Division 5.2 Acute toxicity

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

1. (a)

   the toxicity of the active substance;

2. (b)

   the time course and characteristics of the effects with full details of behavioural changes, clinical signs, where evident, and possible gross pathological findings at post-mortem;

3. (c)

   the possible need to consider establishing acute reference doses (such as ARfD, aAOEL^f1);

4. (d)

   where possible mode of toxic action;

5. (e)

   the relative hazard associated with the different routes of exposure.

While the emphasis shall be on estimating the toxicity ranges involved, the information generated shall 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.