Registration Dossier

Diss Factsheets

Administrative data

Description of key information

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.

To assess the potential for ziprasidone to produce eye irritation in rabbits (New Zealand White), ziprasidone was applied as a powder (44.9 mg) to the conjunctival sac of the left eye; the right eye served as a control.

Animals (n= 3/grp) were evaluated ("... with minimal manipulation and without the use of fluorescein) for 4 days postdosing. Apparently, at 24 hr postdosing, eyes were examined following application of 2% fluorescein.

No signs of ocular irritation were detected in cornea, iris, or conjunctivae. However, according to the text, the following were noted: (1) redness of the conjunctiva in the treated eye of each rabbit, (2) iritis and "slight circumcorneal reddening" in the eye of one rabbit; in this rabbit. By 48 hrs, all treated eyes appeared normal. Again, as in the dermal study, no positive controls were included in the study; also, no inert substance was tested to control for mechanical irritation effects.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No sign of dermal and eye irritation were detected.