OpenLegislation

Division TEST REPORT

United Kingdom

Original text. Later amendments are not shown.

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.