NOAEL Studies Cosmetic Ingredient

HC Yellow No. 4 NOAEL Studies

INCI: HC YELLOW NO. 4

CAS: 59820-43-8

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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IARC Monographs 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
IARC Monographs IARC carcinogenicity classification 3 IARC group - - 1992 IARC Monographs -
NTP ICE cancer 4 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=6838; Record_ID=cancer_2541; Data_Type=WOE; Formulation_Name=HC Yellow 4; Mixture=Chemical; DTXSID=DTXSID6021458; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/75; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021458; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6021458
NTP ICE cancer POLY-3 lowest dose 5000 ppm Rat Dosed feed - In Vivo; Two year cancer bioassay sheet=Data; excel_row=6836; Record_ID=cancer_2539; Data_Type=In Vivo; Formulation_Name=HC yellow 4; Mixture=Chemical; DTXSID=DTXSID6021458; Assay=Two year cancer bioassay; Endpoint=POLY-3 lowest dose; Response=5000; Response_Unit=ppm; Species=Rat; Strain=F344/N; Sex=Male; Route=Dosed feed; Level_of_Evidence=Equivocal evidence; Tissue=Pituitary gland; Location=Pars distalis or unspecified site; Lesion=Adenoma; Reference=TR-419; URL=https://ntp.niehs.nih.gov/publications/reports/tr/400s/tr419/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021458; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6021458
NTP ICE cancer Top dose 5000 ppm Rat Dosed feed - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=6842; Record_ID=cancer_2539; Data_Type=In Vivo; Formulation_Name=HC Yellow 4; Mixture=Chemical; DTXSID=DTXSID6021458; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=5000; Response_Unit=ppm; Species=Rat; Strain=F344/N; Sex=Male; Route=Dosed feed; Reference=TR-419; URL=https://ntp.niehs.nih.gov/publications/reports/tr/400s/tr419/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021458; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6021458
NTP ICE cancer Top dose 10000 ppm Mouse Dosed feed - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=6834; Record_ID=cancer_2538; Data_Type=In Vivo; Formulation_Name=HC Yellow 4; Mixture=Chemical; DTXSID=DTXSID6021458; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=10000; Response_Unit=ppm; Species=Mouse; Strain=B6C3F1; Sex=Male; Route=Dosed feed; Reference=TR-419; URL=https://ntp.niehs.nih.gov/publications/reports/tr/400s/tr419/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021458; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6021458
SCCS Opinion 14 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.001 mg/kg bw rat oral - dermal absorption p.45
SCCS Opinion NOAEL =0.1 % rat oral 10 weeks NOAEL study p.30
SCCS Opinion NOAEL =0.4 % rat - - reproductive toxicity Ref.: 24 Comments, p.36
SCCS Opinion NOAEL =1.5 % rat oral Sub-chronic repeated dose toxicity p.40
SCCS Opinion NOAEL =43 - rabbit dermal 13-week NOAEL study p.43
SCCS Opinion NOAEL =50 mg/kg/d rat oral developmental developmental toxicity p.38
SCCS Opinion NOAEL =50 mg/kg bw/d rat dermal developmental developmental toxicity p.39
SCCS Opinion NOAEL =50 mg/kg bw rat oral - dermal absorption p.45
SCCS Opinion NOAEL =99.2 % rat oral Prenatal developmental toxicity p.37
SCCS Opinion NOAEL =200 mg/kg bw/d rat oral - NOAEL study p.43
SCCS Opinion NOAEL =300 mg/kg bw/d rat dermal developmental developmental toxicity p.39
SCCS Opinion NOAEL =300 mg/kg/d rat oral developmental reproductive toxicity p.46
SCCS Opinion NOAEL =500 mg/kg/d rat oral developmental developmental toxicity p.38
SCCS Opinion NOAEL =5000 ppm rat - 2-year NOAEL study p.22
ToxValDB HESS 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB HESS NOEL <240 mg/kg bw/day Rat oral subchronic; 13 weeks subchronic STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/60da0df8e4b0a676289debac; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.nite.go.jp/en/chem/qsar/hess_update-e.html; TOXICOLOGICAL_EFFECT=Body Weight Changes: decrease|Relative Organ Weight: Right kidney increase, Liver increase, Lungs increase, Thymus increase, Testis increase|Histopathology: Kidney/papilla- Mineralization Thyroid-Pigmentation Uterus-Atrophy; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|nonneoplastic histopathology|organ weight; STUDY_GROUP=HESS:15638546:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_9f8a28f0cc5567b71e8d2c49384a1a91
Regulatory source 26 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 0.1 % rat oral 10 weeks - p.30
Regulatory source - 43 - rabbit dermal 13-week - p.43
Regulatory source - 43 - rat dermal 3 days - p.43
Regulatory source - 50 mg/kg bw/d rat oral 3 days - p.43
Regulatory source - 50 mg/kg bw/d rat oral - - p.43
Regulatory source - 200 mg/kg bw/d rat oral - - p.43
Regulatory source - 300 mg/kg bw/d rat oral 3 days - p.43
Regulatory source - 5000 ppm rat - 2-year - p.22
Regulatory source - 5000 ppm rat dermal 2-year - p.22
Regulatory source - 5000 ppm rat oral 13-week - p.43
Regulatory source dermal absorption =0.001 mg/kg bw rat oral - dermal absorption p.45
Regulatory source dermal absorption =50 mg/kg bw rat oral - dermal absorption p.45
Regulatory source developmental toxicity 0.1 % rat oral 6 weeks developmental toxicity p.41
Regulatory source developmental toxicity 0.4 % - - - developmental toxicity p.40
Regulatory source developmental toxicity 50 mg/kg/d rat oral developmental developmental toxicity p.38
Regulatory source developmental toxicity 50 mg/kg bw/d rat dermal developmental developmental toxicity p.39
Regulatory source developmental toxicity 99.2 % rat oral Prenatal developmental toxicity p.37
Regulatory source developmental toxicity 300 mg/kg bw/d rat dermal developmental developmental toxicity p.39
Regulatory source developmental toxicity 500 mg/kg/d rat oral developmental developmental toxicity p.38
Regulatory source repeated dose toxicity 0.1 % rat oral sub-chronic repeated dose toxicity p.30
Regulatory source repeated dose toxicity 1.5 % rat oral Sub-chronic repeated dose toxicity p.40
Regulatory source reproductive toxicity 0.1 % rat oral - reproductive toxicity p.42
Regulatory source reproductive toxicity 0.1 % rat oral 13-week reproductive toxicity p.43
Regulatory source reproductive toxicity 0.4 % rat - - reproductive toxicity p.36
Regulatory source reproductive toxicity 50 mg/kg/d rat oral developmental reproductive toxicity p.46
Regulatory source reproductive toxicity 300 mg/kg/d rat oral developmental reproductive toxicity p.46
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 0N97D5G157 UNII - - - chemical -