OpenLegislation

Division TEST REPORT

United Kingdom

Original text. Later amendments are not shown.

The test report must include the following specific information:

Test substance:

  • physical nature and, where relevant, physiochemical properties;

  • identification including CAS number if known/established;

  • purity.

Vehicle (if appropriate):

  • justification for choice of vehicle, if other than water.

Test animals:

  • species and strain used;

  • number and age of animals;

  • source, housing conditions, diet, 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 concentration, 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 actual dose (mg/kg body weight/day), if applicable;

  • environmental conditions;

  • details of food and water quality.

Results:

Maternal toxic response data by dose, including but not limited to:

  • the number of animals at the start of the test, the number of animals surviving, the number pregnant, and the number aborting, number of animals delivering early;

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

  • data from animals that do not survive to the scheduled kill should be reported but not included in the inter-group statistical comparisons;

  • day of observation of each abnormal clinical sign and its subsequent course;

  • body weight, body weight change and gravid uterine weight, including, optionally, body weight change corrected for gravid uterine weight;

  • food consumption and, if measured, water consumption;

  • necropsy findings, including uterine weight;

  • NOAEL values for maternal and developmental effects should be reported.

Developmental endpoints by dose for litters with implants, including:

  • number of corpora lutea;

  • number of implantations, number and percent of live and dead foetuses and resorptions;

  • number and percent of pre- and post-implantation losses.

Developmental endpoints by dose for litters with live foetuses, including:

  • number and percent of live offspring;

  • sex ratio;

  • foetal body weight, preferably by sex and with sexes combined;

  • external, soft tissue, and skeletal malformations and other relevant alterations;

  • criteria for categorisation if appropriate;

  • total number and percent of foetuses and litters with any external, soft tissue, or skeletal alteration, as well as the types and incidences of individual anomalies and other relevant alterations.

Discussion of results.

Conclusions.