NOAEL Data IARC Group 3 REACH Registered Cosmetic Ingredient

HC Yellow 4

Also known as: HC Yellow No. 4, Ethanol, 2-​[[2-​(2-​hydroxyethoxy)​-​4-​nitrophenyl]​amino]​-, 2-[[2-(2-Hydroxyethoxy)-4-nitrophenyl]amino]ethanol, 2-[3-Nitro-6-(β-hydroxyethylamino)phenoxy]ethanol, Colorex HCY 4 (+6 more)

CAS 59820-43-8

HC Yellow 4 (CAS 59820-43-8) is a chemical substance; key hazard signal: IARC Group 3. Key regulatory status: REACH registered, 1 regulatory/inventory list, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, SCCS, IARC, ECHA REACH.

View cosmetic safety profile for HC Yellow No. 4 →

SOURCE NOAEL studies
NOAEL studies
45
SOURCE Chemical inventory jurisdictions
Regulatory lists
1
SOURCE EU CLP Annex VI
GHS signal
Not classified

Chemical Identity

CAS, identifiers, formula, and alternate names for the matched substance record.

SOURCE DSSTox identifiers 16 fields
Name
HC Yellow 4
CAS Number
59820-43-8
Molecular Formula
C10H14N2O5
InChI Key
PNENOUKIPPERMY-UHFFFAOYSA-N
Monoisotopic Mass
242.090272
Synonyms
HC Yellow No. 4Ethanol, 2-​[[2-​(2-​hydroxyethoxy)​-​4-​nitrophenyl]​amino]​-2-[[2-(2-Hydroxyethoxy)-4-nitrophenyl]amino]ethanol2-[3-Nitro-6-(β-hydroxyethylamino)phenoxy]ethanolColorex HCY 4PHENOL, N,O-DI(HYDROXYETHYL)-2-AMINO-5-NITRO-N, O-Di(hydroxyethyl)-2-amino-5-nitrophenol2-[[2-(2-hydroxyethoxy)-4-nitrophenyl]amino]-ethanolEC No.: 428-840-72-(3-Nitro-6-(beta-hydroxyethylamino)phenoxy)ethanolUNII-0N97D5G157

IARC Carcinogen Classification

Carcinogenic hazard classification from IARC monograph evaluations.

SOURCE IARC Monographs on the Identification of Carcinogenic Hazards to Humans 1 records
GroupMeaningEvaluatedVolume
Group 3Not classifiable199257

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 4 records
Dye

Regulatory Lists

Inventory, screening, and regulatory list matches from public chemical databases.

SOURCE EPA CPDat 1 records
ListKeywordSource
Europe; Personal care; restrictedEuropean CommissionCosIng

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 45 of 45 studies
ValueUnitEndpointRouteSpeciesSource
0.1%-oralratRegulatory source
43--dermalrabbitRegulatory source
43--dermalratRegulatory source
50mg/kg bw/d-oralratRegulatory source
200mg/kg bw/d-oralratRegulatory source
300mg/kg bw/d-oralratRegulatory source
5000ppm--ratRegulatory source
5000ppm-dermalratRegulatory source
5000ppm-oralratRegulatory source
0N97D5G157UNIIFDA UNII substance identifier--openFDA substances
3IARC groupIARC carcinogenicity classification--IARC Monographs
3unitlessIARC group--NTP ICE cancer
=0.001mg/kg bwNOAELoralratSCCS Opinion
=0.1%NOAELoralratSCCS Opinion
=0.4%NOAEL-ratSCCS Opinion
=1.5%NOAELoralratSCCS Opinion
=43-NOAELdermalrabbitSCCS Opinion
=50mg/kg/dNOAELoralratSCCS Opinion
=50mg/kg bw/dNOAELdermalratSCCS Opinion
=50mg/kg bwNOAELoralratSCCS Opinion
=99.2%NOAELoralratSCCS Opinion
=200mg/kg bw/dNOAELoralratSCCS Opinion
=300mg/kg bw/dNOAELdermalratSCCS Opinion
=300mg/kg/dNOAELoralratSCCS Opinion
=500mg/kg/dNOAELoralratSCCS Opinion
=5000ppmNOAEL-ratSCCS Opinion
<240mg/kg bw/dayNOELoralRatToxValDB HESS
5000ppmPOLY-3 lowest doseDosed feedRatNTP ICE cancer
5000ppmTop doseDosed feedRatNTP ICE cancer
1.000e+4ppmTop doseDosed feedMouseNTP ICE cancer
=0.001mg/kg bwdermal absorptionoralratRegulatory source
=50mg/kg bwdermal absorptionoralratRegulatory source
0.1%developmental toxicityoralratRegulatory source
0.4%developmental toxicity--Regulatory source
50mg/kg/ddevelopmental toxicityoralratRegulatory source
50mg/kg bw/ddevelopmental toxicitydermalratRegulatory source
99.2%developmental toxicityoralratRegulatory source
300mg/kg bw/ddevelopmental toxicitydermalratRegulatory source
500mg/kg/ddevelopmental toxicityoralratRegulatory source
0.1%repeated dose toxicityoralratRegulatory source
1.5%repeated dose toxicityoralratRegulatory source
0.1%reproductive toxicityoralratRegulatory source
0.4%reproductive toxicity-ratRegulatory source
50mg/kg/dreproductive toxicityoralratRegulatory source
300mg/kg/dreproductive toxicityoralratRegulatory source

Showing 45 of 45 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA 1 records
StatusNameEC NumberLink
Registered2-[[2-(2-hydroxyethoxy)-4-nitrophenyl]amino]ethanol428-840-7ECHA overview →

Australian Status (AICIS)

Australian industrial chemicals inventory status and applicable conditions.

SOURCE AICIS inventory 1 records
Inventory Status
listed

SCCS Opinions

EU Scientific Committee opinions tied to the matched substance.

SOURCE SCCS Opinion 2 opinions
OpinionDateConclusionMax Conc.Concerns
SCCS/1385/108 December 2009safe1.0%secondary amine; nitrosamine <50ppb; sensitisation not excluded
SCCS/1230/098 December 2009Based on the data provided, the SCCS is of the opinion that the use of HC Yellow n 4 as a non-oxidative hair dye with a maximum concentration on the head of 1.5 % does not pose a risk to the health of the consumer.1.5%Sensitising potential cannot be excluded; it is a secondary amine prone to nitrosation, should not be used with nitrosating substances; nitrosamine content should be < 50 ppb.

Cosmetic Safety Profile

Same-CAS cosmetic ingredient record for cross-vertical context.

SOURCE CosIng / Ingredients DB
EU Status
restricted
Max
1.5%
Category
Colorant
View full cosmetic safety profile →

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE ChEMBL / DailyMed CHEMBL1573069
ChEMBL Phase
Not listed
Adverse Events
0
Bioactivity
1
View full pharmaceutical profile →

Frequently Asked Questions

What is the NOAEL for HC Yellow 4?

HC Yellow 4 has 45 NOAEL studies in the database. The lowest reported value is 0.001 mg/kg bw via oral in rat. Source: SCCS Opinion.

What regulatory lists include HC Yellow 4?

HC Yellow 4 appears on 1 regulatory/inventory list including Europe; Personal care; restricted. Source: EPA CPDat.

Is HC Yellow 4 a carcinogen according to IARC?

HC Yellow 4 is classified by IARC as Group 3 — not classifiable as to its carcinogenicity to humans (evaluated 1992). Source: IARC Monographs on the Identification of Carcinogenic Hazards to Humans.

Is HC Yellow 4 used in cosmetics?

Yes, HC Yellow 4 is also indexed as a cosmetic ingredient under the name HC Yellow No. 4. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.

Where does the safety data for HC Yellow 4 come from?

Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, IARC Monographs, ECHA REACH, CosIng / Ingredients DB, ChEMBL / DailyMed. All data traces to primary regulatory sources and is updated from official government databases.

Is HC Yellow 4 used outside industrial chemicals?

HC Yellow 4 also appears in cosmetics, pharmaceutical databases.