Poor Cosmetic Ingredient NOAEL Data

Erythrosin

INCI: CI 45430

CAS Number
16423-68-0
Function
Colorant
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.0025% in toothpaste only
๐Ÿ‡บ๐Ÿ‡ธ US Status prohibited
US Notes FDA banned from cosmetics since 1990 due to thyroid tumor findings in rodent studies; not permitted in any US cosmetic product

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Erythrosin. 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

Synthetic red colorant with severe regulatory restrictions; banned from US cosmetics since 1990 and restricted in EU to toothpaste at maximum 0.0025% due to thyroid tumor findings in animal studies.

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Concern Level: High

Regulatory Flags

colorant banned-US restricted-EU endocrine-concern thyroid eu_children_restricted fda_food_additive

Frequently Asked Questions

Is Erythrosin safe in cosmetics?

Synthetic red colorant with severe regulatory restrictions; banned from US cosmetics since 1990 and restricted in EU to toothpaste at maximum 0.0025% due to thyroid tumor findings in animal studies. The EU classifies Erythrosin as "restricted". Safety rating: POOR. 10 toxicological study endpoint(s) are available in our database.

Is Erythrosin allowed in the EU?

Erythrosin EU regulatory status: restricted. Maximum allowed concentration: 0.0025% in toothpaste only. This is based on EU Regulation 1223/2009 and its amendments.

What does Erythrosin do in cosmetics?

Erythrosin functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 16423-68-0.

What is the Margin of Safety for Erythrosin?

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 Erythrosin?

The NOAEL (No Observed Adverse Effect Level) for Erythrosin 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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