Chapter 10. Genetic Toxicology Testing Guidelines and Regulations

  1. Ching-Hung Hsu and
  2. Todd Stedeford
  1. Lutz Müller1 and
  2. Hans-Jörg Martus2

Published Online: 5 AUG 2010

DOI: 10.1002/9780470622728.ch10

Cancer Risk Assessment

Cancer Risk Assessment

How to Cite

Müller, L. and Martus, H.-J. (2010) Genetic Toxicology Testing Guidelines and Regulations, in Cancer Risk Assessment (eds C.-H. Hsu and T. Stedeford), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470622728.ch10

Editor Information

  1. Health, Safety & Environment, Albemarle Corporation, Baton Rouge, Louisiana, USA

Author Information

  1. 1

    Head Full Development Projects, Non-Clinical Drug Safety, F. Hoffmann-La Roche Ltd., Basel, Switzerland

  2. 2

    Genetic Toxicology, Preclinical Safety, Novartis Institutes for BioMedical Research, Basel, Switzerland

Publication History

  1. Published Online: 5 AUG 2010
  2. Published Print: 6 JUL 2010

ISBN Information

Print ISBN: 9780470238226

Online ISBN: 9780470622728



  • genetic toxicology testing guidelines and regulations;
  • Organization for Economic cooperation and Development (OECD) Guidelines for genotoxicity;
  • quintessence for regulatory assessment - in vivo testing for risk assessment


This chapter contains sections titled:

  • Historical Overview of Genotoxicity Testing Guidelines

  • Organization for Economic cooperation and Development (OECD) Guidelines for Genotoxicity

  • International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines for Pharmaceuticals

  • International Workshop on Genotoxicity Tests (IWGT)

  • The International Program on Chemical Safety (IPCS) Under the Auspices of the World Health Organization (WHO)

  • In Vitro Testing

  • In Vivo Testing

  • European Union Guideline for Testing of Chemicals Under the Registration, Evaluation, Authorization and Restriction of Chemical (REACH)

  • Specialty Guidelines for Genotoxicity: Genotoxic Impurities in Pharmaceuticals

  • The Quintessence for Regulatory Assessment: In Vivo Testing for Risk Assessment

  • Summary and Outlook

  • References