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.
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
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.
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.
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.
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: 1AHuman: 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.
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
AntioxidantDyeHardener
Regulatory List Membership (1)
FDA Indirect Food Contact Additives
Expert Verdict
Expert safety assessment and concern-level summary for P-PHENYLENEDIAMINE.
CI Developer 13CI Oxidation Base 10Developer 13EINECS 203-404-7Fur Black 41866Paraphenylen-diamineParaphenylenediaminep-PhenyldiamineRodol DSantoflex ICSantoflex LCUSAF EK-394Fenylenodwuaminap-FenylendiaminUNII-U770QIT64JPPDPPDAp-phenylenediamine basepara-phenylenediamine
Chemical Function
DyeAntioxidantHardener
Regulatory Lists
Indirect additives food contact (10/2018)Europe; Personal care - hair coloringdetected; Europe; Personal care - hair coloringdetected; Europe; Personal care - hair coloringRegulatory Toxicology and PharmacologyCanada; pharmaceuticalCanada; pharmaceuticalEurope; Personal care - hair coloring
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.
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.
Compliance Tools
Check P-PHENYLENEDIAMINE compliance across multiple jurisdictions:
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.