Is HC Blue No. 2 safe in cosmetics?
HC Blue No. 2 has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.
HC Blue No. 2
Also known as: BRN 2148848, EINECS 251-410-3, 2,2'-((4-((2-Hydroxyethyl)amino)-3-nitrophenyl)imino)bis(ethanol), NCI-C54897, 3-Nitro-N(sup 1),N(sup 1),N(sup 4)-tris(2-hydroxyethyl)- (+4 more)
INCI: HC BLUE NO. 2
HC Blue No. 2 (CAS 33229-34-4) is a cosmetic cosmetic ingredient functioning as Hair dyeing - nitroaminophenol-type semi-permanent direct dye. NOAEL 300 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 2.8%; 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 33229-34-4 →
Auto-generated CPSR Part A draft with source citations
Function
Hair dyeing - nitroaminophenol-type semi-permanent direct dye
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
2-[4-[bis(2-hydroxyethyl)amino]-2-nitroanilino]ethanol
InChIKey
MIWUTEVJIISHCP-UHFFFAOYSA-N
Regulatory Status
EU EU Status
restricted
EU Max Conc.
2.8%
US US Status
permitted
US Notes
Permitted under coal tar hair dye exemption (21 CFR 740.2). Listed in FDA VCRP database.
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 Blue No. 2.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for HC Blue No. 2. 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 | =0.0004 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.0004 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.0004 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.0004 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =100 mg/kg bw/day | - | rat | genotoxicity | SCCS_vision_codex |
| NOAEL | =100 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =100 mg/kg/day | oral | rat | developmental toxicity | SCCS_vision_codex |
| NOAEL | =100 mg/kg bw/day | - | rat | genotoxicity | SCCS_vision_codex |
| NOAEL | =100 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =100 mg/kg/day | oral | rat | developmental toxicity | SCCS_vision_codex |
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
cir
York
0 1994
Verdict: unknown
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for HC Blue No. 2 across SCCS product categories, with measured dermal absorption where available.
Sensitization Profile
Contact sensitization data for HC Blue No. 2 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
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: Hair dye substance in non-oxidative hair dye products. Max: 0.028.
JPKR Japan/Korea Cosmetics
Korea (Restricted): max 2.8%
BRIN Brazil/India Cosmetics
India: Restricted · max 0.028
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_hair_dye | 3 | Non-oxidative hair dye (direct) |
| BR | permitted_hair_dye | - | Direct hair dye |
| KR | prohibited | - | - |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (2 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured | 2.8% | in_vitro | - | SCCP/0084 |
| measured | 0.001% | - | - | SCCP/0084 |
Additional Ingredient Properties
3 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"}
ecotoxicity
{"biodegradable": "partial", "biodegradation_days": "90-180", "bioaccumulative": "yes", "aquatic_toxicity_level": "moderate", "coral_reef_safe": "unknown", "marine_toxicity": "moderate toxicity", "freshwater_toxicity": "persistence concerns", "endocrine_disruptor": "no", "persistent_organic_pollutant": "no", "microplastic": "no", "nano_particle": "no", "hawaii_banned": "no", "eu_restricted_environ…
hair_dye
{"cas_number": "33229-34-4", "ingredient_class": "direct_dye", "chemical_class": "nitro", "molecular_weight_Da": "325.36", "color_result_on_hair": "Blue", "shade_range": "fashion_color", "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…
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (3)
Carcinogen Classification
HC Blue No. 2 | 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 Blue 2 | TR-293: Toxicology and Carcinogenesis Studies of HC Blue No. 2 [2,2'-((4-((2-Hydroxyethyl)amino)-3-nitrophenyl)imino)bis(ethanol)] (CASRN 33229-34-4) in F344/N Rats and B6C3F1 Mice (Feed Studies) (1985 ) | 07/27/84 | No Evidence | No Evidence | No Evidence | No Evidence | Under the conditions of these studies, there was no evidence of carcinogenicity in male and female F3
Source: NTP Technical Reports
Evidence for Carcinogenicity
Classification of carcinogenicity: 1) evidence in humans: inadequate; 2) evidence in animals: inadequate. Overall summary evaluation of carcinogenic risk to humans is Group 3: The agent is not classifiable as to its carcinogenicity to humans.
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 Blue No. 2.
Regulatory Flags
eu_children_restricted
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to HC Blue No. 2 by CAS number or substance name.
Studies
29
Lowest NOAEL
0.0004
Highest NOAEL
1000
Units vary across source rows: mg/kg bw/day, mg/kg/day, mg/kg
ToxValDB_ECHA_IUCLID
SCCS_vision_codex
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 2.8% | in_vitro | - |
| 0.001% | - | - |
Known Synonyms
BRN 2148848
EINECS 251-410-3
2,2'-((4-((2-Hydroxyethyl)amino)-3-nitrophenyl)imino)bis(ethanol)
NCI-C54897
3-Nitro-N(sup 1),N(sup 1),N(sup 4)-tris(2-hydroxyethyl)-
p-Phenylenediamine, 3-nitro-N(sup 1),N(sup 1),N(sup 4)-tris(2-hydroxyethyl)-
N(sup 1),N(sup 4),N(sup 4)-Tris(2-hydroxyethyl)-2-nitro-para-phenylenediamine
UNII-6C0EL1931V
2,2'-[[4-[(2-Hydroxyethyl)amino]-3-nitrophenyl]imino]bis-ethanol
Chemical Function
Dye
Regulatory Lists
Europe; Personal care; restricted
Europe; Personal care - hair coloring
children; Europe; Personal care
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
CHEMBL1561876
Frequently Asked Questions
Is HC Blue No. 2 allowed in the EU?
HC Blue No. 2 EU regulatory status: restricted. Maximum allowed concentration: 2.8%. This is based on EU Regulation 1223/2009 and its amendments.
What does HC Blue No. 2 do in cosmetics?
HC Blue No. 2 functions as: Hair dyeing - nitroaminophenol-type semi-permanent direct dye. It is classified as a cosmetic ingredient in our database. CAS number: 33229-34-4.
What is the NOAEL for HC Blue No. 2?
The NOAEL (No Observed Adverse Effect Level) for HC Blue No. 2 is =0.0004 mg/kg based on a dermal absorption study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.
Is HC Blue No. 2 used outside cosmetics?
HC Blue No. 2 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.
Compliance Tools
Check HC Blue No. 2 compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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