Also known as: Acid Orange II, EC No.: 211-199-0, Benzenesulfonic acid, p-(2-hydroxy-1-naphthylazo)-, sodium salt, D&C Orange 4, Acid Leather Orange Extra (+14 more)
INCI: CI 15510
CI 15510 (D&C Orange No. 4 / Acid Orange 7) (CAS 633-96-5) is a cosmetic cosmetic ingredient functioning as Colorant. Synthetic monoazo orange dye (Sodium 4-[(2-hydroxy-1-naphthyl)azo]benz. Reported NOAEL =2.5 mg/kg in rabbit (SCCNFP_vision_codex); EU Regulation 1223/2009 status: restricted, max Not to be used in eye products. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and food safety data.
View industrial chemical safety profile for CAS 633-96-5 →
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Margin of Safety, dermal absorption, and sensitization profile summaries for CI 15510 (D&C Orange No. 4 / Acid Orange 7).
Calculate MoS for your specific formulation with the MoS Calculator.
10 study endpoints 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 |
|---|---|---|---|---|---|
| NOAEL | =2.5 mg/kg | dermal | rabbit | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =2.5 mg/kg | dermal | rabbit | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =2.5 mg/kg | dermal | rabbit | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =2.5 mg/kg | dermal | rabbit | repeated dose toxicity | SCCNFP_vision_codex |
| NOAEL | =5 mg/kg | oral | rat | dermal absorption | SCCNFP_vision_codex |
| NOAEL | =5 mg/kg | oral | rat | dermal absorption | SCCNFP_vision_codex |
| NOAEL | =5 mg/kg | oral | rat | dermal absorption | SCCNFP_vision_codex |
| NOAEL | =5 mg/kg | oral | rat | dermal absorption | SCCNFP_vision_codex |
| NOAEL | =0.83 mg/kg bw/d | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.83 mg/kg bw/d | oral | rat | dermal absorption | SCCS_vision_codex |
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| ASEAN | permitted_colorant | - | All products |
| ASEAN | permitted_colorant | - | All products |
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured | 0.5% | in_vitro | - | SCCS/0057 |
| measured | 0.26% | - | - | SCCS/0057 |
| measured | 0.37% | - | - | SCCS/0057 |
| measured | 0.8% | - | - | SCCS/0158 |
| measured | 0.5% | in_vitro | - | SCCS/0158 |
2 property records from structured ingredient metadata.
Expert safety assessment and concern-level summary for CI 15510 (D&C Orange No. 4 / Acid Orange 7).
Public NOAEL study rows linked to CI 15510 (D&C Orange No. 4 / Acid Orange 7) by CAS number or substance name.
Units vary across source rows: mg/kg bw/d, mg/kg bw/day, mg/kg bw/ day
| Absorption % | Method | Vehicle |
|---|---|---|
| 0.5% | in_vitro | - |
| 0.26% | - | - |
| 0.37% | - | - |
| 0.8% | - | - |
| 0.5% | in_vitro | - |
Same-CAS public records found in food safety data.
Same-CAS food additive or FDA GRAS records from the core public database.
CI 15510 (D&C Orange No. 4 / Acid Orange 7) has a safety rating of "GOOD" in our database. EU status: restricted. US status: restricted. 10 toxicological study endpoint(s) are available in our database.
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.
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.
The NOAEL (No Observed Adverse Effect Level) for CI 15510 (D&C Orange No. 4 / Acid Orange 7) is =2.5 mg/kg based on a repeated dose toxicity study via dermal route in rabbit. A total of 10 study endpoints are available. Source: SCCNFP_vision_codex.
CI 15510 (D&C Orange No. 4 / Acid Orange 7) also appears in industrial chemical safety and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
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