Genotoxicity – Chromosomal Aberation / Mammalian Cells – Japanese MHLW

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 extract induces a pyrogenic response following intravenous injection in additional subjects after the initial test had a equivocal result