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These studies are of value in:
the prediction of genotoxic potential
the early identification of genotoxic carcinogens
the elucidation of the mechanism of action of some carcinogens
To avoid responses that are artifacts of the test system, excessively toxic doses must not be used in either in vitro or in vivo assays for mutagenicity. This approach should be regarded as general guidance. It is important that a flexible approach is adopted, with selection of further tests being' dependant upon interpretation of results at each stage.
In vitro mutagenicity tests (bacterial assay for gene mutation, test for clastogenicity in mammalian cells and test for gene mutation in mammalian cells) must always be performed.
Acceptable test guidelines are:
Directive 92/69/EEC Method B14 — Salmonella Typhimurium reverse mutation assay
Directive 92/69/EEC Method B10 — in vitro mammalian cytogenetic test
Directive 87/302/EEC, Part B — in vitro mammalian cell gene mutation test
If all the results of the in vitro studies are negative further resting must be done with consideration of other relevant information available (including toxicokinetic, toxicodynamic and physico-chemical data and data on analogous substances). The test can be an in vivo study or an in vitro study using a different metabolizing system from that/those previously used.
If the in vitro cytogenetic test is positive, an in vivo test using somatic cells (metaphase analysis in rodent bone marrow or micronucleus test in rodents) must be conducted.
If either of the in vitro gene mutation tests are positive, an in vivo test to investigate unscheduled DNA synthesis or a mouse spot test must be conducted.
Acceptable test guidelines are:
Directive 92/69/EEC Method B12 — Micronucleus test,
Directive 87/302/EEC Part B — Mouse spot test,
Directive 92/69/EEC Method B11 — In vivo Mammalian Bone-Marrow cytogenetic test, Chromosomal analysis.
When any result of an in vivo study in somatic cells is positive, in vivo testing for germ cell effects may be justified. The necessity for conducting these tests will have to be considered on a case by case basis, taking into account information regarding toxicokinetics, use and anticipated exposure. Suitable tests would need to examine interaction with DNA (such as the dominant lethal assay), to look at the potential for inherited effects and possibly make a quantitative assessment of heritable effects. It is recognized that in view of their complexity, the use of quantitative studies would require strong justification.]
Textual Amendments
Substance within the meaning of the definition of Article 2, point 3.
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