Good Cosmetic Ingredient NOAEL Data

CI 19140

CAS Number
1934-21-0
Function
Colorant
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA-approved as FD&C Yellow No. 5; permitted for use in all cosmetics including lip products and eye-area products when conforming to FDA specs; batch certification required; 21 CFR 74.1705

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for CI 19140. 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 750 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 750 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 2500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 2500 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 1500 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 2641 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 984 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 7500 mg/kg bw/day oral mouse Chronic COSMOS_DB

Expert Verdict

Well-established yellow azo dye (Tartrazine/FD&C Yellow 5) with both FDA and EU approval for all cosmetic applications including lips and eye area; broad international acceptance; minority hypersensitivity risk warrants labeling

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Concern Level: Low

Regulatory Flags

azo-dye fda-certified eu-permitted eye-area-permitted lip-safe batch-certification-required hypersensitivity-minority synthetic-colorant eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is CI 19140 safe in cosmetics?

Well-established yellow azo dye (Tartrazine/FD&C Yellow 5) with both FDA and EU approval for all cosmetic applications including lips and eye area; broad international acceptance; minority hypersensitivity risk warrants labeling The EU classifies CI 19140 as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is CI 19140 allowed in the EU?

CI 19140 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 19140 do in cosmetics?

CI 19140 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 1934-21-0.

What is the Margin of Safety for CI 19140?

adequate 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 19140?

The NOAEL (No Observed Adverse Effect Level) for CI 19140 is 750 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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