Is Orange 4 (CI 15510) safe in cosmetics?
Orange 4 (CI 15510) has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Orange 4 (CI 15510)
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
Orange 4 (CI 15510) (CAS 633-96-5) is a cosmetic colorant functioning as Direct (non-reactive) hair colouring agent. Reported NOAEL =2.5 mg/kg in rabbit (SCCNFP Opinion); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
Function
Direct (non-reactive) hair colouring agent
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Chemistry & Identifiers
IUPAC Name
sodium 4-[(2-hydroxynaphthalen-1-yl)diazenyl]benzenesulfonate
InChIKey
CQPFMGBJSMSXLP-UHFFFAOYSA-M
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
No specific restrictions
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Orange 4 (CI 15510).
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Orange 4 (CI 15510). 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 Opinion |
| NOAEL | =2.5 mg/kg | dermal | rabbit | repeated dose toxicity | SCCNFP Opinion |
| NOAEL | =2.5 mg/kg | dermal | rabbit | repeated dose toxicity | SCCNFP Opinion |
| NOAEL | =2.5 mg/kg | dermal | rabbit | repeated dose toxicity | SCCNFP Opinion |
| NOAEL | =5 mg/kg | oral | rat | dermal absorption | SCCNFP Opinion |
| NOAEL | =5 mg/kg | oral | rat | dermal absorption | SCCNFP Opinion |
| NOAEL | =5 mg/kg | oral | rat | dermal absorption | SCCNFP Opinion |
| NOAEL | =5 mg/kg | oral | rat | dermal absorption | SCCNFP Opinion |
| NOAEL | =0.83 mg/kg bw/d | oral | rat | dermal absorption | SCCS Opinion |
| NOAEL | =0.83 mg/kg bw/d | oral | rat | dermal absorption | SCCS Opinion |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex IV — Permitted Colorants
Product type: Orange
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (III - Restricted)
Product type: Hair dye substance in non-oxidative hair dye products.. Max: As from 3 June 2021: 0,5 %..
JPKR Japan/Korea Cosmetics
Korea (Restricted): max 0.1%
BRIN Brazil/India Cosmetics
India: Restricted · max As from 3 June 2021: 0,5 %.
India: Permitted Colorant
Additional Jurisdictional Restrictions (2)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| ASEAN | permitted_colorant | - | All products |
| ASEAN | permitted_colorant | - | All products |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (5 records across 5 sources)
| 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 |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Fragrance
Regulatory List Membership (2)
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
Editorial summary
Preliminary editorial summary for Orange 4 (CI 15510) — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
eu_children_restricted
ifra_fragrance
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Orange 4 (CI 15510) by CAS number or substance name.
Studies
53
Lowest NOAEL
0.83
Highest NOAEL
1000
Units vary across source rows: mg/kg bw/d, mg/kg bw/day, mg/kg bw/ day
SCCS Opinion
SCCNFP Opinion
ECHA
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 0.5% | in_vitro | - |
| 0.26% | - | - |
| 0.37% | - | - |
| 0.8% | - | - |
| 0.5% | in_vitro | - |
Known Synonyms
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
Acid Leather Orange Extra G
Acid Leather Orange Extra PRW
Acid Leather Orange PRW
EINECS 211-199-0
p-((2-Hydroxy-1-naphthyl)azo)benzenesulfonic acid sodium salt
4-((2-Hydroxy-1-naphthyl)azo)benzenesulfonic acid, sodium salt
Kayaku Acid Orange II
Leather Orange Extra
Mitsui Acid Orange II
beta-Naphthyl orange
Nitto Acid Orange II
NSC 101008
NSC 9853
Orange Extra N
Chemical Function
Dye
Fragrance
Regulatory Lists
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
inert_ingredient; non_food_use; Pesticides
IFRA Transparency
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bath salts
children; Europe; Personal care - hair styling and care - shampoo
children; Europe; Personal care
pharmaceutical
Personal care
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
ChEMBL ID
CHEMBL2028473
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Orange GGN
E Number
E111
ADI
DECISION POSTPONED mg/kg bw
Food Category
colorant
Frequently Asked Questions
Is Orange 4 (CI 15510) allowed in the EU?
Orange 4 (CI 15510) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Orange 4 (CI 15510) do in cosmetics?
Orange 4 (CI 15510) functions as: Direct (non-reactive) hair colouring agent. It is classified as a Colorant in our database. CAS number: 633-96-5.
What is the NOAEL for Orange 4 (CI 15510)?
The NOAEL (No Observed Adverse Effect Level) for Orange 4 (CI 15510) 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 Opinion.
Is Orange 4 (CI 15510) used outside cosmetics?
Orange 4 (CI 15510) also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Orange 4 (CI 15510) compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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