Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

HC Orange No. 1

Also known as: EINECS 259-132-4, UNII-Z92U49184U

INCI: HC ORANGE NO. 1

HC Orange No. 1 (CAS 54381-08-7) is a cosmetic cosmetic ingredient functioning as Hair dyeing — semi-permanent direct dye (orange). Reported NOAEL =0.024 mg/kg bw in rat (SCCS Opinion); EU Regulation 1223/2009 status: prohibited, max 1.0%; 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.

View industrial chemical safety profile for CAS 54381-08-7 →

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

Chemistry & Identifiers

Formula
C12H10N2O3
MW
230.22 g/mol
PubChem CID
3846708
IUPAC Name
4-(2-nitroanilino)phenol
InChIKey
HSDSBIUUVWRHTM-UHFFFAOYSA-N

Regulatory Status

EU EU Status prohibited
EU Max Conc. 1.0%
US US Status permitted
US Notes Permitted under coal-tar hair dye exemption; CIR concluded safe at ≤3.0%

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. 1.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for HC Orange No. 1. 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 =0.024 mg/kg bw oral rat dermal absorption SCCS Opinion
NOAEL =0.024 mg/kg bw oral rat dermal absorption SCCS Opinion
NOAEL =0.024 mg/kg bw oral rat dermal absorption SCCS Opinion
NOAEL =0.024 mg/kg bw oral rat dermal absorption SCCS Opinion
NOAEL =25 mg/kg bw/d - - carcinogenicity SCCS Opinion
NOAEL =25 mg/kg bw oral rat dermal absorption SCCS Opinion
NOAEL =25 mg/kg bw/d - - carcinogenicity SCCS Opinion
NOAEL =25 mg/kg bw oral rat dermal absorption SCCS Opinion
NOAEL =25 mg/kg bw/d - - carcinogenicity SCCS Opinion
NOAEL =25 mg/kg bw oral rat dermal absorption SCCS Opinion

Safety Opinions

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

CIR Safety Assessment
Verdict: safe

d, the Expert Panel was reques- ted to consider a conclusion that this ingredient is safe for use in hair dyes at concentrations of at least 1% (Clairol 1996). In support of this position, the comment analyzed the possible human exposure levels that took into consideration the concentrati

Sensitization Profile

Contact sensitization data for HC Orange No. 1 based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
dye
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
para-amino-group
Reaction Type
contact-dermatitis

Source: SCCS; IVDK

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 day substance in non-oxidative hair dye products. Max: 0.01.
BRIN Brazil/India Cosmetics
India: Restricted · max 0.01
Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
CN permitted_hair_dye 1 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_sccs_opinion 1.03% - - SCCP/1164/08

Additional Ingredient Properties

2 property records from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "dye", "cross_reactivity_group": "para-amino-group", "patch_test_frequency_pct": "0.2", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "SCCS; IVDK"}
hair_dye
{"cas_number": "54381-08-7", "ingredient_class": "direct_dye", "chemical_class": "nitro", "molecular_weight_Da": "242.23", "color_result_on_hair": "Orange", "shade_range": "red", "primary_function": "direct_deposit", "requires_developer": "no", "lift_capability_levels": "0", "deposit_only": "yes", "permanence": "semi_permanent", "wash_fastness_shampoos": "6-12", "light_fastness": "moderate", "heat…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (1)
EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for HC Orange No. 1.

Regulatory Flags

eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to HC Orange No. 1 by CAS number or substance name.

Studies
32
Lowest NOAEL
0.024
Highest NOAEL
750

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

SCCS Opinion

Dermal Absorption

View details ->
Absorption % Method Vehicle
1.03% SCCS opinion extraction -

Known Synonyms

EINECS 259-132-4 UNII-Z92U49184U

Chemical Function

Dye

Regulatory Lists

Europe; Personal care; restricted

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
CHEMBL1339868
View full pharmaceutical profile →

Frequently Asked Questions

Is HC Orange No. 1 safe in cosmetics?

HC Orange No. 1 has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by CIR Safety Assessment.

Is HC Orange No. 1 allowed in the EU?

HC Orange No. 1 EU regulatory status: prohibited. Maximum allowed concentration: 1.0%. This is based on EU Regulation 1223/2009 and its amendments.

What does HC Orange No. 1 do in cosmetics?

HC Orange No. 1 functions as: Hair dyeing — semi-permanent direct dye (orange). It is classified as a cosmetic ingredient in our database. CAS number: 54381-08-7.

What is the NOAEL for HC Orange No. 1?

The NOAEL (No Observed Adverse Effect Level) for HC Orange No. 1 is =0.024 mg/kg bw based on a dermal absorption study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS Opinion.

Is HC Orange No. 1 used outside cosmetics?

HC Orange No. 1 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 HC Orange No. 1 have different safety status in cosmetics vs industrial chemicals?

HC Orange No. 1 is prohibited in EU cosmetics at max 1.0% but has active industrial GHS classifications (H312, H315, H319, H332, H335, H400, H411).

Is HC Orange No. 1 in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for HC Orange No. 1 in your formulation.