The micronucleus test is a standard genotoxicity assay that detects chromosomal damage or spindle poisons by identifying micronuclei—small, extra-nuclear bodies containing chromosome fragments or entire chromosomes that were not properly segregated during cell division. It can be performed in vitro using cell cultures or in vivo using animal models like mice, and is widely used in toxicology to screen for potential carcinogens and assess genome stability. The test is considered reliable, can provide information on the mechanism of genotoxicity (clastogenic vs. aneugenic), and is described in OECD guidelines.
If chemical analytical testing and the toxicological risk assessment fails to demonstrate that leachables of a medical device are associated with an acceptable risk for genotoxicity, genotoxicity tests are required to assess the potential presence of toxins that can impact the genetic material of cells. Since no single test can detect all genotoxins, the standard for medical device genotoxicity testing […]