Moderate Cosmetic Ingredient NOAEL Data

CI 40215

CAS Number
1325-54-8
Function
Colorant
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
๐Ÿ‡บ๐Ÿ‡ธ US Status prohibited
US Notes Not listed as FDA-certified color additive for US cosmetics; not in 21 CFR Part 74 or 82

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

1 study endpoint found for CI 40215. 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 300 mg/kg bw/day oral rat oral REACH

Expert Verdict

CI 40215 (Direct Orange 39) is restricted to rinse-off cosmetics only in the EU under Annex IV; not FDA-approved for US cosmetics; low concern in rinse-off applications due to minimal exposure but prohibited for leave-on use; moderate concern if used outside rinse-off designation

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Concern Level: Moderate

Regulatory Flags

direct-dye eu-annex-iv-restricted rinse-off-only not-fda-approved direct-orange-39

Frequently Asked Questions

Is CI 40215 safe in cosmetics?

CI 40215 (Direct Orange 39) is restricted to rinse-off cosmetics only in the EU under Annex IV; not FDA-approved for US cosmetics; low concern in rinse-off applications due to minimal exposure but prohibited for leave-on use; moderate concern if used outside rinse-off designation The EU classifies CI 40215 as "restricted". Safety rating: MODERATE. 1 toxicological study endpoint(s) are available in our database.

Is CI 40215 allowed in the EU?

CI 40215 EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 40215 do in cosmetics?

CI 40215 functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 1325-54-8.

What is the Margin of Safety for CI 40215?

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 40215?

The NOAEL (No Observed Adverse Effect Level) for CI 40215 is 300 mg/kg bw/day based on a oral study via oral route in rat. Source: REACH.

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