Division 2.1 TREATMENT OF RESULTS

Data shall be reported individually and summarised in tabular form, showing for each test group and each generation the number of animals at the start of the test, the number of animals found dead during the test or killed for humane reasons, the time of any death or humane kill, the number of fertile animals, the number of pregnant females, the number of animals showing signs of toxicity, a description of the signs of toxicity observed, including time of onset, duration, and severity of any toxic effects, the types of parental and offspring observations, the types of histopathological changes, and all relevant litter data.

Numerical results should be evaluated by an appropriate, generally accepted statistical method; the. statistical methods should be selected as part of the design of the study and should be justified. Dose-response statistical models may be useful for analysing data. The report should include sufficient information on the method of analysis and the computer program employed, so that an independent reviewer/statistician can re-evaluate and reconstruct the analysis.