NOAEL Studies Cosmetic Ingredient

4-Nitro-O-Phenylenediamine NOAEL Studies

INCI: 4-NITRO-O-PHENYLENEDIAMINE

CAS: 99-56-9

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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CIR Safety Assessment 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =15 mg/kg bw/d rat dermal Chronic NOAEL study 10); (5; 45, p.6
CIR Safety Assessment NOAEL =45 mg/kg bw/d rat dermal Chronic NOAEL study (8; 10); (5, p.6
IARC Monographs 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
IARC Monographs IARC carcinogenicity classification 3 IARC group - - 1987 IARC Monographs -
NTP ICE cancer 3 endpoints
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=9805; Record_ID=cancer_5434; Data_Type=WOE; Formulation_Name=4-Nitro-1,2-phenylenediamine; Mixture=Chemical; DTXSID=DTXSID9020958; 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/DTXSID9020958; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020958
NTP ICE cancer Top dose 750 ppm Rat - - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=9807; Record_ID=cancer_5435; Data_Type=In Vivo; Formulation_Name=4-Nitro-o-phenylenediamine; Mixture=Chemical; DTXSID=DTXSID9020958; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=750; Response_Unit=ppm; Species=Rat; Strain=F344/N; Sex=Male; Reference=TR-180; URL=https://ntp.niehs.nih.gov/publications/reports/tr/100s/tr180/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020958; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020958
NTP ICE cancer Top dose 7500 ppm Mouse - - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=9803; Record_ID=cancer_5432; Data_Type=In Vivo; Formulation_Name=4-Nitro-o-phenylenediamine; Mixture=Chemical; DTXSID=DTXSID9020958; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=7500; Response_Unit=ppm; Species=Mouse; Strain=B6C3F1; Sex=Male; Reference=TR-180; URL=https://ntp.niehs.nih.gov/publications/reports/tr/100s/tr180/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020958; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020958
SCCS Opinion 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.042 mg/kg rat oral 90 day dermal absorption p.55
SCCS Opinion NOAEL =15 mg/kg bw/day dog oral 4-week NOAEL study p.16
SCCS Opinion NOAEL =15 mg/kg rat oral 90 day dermal absorption p.55
SCCS Opinion NOAEL =45 mg/kg/day rat - - NOAEL study p.16
SCCS Opinion NOAEL =45 mg/kg bw/day - - 4-week NOAEL study p.16
SCCS Opinion NOAEL =65 % - oral 90 day reproductive toxicity p.55
SCCS Opinion NOAEL =265 mg/kg/day - - 90 day developmental toxicity p.55
SCCS Opinion NOAEL =500 mg/kg rat oral - NOAEL study p.6
ToxValDB ECOTOX 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB ECOTOX NOEL =340 mg/kg bw/day Rat oral short-term; 1.625 days short-term LONG_REF=Mutat. Res.320(3): 189-205 Uno,Y., H. Takasawa, M. Miyagawa, Y. Inoue, T. Murata, and K. Yoshikawa An In Vivo-In Vitro Replicative DNA Synthesis (RDS) Test Using Rat Hepatocytes as an Early Prediction Assay for Nongenotoxic Hepatocarcinogens Screening of 22 Known Positive and 25 Noncarcinogens 1994; TITLE=An In Vivo-In Vitro Replicative DNA Synthesis (RDS) Test Using Rat Hepatocytes as an Early Prediction Assay for Nongenotoxic Hepatocarcinogens Screening of 22 Known Positive and 25 Noncarcinogens; AUTHOR=Uno,Y., H. Takasawa, M. Miyagawa, Y. Inoue, T. Murata, and K. Yoshikawa; DOI=10.1016/0165-1218(94)90046-9; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75058; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=Cell(s): Viability; STUDY_GROUP=ECOTOX:15605215:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=0ceae7e0d1921ce655d9d34645c00e53
ToxValDB ECOTOX NOEL =500 mg/kg bw/day Mouse oral short-term; 2 days short-term LONG_REF=Mutat. Res.343(2/3): 157-183 Miyagawa,M., H. Takasawa, A. Sugiyama, Y. Inoue, T. Murata, Y. Uno, and K. Yoshikawa The In Vivo-In Vitro Replicative DNA Synthesis (RDS) Test with Hepatocytes Prepared from Male B6C3F1 Mice as an Early Prediction Assay for Putative Nongenotoxic (Ames-Negative) Mouse Hepatocarcinogens 1995; TITLE=The In Vivo-In Vitro Replicative DNA Synthesis (RDS) Test with Hepatocytes Prepared from Male B6C3F1 Mice as an Early Prediction Assay for Putative Nongenotoxic (Ames-Negative) Mouse Hepatocarcinogens; AUTHOR=Miyagawa,M., H. Takasawa, A. Sugiyama, Y. Inoue, T. Murata, Y. Uno, and K. Yoshikawa; DOI=10.1016/0165-1218(95)90082-9; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=75052; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=Cell(s): Viability; STUDY_GROUP=ECOTOX:15603526:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=4dfae0571c47d2f4be1e1bce34b77746
Regulatory source 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 15 mg/kg bw/day dog oral 4-week - p.16
Regulatory source - 45 mg/kg/day rat - - - p.16
Regulatory source - 45 mg/kg bw/day - - 4-week - p.16
Regulatory source - 500 mg/kg rat oral - - p.6
Regulatory source dermal absorption =0.042 mg/kg rat oral 90 day dermal absorption p.55
Regulatory source dermal absorption =15 mg/kg rat oral 90 day dermal absorption p.55
Regulatory source developmental toxicity 15 mg/kg bw/day rat oral 90 day developmental toxicity p.55
Regulatory source developmental toxicity 265 mg/kg/day - - 90 day developmental toxicity p.55
Regulatory source reproductive toxicity 65 % - oral 90 day reproductive toxicity p.55
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 5A9AX7Y0TT UNII - - - chemical -