Registration Dossier
Registration Dossier
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EC number: 811-937-7 | CAS number: 1638586-33-0
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:
- ethyl 3-[(3R)-3-{[(1S)-1-phenylethyl]amino}-2,3,4,9-tetrahydro-1H-carbazol-9-yl]propanoate
- EC Number:
- 811-937-7
- Cas Number:
- 1638586-33-0
- Molecular formula:
- C25H30N2O2
- IUPAC Name:
- ethyl 3-[(3R)-3-{[(1S)-1-phenylethyl]amino}-2,3,4,9-tetrahydro-1H-carbazol-9-yl]propanoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: aqua ad iniectabilia to ensure good contact with the skin
- Controls:
- other: The test site surrounding untreated skin served as a control
- Duration of treatment / exposure:
- Exposure time 4 hours
- Observation period:
- Evaluation 60 minutes, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- erythema, eschar and oedema formation
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Remarks:
- erythema, eschar and oedema formation
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Remarks:
- erythema, eschar and oedema formation
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Remarks:
- erythema, eschar and 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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