Division 3.1 Single-dose toxicity

Single-dose toxicity studies may be used to predict:

• the possible effects of acute overdosage in the target species,

• the possible effects of accidental administration to humans,

• the doses which may usefully be employed in the repeat dose studies.

Single-dose toxicity studies should reveal the acute toxic effects of the substance and the time course for their onset and remission.

The studies to be carried out shall be selected with a view to providing information on user safety, e.g. if substantial exposure by inhalation or dermal contact of the user of the veterinary medicinal product is anticipated, those routes of exposure shall be studied.