Regulatory aspects of genotoxicity testing: from hazard identification to risk assessment

Mutat Res. 2008 Nov 17;657(1):84-90. doi: 10.1016/j.mrgentox.2008.09.004. Epub 2008 Sep 24.


This symposium focused on the use of tests for chromosomal damage, and other genotoxicity measures, for detection of potentially harmful chemicals. The speakers discussed the information that has been gained over the last three decades about the use of "short-term tests" for genotoxicity in cultured cells and in animals (mainly rodents), and the ongoing debates about the rational use of data from such experimental systems in trying to extrapolate to an understanding of potential human risk. The overall theme was that the field of regulatory toxicology currently is over-reliant on qualitative outcomes of in vitro hazard-screening tests, generally conducted at the maximum achievable exposures, and needs a more realistic approach that incorporates in vivo exposure levels and dose-response information.

MeSH terms

  • Animals
  • Cells, Cultured
  • Chromosome Aberrations
  • Dose-Response Relationship, Drug
  • Guidelines as Topic
  • Hazardous Substances / toxicity
  • Humans
  • Mutagenicity Tests / methods*
  • Risk Assessment / methods*
  • Toxicology / methods


  • Hazardous Substances