Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (Text with EEA relevance)
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Changes over time for: Division 6.2.
Timeline of Changes
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EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
6.2.CharacterisationU.K.
1.Each test and reference item should be appropriately identified (e.g. code, chemical abstracts service registry number (CAS number), name, biological parameters).U.K.
2.For each study, the identity, including batch number, purity, composition, concentrations, or other characteristics to appropriately define each batch of the test or reference items should be known.U.K.
3.In cases where the test item is supplied by the sponsor, there should be a mechanism, developed in cooperation between the sponsor and the test facility, to verify the identity of the test item subject to the study.U.K.
4.The stability of test and reference items under storage and test conditions should be known for all studies.U.K.
5.If the test item is administered or applied in a vehicle, the homogeneity, concentration and stability of the test item in that vehicle should be determined. For test items used in field studies (e.g. tank mixes), these may be determined through separate laboratory experiments.U.K.
6.A sample for analytical purposes from each batch of test item should be retained for all studies except short-term studies.U.K.
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