Genotoxicity – Bacterial Reverse Mutation Study

Genotoxicity studies are conducted to detect the risk of gene mutations, change in number or structure of a cell, and chromosomal or DNA damage caused by a medical device, bio-material, or their extracts. Since no single test can detect all genotoxic agents, a battery approach is usually taken to meet study and regulatory objective utilizing both mammalian and non-mammalian cell culture models

The purpose of this study is to determine if a test solution induces a pyrogenic response following intravenous injection in additional naive subjects after the original test had a equivocal result