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Toxicological information

Acute Toxicity: oral

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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
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
500 and 2000 mg/kg
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

Sedation was the primary clinical sign. CNS signs tended to have a more rapid onset and prolonged duration with  i. p. dosing (respect p.o. route) . No target organ for toxicity was identified.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
For ziprasidone hydrochloride monohydrate the mouse LD50 is > 2000 mg/kg/bw.
Executive summary:

The acute toxicity of the substance was tested in mice. As a results, the mouse LD50 is > 2000 mg/kg/bw, so the substance is not classified for acute oral toxicity.