Journal
ENVIRONMENTAL AND MOLECULAR MUTAGENESIS
Volume 62, Issue 3, Pages 227-237Publisher
WILEY
DOI: 10.1002/em.22427
Keywords
flow cytometry; genotoxicity; mutagen; mutation assay; Pig‐ a gene
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Funding
- National Institutes of Health, National Institute of Environmental Health Sciences [R44-ES028163]
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This article provides guidance on best practices for designing and conducting rodent Pig-a studies to evaluate test substance safety, with a focus on the rat model. Various aspects of assay conduct, including laboratory proficiency, minimum number of animals per dose group, preferred treatment and blood sampling schedule, and statistical analysis are described.
The rodent Pig-a assay is a flow cytometric, phenotype-based method used to measure in vivo somatic cell mutation. An Organization for Economic Co-operation and Development (OECD) test guideline is currently being developed to support routine use of the assay for regulatory purposes (OECD project number 4.93). This article provides advice on best practices for designing and conducting rodent Pig-a studies in support of evaluating test substance safety, with a focus on the rat model. Various aspects of assay conduct, including laboratory proficiency, minimum number of animals per dose group, preferred treatment and blood sampling schedule, and statistical analysis are described.
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