael_value":"","noael_unit":"mg/kg/day","noael_value":"134","page":48,"route":"oral","species":"rat","study_id":"PRS62_noael_003"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | OE624J2447 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H8N2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"OE624J2447"} |
| openFDA substances | FDA UNII substance identifier | OE624J2447 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H8N2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"OE624J2447"} |
| openFDA substances | FDA UNII substance identifier | OE624J2447 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H8N2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"OE624J2447"} |
| openFDA substances | FDA UNII substance identifier | OE624J2447 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H8N2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"OE624J2447"} |