NOAEL Studies Colorant

Orange 4 (CI 15510) NOAEL Studies

INCI: CI 15510

CAS: 633-96-5

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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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=6008; RecordID=ARPathway2016_1427; DatasetName=ARPathway2016; DTXSID=DTXSID0038881; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0038881
SCCNFP Opinion 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP Opinion NOAEL =2.5 mg/kg rabbit dermal Sub-chronic repeated dose toxicity p.8
SCCNFP Opinion NOAEL =5 mg/kg rat oral - dermal absorption p.13
SCCS Opinion 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.83 mg/kg bw/d rat oral 13-week dermal absorption p.25
SCCS Opinion NOAEL =2.5 mg/kg bw/day - - - NOAEL study p.18
SCCS Opinion NOAEL =2.5 mg/kg bw/ day rabbit dermal - NOAEL study p.18
SCCS Opinion NOAEL =2.5 mg/kg bw/d rat oral 13-weeks NOAEL study p.25
SCCS Opinion NOAEL =2.5 mg/kg bw/d rat oral 13-week NOAEL study p.28
SCCS Opinion NOAEL =5 mg/kg bw/day human - - NOAEL study p.24
SCCS Opinion NOAEL =5 mg/kg bw/d rat oral 13-weeks dermal absorption p.25
SCCS Opinion NOAEL =5 mg/kg bw/d rat oral 13-week dermal absorption p.28
SCCS Opinion NOAEL =50 % rat oral 13-week dermal absorption p.28
ECHA 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA LOAEL =5 mg/kg bw/day Rat oral - reproduction developmental QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac26e4b0a7c65d1bd95d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/9/3?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; TOXICOLOGICAL_EFFECT=maternal: mortality; TOXICOLOGICAL_EFFECT_CATEGORY=mortality/survival; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822587_15823625: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_ed1046f0a98505f8ceabde0a6e0c4b41
ECHA LOAEL =100 mg/kg bw/day Rat oral - reproduction developmental QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac26e4b0a7c65d1bd963; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/9/3?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; TOXICOLOGICAL_EFFECT=maternal: clinical signs; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822587_15823625: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_dcbafb106d3582775019184ed544d2da
ECHA NOAEL =1000 mg/kg bw/day Rat oral - developmental QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac26e4b0a7c65d1bd95d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/9/3?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15821263_15823411_15823655_15823732:-:-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_65f1b0be7aa4b35d068cf04db1572cd1
ToxValDB GESTIS DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB GESTIS DNEL DNEL systemic =0.176 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:15633929:-:--; 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_1091a27f6f83ca1c4031bd953d08b001
Regulatory source 13 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 5 mg/kg rat oral 13-weeks - p.18
Regulatory source dermal absorption 5 mg/kg rat oral - dermal absorption p.13
Regulatory source genotoxicity 2.5 mg/kg rat oral 13-weeks genotoxicity p.18
Regulatory source repeated dose toxicity 2.5 mg/kg rabbit dermal Sub-chronic repeated dose toxicity p.8
Regulatory source - 2.5 mg/kg bw/day - - - - p.18
Regulatory source - 2.5 mg/kg bw/ day rabbit dermal - - p.18
Regulatory source - 2.5 mg/kg bw/d rat oral 13-weeks - p.25
Regulatory source - 2.5 mg/kg bw/d rat oral 13-week - p.28
Regulatory source - 5 mg/kg bw/day human - - - p.24
Regulatory source dermal absorption =0.83 mg/kg bw/d rat oral 13-week dermal absorption p.25
Regulatory source dermal absorption 5 mg/kg bw/d rat oral 13-weeks dermal absorption p.25
Regulatory source dermal absorption 5 mg/kg bw/d rat oral 13-week dermal absorption p.28
Regulatory source dermal absorption 50 % rat oral 13-week dermal absorption p.28
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier Q1LIY3BO0U UNII - - - chemical -