Registration Dossier

Administrative data

specific investigations: other studies
Adequacy of study:
other information

Data source

Reference Type:
other: Body responsible for the test

Materials and methods

Principles of method if other than guideline:
Test procedure:
Annex V

Results and discussion

Details on results:
Sex Dose(mg/kg) No. of animals Perfusion time (hrs)

M 0 5 2

M 0 5 16

M 666.7 4 2

M 666.7 4 16

M 2000 4 2

M 2000 4 16

The maximum recommended dose of 2000mg/kg was used in this
study. Clinical signs of hunched posture, lethargy, ataxia,
splayed gait and tip toe gait where also seen at this dose

Result = Negative

Applicant's summary and conclusion