Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

HC Red No. 3

Also known as: BRN 2110120, EINECS 220-701-7, NCI-C54922, N(sup 1)-(2-Hydroxyethyl)-2-nitro-p-phenylenediamine, UNII-51CPX7M1SQ (+1 more)

INCI: HC RED NO. 3

HC Red No. 3 (CAS 2871-01-4) is a cosmetic cosmetic ingredient functioning as Non-oxidative (semi-permanent) and oxidative hair dye. NOAEL 200 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited, max 3.0%; 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 2871-01-4 →

Auto-generated CPSR Part A draft with source citations
Function
Non-oxidative (semi-permanent) and oxidative hair dye
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C8H11N3O3
MW
197.19 g/mol
EC Number
220-701-7
PubChem CID
3465817
IUPAC Name
2-(4-amino-2-nitroanilino)ethanol
InChIKey
GZGZVOLBULPDFD-UHFFFAOYSA-N

Regulatory Status

EU EU Status prohibited
EU Max Conc. 3.0%
US US Status permitted
US Notes Permitted under coal tar hair dye exemption (FD&C Act §601(a), 21 CFR 70.3(u)). CIR: safe with conditions.

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 Red No. 3.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for HC Red 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 =0.003 mg/kg bw oral mouse dermal absorption SCCS_vision_codex
NOAEL =0.003 mg/kg bw oral mouse dermal absorption SCCS_vision_codex
NOAEL =0.003 mg/kg bw oral mouse dermal absorption SCCS_vision_codex
NOAEL =0.003 mg/kg bw oral mouse dermal absorption SCCS_vision_codex
NOAEL =0.01 mg/kg bw oral mouse dermal absorption SCCS_vision_codex
NOAEL =0.01 mg/kg bw oral mouse dermal absorption SCCS_vision_codex
NOAEL =0.01 mg/kg bw oral mouse dermal absorption SCCS_vision_codex
NOAEL =0.01 mg/kg bw oral mouse dermal absorption SCCS_vision_codex
NOAEL =0.015 mg/kg bw oral mouse dermal absorption SCCS_vision_codex
NOAEL =0.015 mg/kg bw oral mouse dermal absorption SCCS_vision_codex

Safety Opinions

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

cir
Verdict: unknown

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for HC Red No. 3 across SCCS product categories, with measured dermal absorption where available.

Sensitization Profile

Contact sensitization data for HC Red No. 3 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: IVDK; NACDG; ESSCA

IARC Carcinogenicity

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

IARC Group
3
Volume
57
Evaluation Year
1992

Sensitization AOP Dashboard

Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.

DPRA Cys %
95.8%
DPRA Lys %
14.5%
KeratinoSens IC50
510.4 µM
hCLAT CV75
500 µg/mL
LLNA EC3
2%
NESIL
500 µg/cm²
LLNA: Strong (1A) GHS: 1A

Source: LLNA: CosmEur database; DPRA: Cosmetics Europe; KS: Cosmetics Europe; hCLAT: Cosmetics Europe

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.

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) 3,0%.
JPKR Japan/Korea Cosmetics
Korea (Restricted): max 0.45%
BRIN Brazil/India Cosmetics
India: Restricted · max (b) 3,0%
Additional Jurisdictional Restrictions (2)
Jurisdiction Status Max % Product Type
CN permitted_hair_dye 1 Non-oxidative hair dye (direct)
BR permitted_hair_dye - Direct/non-oxidative hair dye

Expanded Dermal Absorption Data

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

Roberts Skin Permeation (Mendeley 2022)
MW: 197.191
Log Kow: 0.661
Log Kp: -1.6705888516886631
Log Jmax: -7.874293994240627

Source: Roberts_Cheruvu_Mendeley_2022

Aggregated DA Values (5 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured 98.7% - - SCCS/0043
measured 2.0% - - SCCS/0043
measured 0.072% - - SCCS/0043
measured 0.101% - - SCCS/0043
measured 0.173% - - SCCS/0043

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": "IVDK; NACDG; ESSCA"}
hair_dye
{"cas_number": "2871-01-4", "ingredient_class": "direct_dye", "chemical_class": "nitro", "molecular_weight_Da": "280.28", "color_result_on_hair": "Red-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", "h…

PubChem Annotations

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

Safety (3)
Carcinogen Classification
HC Red No. 3 | Group 3: Not classifiable as to its carcinogenicity to humans | Volume 57: (1993) Occupational Exposures of Hairdressers and Barbers and Personal Use of Hair Colourants; Some Hair Dyes, Cosmetic Colourants, Industrial Dyestuffs and Aromatic Amines
Source: International Agency for Research on Cancer (IARC)
Carcinogen Classification
HC Red 3 | TR-281: Toxicology and Carcinogenesis Studies of HC Red No. 3 [2,((Amino-2-nitrophenyl)amino)ethanol] (CASRN 2871-01-4) In F344/N Rats and B6C3F1 Mice (Gavage Studies) (1986 ) | 03/29/85 | No Evidence | No Evidence | Equivocal Evidence | Inadequate Experiment | Under the conditions of these 2-year gavage studies of HC Red No. 3, there was no evidence of carcinogenicity for male
Source: NTP Technical Reports
Evidence for Carcinogenicity
Evaluation: There is inadequate evidence in humans for the carcinogenicity of HC Red No. 3. There is inadequate evidence in experimental animals for the carcinogenicity of HC Red No. 3. Overall evaluation: HC Red No. 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 Restricted for Children (Cosmetics) EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for HC Red No. 3.

Regulatory Flags

eu_children_restricted eu_cosing_listed

NOAEL Studies Summary

View details ->

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

Studies
70
Lowest NOAEL
0.003
Highest NOAEL
1000

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

ToxValDB_ECHA_IUCLID SCCS_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
98.7% - -
2.0% - -
0.072% - -
0.101% - -
0.173% - -

Known Synonyms

BRN 2110120 EINECS 220-701-7 NCI-C54922 N(sup 1)-(2-Hydroxyethyl)-2-nitro-p-phenylenediamine UNII-51CPX7M1SQ 2-[(4-Amino-2-nitrophenyl)amino]-ethanol

Chemical Function

Dye

Regulatory Lists

Europe; Personal care - hair coloring children; Europe; Personal care children; 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
CHEMBL3185903
View full pharmaceutical profile →

Frequently Asked Questions

Is HC Red No. 3 safe in cosmetics?

HC Red No. 3 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.

Is HC Red No. 3 allowed in the EU?

HC Red No. 3 EU regulatory status: prohibited. Maximum allowed concentration: 3.0%. This is based on EU Regulation 1223/2009 and its amendments.

What does HC Red No. 3 do in cosmetics?

HC Red No. 3 functions as: Non-oxidative (semi-permanent) and oxidative hair dye. It is classified as a cosmetic ingredient in our database. CAS number: 2871-01-4.

What is the NOAEL for HC Red No. 3?

The NOAEL (No Observed Adverse Effect Level) for HC Red No. 3 is =0.003 mg/kg bw based on a dermal absorption study via oral route in mouse. A total of 10 study endpoints are available. Source: SCCS_vision_codex.

Is HC Red No. 3 used outside cosmetics?

HC Red No. 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 HC Red No. 3 have different safety status in cosmetics vs industrial chemicals?

HC Red No. 3 is prohibited in EU cosmetics at max 3.0% but has active industrial GHS classifications (H315, H317, H319, H335, H411).

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