Good Cosmetic Ingredient NOAEL Data

FD&C Blue No. 1 (CI 42090)

INCI: FD&C BLUE NO. 1

CAS Number

3844-45-9

Function

Solvent

Safety Rating

GOOD

Regulatory Status

🇪🇺 EU Status permitted

🇺🇸 US Status permitted

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

Safety Data

Margin of Safety (MoS)

not established

Dermal Absorption

negligible

Sensitization

none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for FD&C Blue No. 1 (CI 42090). 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	1000 mg/kg bw/day	oral	rat	Multigeneration Reproductive	COSMOS_DB
NOAEL	2000 mg/kg bw/day	oral	rat	Reproductive-developmental	COSMOS_DB
NOAEL	1000 mg/kg bw/day	oral	rat	Chronic	COSMOS_DB
NOAEL	1000 mg/kg bw/day	oral	rat	Carcinogenicity	COSMOS_DB
NOAEL	250 mg/kg bw/day	oral	mouse	Carcinogenicity	COSMOS_DB
NOAEL	1500 mg/kg bw/day	oral	rat	Chronic	COSMOS_DB
NOAEL	200 mg/kg bw/day	oral	rabbit	Developmental	COSMOS_DB
NOAEL	2500 mg/kg bw/day	oral	rat	Chronic	COSMOS_DB
NOAEL	1000 mg/kg bw/day	oral	dog	Chronic	COSMOS_DB
NOAEL	2000 mg/kg bw/day	oral	rat	Reproductive	COSMOS_DB

Expert Verdict

Good safety profile with negligible systemic absorption; generally considered safe for cosmetic use.

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Concern Level: Low

Regulatory Flags

eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is FD&C Blue No. 1 (CI 42090) safe in cosmetics?

Good safety profile with negligible systemic absorption; generally considered safe for cosmetic use. The EU classifies FD&C Blue No. 1 (CI 42090) as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is FD&C Blue No. 1 (CI 42090) allowed in the EU?

FD&C Blue No. 1 (CI 42090) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does FD&C Blue No. 1 (CI 42090) do in cosmetics?

FD&C Blue No. 1 (CI 42090) functions as: Solvent. It is classified as a Cosmetic Ingredient in our database. CAS number: 3844-45-9.

What is the Margin of Safety for FD&C Blue No. 1 (CI 42090)?

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 FD&C Blue No. 1 (CI 42090)?

The NOAEL (No Observed Adverse Effect Level) for FD&C Blue No. 1 (CI 42090) is 1000 mg/kg bw/day based on a Multigeneration Reproductive study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check FD&C Blue No. 1 (CI 42090) 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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