Good Cosmetic Ingredient NOAEL Data

CI 73015

CAS Number

860-22-0

Function

Colorant

Safety Rating

GOOD

Regulatory Status

🇪🇺 EU Status permitted

🇺🇸 US Status permitted

US Notes FDA permanently listed as FD&C Blue No. 2 (21 CFR 74.102, 74.1102, 74.3102, 82.102); permitted for foods, ingested drugs, and cosmetics generally; batch certification required; cannot be used in the eye area unless explicitly specified; also permitted in nylon surgical sutures (NTE 1%) and bone cement aluminum lake (NTE 0.1%)

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

Safety Data

Margin of Safety (MoS)

not established

Dermal Absorption

low

Sensitization

low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for CI 73015. 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	rat	Developmental	COSMOS_DB
NOAEL	250 mg/kg bw/day	oral	rabbit	Developmental	COSMOS_DB
NOAEL	2500 mg/kg bw/day	oral	rat	Chronic	COSMOS_DB
NOAEL	2400 mg/kg bw/day	oral	mouse	Chronic	COSMOS_DB
NOAEL	250 mg/kg bw/day	oral	rat	Multigeneration Reproductive	COSMOS_DB
NOAEL	250 mg/kg bw/day	oral	rat	Reproductive-developmental	COSMOS_DB
NOAEL	250 mg/kg bw/day	oral	rabbit	Developmental	COSMOS_DB
NOAEL	250 mg/kg bw/day	oral	rat	Developmental	COSMOS_DB
NOAEL	1350 mg/kg bw/day	oral	swine	Subchronic	COSMOS_DB
NOAEL	7500 mg/kg bw/day	oral	mouse	Chronic	COSMOS_DB

Expert Verdict

⚠️

Concern Level: Low

Regulatory Flags

fda-certified water-soluble not-for-eye-area eu-annex-iv food-grade-also fda_food_additive

Frequently Asked Questions

Is CI 73015 safe in cosmetics?

Indigo Carmine blue dye (FD&C Blue No. 2; CAS 860-22-0); EU-permitted colorant; FDA permanently listed for foods, ingested drugs, and cosmetics; water-soluble with good safety profile; restricted from eye area; batch certification required in the US; widely used with well-established safety record The EU classifies CI 73015 as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is CI 73015 allowed in the EU?

CI 73015 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 73015 do in cosmetics?

CI 73015 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 860-22-0.

What is the Margin of Safety for CI 73015?

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 73015?

The NOAEL (No Observed Adverse Effect Level) for CI 73015 is 250 mg/kg bw/day based on a Developmental study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check CI 73015 compliance across multiple jurisdictions:

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Ingredient Decoder

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82 Allergen Checker

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Substance Compliance

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MoS Calculator

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Heavy Metal Limits

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