Moderate Colorant NOAEL Data

CI 15985 Yellow 6 Lake

Also known as: C.I. 15985, C.I. Food Yellow 3, 2-Naphthalenesulfonic acid, 6-hydroxy-5-[(4-sulfophenyl)azo]-, disodium salt, D and C Yellow 6, L. Orange Z2010 (+15 more)

INCI: CI 15985 YELLOW 6 LAKE

CI 15985 Yellow 6 Lake (CAS 2783-94-0) is a cosmetic colorant functioning as cosmetic colorant. NOAEL 100 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 3%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.

View industrial chemical safety profile for CAS 2783-94-0 →

Auto-generated CPSR Part A draft with source citations
Function
cosmetic colorant
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C16H10N2Na2O7S2
MW
452.4 g/mol
EC Number
220-491-7
PubChem CID
17730
IUPAC Name
disodium;6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
InChIKey
OIQPTROHQCGFEF-UHFFFAOYSA-L

Regulatory Status

EU EU Status permitted
EU Max Conc. 3%
US US Status restricted
US Notes OTC drug classification applies

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for CI 15985 Yellow 6 Lake.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for CI 15985 Yellow 6 Lake. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL 243 mg/kg bw/day oral mouse Reproductive COSMOS_DB
NOAEL 750 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL =0.005 mg/kg bw - Rat Acute toxicity INCHEM_WHO_jecfa_jecmono_v65je01
NOAEL =0.005 mg/kg bw - Rat Acute toxicity INCHEM_WHO_jecfa_jecmono_v65je01
NOAEL =0.01 mg/kg bw/day oral - Neurotoxicity INCHEM_WHO_jecfa_jecmono_v65je01
NOAEL =0.01 mg/kg bw/day oral - Neurotoxicity INCHEM_WHO_jecfa_jecmono_v65je01
NOAEL =0.01 mg/kg bw/day oral - Neurotoxicity INCHEM_WHO_jecfa_jecmono_v65je01
NOAEL =0.02 mg/kg bw/day oral Rabbit Toxicology study INCHEM_WHO_jecfa_jecmono_v65je01
NOAEL =0.02 mg/kg bw/day oral Rabbit Toxicology study INCHEM_WHO_jecfa_jecmono_v65je01
NOAEL =0.02 mg/kg bw/day oral Rabbit Toxicology study INCHEM_WHO_jecfa_jecmono_v65je01

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for CI 15985 Yellow 6 Lake across SCCS product categories, with measured dermal absorption where available.

EPA ToxValDB — Toxicity Values

10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint Value Species Route Duration Source
NOAEL =148 mg/kg-day Mouse oral chronic ECHA IUCLID
NOAEL =148 mg/kg-day Mouse oral chronic ECHA IUCLID
NOAEL =500 mg/kg-day Rat oral - ECHA IUCLID
NOAEL =500 mg/kg-day Rat oral - ECHA IUCLID
NOAEL =500 mg/kg-day Rat oral - ECHA IUCLID
NOAEL =375 mg/kg-day Rat oral short-term EFSA
LOEL =1000 mg/kg-day Rat oral subchronic ECHA IUCLID
NOAEL =250 mg/kg-day Mouse oral - ECHA IUCLID
NOAEL =250 mg/kg-day Mouse oral - ECHA IUCLID
NOAEL =1000 mg/kg-day Rat oral - ECHA IUCLID

IARC Carcinogenicity

International Agency for Research on Cancer (WHO) monograph evaluation.

IARC Group
3
Volume
8, Sup 7
Evaluation Year
1987

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex IV — Permitted Colorants
Product type: Yellow

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

SA Saudi SFDA (IV - Colorants)
BRIN Brazil/India Cosmetics
India: Permitted Colorant
Additional Jurisdictional Restrictions (2)
Jurisdiction Status Max % Product Type
CN permitted_colorant - All cosmetics (Class 1)
ASEAN permitted_colorant - All products

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (1)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Dye Flavouring and nutrient Fragrance
Regulatory List Membership (4)
EU Restricted for Children (Cosmetics) IFRA Fragrance Transparency List EPA Safer Chemical Ingredients List (SCIL) FDA Substances Added to Food (EAFUS)

Expert Verdict

Expert safety assessment and concern-level summary for CI 15985 Yellow 6 Lake.

Regulatory Flags

eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to CI 15985 Yellow 6 Lake by CAS number or substance name.

Studies
71
Lowest NOAEL
0.005
Highest NOAEL
6000

Units vary across source rows: mg/kg bw, mg/kg bw/day, mg/kg diet

INCHEM_WHO_jecfa_jecmono_v65je01 ToxValDB_ECHA_IUCLID COSMOS_DB

Known Synonyms

C.I. 15985 C.I. Food Yellow 3 2-Naphthalenesulfonic acid, 6-hydroxy-5-[(4-sulfophenyl)azo]-, disodium salt D and C Yellow 6 L. Orange Z2010 A.F. Yellow No. 5 Aizen Food Yellow No. 5 Disodium 6-hydroxy-5-((4-sulfophenyl)azo)-2-naphthalenesulfonate Disodium salt of 1-p-sulphophenylazo-2-naphthol-6-sulphonic acid Dye FDC Yellow No. 6 Dye Sunset Yellow EINECS 220-491-7 FD and C No. 6 6-Hydroxy-5-((p-sulfophenyl)azo)-2-naphthalenesulfonic acid, disodium salt 6-Hydroxy-5-((p-sulphophenyl)azo)-2-naphthalenesulphonic acid, disodium salt 6-Hydroxy-5-((4-sulphophenyl)azo)-2-naphthalenesulphonic acid, disodium salt 2-Naphthalenesulfonic acid, 6-hydroxy-5-((4-sulfophenyl)azo)-, disodiumsalt NCI-C53907 Orange Yellow S. AF Orange Yellow S. FQ

Chemical Function

Dye Fragrance

Regulatory Lists

IFRA Transparency inert_ingredient; non_food_use; Pesticides children; Europe; Personal care children; Europe; Personal care - specialized bath products - bath salts children; Europe; Personal care - hair styling and care - shampoo children; Europe; Personal care children; Europe; Personal care general_foods pharmaceutical Personal care food_additive; Substances Added to Food (formerly EAFUS) (2/2019) SCIL (9/2019)

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical and food safety data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
E110
ChEMBL ID
CHEMBL1371409
View full pharmaceutical profile →
SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Sunset Yellow FCF (FD&C Yellow 6)
E Number
E110
ADI
4 mg/kg bw
Food Category
colorant
View full food safety profile →

Frequently Asked Questions

Is CI 15985 Yellow 6 Lake safe in cosmetics?

CI 15985 Yellow 6 Lake has a safety rating of "MODERATE" in our database. EU status: permitted. US status: restricted. 10 toxicological study endpoint(s) are available in our database.

Is CI 15985 Yellow 6 Lake allowed in the EU?

CI 15985 Yellow 6 Lake EU regulatory status: permitted. Maximum allowed concentration: 3%. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 15985 Yellow 6 Lake do in cosmetics?

CI 15985 Yellow 6 Lake functions as: cosmetic colorant. It is classified as a Colorant in our database. CAS number: 2783-94-0.

What is the NOAEL for CI 15985 Yellow 6 Lake?

The NOAEL (No Observed Adverse Effect Level) for CI 15985 Yellow 6 Lake is 243 mg/kg bw/day based on a Reproductive study via oral route in mouse. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is CI 15985 Yellow 6 Lake used outside cosmetics?

CI 15985 Yellow 6 Lake also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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