Registration Dossier
Registration Dossier
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EC number: 806-795-8 | CAS number: 909419-73-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- APPROVAL PACKAGE FOR: APPLICATION NUMBER 20-825. Pharmacology Review(s).
- Bibliographic source:
- Food and Drug Administration - Center for Drug Evaluation and research.
- Report date:
- 2000
Materials and methods
Test material
- Reference substance name:
- 5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one;hydrate;hydrochloride
- Cas Number:
- 138982-67-9
- Molecular formula:
- C21H24Cl2N4O2S
- IUPAC Name:
- 5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one;hydrate;hydrochloride
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- 2000 mg
- Duration of treatment / exposure:
- 24 h.
- Number of animals:
- 5
Results and discussion
Any other information on results incl. tables
In the dermal study, no drug-related mortality or clinical signs or changes in body wt or food consumption were observed, nor were any signs of dermal irritation detected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of dermal irritation are detected.
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