Moderate Cosmetic Ingredient NOAEL Data

Acid Red 51 (Erythrosine)

INCI: CI 45430

CAS Number
16423-68-0
Function
Cosmetic colorant
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status prohibited
US Notes De-listed for cosmetics in 1990. FD&C Red No. 3 was permanently listed only for food and ingested drugs; FDA revoked food authorization in early 2025.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Acid Red 51 (Erythrosine). 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 800 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 500 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral swine Subchronic 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 500 mg/kg bw/day oral gerbil Carcinogenicity COSMOS_DB
NOAEL 750 mg/kg bw/day oral gerbil Chronic COSMOS_DB

Expert Verdict

Acid Red 51 is prohibited in EU cosmetics and de-listed for US cosmetics due to iodine content and thyroid disruption concerns; FDA revoked its food authorization in 2025.

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Concern Level: High

Regulatory Flags

colorant eu_children_restricted fda_food_additive

Frequently Asked Questions

Is Acid Red 51 (Erythrosine) safe in cosmetics?

Acid Red 51 is prohibited in EU cosmetics and de-listed for US cosmetics due to iodine content and thyroid disruption concerns; FDA revoked its food authorization in 2025. The EU classifies Acid Red 51 (Erythrosine) as "prohibited". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Acid Red 51 (Erythrosine) allowed in the EU?

Acid Red 51 (Erythrosine) EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Acid Red 51 (Erythrosine) do in cosmetics?

Acid Red 51 (Erythrosine) functions as: Cosmetic colorant. It is classified as a cosmetic ingredient in our database. CAS number: 16423-68-0.

What is the Margin of Safety for Acid Red 51 (Erythrosine)?

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 Acid Red 51 (Erythrosine)?

The NOAEL (No Observed Adverse Effect Level) for Acid Red 51 (Erythrosine) is 800 mg/kg bw/day based on a Developmental study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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