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 15510 (D&C Orange No. 4 / Acid Orange 7). 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 |
|---|---|---|---|---|---|
| LOAEL | 2.5 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
Expert Verdict
CI 15510 (D&C Orange No. 4) is EU Annex IV listed with a restriction prohibiting use in eye area products and in the US is permanently listed under 21 CFR 74.2254 for externally applied cosmetics only with mandatory FDA batch certification required, with regulatory restrictions well aligned between both regions and low concern outside the eye area.
Regulatory Flags
Frequently Asked Questions
Is CI 15510 (D&C Orange No. 4 / Acid Orange 7) safe in cosmetics?
CI 15510 (D&C Orange No. 4) is EU Annex IV listed with a restriction prohibiting use in eye area products and in the US is permanently listed under 21 CFR 74.2254 for externally applied cosmetics only with mandatory FDA batch certification required, with regulatory restrictions well aligned between both regions and low concern outside the eye area. The EU classifies CI 15510 (D&C Orange No. 4 / Acid Orange 7) as "restricted". Safety rating: GOOD. 1 toxicological study endpoint(s) are available in our database.
Is CI 15510 (D&C Orange No. 4 / Acid Orange 7) allowed in the EU?
CI 15510 (D&C Orange No. 4 / Acid Orange 7) EU regulatory status: restricted. Maximum allowed concentration: Not to be used in eye products. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 15510 (D&C Orange No. 4 / Acid Orange 7) do in cosmetics?
CI 15510 (D&C Orange No. 4 / Acid Orange 7) functions as: Colorant. Synthetic monoazo orange dye (Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate and its insoluble barium, strontium, and zirconium lakes, salts and pigments), also known as D&C Orange No. 4, Acid Orange 7, and Orange II. Water-soluble sodium salt or insoluble lake form. Widely used in cosmetics, hair dyes, and personal care products to impart an orange color.. It is classified as a cosmetic ingredient in our database. CAS number: 633-96-5.
What is the Margin of Safety for CI 15510 (D&C Orange No. 4 / Acid Orange 7)?
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 15510 (D&C Orange No. 4 / Acid Orange 7)?
The NOAEL (No Observed Adverse Effect Level) for CI 15510 (D&C Orange No. 4 / Acid Orange 7) is 2.5 mg/kg bw/day based on a Subchronic study via oral route in rat. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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