# 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 1.5.3: Limit test

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

The limit test is primarily used in situations where the experimenter has information indicating that the test material is likely to be nontoxic, i.e., having toxicity only above regulatory limit doses. Information about the toxicity of the test material can be gained from knowledge about similar tested compounds or similar tested mixtures or products, taking into consideration the identity and percentage of components known to be of toxicological significance. In those situations where there is little or no information about its toxicity, or in which the test material is expected to be toxic, the main test should be performed.
A limit test at one dose level of 2000 mg/kg body weight may be carried out with six animals (three animals per step). Exceptionally a limit test at one dose level of 5000 mg/kg may be carried out with three animals (see Annex 2). If test substance-related mortality is produced, further testing at the next lower level may need to be carried out.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/n4/division/B.1/division/1/division/1.5/division/1.5.3 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-n4/division-B.1/division-1/division-1.5/division-1.5.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.