Moderate Cosmetic Ingredient NOAEL Data

Dactylopius Coccus Extract

INCI: CI 75470

CAS Number
1390-65-4
Function
Colorant
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. Permitted colorant under EU Annex IV; must comply with purity specifications; labeling required
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Approved for use in cosmetics generally including eye area per 21 CFR 73.2087; GMP limits apply

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for Dactylopius Coccus Extract. 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

Expert Verdict

Vivid natural red colorant derived from cochineal insects; documented allergen with IgE-mediated reactions including urticaria, asthma, and anaphylaxis; not suitable for vegan formulations; must disclose on label and screen for sensitive populations.

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Concern Level: High

Regulatory Flags

animal-derived not-vegan allergen-risk anaphylaxis-reported annex-iv-colorant insect-derived carmine fda_food_additive

Frequently Asked Questions

Is Dactylopius Coccus Extract safe in cosmetics?

Vivid natural red colorant derived from cochineal insects; documented allergen with IgE-mediated reactions including urticaria, asthma, and anaphylaxis; not suitable for vegan formulations; must disclose on label and screen for sensitive populations. The EU classifies Dactylopius Coccus Extract as "restricted". Safety rating: MODERATE. 5 toxicological study endpoint(s) are available in our database.

Is Dactylopius Coccus Extract allowed in the EU?

Dactylopius Coccus Extract EU regulatory status: restricted. Maximum allowed concentration: Permitted colorant under EU Annex IV; must comply with purity specifications; labeling required. This is based on EU Regulation 1223/2009 and its amendments.

What does Dactylopius Coccus Extract do in cosmetics?

Dactylopius Coccus Extract functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 1390-65-4.

What is the Margin of Safety for Dactylopius Coccus Extract?

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 Dactylopius Coccus Extract?

The NOAEL (No Observed Adverse Effect Level) for Dactylopius Coccus Extract 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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