Good Cosmetic Ingredient NOAEL Data

FD&C Yellow No. 5 (CI 19140)

INCI: FD&C YELLOW NO. 5

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

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
EU Max Conc. 0.11%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for FD&C Yellow No. 5 (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

Good safety profile with established concentration limits; generally considered safe for cosmetic use.

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Concern Level: Low

Regulatory Flags

eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is FD&C Yellow No. 5 (CI 19140) safe in cosmetics?

Good safety profile with established concentration limits; generally considered safe for cosmetic use. The EU classifies FD&C Yellow No. 5 (CI 19140) as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is FD&C Yellow No. 5 (CI 19140) allowed in the EU?

FD&C Yellow No. 5 (CI 19140) EU regulatory status: permitted. Maximum allowed concentration: 0.11%. This is based on EU Regulation 1223/2009 and its amendments.

What does FD&C Yellow No. 5 (CI 19140) do in cosmetics?

FD&C Yellow No. 5 (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 FD&C Yellow No. 5 (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 FD&C Yellow No. 5 (CI 19140)?

The NOAEL (No Observed Adverse Effect Level) for FD&C Yellow No. 5 (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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