Evaluation and interpretation of cytogenetic test results based on biological relevance

The evaluation and interpretation of cytogenetic test data are discussed from the perspective of biological relevance. The reliability of tests must be considered, before evaluation and interpretation. Statistical procedures are important for the evaluation of test data, but for human health risk assessment, biological relevance is essential. Cell culture conditions must be carefully considered. Cells must be healthy in the physiologically controlled culture medium. Osmolality, pH, and temperature are critical factors in keeping the culture medium physiologically normal and avoiding artifactual responses. Careful attention must be paid to the exposure of test chemicals to target cells, in both in vitro and in vivo tests. For in vivo tests, absorption, distribution, metabolism, and excretion are critical issues that affect the exposure of the target cells to the test chemical. The dose-response relationship and reproducibility are also critical factors in biological reliability. I also discuss why so many chemicals show positive results in in vitro cytogenetic assays.