Moderate Cosmetic Ingredient NOAEL Data

CI 69825

CAS Number
130-20-1
Function
Colorant
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status restricted
🇺🇸 US Status restricted
US Notes FDA permanently listed as D&C Blue No. 9 (21 CFR 73.3119 / 74.1109) for use in surgical sutures (cotton and silk) only, NTE 2.5%; not approved for general cosmetic use; EU Annex IV listing details limited in public sources

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

2 study endpoints found for CI 69825. 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 oral REACH
NOAEL >=1000 mg/kg bw/day oral - oral REACH

Expert Verdict

Indanthrone Blue vat dye (Pigment Blue 64; D&C Blue No. 9); FDA approval limited to surgical sutures only, not cleared for general cosmetic use; EU Annex IV entry not fully confirmed in accessible CosIng data; regulatory verification essential before formulation

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Concern Level: Moderate

Regulatory Flags

not-for-general-cosmetics fda-device-sutures-only vat-dye regulatory-verification-needed limited-cosmetic-data eu_cosing_listed

Frequently Asked Questions

Is CI 69825 safe in cosmetics?

Indanthrone Blue vat dye (Pigment Blue 64; D&C Blue No. 9); FDA approval limited to surgical sutures only, not cleared for general cosmetic use; EU Annex IV entry not fully confirmed in accessible CosIng data; regulatory verification essential before formulation The EU classifies CI 69825 as "restricted". Safety rating: MODERATE. 2 toxicological study endpoint(s) are available in our database.

Is CI 69825 allowed in the EU?

CI 69825 EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 69825 do in cosmetics?

CI 69825 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 130-20-1.

What is the Margin of Safety for CI 69825?

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 69825?

The NOAEL (No Observed Adverse Effect Level) for CI 69825 is >=1000 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.

Compliance Tools

Check CI 69825 compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
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