Title: ECVAM Retrospective Validation of In Vitro Micronucleus Test (MNT)
Citation: MUTAGENESIS vol. 23 no. 4 p. 271-283
Publication Year: 2008
JRC N°: JRC40504
ISSN: 0267-8357
URI: http://mutage.oxfordjournals.org/cgi/reprint/23/4/271
DOI: 10.1093/mutage/gen010
Type: Articles in periodicals and books
Abstract: In the past decade several studies comparing the in vitro chromosome aberration test (CAT) and the micronucleus test (MNT) in vitro were performed. A high correlation was observed in each of the studies (>85%), however, no formal validation for the micronucleus in vitro assay has been carried out. Therefore a working group was established by the European Centre for the Validation of Alternative Methods (ECVAM) to pool together the existing data, in order to evaluate the validity of the MNT in vitro on the basis of the modular validation approach. The primary focus of this retrospective validation was on the evaluation of the potential of the MNT in vitro as alternative to the standard chromosome aberration assay in vitro. The working group evaluated in a first step the available published data and came to the conclusion, that two publications (von der Hude W. et al., 2000; Lorge E. et al., 2006) met the criteria for a retrospective validation according to the criteria previously defined by the working group. These two studies were evaluated in depth (including the re-analysis of raw data) and provided the information required for assessing the reliability (reproducibility) of the test. For the assessment of the concordance between the MNT in vitro and the CAT in vitro additional published data were considered. Based on this retrospective validation, the ECVAM Validation Management Team concluded that the MNT in vitro is reliable and relevant and can therefore be used as an alternative method to the CAT in vitro. Following peer review, these conclusions were formally endorsed by the ECVAM Scientific Advisory Committee.
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