# 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: CRITERIA FOR CLASSIFICATION OF TEST SUBSTANCES WITH EXPECTED LD50 VALUES EXCEEDING 2000 MG/KG WITHOUT THE NEED FOR TESTING

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

Criteria for hazard Category 5 are intended to enable the identification of test substances which are of relatively low acute toxicity hazard but which, under certain circumstances may present a danger to vulnerable populations. These substances are anticipated to have an oral or dermal LD50 in the range of 2000-5000 mg/kg or equivalent doses for other routes. The test substance should be classified in the hazard category defined by: 2000mg/kg < LD50 < 5000mg/kg (Category 5 in the GHS) in the following cases:
a)) If directed to this category by any of the testing schemes of Annex 1a-1d, based on mortality incidences;
b)) if reliable evidence is already available that indicates the LD50 to be in the range of Category 5 values; or other animal studies or toxic effects in humans indicate a concern for human health of an acute nature.
c)) through extrapolation, estimation or measurement of data if assignment to a more hazardous class is not warranted, and
reliable information is available indicating significant toxic effects in humans, or
any mortality is observed when tested up to Category 4 values by the oral route, or
where expert judgement confirms significant clinical signs of toxicity, when tested up to Category 4 values, except for diarrhoea, piloerection or an ungroomed appearance, or
where expert judgement confirms reliable information indicating the potential for significant acute effects from the other animal studies.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/n4/division/7/division/1 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-n4/division-7/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.