# 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: GENERAL CONSIDERATIONS

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

In the interest of sound science and animal welfare, it is important to avoid the unnecessary use of animals and to minimise any testing that is likely to produce severe responses in animals. All information on a substance relevant to its potential skin corrosivity/irritancy should be evaluated prior to considering in vivo testing. Sufficient evidence may already exist to classify a test substance as to its dermal corrosion or irritation potential without the need to conduct testing in laboratory animals. Therefore, utilising a weight-of-the-evidence analysis and a sequential testing strategy, will minimise the need for in vivo testing, especially if the substance is likely to produce severe reactions.
It is recommended that a weight-of-the-evidence analysis be used to evaluate existing information regarding the skin irritation and corrosion of substances to determine whether additional studies, other than in vivo dermal studies, should be performed to help characterise such potential. Where further studies are needed, it is recommended that the sequential testing strategy be utilised to develop the relevant experimental data. For substances which have no testing history, the sequential testing strategy should be utilised to develop the data set needed to evaluate its dermal corrosion/irritation potential. The testing strategy described in this Annex was developed at an OECD workshop (1) and was later affirmed and expanded in the Harmonised Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances, as endorsed by the 28th Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, in November 1998 (2).
Although this sequential testing strategy is not an integral part of testing method B.4, it expresses the recommended approach for the determination of skin irritation/corrosion characteristics. This approach represents both best practice and an ethical benchmark for in vivo testing for skin irritation/corrosion. The testing method provides guidance for the conduct of the in vivo test and summarises the factors that should be addressed before initiating such a test. The strategy provides an approach for the evaluation of existing data on the skin irritation/corrosion properties of test substances and a tiered approach for the generation of relevant data on substances for which additional studies are needed, or for which no studies have been performed. It also recommends the performance of validated and accepted in vitro or ex vivo tests for skin corrosion/irritation under specific circumstances.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/n5/division/ANNEX/division/1 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-n5/division-ANNEX/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.