Poor Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

m-Phenylenediamine

INCI: M-PHENYLENEDIAMINE

CAS Number
108-45-2
Function
Hair dye (formerly)
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status prohibited
🇺🇸 US Status permitted
US Notes Key Hazard

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

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
LOEL 8.8 other 1991 rat inhalation REACH
LOAEL 10 other oral rat oral REACH
LOAEL 10 other oral mouse oral REACH
LOEL 44 other 1991 rat inhalation REACH
LOEL 72.875 other 1991 rat inhalation REACH
LOEL 185 mg/kg bw/day oral rat oral REACH
NOAEL 200 mg/kg bw/day oral rat oral REACH
NOAEL 150 mg/kg bw/day oral rat oral REACH
NOAEL 1000 mg/kg bw/day oral mouse oral REACH
NOAEL 150 mg/kg bw/day oral rat oral 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 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

Expert Verdict

m-Phenylenediamine is prohibited in the EU but permitted in the US; classified as a poor safety profile with high sensitization risk.

⚠️
Concern Level: High

Regulatory Flags

eu_banned_cosmetics eu_cosing_listed

Frequently Asked Questions

Is m-Phenylenediamine safe in cosmetics?

m-Phenylenediamine is prohibited in the EU but permitted in the US; classified as a poor safety profile with high sensitization risk. The EU classifies m-Phenylenediamine as "prohibited". Safety rating: POOR. 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 Margin of Safety for m-Phenylenediamine?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for m-Phenylenediamine?

The NOAEL (No Observed Adverse Effect Level) for m-Phenylenediamine is 8.8 other based on a inhalation study via 1991 route in rat. A total of 10 study endpoints are available. Source: REACH.

Compliance Tools

Check m-Phenylenediamine compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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