p-Phenylenediamine: What the SCCS Concluded About Safety in Cosmetics
p-Phenylenediamine safety summary from SCCS/1443/11: SCCS conclusion, NOAEL, maximum concentration or conditions, and source-linked context.
p-Phenylenediamine is covered by SCCS/1443/11, an SCCS-family cosmetic safety opinion dated 2012-06-27. The opinion conclusion for this opinion is direct enough for a substance-specific summary: no concern regarding systemic toxicity is raised, when PPD is used in oxidative hair colouring products at on-head concentrations of up to 2.0%
Core Opinion Facts
- Opinion: SCCS/1443/11
- Opinion date: 2012-06-27
- Primary substance: p-Phenylenediamine
NOAEL Values Cited in the Opinion
The no-observed-adverse-effect data below is shown only from the SCCS source fields for this opinion. It is not a calculated margin-of-safety output.
| Endpoint | Value | Unit | Study context |
|---|---|---|---|
| subchronic_oral_toxicity | 8 | mg/kg bw/d | rat, 13-week oral gavage, OECD 408 (1981) |
| developmental_toxicity | 10 | mg/kg bw/day | rat, gavage developmental toxicity study |
| maternal_toxicity_NOEL | 5 | mg/kg bw/day | rat, gavage developmental toxicity study |
Maximum Concentration or Conditions
Conditions from the Opinion
no concern regarding systemic toxicity is raised, when PPD is used in oxidative hair colouring products at on-head concentrations of up to 2.0%; it is unlikely that p-phenylenediamine in oxidative hair dye formulations would pose a carcinogenic risk for the consumer; The continued use of p-phenylenediamine in hair dyes remains a considerable concern for consumer safety
How to Read This Safety Conclusion
The key point for formulators is the match between the named ingredient, the cited NOAEL, and the SCCS conclusion. A NOAEL is a study point of departure, not a standalone permission to use p-Phenylenediamine at any level. The SCCS conclusion and any concentration or product-type conditions remain the controlling context for cosmetic use.
The source also matters because SCCS opinions can be ingredient-specific. The internal ingredient page for p-Phenylenediamine should be treated as the substance hub, while SCCS/1443/11 is the opinion-level page for the committee record.
Practical Formulation Takeaway
For a formula review, start with the identity check: confirm the INCI name, CAS number, and opinion reference align with the material in the formula. Then compare the intended product type against the SCCS concentration or condition language above. If the formulation uses a different exposure route, product category, or concentration basis, the SCCS conclusion should not be stretched beyond what SCCS/1443/11 actually assessed.
Review Notes
The conservative reading is to keep p-Phenylenediamine tied to this exact opinion. The opinion number, date, NOAEL table, and condition language all travel together. If a later formula review uses a different CAS identity, product type, or concentration basis, the source should be checked again rather than reusing this summary as a blanket answer.
This page is therefore an indexable safety summary, not a replacement for the committee text. It gives search readers the core SCCS facts for p-Phenylenediamine and keeps the source handle visible for audit.
Source
- SCCS opinion: SCCS/1443/11
- Source file: sccs_o_094.pdf
- Extraction JSON: SCCS Scientific Opinions