Division I.5

Test reports shall include the following information (where applicable):

1. (a)

   chemical identification of the test pharmacologically active substance, including the isomer ratio and the enantiomers, if appropriate;

2. (b)

   purity of the test substance;

3. (c)

   formulation of the administered drug and method of dose preparation;

4. (d)

   stability, including stability in vehicle and feed when so administered;

5. (e)

   mode of dose administration (dose (expressed in mg/kg body weight), frequency of dosing, and duration of treatment);

6. (f)

   for administration of the test substance other than in the diet or drinking water: the characteristics of the vehicle, including toxicological characteristics;

7. (g)

   species, strain and source of test animals used, use of specific pathogen free animals, sex of the dosed animals, age of the animals at the beginning of the dosing, number of dosed animals;

8. (h)

   dose levels and route and frequency of administration (with dosage in mg/kg bodyweight/day), test period, parameters followed, frequency of observation; conditions of animal husbandry including environmental conditions, water and food consumption (especially for drugs administered in drinking water and/or feed);

9. (i)

   sampling time points;

10. (j)

    description of toxic signs with the inclusion of time of onset, degree and duration (for safety tests), where appropriate;

11. (k)

    results of the clinical observations, gross necropsy, histopathology and of all other parameters investigated (for safety tests), where appropriate;

12. (l)

    where appropriate, an estimate of a no observed (adverse) effect level (‘NO(A)EL’) or lowest observed (adverse) effect level (‘LO(A)EL’) or lower bound of the benchmark dose (‘BMDL’) (for safety tests);

13. (m)

    weight of dosed animals;

14. (n)

    milk and egg production (if applicable);

15. (o)

    specific activity and radio-purity of labelled substances (for residues tests);

16. (p)

    sample collection, sample size, and sample storage;

17. (q)

    analytical methods: a complete description of the procedure, including preparation of analytical samples, instrumentation and data derived from standards, control tissues, fortified tissues and tissues with incurred residues; validation data for the analytical method shall be provided, including limit of detection, limit of quantification, linearity in and around the relevant range of concentrations, stability, accuracy, precision and susceptibility to interferences;

18. (r)

    raw data of all test results including those of the analytical method used to determine the residues in the edible tissues or products, methods of calculation.