Registration Dossier
Registration Dossier
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EC number: 247-201-1 | CAS number: 25711-72-2
Skin sensitisation
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:
- 2 007
- Bibliographic source:
- Cosmetic Ingredient Review, 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- p-phenylenediamine
- EC Number:
- 203-404-7
- EC Name:
- p-phenylenediamine
- Cas Number:
- 106-50-3
- Molecular formula:
- C6H8N2
- IUPAC Name:
- 1,4-diaminobenzene
- 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
Constituent 1
- 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 chemical
- 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.
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