Commission Directive 2004/73/ECShow full title

3 REPORTING U.K.

TEST REPORT U.K.

The test report must include the following information:

Test substance:

• physical nature and, where relevant, physicochemical properties;

• identification data;

• purity.

Vehicle (if appropriate):

• justification for choice of vehicle if other than water.

Test animals:

• species/strain used;

• number, age and sex of animals;

• source, housing conditions, diet, nesting materials, etc.;

• individual weights of animals at the start of the test.

Test conditions:

• rationale for dose level selection;

• details of test substance formulation/diet preparation, achieved concentrations;

• stability and homogeneity of the preparation;

• details of the administration of the test substance;

• conversion from diet/drinking water test substance concentration (ppm) to the achieved dose (mg/kg body weight/day), if applicable;

• details of food and water quality.

Results:

• food consumption, and water consumption if available, food efficiency (body weight gain per gram of food consumed), and test material consumption for P and F1 animals, except for the period of cohabitation and for at least the last third of lactation;

• absorption data (if available);

• body weight data for P and F1 animals selected for mating;

• litter and pup weight data;

• body weight at sacrifice and absolute and relative organ weight data for the parental animals;

• nature, severity and duration of clinical observations (whether reversible or not);

• time of death during the study or whether animals survived to termination;

• toxic response data by sex and dose, including indices of mating, fertility, gestation, birth, viability, and lactation; the report should indicate the numbers used in calculating these indices;

• toxic or other effects on reproduction, offspring, post-natal growth, etc.;

• necropsy findings;

• detailed description of all histopathological findings;

• number of P and F1 females cycling normally and cycle length;

• total cauda epididymal sperm number, percent progressively motile sperm, percent morphologically normal sperm, and percent of sperm with each identified abnormality;

• time-to-mating, including the number of days until mating;

• gestation length;

• number of implantations, corpora lutea, litter size;

• number of live births and post-implantation loss;

• number of pups with grossly visible abnormalities, if determined the number of runts should be reported;

• data on physical landmarks in pups and other post natal developmental data; physical landmarks evaluated should be justified;

• data on functional observations in pups and adults, as applicable;

• tatistical treatment of results, where appropriate.

Discussion of results.

Conclusions, including NOAEL values for maternal and offspring effects.