Analysis of historical negative control group data from the rat in vivo micronucleus assay

•Historical negative control data are important for assessing data quality and for interpretation of the in vivo micronucleus assay•10 laboratories’ data from rat in vivo micronucleus experiments were analyzed statistically.•Mean incidence ranged from 0.44 to 2.22 micronucleated cells/1000 cells A d...

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Published in:	Mutation research Vol. 849; p. 503086
Main Authors:	Lovell, D.P., Fellows, M., Saul, J., Whitwell, J., Custer, L., Dertinger, S., Escobar, P., Fiedler, R., Hemmann, U., Kenny, J., Smith, R., van der Leede, B.M., Zeller, A.
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01-01-2020
Subjects:	Animals Female Historical negative control data In vivo micronucleus assay Laboratory Proficiency Testing - statistics & numerical data Male Micronuclei, Chromosome-Defective - statistics & numerical data Micronucleus Tests - standards Micronucleus Tests - statistics & numerical data Observer Variation Quality Control Quality control statistics Rats Rats, Sprague-Dawley Rats, Wistar Reproducibility of Results Wistar and Sprague Dawley rats Wistar and Sprague Dawley rats In vivo micronucleus assay Historical negative control data Quality control statistics
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Summary:	•Historical negative control data are important for assessing data quality and for interpretation of the in vivo micronucleus assay•10 laboratories’ data from rat in vivo micronucleus experiments were analyzed statistically.•Mean incidence ranged from 0.44 to 2.22 micronucleated cells/1000 cells A database of micronuclei counts for historical negative control data from rat in vivo micronuclei tests performed in 10 different laboratories was established. Data were available from over 4000 negative control rats from 10 laboratories. The mean frequency of micronucleated cells (MN)/1000 cells ranged from 0.44 to 2.22, a 5-fold range. Overall there were no major sex or strain differences in frequency, although there were some small but statistically significant differences within laboratories. There was appreciable variability between experiments compared with variability within experiments in some laboratories. No specific factor was identified which could explain this variability although it was noted that many different vehicles were used in the experiments. It is hoped that these data will help laboratories beginning studies with the rat micronucleus assay and those involved in the assessment of micronucleus assay results.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1383-5718 1879-3592 1873-135X
DOI:	10.1016/j.mrgentox.2019.503086