Good Cosmetic Ingredient NOAEL Data

CI 18050

CAS Number

3734-67-6

Function

Colorant

Safety Rating

GOOD

Regulatory Status

🇪🇺 EU Status permitted

🇺🇸 US Status restricted

US Notes Not listed as an approved FDA color additive for cosmetics in the US; use would require FDA certification under 21 CFR; classified as Ext. D&C Red No. 11 in some contexts but not currently on FDA permitted list

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

4 study endpoints found for CI 18050. 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	20 mg/kg bw/day	oral	mouse	oral	REACH
LOAEL	50 mg/kg bw/day	oral	rat	oral	REACH
LOAEL	50 mg/kg bw/day	oral	rat	oral	REACH
LOAEL	20 mg/kg bw/day	oral	mouse	oral	REACH

Expert Verdict

EU-permitted red azo dye restricted from lip and eye area application; not clearly listed on FDA approved color additive roster; suitable for rinse-off and non-mucous-membrane EU products only

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Concern Level: Moderate

Regulatory Flags

azo-dye eu-permitted mucous-membrane-restriction not-fda-approved synthetic-colorant allergen-potential ifra_fragrance eu_cosing_listed

Frequently Asked Questions

Is CI 18050 safe in cosmetics?

EU-permitted red azo dye restricted from lip and eye area application; not clearly listed on FDA approved color additive roster; suitable for rinse-off and non-mucous-membrane EU products only The EU classifies CI 18050 as "permitted". Safety rating: GOOD. 4 toxicological study endpoint(s) are available in our database.

Is CI 18050 allowed in the EU?

CI 18050 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 18050 do in cosmetics?

CI 18050 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 3734-67-6.

What is the Margin of Safety for CI 18050?

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 18050?

The NOAEL (No Observed Adverse Effect Level) for CI 18050 is 20 mg/kg bw/day based on a oral study via oral route in mouse. A total of 4 study endpoints are available. Source: REACH.

Compliance Tools

Check CI 18050 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

Check compliance across 55 jurisdictions

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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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