Moderate Cosmetic Ingredient NOAEL Data

Basic Orange 31

INCI: BASIC ORANGE 31

Basic Orange 31 (CAS 97404-02-9) is a cosmetic cosmetic ingredient functioning as Hair Dyeing (semi-permanent / direct dye). Reported NOAEL =15 mg/kg in rat (SCCNFP_vision_codex); EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.

View industrial chemical safety profile for CAS 97404-02-9 →

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

Chemistry & Identifiers

EC Number
306-764-4

Regulatory Status

EU EU Status prohibited
US US Status restricted
US Notes Not an approved color additive; usable under coal-tar hair dye exemption with caution statement

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Basic Orange 31.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Basic Orange 31. 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 =15 mg/kg dermal rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =15 mg/kg dermal rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =15 mg/kg dermal rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =15 mg/kg dermal rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =18 mg/kg dermal rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =18 mg/kg bw/day oral - repeated dose toxicity SCCNFP_vision_codex
NOAEL =18 mg/kg dermal rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =18 mg/kg bw/day oral - repeated dose toxicity SCCNFP_vision_codex
NOAEL =18 mg/kg dermal rat repeated dose toxicity SCCNFP_vision_codex
NOAEL =18 mg/kg bw/day oral - repeated dose toxicity SCCNFP_vision_codex

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
1 - 10 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.

KR Korea MFDS Annex 2 (Restricted)
Category: Restricted. Max: 산화염모제에 0.5%. 그 외 사용기준은 「화장품의 색소종류와 기준 및 시험방법」에 따름
SA Saudi SFDA (III - Restricted)
Product type: (a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products. Max: (b) 1,0 %.
BRIN Brazil/India Cosmetics
India: Restricted · max (b) 1,0 %
Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
CN permitted_hair_dye 0.5 Non-oxidative hair dye

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (1 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured 0.06% - - SCCS/0082

Additional Ingredient Properties

1 property record from structured ingredient metadata.

hair_dye
{"cas_number": "97404-02-9", "ingredient_class": "direct_dye", "chemical_class": "azo", "color_result_on_hair": "Orange", "shade_range": "red", "primary_function": "direct_deposit", "requires_developer": "no", "deposit_only": "yes", "permanence": "semi_permanent", "wash_fastness_shampoos": "8-15", "light_fastness": "moderate", "oxidation_mechanism": "direct_absorption", "hair_penetration_depth": "…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (2)
EU Restricted for Children (Cosmetics) EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Basic Orange 31.

Regulatory Flags

eu_children_restricted eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Basic Orange 31 by CAS number or substance name.

Studies
60
Lowest NOAEL
0.0011
Highest NOAEL
60

Units vary across source rows: mg/kg bw/day, mg/kg bw, mg/kg

SCCS_vision_codex SCCNFP_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
0.06% - -

Chemical Function

Dye

Regulatory Lists

children; Europe; Personal care Europe; Personal care - hair coloring Europe; Personal care - hair coloring Europe; Personal care - hair coloring Europe; Personal care; restricted

Australian Status

AICIS status: listed_with_terms

Specific information requirements: Obligations to provide information apply. These obligations are: 1. A person introducing this chemical must tell us in writing within 28 calendar days if any of the following circumstances have occurred in relation to their introduction (importation or manufacture): a. the introduction volume of the chemical exceeds 1...

Frequently Asked Questions

Is Basic Orange 31 safe in cosmetics?

Basic Orange 31 has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: restricted. 10 toxicological study endpoint(s) are available in our database.

Is Basic Orange 31 allowed in the EU?

Basic Orange 31 EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Basic Orange 31 do in cosmetics?

Basic Orange 31 functions as: Hair Dyeing (semi-permanent / direct dye). It is classified as a cosmetic ingredient in our database. CAS number: 97404-02-9.

What is the NOAEL for Basic Orange 31?

The NOAEL (No Observed Adverse Effect Level) for Basic Orange 31 is =15 mg/kg based on a repeated dose toxicity study via dermal route in rat. A total of 10 study endpoints are available. Source: SCCNFP_vision_codex.

Is Basic Orange 31 used outside cosmetics?

Basic Orange 31 also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does Basic Orange 31 have different safety status in cosmetics vs industrial chemicals?

Basic Orange 31 is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H312, H317, H318, H332, H411).

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