NOAEL Studies Colorant

D&C Yellow No. 10 (Quinoline Yellow) NOAEL Studies

INCI: CI 47005

CAS: 8004-92-0

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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EFSA 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA NOAEL =50 mg/kg bw/day Rat oral: feed - chronic/long term toxicity EFSA ANS - 2009 - OutputID 393 - neurology - neurotoxicity - Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive - doi:10.2903/j.efsa.2009.1329
EFSA ADI =0.5 mg/kg bw/day Consumers - - ADI EFSA ANS - 2009 - OutputID 393 - Consumers - Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive - doi:10.2903/j.efsa.2009.1329
EFSA NOAEL =50 mg/kg bw/day Rat oral - chronic LONG_REF=EFSA ANS (2009). Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive. doi:10.2903/j.efsa.2009.1329.; TITLE=Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2009.1329; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=neurology; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=EFSA_dup_-_15614322_15614323_15614324: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_2f4657c6f0b614cd2678a4c47599c430
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=6074; RecordID=ARPathway2016_1595; DatasetName=ARPathway2016; DTXSID=DTXSID0041721; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0041721
SCCS Opinion 10 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.0783 mg/kg bw rat oral chronic reproductive toxicity p.28
SCCS Opinion NOAEL =3 % - - 90 d NOAEL study p.19
SCCS Opinion NOAEL =4 - - - - NOAEL study p.19
SCCS Opinion NOAEL =50 mg/kg bw/day rat oral Subacute repeated dose toxicity p.19
SCCS Opinion NOAEL >50 - rat - Chronic NOAEL study p.19
SCCS Opinion NOAEL =100 mg/kg bw rat oral Subacute repeated dose toxicity p.19
SCCS Opinion NOAEL =250 mg/kg bw/day rat oral chronic reproductive toxicity p.19
SCCS Opinion NOAEL =1000 mg/kg bw/day rat oral subacute repeated dose toxicity p.19
SCCS Opinion NOAEL =1500 - rat oral Subchronic repeated dose toxicity p.19
SCCS Opinion NOAEL =2500 - rat - Subchronic repeated dose toxicity p.19
WHO/JECFA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
WHO/JECFA ADI <=3 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afc40e4b0d99f5a87c094; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/871; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=WHO JECFA ADI:15715379:-:--; 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_f770ec99db86ee002f4a13ff0abd72a8
Regulatory source 17 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 3 % - - 90 d - p.19
Regulatory source - 4 - - - - - p.19
Regulatory source - >50 - rat - Chronic - p.19
Regulatory source repeated dose toxicity 50 mg/kg bw/day rat oral Subacute repeated dose toxicity p.19
Regulatory source repeated dose toxicity 50 mg/kg bw/day rat oral 18 day repeated dose toxicity p.21
Regulatory source repeated dose toxicity 50 mg/kg bw/day rat oral chronic repeated dose toxicity p.21
Regulatory source repeated dose toxicity 100 mg/kg bw rat oral Subacute repeated dose toxicity p.19
Regulatory source repeated dose toxicity 1000 mg/kg bw/day rat oral subacute repeated dose toxicity p.19
Regulatory source repeated dose toxicity 1500 - rat oral Subchronic repeated dose toxicity p.19
Regulatory source repeated dose toxicity 2500 - rat - Subchronic repeated dose toxicity p.19
Regulatory source reproductive toxicity =0.0783 mg/kg bw rat oral chronic reproductive toxicity p.28
Regulatory source reproductive toxicity 50 mg/kg bw/day rat oral chronic reproductive toxicity p.22
Regulatory source reproductive toxicity 50 mg/kg bw / day rat oral chronic reproductive toxicity p.22
Regulatory source reproductive toxicity 50 mg/kg bw/day rat dermal chronic reproductive toxicity p.28
Regulatory source reproductive toxicity =50 mg/kg bw/d rat oral chronic reproductive toxicity p.28
Regulatory source reproductive toxicity 250 mg/kg bw/day rat oral chronic reproductive toxicity p.19
Regulatory source reproductive toxicity 1000 mg/kg bw/day rat oral chronic reproductive toxicity p.19
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 35SW5USQ3G UNII - - - mixture -