# 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 1.4.6: Experimental schedules

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

Daily dosing of the parental (P) males and females shall begin when they are 5 to 9 weeks old. Daily dosing of the F1 males and females shall begin at weaning; it should be kept in mind that in cases of test substance administration via diet or drinking water, direct exposure of the F1 pups to the test substance may already occur during the lactation period. For both sexes (P and F1), dosing shall be continued for at least 10 weeks before the mating period. Dosing is continued in both sexes during the 2 week mating period. Males should be humanely killed and examined when they are no longer needed for assessment of reproductive effects. For parental (P) females, dosing should continue throughout pregnancy and up to the weaning of the F1 offspring. Consideration should be given to modifications in the dosing schedule based on available information on the test substance, including existing toxicity data, induction of metabolism or bioaccumulation. The dose to each animal should normally be based on the most recent individual body weight determination. However, caution should be exercised when adjusting the dose during the last trimester of pregnancy.
Treatment of the P and F1 males and females shall continue until termination. All P and F1 adult males and females should be humanely killed when they are no longer needed for assessment of reproductive effects. F1 offspring not selected for mating and all F2 offspring should be humanely killed after weaning.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/n8/division/B.35/division/1/division/1.4/division/1.4.6 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-n8/division-B.35/division-1/division-1.4/division-1.4.6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.