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Division 2.2 EVALUATION OF RESULTS

United Kingdom

Original text. Later amendments are not shown.

The findings of the Prenatal Developmental Toxicity Study should be evaluated in terms of the observed effects. The evaluation will include the following information:

  • maternal and embryo/foetal test results, including the evaluation of the relationship, or lack thereof, between the exposure of the animals to the test substance and the incidence and severity of all findings;

  • criteria used for categorising foetal external, soft tissue, and skeletal alterations if categorisation has been done;

  • when appropriate, historical control data to enhance interpretation of study results;

  • the numbers used in calculating all percentages or indices;

  • adequate statistical analysis of the study findings, when appropriate, which should include sufficient information on the method of analysis, so that an independent reviewer/statistician can re-evaluate and reconstruct the analysis;

In any study which demonstrates the absence of any toxic effects, further investigations to establish absorption and bioavailability of the test substance should be considered.