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 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.