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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Veröffentlicht in:Mutation research 2020-01, Vol.849, p.503086-503086, Article 503086
Hauptverfasser: 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.
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container_title Mutation research
container_volume 849
creator 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.
description •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.
doi_str_mv 10.1016/j.mrgentox.2019.503086
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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. 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1879-3592
1873-135X
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source MEDLINE; Elsevier ScienceDirect Journals
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
title Analysis of historical negative control group data from the rat in vivo micronucleus assay
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