title: The position of the in vitro micronucleus test within the battery of screening for genotoxic potential determination and the regulatory guidelines.
abstract: The in vitro micronucleus test is available to demonstrate the clastogenic and aneugenic potencies of chemicals. This test is easier to evaluate than metaphase analysis and, although used routinely by some laboratories as a prescreening test for the determination of chromosomal mutation induction potency, it has not been recognised by regulatory authorities as a test to be included in the battery of assays for human risk assessment. This limitation is due to the lack of a fixed protocol, a limited data bank, particularly in the case of clastogens, and to the lack of sufficient robust interlaboratory validation studies. If we aim to recognize this test in the form of an OECD guideline and to introduce it as an alternative to in vitro metaphase analysis in cell culture, it is necessary to begin a collaborative study in order to determine the best protocol which is valid for the detection of all clastogens as well as to determine clearly the limits of the test. The use of this in vitro test as a prescreening assay could be very useful as it takes structural and numerical chromosomal abnormalities into account and is simpler to perform than in vitro metaphase analysis.
authors.affiliation: Institut Pasteur de Lille, Laboratory of Toxicology, France.
authors.forename: D
authors.initials: D
authors.lastname: Marzin
mesh_terms: D004353:Drug Evaluation, Preclinical / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D015162:Micronucleus Tests; D018570:Risk Assessment; D018675:Toxicity Tests