Commission Regulation (EU) No 544/2011 (repealed)Show full title

Test substance

(vi) A detailed description (specification) of the material used, as provided for under point 1.11 must be provided. Where testing is done using active substance the material used shall be of that specification that will be used in the manufacture of preparations to be authorised except where radiolabelled material is used.

(vii) Where studies are conducted using active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using active substance as manufactured, unless it can be justified that the test material used is essentially the same, for the purposes of ecotoxicological testing and assessment. In cases of uncertainty, appropriate bridging studies must be submitted to serve as a basis for a decision as to the possible need for repetition of the studies.

(viii) In the case of studies in which dosing extends over a period, dosing shall preferably be done using a single batch of active substance if stability permits.

Whenever a study implies the use of different doses, the relationship between dose and adverse effect must be reported.

(ix) For all feeding studies, average achieved dose must be reported, including where possible the dose in mg/kg body weight. Where dosing via the diet is utilised the test compound must be distributed uniformly in the diet.

(x) It may be necessary to conduct separate studies for metabolites, degradation or reaction products, where these products can constitute a relevant risk to non-target organisms and where their effects cannot be evaluated by the available results relating to the active substance. Before such studies are performed the information from Sections 5, 6 and 7 has to be taken into account.