NOAEL Studies Cosmetic Ingredient

HC Red No. 3 NOAEL Studies

INCI: HC RED NO. 3

CAS: 2871-01-4

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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COSMOS DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB LOAEL 15 mg/kg bw/day mouse oral 13 week Subchronic SCCS; Toxicology and Carcinogenesis Studies of HC Red No. 3 in F344/N Rats and B6C3F1Mice (Gavage Studies), National Toxicology Program, Technical Report Series No. 281,January 1986, DHHS
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 acute oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE acute oral LD50 >1000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_5033; row=3909; data_type=In Vivo; mixture=Chemical; chemical_name=HC Red 3; preferred_name=HC Red 3; dtxsid=DTXSID2021236; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021236; source_file=acute_oral.xlsx
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=2609; Record_ID=cancer_34; Data_Type=WOE; Formulation_Name=HC Red 3; Mixture=Chemical; DTXSID=DTXSID2021236; 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/DTXSID2021236; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021236
NTP ICE cancer Top dose 250 mg/kg bw/day Mouse Gavage - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=2606; Record_ID=cancer_32; Data_Type=In Vivo; Formulation_Name=HC Red 3; Mixture=Chemical; DTXSID=DTXSID2021236; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=250; Response_Unit=mg/kg/day; Species=Mouse; Strain=B6C3F1; Sex=Male; Route=Gavage; Reference=TR-281; URL=https://ntp.niehs.nih.gov/publications/reports/tr/200s/tr281/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021236
NTP ICE cancer Top dose 500 mg/kg bw/day Rat Gavage - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=2611; Record_ID=cancer_37; Data_Type=In Vivo; Formulation_Name=HC Red 3; Mixture=Chemical; DTXSID=DTXSID2021236; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=500; Response_Unit=mg/kg/day; Species=Rat; Strain=F344/N; Sex=Female; Route=Gavage; Reference=TR-281; URL=https://ntp.niehs.nih.gov/publications/reports/tr/200s/tr281/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021236
NTP ICE skin sensitization 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE skin sensitization EC3 2.2 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13175; Record_ID=skin_sensitization_invivo_3200; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2021236; Assay=LLNA; Endpoint=EC3; Response=2.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021236
SCCS Opinion 16 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.003 mg/kg bw mouse oral 90-day dermal absorption p.48
SCCS Opinion NOAEL =0.01 mg/kg bw mouse oral 90-day dermal absorption p.45
SCCS Opinion NOAEL =0.015 mg/kg bw mouse oral 90-day dermal absorption p.48
SCCS Opinion NOAEL =0.02 % mouse oral Chronic NOAEL study p.22
SCCS Opinion NOAEL =45 mg/kg bw/d mouse oral 90-day dermal absorption p.48
SCCS Opinion NOAEL =50 % mouse oral 90-day dermal absorption p.48
SCCS Opinion NOAEL =90 mg/kg bw/d mouse oral 90-day dermal absorption p.45
SCCS Opinion NOAEL =97.5 - - - - NOAEL study p.44
SCCS Opinion NOAEL =125 mg/kg bw/d rat - 5 days NOAEL study p.21
SCCS Opinion NOAEL =200 mg/kg/d rabbit oral developmental developmental toxicity p.43
SCCS Opinion NOAEL =200 mg/kg bw/d rabbit oral developmental developmental toxicity p.45
SCCS Opinion NOAEL =250 mg/kg bw/d rat oral 5 days NOAEL study p.21
SCCS Opinion NOAEL =500 mg/kg bw/d rat oral 14-day repeated dose toxicity p.20
SCCS Opinion NOAEL =1000 mg/kg bw/d rat oral 14-day repeated dose toxicity p.20
SCCS Opinion NOAEL =1000 mg/kg/d rabbit oral developmental developmental toxicity p.43
SCCS Opinion NOAEL =7800 ppm - - 13 days reproductive toxicity p.41
ECHA 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA NOAEL =200 mg/kg bw/day Rat oral - reproduction developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac1ae4b0a7c65d1bd5a2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22771/7/9/3?documentUUID=2ac25915-d18c-4c07-82b1-eed21940e2da; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical signs; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15823058_15824717:F:-maternal; 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_11b3a43756889e85f14d9dd54e56dbc6
ECHA NOAEL >250 mg/kg bw/day Mouse oral subchronic; 13 weeks subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae06e4b0a7c65d1c71e2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22771/7/6/2?documentUUID=2ac25915-d18c-4c07-82b1-eed21940e2da; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical signs|gross pathology|histopathology: non-neoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|gross pathology|nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15849377:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_d27ba623329de4eb9d85f97dfb7aa9b3
ECHA NOAEL >500 mg/kg bw/day Mouse oral short-term; 14 days short-term QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb04e4b0a7c65d2248ba; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22771/7/6/2?documentUUID=2ac25915-d18c-4c07-82b1-eed21940e2da; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=clinical signs|gross pathology|mortality; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|gross pathology|mortality/survival; STUDY_GROUP=ECHA IUCLID:15849375:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_648207453de897c2994217d326904565
ECHA NOAEL =1000 mg/kg bw/day Rat oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac1ae4b0a7c65d1bd59a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22771/7/9/3?documentUUID=2ac25915-d18c-4c07-82b1-eed21940e2da; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15823058_15824717:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_222d0559cef807d44d496b09b41ed244
Regulatory source 23 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 0.02 % mouse oral Chronic - p.22
Regulatory source - 97.5 - - - - - p.44
Regulatory source - 125 mg/kg bw/d rat - 5 days - p.21
Regulatory source - 250 mg/kg bw/d rat oral 5 days - p.21
Regulatory source - 250 mg/kg bw/d rat - 5 days - p.21
Regulatory source dermal absorption =0.003 mg/kg bw mouse oral 90-day dermal absorption p.48
Regulatory source dermal absorption =0.01 mg/kg bw mouse oral 90-day dermal absorption p.45
Regulatory source dermal absorption =0.015 mg/kg bw mouse oral 90-day dermal absorption p.48
Regulatory source dermal absorption =45 mg/kg bw/d mouse oral 90-day dermal absorption p.48
Regulatory source dermal absorption 50 % mouse oral 90-day dermal absorption p.48
Regulatory source dermal absorption =90 mg/kg bw/d mouse oral 90-day dermal absorption p.45
Regulatory source developmental toxicity 200 mg/kg/d rabbit oral developmental developmental toxicity p.43
Regulatory source developmental toxicity 200 mg/kg/d rat oral developmental developmental toxicity p.46
Regulatory source developmental toxicity 200 mg/kg bw/d rabbit oral developmental developmental toxicity p.45
Regulatory source developmental toxicity 200 mg/kg bw/d rat oral developmental developmental toxicity p.49
Regulatory source developmental toxicity 1000 mg/kg/d rabbit oral developmental developmental toxicity p.43
Regulatory source developmental toxicity 1000 mg/kg bw/d rat oral 5 days developmental toxicity p.46
Regulatory source developmental toxicity 1000 mg/kg/d rat oral developmental developmental toxicity p.46
Regulatory source developmental toxicity 1000 mg/kg bw/d rabbit oral developmental developmental toxicity p.45
Regulatory source developmental toxicity 1000 mg/kg bw/d rat oral developmental developmental toxicity p.49
Regulatory source repeated dose toxicity 500 mg/kg bw/d rat oral 14-day repeated dose toxicity p.20
Regulatory source repeated dose toxicity 1000 mg/kg bw/d rat oral 14-day repeated dose toxicity p.20
Regulatory source reproductive toxicity 7800 ppm - - 13 days reproductive toxicity p.41
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 51CPX7M1SQ UNII - - - chemical -