Moderate Cosmetic Ingredient NOAEL Data GHS Classified Sensitization Data

P-PHENYLENEDIAMINE

Also known as: CI Developer 13, CI Oxidation Base 10, Developer 13, EINECS 203-404-7, Fur Black 41866 (+14 more)

P-PHENYLENEDIAMINE (CAS 106-50-3) is a cosmetic cosmetic ingredient functioning as Hair Dyeing. NOAEL 4 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max III/8a. 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 106-50-3 →

Auto-generated CPSR Part A draft with source citations
Function
Hair Dyeing
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C6H8N2
MW
108.14 g/mol
EC Number
203-404-7
PubChem CID
7814
IUPAC Name
benzene-1,4-diamine
InChIKey
CBCKQZAAMUWICA-UHFFFAOYSA-N

Regulatory Status

EU EU Status restricted
EU Max Conc. III/8a
US US Status permitted
US Notes CIR: S - IJT 32(Suppl. 4):41-64, 2013

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Toxicological Studies

10 study endpoints found for P-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 4 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL =4 mg/kg/day oral rat NOAEL study SCCNFP_vision_codex
NOAEL =4 mg/kg bw - human irritation SCCNFP_vision_codex
NOAEL =4 mg/kg/day oral rat NOAEL study SCCNFP_vision_codex
NOAEL =4 mg/kg bw - human irritation SCCNFP_vision_codex
NOAEL =4 mg/kg/day oral rat NOAEL study SCCNFP_vision_codex
NOAEL =4 mg/kg bw - human irritation SCCNFP_vision_codex
NOAEL =4 mg/kg/day oral rat NOAEL study SCCNFP_vision_codex
NOAEL =4 mg/kg bw - human irritation SCCNFP_vision_codex
NOAEL =5 mg/kg bw/day oral rat repeated dose toxicity SCCNFP_vision_codex

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. Inhalation of dust may cause asthmatic reactions. See Notes. Ingestion could cause swelling of mouth and throat. The substance may cause effects on the blood. This may result in the formation of methaemoglobin. Exposure could cause death.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. Repeated or prolonged inhalation may cause asthma. The substance may have effects on the kidneys. This may result in kidney impairment.
Routes of Exposure
The substance can be absorbed into the body by inhalation, through the skin and by ingestion.

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for P-PHENYLENEDIAMINE across SCCS product categories, with measured dermal absorption where available.

Sensitization Profile

Contact sensitization data for P-PHENYLENEDIAMINE based on clinical patch test studies and IFRA standards.

Sensitization Rate
high
Allergen Class
dye
EU Allergen Listed
no
Patch Test Positive Rate
4.5%
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
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.

Signal Word
Danger
Pictograms
Acute ToxicityEnvironmental Hazard
Hazard Class and Category
Acute Tox. 3 *; Acute Tox. 3 *; Acute Tox. 3 *; Eye Irrit. 2; Skin Sens. 1; Aquatic Acute 1; Aquatic Chronic 1
Hazard Statements
  • H331 Toxic if inhaled
  • H311 Toxic in contact with skin
  • H301 Toxic if swallowed
  • H319 Causes serious eye irritation
  • H317 May cause an allergic skin reaction
  • H400 Very toxic to aquatic life
  • H410 Very 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.

DPRA Cys %
92.3%
DPRA Lys %
23.5%
KeratinoSens IC50
424.965 µM
hCLAT CV75
31.85 µg/mL
LLNA EC3
0.13%
NESIL
7 µg/cm²
LLNA: Strong (1A) GHS: 1A Human: positive

Source: LLNA: Kimber et al. (1991) | White et al. (2006); DPRA: Bauch et al. 2011 [DOI:10.1016/j.tiv.2011.05.030] | Jaworska 2011 [DOI:10.1002/jat.2869]; KS: Emter et al. 2010 [DOI:10.1016/j.taap.2010.03.009] | Bauch et al. 2011 [DOI:10.1016/j.tiv.2011.05.030]; hCLAT: Bauch et al. 2011 [DOI:10.1016/j.tiv.2011.05.030] | Ashikaga et al. 2010 [DOI:10.1177/026119291003800403]; HPPT: [27] Kligman AM (1966): https://doi.org/10.1038/jid.1966.160

HRIPT Human Patch Test Studies

5 human repeat insult patch tests aggregated from dermatological literature.

Test Type N Sensitized Dose µg/cm² NESIL µg/cm² Potency
HRIPT - 0 - - extreme
HRIPT - 0 - - extreme
HMT - 0 62.07 - -
HMT - 0 124.14 - -
HMT - 0 620.69 - -

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Cosmetic-Specific Mechanism
Category: other
Receptor targets: AhR
LOEC: 10 µM
EU status: restricted (max 2%)

agonist (AhR)

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
10,000 - 100,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)

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.

JPKR Japan/Korea Cosmetics
Korea (Restricted): max 2.0
Additional Jurisdictional Restrictions (10)
Jurisdiction Status Max % Product Type
CN permitted_hair_dye 2 Oxidative hair dye products
IN restricted 6.0 hair dye products (general consumer)
IN restricted 10.0 hair dye products (professional salon)
AU restricted - hair dyes
GCC restricted 2.0 Oxidative hair dye products only
BR banned - Permitted only as hair dye per RDC 530/2021 Annex I
BR restricted 6 Oxidative hair dyes only; Gen and professional use
BR permitted_hair_dye 6 (as free base) Oxidative hair dyes; gen and professional use

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

EPA Dryad Skin Absorption (physics-based)
MW: 108.141
LogP: -0.298554
Kp epidermis: 0.00178 cm/h
% dose epidermis: 0.9%
% dose stratum corneum: 0.92%
% dose dermis: 0.9%

Source: EPA_Dryad_Skin_Absorption_2024

Roberts Skin Permeation (Mendeley 2022)
MW: 108.1
Log Kow: -0.25
Log Kp: -3.619788758288394
Log Jmax: -6.966576244513051

Source: Roberts_Cheruvu_Mendeley_2022

Aggregated DA Values (1 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured_in_vitro 0.15 In vitro — Franz static cells - SCCS/1280/09; CIR 2024 (2009)

Typical Use Concentrations

Reported concentration ranges per product category from SCCS/CIR/industry sources.

Product Category Typical Range Max Reported Source
Permanent Hair Color 0.5–2 2 CIR/VCRP

Additional Ingredient Properties

2 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": "4.5", "sensitization_rate": "high", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "IVDK; NACDG; ESSCA"}
hair_dye
{"cas_number": "106-50-3", "ingredient_class": "oxidative_dye_precursor", "color_index_CI_number": "76003", "chemical_class": "para_phenylenediamine", "molecular_weight_Da": "108.14", "color_result_on_hair": "Blue-black base", "shade_range": "black", "primary_function": "precursor", "oxidative_dye_type": "primary_intermediate", "requires_developer": "yes", "developer_volume_compatibility": "10/20/…

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (5)
Carcinogen Classification
para-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.
Source: Hazardous Substances Data Bank (HSDB)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
ICSC Safety Card
0805
Source: ILO-WHO International Chemical Safety Cards (ICSCs)
Skin Eye Respiratory Irritation
... Is a skin and respiratory system sensitizer ... | Eye irritation.
Source: Hazardous Substances Data Bank (HSDB)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Antioxidant Dye Hardener
Regulatory List Membership (1)
FDA Indirect Food Contact Additives

Expert Verdict

Expert safety assessment and concern-level summary for P-PHENYLENEDIAMINE.

Regulatory Flags

cosing-sourced eu-restricted needs-enrichment endocrine_disruptor

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to P-PHENYLENEDIAMINE by CAS number or substance name.

Studies
108
Lowest NOAEL
0.04
Highest NOAEL
50

Units vary across source rows: mg/kg bw/day, mg/kg bw, mg/kg

COSMOS_DB ToxValDB_ECHA_IUCLID SCCS_vision_codex SCCNFP_vision_codex ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip

Dermal Absorption

View details ->
Absorption % Method Vehicle
0.15 In vitro — Franz static cells Oxidative hair dye + developer

Known Synonyms

CI Developer 13 CI Oxidation Base 10 Developer 13 EINECS 203-404-7 Fur Black 41866 Paraphenylen-diamine Paraphenylenediamine p-Phenyldiamine Rodol D Santoflex IC Santoflex LC USAF EK-394 Fenylenodwuamina p-Fenylendiamin UNII-U770QIT64J PPD PPDA p-phenylenediamine base para-phenylenediamine

Chemical Function

Dye Antioxidant Hardener

Regulatory Lists

Indirect additives food contact (10/2018) Europe; Personal care - hair coloring detected; Europe; Personal care - hair coloring detected; Europe; Personal care - hair coloring Regulatory Toxicology and Pharmacology Canada; pharmaceutical Canada; pharmaceutical Europe; Personal care - hair coloring

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
CHEMBL403741
View full pharmaceutical profile →

Frequently Asked Questions

Is P-PHENYLENEDIAMINE safe in cosmetics?

P-PHENYLENEDIAMINE has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.

Is P-PHENYLENEDIAMINE allowed in the EU?

P-PHENYLENEDIAMINE EU regulatory status: restricted. Maximum allowed concentration: III/8a. This is based on EU Regulation 1223/2009 and its amendments.

What does P-PHENYLENEDIAMINE do in cosmetics?

P-PHENYLENEDIAMINE functions as: Hair Dyeing. It is classified as a cosmetic ingredient in our database. CAS number: 106-50-3.

What is the NOAEL for P-PHENYLENEDIAMINE?

The NOAEL (No Observed Adverse Effect Level) for P-PHENYLENEDIAMINE is 4 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is P-PHENYLENEDIAMINE used outside cosmetics?

P-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 P-PHENYLENEDIAMINE have different safety status in cosmetics vs industrial chemicals?

P-PHENYLENEDIAMINE is classified GHS Danger (H301, H311, H331, H317, H319, H370, H400, H410) in the chemicals database but is restricted in EU cosmetics at max III/8a.

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