Moderate Cosmetic Ingredient NOAEL Data

HC Orange No. 3

INCI: HC ORANGE NO. 3

HC Orange No. 3 (CAS 81612-54-6) is a cosmetic cosmetic ingredient functioning as Hair dyeing — semi-permanent direct dye (orange). Reported NOAEL =100 mg/kg bw/day in rat (SCCNFP_vision_codex); EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database.

View industrial chemical safety profile for CAS 81612-54-6 →

Auto-generated CPSR Part A draft with source citations
Function
Hair dyeing — semi-permanent direct dye (orange)
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C11H16N2O6
MW
272.25 g/mol
PubChem CID
21909542
IUPAC Name
3-[4-(2-hydroxyethylamino)-3-nitrophenoxy]propane-1,2-diol
InChIKey
SZWQTBKBBNGUAB-UHFFFAOYSA-N

Regulatory Status

EU EU Status prohibited
US US Status permitted
US Notes Permitted under coal-tar hair dye exemption (FD&C Act §601(a))

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for HC Orange No. 3.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

8 study endpoints found for HC Orange No. 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 =100 mg/kg bw/day - rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =100 mg/kg bw/day - rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =100 mg/kg bw/day - rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =100 mg/kg bw/day - rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =300 mg/kg bw/day - rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =300 mg/kg bw/day - rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =300 mg/kg bw/day - rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =300 mg/kg bw/day - rat repeated dose toxicity SCCNFP_vision_codex

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex II — Prohibited
Ref: 1237
(EC) 2009/1223

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 (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 1237
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
KR prohibited - -

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 HC Orange No. 3.

Regulatory Flags

eu_banned_cosmetics eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to HC Orange No. 3 by CAS number or substance name.

Studies
8
Lowest NOAEL
100 mg/kg bw/day
Highest NOAEL
300 mg/kg bw/day
SCCNFP_vision_codex

Chemical Function

Dye

Regulatory Lists

banned; Europe; Personal care

Frequently Asked Questions

Is HC Orange No. 3 safe in cosmetics?

HC Orange No. 3 has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: permitted. 8 toxicological study endpoint(s) are available in our database.

Is HC Orange No. 3 allowed in the EU?

HC Orange No. 3 EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does HC Orange No. 3 do in cosmetics?

HC Orange No. 3 functions as: Hair dyeing — semi-permanent direct dye (orange). It is classified as a cosmetic ingredient in our database. CAS number: 81612-54-6.

What is the NOAEL for HC Orange No. 3?

The NOAEL (No Observed Adverse Effect Level) for HC Orange No. 3 is =100 mg/kg bw/day based on a repeated dose toxicity study via oral route in rat. A total of 8 study endpoints are available. Source: SCCNFP_vision_codex.

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