Moderate Colorant NOAEL Data

CI 15985 Yellow 6 Lake

INCI: CI 15985 YELLOW 6 LAKE

CAS Number
2783-94-0
Function
cosmetic colorant
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
EU Max Conc. 3%
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes OTC drug classification applies

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

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 1000 mg/kg bw/day oral swine Subchronic COSMOS_DB
NOAEL 2400 mg/kg bw/day oral mouse Chronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 750 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 2500 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 7500 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 300 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

Expert Verdict

CI 15985 Yellow 6 Lake is a permitted colorant with regulatory approval in EU and OTC drug status in US; however, insufficient safety data exists and further assessment is recommended.

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Concern Level: Moderate

Regulatory Flags

eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is CI 15985 Yellow 6 Lake safe in cosmetics?

CI 15985 Yellow 6 Lake is a permitted colorant with regulatory approval in EU and OTC drug status in US; however, insufficient safety data exists and further assessment is recommended. The EU classifies CI 15985 Yellow 6 Lake as "permitted". Safety rating: MODERATE. 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 Margin of Safety for CI 15985 Yellow 6 Lake?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for CI 15985 Yellow 6 Lake?

The NOAEL (No Observed Adverse Effect Level) for CI 15985 Yellow 6 Lake is 1000 mg/kg bw/day based on a Subchronic study via oral route in swine. A total of 10 study endpoints are available. Source: COSMOS_DB.

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