OpenLegislation

Division 3.1 TEST REPORT

United Kingdom

Original text. Later amendments are not shown.

The report must include the following information:

Test substance:

  • common name, chemical name, CAS number, structural formula (indicating position of the label(s) when radiolabelled material is used) and relevant physical-chemical properties;

  • purity (impurities) of test substance;

  • radiochemical purity of labelled chemical and molar activity (where appropriate).

Reference substances:

  • chemical name and structure of reference substances used for the characterisation and/or identification of transformation products

Test sediments and waters:

  • location and description of aquatic sediment sampling site(s) including, if possible, contamination history;

  • all information relating to the collection, storage (if any) and acclimation of water-sediment systems;

  • characteristics of the water-sediment samples as listed in Table in section 1.8.2.2.

Test conditions:

  • test system used (e.g. flow-through, biometer, way of ventilation, method of stirring, water volume, mass of sediment, thickness of both water and sediment layer, dimension of test vessels, etc.)

  • application of test substance to test system: test concentration used, number of replicates and controls mode of application of test substance (e.g. use of solvent if any), etc.

  • incubation temperature;

  • sampling times;

  • extraction methods and efficiencies as well as analytical methods and detection limits;

  • methods for characterisation/identification of transformation products;

  • deviations from the test protocol or test conditions during the study.

Results:

  • raw data figures of representative analyses (all raw data have to be stored in the GLP-archive);

  • repeatability and sensitivity of the analytical methods used;

  • rates of recovery (% values for a valid study are given in section 1.7.1);

  • tables of results expressed as % of the applied dose and in mgkg-1 in water, sediment and total system (% only) for the test substance and, if appropriate, for transformation products and non-extractable radioactivity;

  • mass balance during and at the end of the studies;

  • a graphical representation of the transformation in the water and sediment fractions and in total system (including mineralisation);

  • mineralisation rates;

  • half-life, DT50 and, if appropriate, DT75 and DT90 values for the test substance and, where appropriate, for major transformation products including confidence limits in water, sediment and in total system;

  • an assessment of the transformation kinetics of the test substance and, where appropriate, the major transformation products;

  • a proposed pathway of transformation, where appropriate;

  • discussion of results.