# 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 1.3: PRINCIPLE OF THE TEST

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

It is the principle of the test that, based on a stepwise procedure with the use of a minimum number of animals per step, sufficient information is obtained on the acute toxicity of the test substance to enable its classification. The substance is administered orally to a group of experimental animals at one of the defined doses. The substance is tested using a stepwise procedure, each step using three animals of a single sex (normally females). Absence or presence of compound-related mortality of the animals dosed at one step will determine the next step, i.e.;
no further testing is needed,
dosing of three additional animals, with the same dose
dosing of three additional animals at the next higher or the next lower dose level.
Details of the test procedure are described in Annex 1. The method will enable a judgement with respect to classifying the test substance to one of a series of toxicity classes defined by fixed LD50 cut-off values.

---
Source: https://www.legislation.gov.uk/eudr/2004/73/annex/n4/division/B.1/division/1/division/1.3 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-n4/division-B.1/division-1/division-1.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.