Also known as: 4-13-00-00079, meta-Aminoaniline, Benzene, 1,3-diamino-, meta-Benzenediamine, BRN 0471357 (+8 more)
INCI: M-PHENYLENEDIAMINE
m-Phenylenediamine (CAS 108-45-2) is a cosmetic cosmetic ingredient functioning as Hair dye (formerly). NOAEL 6 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited; 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.
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for m-Phenylenediamine.
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Toxicological Studies
10 study endpoints found for m-Phenylenediamine. 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
=5 mg/kg
-
rat
developmental toxicity
CIR_vision_codex
NOAEL
=5 mg/kg
-
rat
developmental toxicity
CIR_vision_codex
NOAEL
=5 mg/kg
-
rat
developmental toxicity
CIR_vision_codex
NOAEL
=5 mg/kg
-
rat
developmental toxicity
CIR_vision_codex
NOAEL
=134 mg/kg/day
oral
rat
repeated dose toxicity
CIR_vision_codex
NOAEL
=134 mg/kg/day
oral
rat
repeated dose toxicity
CIR_vision_codex
NOAEL
=134 mg/kg/day
oral
rat
repeated dose toxicity
CIR_vision_codex
NOAEL
=134 mg/kg/day
oral
rat
repeated dose toxicity
CIR_vision_codex
NOAEL
=20 mg/kg bw/day
oral
Rat
repeat dose other
ToxValDB_ECHA_IUCLID
NOAEL
=30 mg/kg bw/day
oral
Rat
developmental
ToxValDB_ECHA_IUCLID
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Short-term Exposure Effects
The substance is irritating to the eyes and skin. The substance may cause effects on the kidneys and blood. This may result in renal failure and the formation of methaemoglobin. The effects may be delayed. Medical observation is indicated.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. The substance may have effects on the kidneys. This may result in renal failure.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its vapour, through the skin and by ingestion.
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 m-Phenylenediamine across SCCS product categories, with measured dermal absorption where available.
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
16, Sup 7
Evaluation Year
1987
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
H410Very toxic to aquatic life with long lasting effects
Inserted via ATP: CLP00
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
GHS: inconclusive
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification:Restricted (Annex XVII)
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1204
(EC) 2009/1223
CMR:Mutagenic Cat. 2()
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 (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 1204
JPKR Japan/Korea Cosmetics
Korea (Prohibited): Genotoxic, banned 2022; Category: General
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (2)
Jurisdiction
Status
Max %
Product Type
CN
permitted_hair_dye
0.2
Oxidative hair dye products
KR
prohibited
-
-
Additional Ingredient Properties
1 property record from structured ingredient metadata.
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (4)
Carcinogen Classification
meta-Phenylenediamine | Group 3: Not classifiable as to its carcinogenicity to humans | Volume 16: (1978) Some Aromatic Amines and Related Nitro Compounds – Hair Dyes, Colouring Agents and Miscellaneous Industrial Chemicals | Volume Sup 7: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, 1987; 440 pages; ISBN 92-832-1411-0 (out of print)
Source: International Agency for Research on Cancer (IARC)
Evidence for Carcinogenicity
No data are available in humans. Inadequate evidence of carcinogenicity in animals. OVERALL EVALUATION: Group 3: The agent is not classifiable as to its carcinogenicity to humans. | A4; Not classifiable as a human carcinogen. /m-Phenylenediamine/
Source: Hazardous Substances Data Bank (HSDB)
ICSC Safety Card
1302
Source: ILO-WHO International Chemical Safety Cards (ICSCs)
Skin Eye Respiratory Irritation
STRONG IRRITANT TO SKIN. TOXIC BY ... INHALATION.
Source: Hazardous Substances Data Bank (HSDB)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (3)
EU Banned in CosmeticsFDA Indirect Food Contact AdditivesEU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for m-Phenylenediamine.
m-Phenylenediamine has a safety rating of "POOR" 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 m-Phenylenediamine allowed in the EU?
m-Phenylenediamine EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does m-Phenylenediamine do in cosmetics?
m-Phenylenediamine functions as: Hair dye (formerly). It is classified as a cosmetic ingredient in our database. CAS number: 108-45-2.
What is the NOAEL for m-Phenylenediamine?
The NOAEL (No Observed Adverse Effect Level) for m-Phenylenediamine is =5 mg/kg based on a developmental toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: CIR_vision_codex.
Is m-Phenylenediamine used outside cosmetics?
m-Phenylenediamine 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 m-Phenylenediamine have different safety status in cosmetics vs industrial chemicals?
m-Phenylenediamine is prohibited in EU cosmetics but has active industrial GHS classifications (H301, H311, H331, H317, H319, H341, H400, H410).
Compliance Tools
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