Good Cosmetic Ingredient NOAEL Data

Acid Yellow 3 Aluminum Lake

INCI: ACID YELLOW 3 ALUMINUM LAKE

CAS Number
12225-21-7
Function
Colorant (pigment/lake form)
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA-listed as D&C Yellow No. 10 Aluminum Lake; permitted in cosmetics

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 Acid Yellow 3 Aluminum 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 750 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 750 mg/kg bw/day oral rat Chronic 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

Restricted under Annex III entry 326 with concentration limits; parent dye restrictions apply in hair dye applications but aluminum lake form is permitted in other cosmetic uses.

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Concern Level: Low

Regulatory Flags

colorant epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Acid Yellow 3 Aluminum Lake safe in cosmetics?

Restricted under Annex III entry 326 with concentration limits; parent dye restrictions apply in hair dye applications but aluminum lake form is permitted in other cosmetic uses. The EU classifies Acid Yellow 3 Aluminum Lake as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Acid Yellow 3 Aluminum Lake allowed in the EU?

Acid Yellow 3 Aluminum Lake EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does Acid Yellow 3 Aluminum Lake do in cosmetics?

Acid Yellow 3 Aluminum Lake functions as: Colorant (pigment/lake form). It is classified as a cosmetic ingredient in our database. CAS number: 12225-21-7.

What is the Margin of Safety for Acid Yellow 3 Aluminum Lake?

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 Acid Yellow 3 Aluminum Lake?

The NOAEL (No Observed Adverse Effect Level) for Acid Yellow 3 Aluminum Lake is 750 mg/kg bw/day based on a Multigeneration Reproductive study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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