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

Autor: Lovell DP; St George's Medical School, University of London, Cranmer Terrace, London, SW17 0RE, UK. Electronic address: dlovell@sgul.ac.uk., Fellows M; Astra Zeneca, Drug Safety and Metabolism, Cambridge, CB4 0WG, UK., Saul J; Covance Laboratories, Harrogate, North Yorkshire, HG3 1PY, UK., Whitwell J; Covance Laboratories, Harrogate, North Yorkshire, HG3 1PY, UK., Custer L; Bristol-Myers Squibb, New Brunswick, NJ, USA., Dertinger S; Litron Laboratories, Rochester, NY, USA., Escobar P; Merck Co. & Inc., West Point, PA, USA., Fiedler R; Covance Laboratories, Greenfield, IN, USA., Hemmann U; Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany., Kenny J; GlaxoSmithKline, Ware, Hertfordshire, UK., Smith R; Covance Laboratories, Harrogate, North Yorkshire, HG3 1PY, UK., van der Leede BM; Janssen R&D, A Division of Janssen Pharmaceutica N.V., Beerse, Belgium., Zeller A; Pharmaceutical Sciences, pRED Innovation Center Basel, F. Hoffmann-La Roche Ltd, 4070 Basel, Switzerland.
Jazyk: angličtina
Zdroj: Mutation research. Genetic toxicology and environmental mutagenesis [Mutat Res Genet Toxicol Environ Mutagen] 2020 Jan; Vol. 849, pp. 503086. Date of Electronic Publication: 2019 Oct 12.
DOI: 10.1016/j.mrgentox.2019.503086
Abstrakt: 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.
(Copyright © 2019. Published by Elsevier B.V.)
Databáze: MEDLINE
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