Division 5.2 Acute toxicityF1

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

• the toxicity of the active substance,

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

• where possible mode of toxic action, and

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

While the emphasis must be on estimating the toxicity ranges involved, the information generated must also permit the active substance to be classified in accordance with Regulation (EC) No 1272/2008. The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations.