Moderate Cosmetic Ingredient NOAEL Data GHS Classified Sensitization Data

P-PHENYLENEDIAMINE

CAS Number
106-50-3
Function
Hair Dyeing
Safety Rating
MODERATE

Regulatory Status

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

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Toxicological Studies

7 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
LOAEL 8 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 16 mg/kg bw/day oral rat oral REACH
NOEL 681 ppm oral rat oral REACH
NOAEL 1 mg/kg bw/day dermal rat dermal REACH
LOAEL 1 mg/kg bw/day dermal rat dermal REACH
LOAEL 32.95 other other - other REACH

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.

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

Expert Verdict

P-PHENYLENEDIAMINE is listed in the EU CosIng database with functions: Hair Dyeing It is restricted under EU Cosmetics Regulation. Restriction: III/8a.

⚠️
Concern Level: Medium

Regulatory Flags

cosing-sourced eu-restricted needs-enrichment endocrine_disruptor

Frequently Asked Questions

Is P-PHENYLENEDIAMINE safe in cosmetics?

P-PHENYLENEDIAMINE is listed in the EU CosIng database with functions: Hair Dyeing It is restricted under EU Cosmetics Regulation. Restriction: III/8a. The EU classifies P-PHENYLENEDIAMINE as "Restricted". Safety rating: MODERATE. 7 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 7 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check P-PHENYLENEDIAMINE compliance across multiple jurisdictions:

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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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