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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from Peer -reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Safety Assessment of p-Phenylenediamine, p-Phenylenediamine HCl, and p-Phenylenediamine Sulfate
Author:
Cosmetic Ingredient Review Expert Panel
Year:
2007
Bibliographic source:
Cosmetic Ingredient Review, 2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitizing potential of p-Phenylenediamine in guinea pigs.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Not specified.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material: p-phenylenediamine
- Molecular formula: C6H8N2
- Molecular weight: 108.1432 g/mol
- Substance type: Organic
- Physical State: Solid
Specific details on test material used for the study:
- Name of test material: p-phenylenediamine
- Molecular formula: C6H8N2
- Molecular weight: 108.1432 g/mol
- Substance type: Organic
- Physical State: Solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10%
Day(s)/duration:
48 hour
Challenge
Route:
other: epicutaneous,
Vehicle:
water
Concentration / amount:
0.5%
Day(s)/duration:
48 hour
No. of animals per dose:
20 animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:7
- Exposure period: 48
- Test groups: 20 guinea pigs
- Control group: No data available.
- Site: Topical application (occlusive patches)
- Frequency of applications: 7 successive
topical applications for 48 hour
- Duration: 14 days
- Concentrations: 10% aqueous

B. CHALLENGE EXPOSURE
- No. of exposures: No data available.
- Day(s) of challenge: 28 days
- Exposure period: 48 hour
- Test groups: 20 guinea pigs
- Control group: No data available.
- Site: Topical application
- Concentrations: 0.5% aqueous
- Evaluation (hr after challenge): 48 hour

OTHER; These results were confirmed at microscopic examination.
Challenge controls:
No data available.
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: Challenge
Hours after challenge:
48
Group:
test group
Dose level:
0.5% in water
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
Positive reaction for skin sensitization was observed in Dunkin Hartley guinea pigs.
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Strong sensitizer.
Conclusions:
The skin sensitization test for p-Phenylenediamine was observed in Dunkin Hartley guinea pigs byGuinea pig maximisation test . Thus p-Phenylenediamine was considered to be strong sensitizing in Dunkin Hartley guinea pigs.
Executive summary:

The skin sensitization test for p-Phenylenediamine ( 106-50-3 )was observed in Dunkin Hartley guinea pigs by Guinea pig maximisation test . A group of 20 adult Albino Dunkin-Hartley guinea pigs were observed for skin sensitization test. In induction phase, 7 successive topical applications of 10% aqueous p-Phenylenediamine were applied as 48-hour occlusive patches. After a rest period of 28 days, a 48-hour occlusive challenge patch containing 0.5% aqueous p -Phenylenediamine was applied. Eleven of the 20 guinea pigs were sensitized, and these results were confirmed at microscopic examination. Therefore p-Phenylenediamine ( 106-50-3 ) was considered to be strong sensitizer in Albino Dunkin-Hartley guinea pigs.