# Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance), Division 2.2: EVALUATION OF RESULTS

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/n7/division/B.31/division/2/division/2.2 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-n7/division-B.31/division-2/division-2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.