Registration Dossier
Registration Dossier
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EC number: 202-951-9 | CAS number: 101-54-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N-(4-aminophenyl)aniline
- EC Number:
- 202-951-9
- EC Name:
- N-(4-aminophenyl)aniline
- Cas Number:
- 101-54-2
- Molecular formula:
- C12H12N2
- IUPAC Name:
- N1-phenylbenzene-1,4-diamine
- Details on test material:
- p-aminodiphenylamin dest.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- Concentration: 0.5 other: g
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- up to 7 d
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: no adverse effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: no adverse effects observed
- Other effects:
- No adverse effects observed during the study
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
In an OECD Guideline study (TG 404) 500 mg of ADPA (moistened with water) was applied under semi-occlusive conditions to the clipped intact skin of 3 rabbits for 4 hours. There were no signs of irritation at 1, 24, 48, 72 hours and 7 days. The skin response scored according to the method of Draize was all time points 0 (Bayer AG 1982a).
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