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
2 study endpoints found for CI 15880 (D&C Red No. 34 / Pigment Red 63:1). 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 | >=0.3 other | oral | rat | oral | REACH |
| NOAEL | >=0.3 other | oral | - | oral | REACH |
Expert Verdict
CI 15880 (D&C Red No. 34) is restricted in the EU as prohibited in hair dye products under Annex II entry 1349 but permitted in other external applications including nail polish. In the US, it is FDA-listed under 21 CFR 74.2334 for externally applied cosmetics with mandatory batch certification, excluding use near eyes or lips. Safety profile is favorable with low sensitization potential and negligible systemic absorption due to its insoluble pigment nature.
Regulatory Flags
Frequently Asked Questions
Is CI 15880 (D&C Red No. 34 / Pigment Red 63:1) safe in cosmetics?
CI 15880 (D&C Red No. 34) is restricted in the EU as prohibited in hair dye products under Annex II entry 1349 but permitted in other external applications including nail polish. In the US, it is FDA-listed under 21 CFR 74.2334 for externally applied cosmetics with mandatory batch certification, excluding use near eyes or lips. Safety profile is favorable with low sensitization potential and negligible systemic absorption due to its insoluble pigment nature. The EU classifies CI 15880 (D&C Red No. 34 / Pigment Red 63:1) as "restricted". Safety rating: GOOD. 2 toxicological study endpoint(s) are available in our database.
Is CI 15880 (D&C Red No. 34 / Pigment Red 63:1) allowed in the EU?
CI 15880 (D&C Red No. 34 / Pigment Red 63:1) EU regulatory status: restricted. Maximum allowed concentration: Not permitted in hair dye products (EU Annex II/1349). This is based on EU Regulation 1223/2009 and its amendments.
What does CI 15880 (D&C Red No. 34 / Pigment Red 63:1) do in cosmetics?
CI 15880 (D&C Red No. 34 / Pigment Red 63:1) functions as: Colorant. Synthetic azo pigment (Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate), also known as D&C Red No. 34, Pigment Red 63, and Pigment Red 63:1. Insoluble calcium lake pigment providing a red hue. Used predominantly in nail polish, nail lacquers, and other externally applied cosmetics. Prohibited for use in hair dye products in the EU under Annex II.. It is classified as a cosmetic ingredient in our database. CAS number: 6417-83-0.
What is the Margin of Safety for CI 15880 (D&C Red No. 34 / Pigment Red 63:1)?
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 15880 (D&C Red No. 34 / Pigment Red 63:1)?
The NOAEL (No Observed Adverse Effect Level) for CI 15880 (D&C Red No. 34 / Pigment Red 63:1) is >=0.3 other based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.
Compliance Tools
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