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 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.
US NotesPermitted 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 Opinion
NOAEL
=0.0004 mg/kg
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=0.0004 mg/kg
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=0.0004 mg/kg
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=100 mg/kg bw/day
-
rat
genotoxicity
SCCS Opinion
NOAEL
=100 mg/kg
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=100 mg/kg/day
oral
rat
developmental toxicity
SCCS Opinion
NOAEL
=100 mg/kg bw/day
-
rat
genotoxicity
SCCS Opinion
NOAEL
=100 mg/kg
oral
rat
dermal absorption
SCCS Opinion
NOAEL
=100 mg/kg/day
oral
rat
developmental toxicity
SCCS Opinion
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
CIR Safety AssessmentYork
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.
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
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…
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
Editorial summary
Preliminary editorial summary for HC Blue No. 2 — not a computed safety verdict. See the sourced toxicological data above.
Europe; Personal care; restrictedEurope; Personal care - hair coloringchildren; Europe; Personal carechildren; Europe; Personal carechildren; Europe; Personal care
Australian Status
AICIS status:listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCEChEMBL / DrugCentral / FAERSDB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
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 Safety Assessment.
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 Opinion.
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
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