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Description of key information

The acute toxicity of the substance was tested in albino mice and Sprague-Dawley rats. The substance was administered to mice (strain nor specified) at doses of 500 and 2000 mg/kg p.o. (3/sex/groups) and 300, 500, and 1000 mg/kg i.p. (3M only).

Rats received doses of 500 and 2000 mg/kg p.o. (3/sex) and 500 and 2000 mg/kg i.p. (3M only).

Drug-related deaths occurred only in male mice at 1000 mg/kg i. p. Sedation was the primary clinical sign with both routes. CNS signs tended to have a more rapid onset and prolonged duration with i. p. dosing. No target organ for toxicity was identified.

LD50's were calculated to be >2000 mg/kg p.o. in both mice and rats and >2000 mg/kg i.p. in rats, and 500-1000 mg/kg i.p. in mice.

This study was not definitive due to the lack of a complete battery of measurements, of control groups, and the small n/group.

 

The available date are conclusive but not sufficient for the classification of the substance for acute oral toxicity.

To assess dermal toxicity, ziprasidone was applied to intact skin at a single dose of 2000 mg for 24 hrs. Animals (n= 5) were examined 2 days after drug application. 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 if dermal irritation detected.

The available date are conclusive but not sufficient for the classification of the substance for acute dermal toxicity

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

Oral and dermal LD50's were calculated to be >2000 mg/kg.