Poor Cosmetic Ingredient Sensitization Data

N-Phenyl-p-Phenylenediamine

INCI: N-PHENYL-P-PHENYLENEDIAMINE

CAS Number
101-54-2 (free base); 2198-59-6 (HCl); 4698-29-7 (sulfate)
Function
Oxidative hair dye
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.2%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted under coal tar hair dye exemption (21 USC 361(a)); CIR: safe up to 1.7% as free base; caution statement per 21 CFR 740.2

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for N-Phenyl-p-Phenylenediamine based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
dye
EU Allergen Listed
no
Patch Test Positive Rate
0.8%
Cross-reactivity Group
para-amino-group
Reaction Type
contact-dermatitis

Source: IVDK; NACDG; ESSCA

Expert Verdict

Restricted oxidative hair dye colorant with adequate margin of safety despite poor safety profile; permitted in US under coal tar exemption with concentration limits and required caution labeling.

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Concern Level: High

Frequently Asked Questions

Is N-Phenyl-p-Phenylenediamine safe in cosmetics?

Restricted oxidative hair dye colorant with adequate margin of safety despite poor safety profile; permitted in US under coal tar exemption with concentration limits and required caution labeling. The EU classifies N-Phenyl-p-Phenylenediamine as "restricted". Safety rating: POOR.

Is N-Phenyl-p-Phenylenediamine allowed in the EU?

N-Phenyl-p-Phenylenediamine EU regulatory status: restricted. Maximum allowed concentration: 0.2%. This is based on EU Regulation 1223/2009 and its amendments.

What does N-Phenyl-p-Phenylenediamine do in cosmetics?

N-Phenyl-p-Phenylenediamine functions as: Oxidative hair dye. It is classified as a cosmetic ingredient in our database. CAS number: 101-54-2 (free base); 2198-59-6 (HCl); 4698-29-7 (sulfate).

What is the Margin of Safety for N-Phenyl-p-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.

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