Good Colorant NOAEL Data

FD&C Blue No. 1

INCI: FD&C BLUE NO. 1

CAS Number
3844-45-9
Function
colorant
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
EU Max Conc. 0.5% (hair dye); permitted for lip products per EU Cosmetics Regulation Annex IV
🇺🇸 US Status permitted
US Notes Batch certification mandatory under 21 CFR 74.2101 and Part 80. Approved for all cosmetics at GMP levels. Also listed under 21 CFR 74.101 (food) and 74.1101 (drugs). Permanently listed since 1969.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for FD&C Blue No. 1. 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

FD&C Blue No. 1 is a permitted colorant in both EU (Annex IV, max 0.5% for hair dyes) and US (21 CFR 74.2101 with required batch certification) with good safety profile, low absorption, and no sensitization risk.

⚠️
Concern Level: Low

Regulatory Flags

batch-certification-required annex-iv-permitted low-dermal-absorption triphenylmethane-dye hair-dye-max-0.5-pct sccnfp-assessed e133-food-approved color-additive eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is FD&C Blue No. 1 safe in cosmetics?

FD&C Blue No. 1 is a permitted colorant in both EU (Annex IV, max 0.5% for hair dyes) and US (21 CFR 74.2101 with required batch certification) with good safety profile, low absorption, and no sensitization risk. The EU classifies FD&C Blue No. 1 as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is FD&C Blue No. 1 allowed in the EU?

FD&C Blue No. 1 EU regulatory status: permitted. Maximum allowed concentration: 0.5% (hair dye); permitted for lip products per EU Cosmetics Regulation Annex IV. This is based on EU Regulation 1223/2009 and its amendments.

What does FD&C Blue No. 1 do in cosmetics?

FD&C Blue No. 1 functions as: colorant. It is classified as a Colorant in our database. CAS number: 3844-45-9.

What is the Margin of Safety for FD&C Blue No. 1?

adequate 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?

The NOAEL (No Observed Adverse Effect Level) for FD&C Blue No. 1 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 compliance across multiple jurisdictions:

🔬
Ingredient Decoder
Paste a full ingredient list for instant analysis
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82 Allergen Checker
Check for EU declarable fragrance allergens
 🧪
Substance Compliance
Check compliance across 55 jurisdictions
 🧮
MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

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