NOAEL Data IARC Group 3 Cosmetic Ingredient

4-Nitro-1,2-phenylenediamine

Also known as: 4-Nitro-o-phenylenediamine, 4-13-00-00075, BRN 0608106, EINECS 202-766-3, NCI-C03941 (+8 more)

CAS 99-56-9

4-Nitro-1,2-phenylenediamine (CAS 99-56-9) is a chemical substance; key hazard signal: IARC Group 3. Key regulatory status: 1 regulatory/inventory list, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, SCCS, IARC, ILO ICSC.

View cosmetic safety profile for 4-Nitro-O-Phenylenediamine →

SOURCE NOAEL studies
NOAEL studies
26
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 18 fields
Name
4-Nitro-1,2-phenylenediamine
CAS Number
99-56-9
Molecular Formula
C6H7N3O2
InChI Key
RAUWPNXIALNKQM-UHFFFAOYSA-N
Monoisotopic Mass
153.053826
Synonyms
4-Nitro-o-phenylenediamine4-13-00-00075BRN 0608106EINECS 202-766-3NCI-C039414-Nitro-para-phenylenediamine4-Nitrophenylenediamine4-Nitro-o-phenylene-diamine4-Nitro-1,2-fenylendiaminNitro-o-phenylenediamineUNII-5A9AX7Y0TTp-nitro-o-phenylendiamine

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 classifiable198716, Sup 7

ICSC Chemical Safety

International Chemical Safety Card hazard and exposure summary.

SOURCE WHO/JECFA 1 records
FieldValue
Long-term EffectsRepeated or prolonged contact may cause skin sensitization.

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 2 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 26 of 26 studies
ValueUnitEndpointRouteSpeciesSource
15mg/kg bw/day-oraldogRegulatory source
45mg/kg/day--ratRegulatory source
45mg/kg bw/day---Regulatory source
500mg/kg-oralratRegulatory source
5A9AX7Y0TTUNIIFDA UNII substance identifier--openFDA substances
3IARC groupIARC carcinogenicity classification--IARC Monographs
3unitlessIARC group--NTP ICE cancer
=0.042mg/kgNOAELoralratSCCS Opinion
=15mg/kg bw/dNOAELdermalratCIR Safety Assessment
=15mg/kg bw/dayNOAELoraldogSCCS Opinion
=15mg/kgNOAELoralratSCCS Opinion
=45mg/kg bw/dNOAELdermalratCIR Safety Assessment
=45mg/kg/dayNOAEL-ratSCCS Opinion
=45mg/kg bw/dayNOAEL--SCCS Opinion
=65%NOAELoral-SCCS Opinion
=265mg/kg/dayNOAEL--SCCS Opinion
=500mg/kgNOAELoralratSCCS Opinion
=340mg/kg bw/dayNOELoralRatToxValDB ECOTOX
=500mg/kg bw/dayNOELoralMouseToxValDB ECOTOX
750ppmTop dose-RatNTP ICE cancer
7500ppmTop dose-MouseNTP ICE cancer
=0.042mg/kgdermal absorptionoralratRegulatory source
=15mg/kgdermal absorptionoralratRegulatory source
15mg/kg bw/daydevelopmental toxicityoralratRegulatory source
265mg/kg/daydevelopmental toxicity--Regulatory source
65%reproductive toxicityoral-Regulatory source

Showing 26 of 26 studies

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
SCCP/1006/0619 December 2006not safe-genotoxicity; low MoS
SCCP/0980/062006-12-19Based on the information provided, the SCCP is of the opinion that the use of 4-Nitro-o-phenylenediamine itself as an oxidative hair dye substance at a maximum concentration of 0.5% in the finished cosmetic product (after mixing with hydrogen peroxide) does not pose a risk to the health of the consumer, apart from its sensitising potential.0.5%Sensitising potential (extremely potent skin sensitiser). Induces mutations in Salmonella in vitro, but not genotoxic in vivo; genotoxicity/mutagenicity studies on finished hair dye formulations still required. IARC Group 3.

Cosmetic Safety Profile

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

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

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE ChEMBL / DailyMed CHEMBL433721
ChEMBL Phase
Not listed
Adverse Events
0
Bioactivity
1
View full pharmaceutical profile →

Frequently Asked Questions

What is the NOAEL for 4-Nitro-1,2-phenylenediamine?

4-Nitro-1,2-phenylenediamine has 26 NOAEL studies in the database. The lowest reported value is 0.042 mg/kg via oral in rat. Source: SCCS Opinion.

What regulatory lists include 4-Nitro-1,2-phenylenediamine?

4-Nitro-1,2-phenylenediamine appears on 1 regulatory/inventory list including Europe; Personal care; restricted. Source: EPA CPDat.

Is 4-Nitro-1,2-phenylenediamine a carcinogen according to IARC?

4-Nitro-1,2-phenylenediamine is classified by IARC as Group 3 — not classifiable as to its carcinogenicity to humans (evaluated 1987). Source: IARC Monographs on the Identification of Carcinogenic Hazards to Humans.

Is 4-Nitro-1,2-phenylenediamine used in cosmetics?

Yes, 4-Nitro-1,2-phenylenediamine is also indexed as a cosmetic ingredient under the name 4-Nitro-O-Phenylenediamine. 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 4-Nitro-1,2-phenylenediamine come from?

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

Is 4-Nitro-1,2-phenylenediamine used outside industrial chemicals?

4-Nitro-1,2-phenylenediamine also appears in cosmetics, pharmaceutical databases.