Moderate Colorant NOAEL Data

CI 16035 (Allura Red AC)

INCI: CI 16035

CAS Number
25956-17-6
Function
Colorant, Hair Dyeing Agent
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 0.4% (hair dye use only)
🇺🇸 US Status permitted
US Notes Listed as FD&C Red No. 40. Permanently listed color additive. FDA batch certification required for each lot. Permitted in foods, drugs, and cosmetics generally, including eye area and lip products (aluminum lake form also permitted for eye area). Separate from EU nomenclature — labeling must use CI 16035 in EU, FD&C Red No. 40 in US context.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for CI 16035 (Allura Red AC). 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 250 mg/kg bw/day oral dog Short Term Toxicity COSMOS_DB
NOAEL 5190 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2595 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 2595 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 7785 mg/kg bw/day oral mouse Chronic COSMOS_DB
NOAEL 2595 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 7785 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 2595 mg/kg bw/day oral rat Reproductive-developmental COSMOS_DB
NOAEL 200 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 2595 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB

Expert Verdict

CAS 25956-17-6. EU: permitted colorant for general cosmetics (Annex IV/32, no max), restricted as hair dye (Annex III/191, max 0.4%). US: permanently listed FD&C Red No. 40, FDA batch certification required, permitted in all cosmetics including eye area. Acute toxicity very low (oral LD50 >10,000 mg/kg rat). Non-sensitizing and non-irritating. Genotoxicity signals are a concern: positive Ames test with metabolic activation; recent data shows DNA damage and low-grade colonic inflammation in vivo at ADI-equivalent dose. Azo bond cleavage produces potentially genotoxic metabolites. Contamination risk with benzidine and p-cresidine requires supplier COA verification. No accepted MoS exists — CPSR will require new absorption data or justified default.

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Concern Level: High

Regulatory Flags

no-accepted-mos genotoxicity-signal azo-dye dual-annex-listing fda-batch-certification-required contamination-risk hair-dye-restricted-0.4pct leave-on-risk-assessment-required eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is CI 16035 (Allura Red AC) safe in cosmetics?

CAS 25956-17-6. EU: permitted colorant for general cosmetics (Annex IV/32, no max), restricted as hair dye (Annex III/191, max 0.4%). US: permanently listed FD&C Red No. 40, FDA batch certification required, permitted in all cosmetics including eye area. Acute toxicity very low (oral LD50 >10,000 mg/kg rat). Non-sensitizing and non-irritating. Genotoxicity signals are a concern: positive Ames test with metabolic activation; recent data shows DNA damage and low-grade colonic inflammation in vivo at ADI-equivalent dose. Azo bond cleavage produces potentially genotoxic metabolites. Contamination risk with benzidine and p-cresidine requires supplier COA verification. No accepted MoS exists — CPSR will require new absorption data or justified default. The EU classifies CI 16035 (Allura Red AC) as "restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is CI 16035 (Allura Red AC) allowed in the EU?

CI 16035 (Allura Red AC) EU regulatory status: restricted. Maximum allowed concentration: 0.4% (hair dye use only). This is based on EU Regulation 1223/2009 and its amendments.

What does CI 16035 (Allura Red AC) do in cosmetics?

CI 16035 (Allura Red AC) functions as: Colorant, Hair Dyeing Agent. It is classified as a Colorant in our database. CAS number: 25956-17-6.

What is the Margin of Safety for CI 16035 (Allura Red AC)?

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 CI 16035 (Allura Red AC)?

The NOAEL (No Observed Adverse Effect Level) for CI 16035 (Allura Red AC) is 250 mg/kg bw/day based on a Short Term Toxicity study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check CI 16035 (Allura Red AC) compliance across multiple jurisdictions:

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Ingredient Decoder
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Substance Compliance
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MoS Calculator
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