CI 40215
Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
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
Regulatory Flags
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.
Compliance Tools
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Related Ingredients
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