Poor Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed

Acid Orange 3

Also known as: Acid Fast Yellow E5R, Acid Leather Light Brown G, 2-Anilino-5-(2,4-dinitroanilino)benzenesulfonic acid sodium salt, Coranil Brown H EPS, Dimacide Yellow N-5RL (+15 more)

INCI: ACID ORANGE 3

Acid Orange 3 (CAS 6373-74-6) is a cosmetic cosmetic ingredient functioning as Hair Dyeing. Reported NOAEL =1000 mg/kg bw/day in Mouse (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: prohibited; 1 safety opinion reviewed (cir). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 6373-74-6 →

Auto-generated CPSR Part A draft with source citations
Function
Hair Dyeing
Safety Rating
POOR

Chemistry & Identifiers

Formula
C18H13N4NaO7S
MW
452.4 g/mol
EC Number
228-921-5
PubChem CID
5284435
IUPAC Name
sodium 2-anilino-5-(2,4-dinitroanilino)benzenesulfonate
InChIKey
KKBFCPLWFWQNFB-UHFFFAOYSA-M

Regulatory Status

EU EU Status prohibited
US US Status prohibited
US Notes Not FDA-approved; not listed for cosmetic use

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Acid Orange 3.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Acid Orange 3. 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 =1000 mg/kg bw/day oral Mouse short-term ToxValDB_ECHA_IUCLID
NOAEL =1500 mg/kg bw/day oral Rat short-term ToxValDB_ECHA_IUCLID

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir 3 February 2000
Verdict: safe

ion can avoid significant exposure. Accordingly, the Expert Panel concluded that Acid Orange 3 is safe for use in hair dye formulations at concentrations less than or equal to 0.2%. INTRODUCTION Acid Orange 3 is a nitro color that functions as a hair colorant in hair dyes and colors (Wenninger, C

IARC Carcinogenicity

International Agency for Research on Cancer (WHO) monograph evaluation.

IARC Group
3
Volume
57
Evaluation Year
1992

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

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.

Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
KR prohibited - -

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (2)
Carcinogen Classification
C.I. Acid Orange 3 | TR-335: Toxicology and Carcinogenesis Studies of C.I. Acid Orange 3 (CASRN 6373-74-6) in F344/N Rats and B6C3F1 Mice (Gavage Studies) (1988 ) | 07/14/87 | No Evidence | Clear Evidence | No Evidence | No Evidence | Under the conditions of these 2-year gavage studies, there was no evidence of carcinogenic activity of C.I. Acid Orange 3 for male F344/N rats administered
Source: NTP Technical Reports
Evidence for Carcinogenicity
Evaluation: There is inadequate evidence in humans for the carcinogenicity of CI Acid Orange 3. There is limited evidence in experimental animals for the carcinogenicity of CI Acid Orange 3. Overall evaluation: CI Acid Orange 3 is not classifiable as to its carcinogenicity to humans (Group 3).
Source: Hazardous Substances Data Bank (HSDB)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (2)
EU Banned in Cosmetics EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Acid Orange 3.

Regulatory Flags

potential-allergen eu_banned_cosmetics eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Acid Orange 3 by CAS number or substance name.

Studies
2
Lowest NOAEL
1000 mg/kg bw/day
Highest NOAEL
1500 mg/kg bw/day
ToxValDB_ECHA_IUCLID

Known Synonyms

Acid Fast Yellow E5R Acid Leather Light Brown G 2-Anilino-5-(2,4-dinitroanilino)benzenesulfonic acid sodium salt Coranil Brown H EPS Dimacide Yellow N-5RL 5-((2,4-Dinitrophenyl)amino)-2-(phenylamino)benzenesulfonic acid monosodium salt Duasyn Acid Yellow RRT EINECS 228-921-5 Elbenyl Orange A-3RD Erio Yellow AEN Heliacid Light Yellow 4R Intranyl Orange T-4R Lanaperl Yellow Brown GT Nailamide Yellow Brown E-L NCI-C54911 Nylocrom Yellow 3R Nylosan Yellow E-3R Polan Yellow E-3R Sellacid Yellow AEN Solanile Yellow E

Chemical Function

Dye

Regulatory Lists

banned; Europe; Personal care

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

ChEMBL ID
CHEMBL3181851
View full pharmaceutical profile →

Frequently Asked Questions

Is Acid Orange 3 safe in cosmetics?

Acid Orange 3 has a safety rating of "POOR" in our database. EU status: prohibited. US status: prohibited. 2 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Acid Orange 3 allowed in the EU?

Acid Orange 3 EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Acid Orange 3 do in cosmetics?

Acid Orange 3 functions as: Hair Dyeing. It is classified as a cosmetic ingredient in our database. CAS number: 6373-74-6.

What is the NOAEL for Acid Orange 3?

The NOAEL (No Observed Adverse Effect Level) for Acid Orange 3 is =1000 mg/kg bw/day based on a short-term study via oral route in Mouse. A total of 2 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.

Is Acid Orange 3 used outside cosmetics?

Acid Orange 3 also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does Acid Orange 3 have different safety status in cosmetics vs industrial chemicals?

Acid Orange 3 is prohibited in EU cosmetics but has active industrial GHS classifications (H315, H317, H318, H319, H335).

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