# 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: TESTING AT DOSES ABOVE 2000 MG/KG

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

Recognising the need to protect animal welfare, testing of animals in Category 5 (5000 mg/kg) ranges is discouraged and should only be considered when there is a strong likelihood that results of such a test have a direct relevance for protecting human or animal health (10). No further testing should be conducted at higher dose levels.
When testing is required a dose of 5000mg/kg, only one step (i.e. three animals) is required. If the first animal dosed dies, then dosing proceeds at 2000mg/kg in accordance with the flow charts in Annex 1. If the first animal survives, two further animals are dosed. If only one of the three animals dies, the LD50 value is expected to exceed 5000mg/kg. If both animals die, then dosing proceeds at 2000mg/kg.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/n4/division/7/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-n4/division-7/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.