Registration Dossier
Registration Dossier
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EC number: 205-201-9 | CAS number: 135-57-9
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: Performed to OECD methods in 1987 and although not performed to recognised GLP, followed principles of Good Laboratory Practice
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N'-dithiodi-o-phenylenedibenzamide
- EC Number:
- 205-201-9
- EC Name:
- N,N'-dithiodi-o-phenylenedibenzamide
- Cas Number:
- 135-57-9
- Molecular formula:
- C26H20N2O2S2
- IUPAC Name:
- N-{2-[(2-benzamidophenyl)disulfanyl]phenyl}benzamide
- Test material form:
- solid: crystalline
- Details on test material:
- Yellow cyrstalline powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The animals were kept in quarantine for 14 days before the study and fully examined for health 1 day before testing
Room temperature 20 C (+/- 2C)
Relative humidity ca 50%
Light / dark conditions, 12 hourly
Ventilation, 10 changes per hour
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg dispersed in water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Up to 14 days
- Number of animals:
- 3 Rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No adverse effects
- Remarks:
- No adverse effects
- Remarks on result:
- other: No adverse effects
- Remarks:
- No adverse effects
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No adverse effects
- Remarks:
- No adverse effects
- Remarks on result:
- other: No adverse effects
- Remarks:
- No adverse effects
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No adverse effects
- Remarks:
- No adverse effects
- Remarks on result:
- other: No adverse effects
- Remarks:
- No adverse effects
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No adverse effects
- Remarks:
- No adverse effects
- Remarks on result:
- other: No adverse effects
- Remarks:
- No adverse effects
- Other effects:
- No adverse effects reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No adverse effects following 4 hour exposure of wetted material with semi-occlusive dressing
- Executive summary:
Valid study, showing no adverse effects
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