ABSTRACT
Gene mutation is a vital endpoint for genetic toxicology. The International Council for Harmonization (ICH) M7 Guideline listed the rodent phosphatidylinositol glycan class-A (Pig-a) mutation assay as a suitable following-up system for evaluating impurities that were positive in vitro mutation assays. As a new in vivo somatic cell mutagenicity approach, the distinct advantages of the rodent Pig-a gene mutation assay over such approaches as the transgenic rodent mutation assay are cost-effective, simple and fast. Recently, based on the high conservation of the PIG-A locus, in vitro PIG-A mutation assays in human peripheral blood and human cell lines have been developed, which can be used to monitor and assess clinical gene mutation and pre-clinical genetic toxicology. Here, we review the human cells and methods of PIG-A gene mutation assay, such as human peripheral red blood cells, reticulocyte cells, leukocyte cells, TK6 cells and MCL-5 cells.
