Division 5.3 Short-term toxicityF1

Short-term toxicity studies must be designed to provide information as to the amount of the active substance that can be tolerated without toxic effects under the conditions of the study. Such studies provide useful data on the risks for those handling and using preparations containing the active substance. In particular, short-term studies provide an essential insight into possible cumulative actions of the active substance and the risks to workers who may be intensively exposed. In addition short-term studies provide information useful in the design of chronic toxicity studies.

The studies, data and information to be provided and evaluated, must be sufficient to permit the identification of effects following repeated exposure to the active substance, and in particular to further establish, or indicate:

• the relationship between dose and adverse effects,

• toxicity of the active substance including where possible the Noael,

• target organs, where relevant,

• the time course and characteristics of poisoning with full details of behavioural changes and possible pathological findings at post-mortem,

• specific toxic effects and pathological changes produced,

• where relevant the persistence and reversibility of certain toxic effects observed, following discontinuation of dosing,

• where possible, the mode of toxic action, and

• the relative hazard associated with the different routes of exposure.