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 (ECHA); EU Regulation 1223/2009 status: prohibited; 1 safety opinion reviewed (CIR Safety Assessment). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
US NotesNot FDA-approved; not listed for cosmetic use
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Acid Orange 3.
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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
ECHA
NOAEL
=1500 mg/kg bw/day
oral
Rat
short-term
ECHA
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
CIR Safety Assessment3 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 CosmeticsEU CosIng Cosmetics Ingredient Database
Editorial summary
Preliminary editorial summary for Acid Orange 3 — not a computed safety verdict. See the sourced toxicological data above.
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 Safety Assessment.
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: ECHA.
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).
Compliance Tools
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