Good Cosmetic Ingredient NOAEL Data Sensitization Data Dermal Penetration

Carmine (CI 75470)

CAS Number
1390-65-4
Function
Deodorizer; Dye; Flavouring and nutrient
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for Carmine (CI 75470). 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 500 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Developmental COSMOS_DB
dose_tested 500 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
dose_tested 1000 mg/kg bw/day oral rat Developmental COSMOS_DB

Sensitization Profile

Contact sensitization data for Carmine (CI 75470) based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
dye
EU Allergen Listed
no
Patch Test Positive Rate
0.3%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: IVDK; NACDG

Dermal Penetration Profile

Skin absorption and penetration characteristics of Carmine (CI 75470), relevant to systemic exposure and MoS calculations.

Absorption %
0.1-0.5%
Penetration Level
surface
Penetration Depth
surface only
Molecular Weight
Variable Da
Log P
n/a
Systemic Absorption
minimal
Topical Bioavailability
0.05-0.2%
Safety Margin Factor
minimal
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: CIR

Expert Verdict

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Concern Level: Low

Regulatory Flags

fda_food_additive

Frequently Asked Questions

Is Carmine (CI 75470) safe in cosmetics?

Carmine (CI 75470) has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 5 toxicological study endpoint(s) are available in our database.

Is Carmine (CI 75470) allowed in the EU?

Carmine (CI 75470) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Carmine (CI 75470) do in cosmetics?

Carmine (CI 75470) functions as: Deodorizer; Dye; Flavouring and nutrient. It is classified as a Cosmetic Ingredient in our database. CAS number: 1390-65-4.

What is the Margin of Safety for Carmine (CI 75470)?

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 Carmine (CI 75470)?

The NOAEL (No Observed Adverse Effect Level) for Carmine (CI 75470) is 500 mg/kg bw/day based on a Carcinogenicity study via oral route in rat. A total of 5 study endpoints are available. Source: COSMOS_DB.

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