Division 5.10 Summary of mammalian toxicity and overall evaluationF1

A summary of all data and information provided under paragraphs 5.1 through 5.10, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base.

Where relevant, in the light of findings with respect to the analytical profile of batches of the active substance (point 1.11) and any bridging studies conducted (point (iv) of the introduction to Section 5), the relevance of the data as submitted to the assessment of the toxicological profile of the active substance as manufactured, must be argued.

On the basis of an assessment of the data base, and the relevant decision making criteria and guidelines, justifications must be submitted for the Noaels proposed for each relevant study.

On the basis of these data scientifically reasoned proposals for the establishment of ADI and AOEL(s) for the active substance must be submitted.