Registration Dossier
Registration Dossier
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EC number: 806-795-8 | CAS number: 909419-73-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 500 and 2000 mg/kg p.o.
- No. of animals per sex per dose:
- 3
- Control animals:
- not specified
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
LD50's were calculated to be >2000 mg/kg p.o.
This study was not definitive due to the lack of a complete battery of measurements, of control groups, and the small n/group.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- For ziprasidone hydrochloride monohydrate the rat LD50 is > 2000 mg/kg/bw.
- Executive summary:
The acute toxicity of the substance was tested in Sprague-Dawley rats. As a results, the rat LD50 is > 2000 mg/kg/bw, so the substance is not classified for acute oral toxicity.
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