# 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: Main Study

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

The decision rules governing the sequential procedure presented in Annex 2 are extended to include a 5000 mg/kg dose level. Thus, when a main study starting dose of 5000 mg/kg is used, outcome A (≥2 deaths) will require the testing of a second group at 2000 mg/kg; outcome B (evident toxicity and/or ≤1 death) or C (no toxicity) will result in the substance being unclassified according to GHS. Similarly, if a starting dose other than 5000 mg/kg is used then testing will progress to 5000 mg/kg in the event of outcome C at 2000 mg/kg; a subsequent 5000 mg/kg outcome A will result in the substance being assigned to GHS Category 5 and outcomes B or C will lead to the substance being unclassified.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/2B/division/6/division/4 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-2B/division-6/division-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.