Good Cosmetic Ingredient NOAEL Data

CI 40850

CAS Number
514-78-3
Function
Colorant (orange carotenoid pigment)
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status restricted
US Notes Not FDA-listed as a color additive for cosmetics

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for CI 40850. 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 313 mg/kg bw/day oral dog Subchronic COSMOS_DB
NOAEL 3000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 50 mg/kg bw/day oral dog Subchronic COSMOS_DB
NOAEL 313 mg/kg bw/day oral dog Short Term Toxicity COSMOS_DB
NOAEL 140 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 30 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 5 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 12.5 mg/kg bw/day oral mouse Subchronic COSMOS_DB
NOAEL 45 mg/kg bw/day oral mouse Special Toxicology Study COSMOS_DB
NOAEL 1000 mg/kg bw/day oral monkey Subchronic COSMOS_DB

Expert Verdict

Permitted in EU as a colorant with negligible absorption and no sensitization risk; not FDA-approved for cosmetic use in the US due to lack of color additive listing, though oral toxicity concerns are not relevant to topical cosmetic applications.

⚠️
Concern Level: Low

Regulatory Flags

colorant fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is CI 40850 safe in cosmetics?

Permitted in EU as a colorant with negligible absorption and no sensitization risk; not FDA-approved for cosmetic use in the US due to lack of color additive listing, though oral toxicity concerns are not relevant to topical cosmetic applications. The EU classifies CI 40850 as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is CI 40850 allowed in the EU?

CI 40850 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 40850 do in cosmetics?

CI 40850 functions as: Colorant (orange carotenoid pigment). It is classified as a cosmetic ingredient in our database. CAS number: 514-78-3.

What is the Margin of Safety for CI 40850?

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 CI 40850?

The NOAEL (No Observed Adverse Effect Level) for CI 40850 is 313 mg/kg bw/day based on a Subchronic study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check CI 40850 compliance across multiple jurisdictions:

🔬
Ingredient Decoder
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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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