Registration Dossier
Registration Dossier
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EC number: 812-024-6 | CAS number: 1638534-24-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (3R)-N-[(1S)-phenylethyl]-2,3,4,9-tetrahydro-1H-carbazol-3-amine hydrochloride
- EC Number:
- 812-024-6
- Cas Number:
- 1638534-24-3
- Molecular formula:
- C20H23ClN2
- IUPAC Name:
- (3R)-N-[(1S)-phenylethyl]-2,3,4,9-tetrahydro-1H-carbazol-3-amine hydrochloride
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- pulverized solid moistened with water to ensure good contact with the skin
- Controls:
- other: The test site surrounding untreated skin served as a control
- Duration of treatment / exposure:
- Expsoure time 4 hours
- Observation period:
- 60 minutes, 24,48 and 72 hours after patch removal
- Number of animals:
- 3 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- Erythema, eschar, oedema formation
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Remarks:
- Erythema, eschar, oedema formation
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Remarks:
- Erythema, eschar, oedema formation
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Remarks:
- Erythema, eschar, oedema formation
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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