Moderate Cosmetic Ingredient NOAEL Data

CI 16185

CAS Number
915-67-3
Function
Colorant
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status restricted
🇺🇸 US Status prohibited
US Notes Delisted by FDA in February 1976 (FD&C Red No. 2); banned as suspected carcinogen after studies showed increased malignant tumors in female rats at high doses; 21 CFR 81.10 and 81.30

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for CI 16185. 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 47 mg/kg bw/day oral rat oral REACH
NOAEL 0.1 other dermal code:3543 dermal REACH
NOAEL 1260 mg/kg bw/day oral rat oral REACH
NOAEL 50 mg/kg bw/day oral mouse oral REACH
NOAEL 2462 mg/kg bw/day oral rat oral REACH

Expert Verdict

EU-restricted red azo dye with limitations excluding use in hair dye products and near mucous membranes; banned in the US since 1976 due to carcinogenicity concerns in animal studies.

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Concern Level: Moderate

Regulatory Flags

azo-dye banned-in-us eu-restricted potential-carcinogen not-for-hair-dye synthetic-colorant eu_children_restricted eu_banned_cosmetics fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is CI 16185 safe in cosmetics?

EU-restricted red azo dye with limitations excluding use in hair dye products and near mucous membranes; banned in the US since 1976 due to carcinogenicity concerns in animal studies. The EU classifies CI 16185 as "restricted". Safety rating: MODERATE. 5 toxicological study endpoint(s) are available in our database.

Is CI 16185 allowed in the EU?

CI 16185 EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 16185 do in cosmetics?

CI 16185 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 915-67-3.

What is the Margin of Safety for CI 16185?

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 16185?

The NOAEL (No Observed Adverse Effect Level) for CI 16185 is 47 mg/kg bw/day based on a oral study via oral route in rat. A total of 5 study endpoints are available. Source: REACH.

Compliance Tools

Check CI 16185 compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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