# 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 1.6.3: Ophthalmology

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

For studies longer than 28 days duration, ophthalmologic examination, using an ophthalmoscope or an equivalent suitable instrument, should be made prior to the administration of the test substance and at the termination of the study, preferably on all animals, but at least on animals in the high dose and control groups. If changes in the eyes are detected or, if clinical signs indicate the need, all animals should be examined. For long term studies, an ophthalmologic examination should also be carried out at 13 weeks. Ophthalmologic examinations need not to be conducted if this data is already available from others studies of similar duration and at similar dose levels.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/2H/division/B.43/division/1/division/1.6/division/1.6.3 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-2H/division-B.43/division-1/division-1.6/division-1.6.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.