© 2014

Regulatory Toxicology

  • Franz-Xaver Reichl
  • Michael Schwenk


  • Experts from the various fields of regulatory toxicology have cooperated to produce a harmonized and up-to-date handbook

  • Describes modern test systems, explains basic risk concepts and discusses the dogmas in the different regulation areas

  • Provides a unique insight in the process of toxicological risk assessment, from cell to population

Reference work

Table of contents

  1. Front Matter
    Pages 1-27
  2. The “Modus Operandi” of Regulatory Toxicology

    1. Front Matter
      Pages 1-2
    2. Michael Schwenk, H. Paul A. Illing
      Pages 21-30
    3. Dietrich Henschler, Wolfgang Dekant
      Pages 49-55
    4. Werner Lilienblum, Stephen Harston
      Pages 57-63
    5. Maged Younes
      Pages 65-71
  3. Approaches Used

    1. Front Matter
      Pages 73-74
    2. Karl Georg Heimann, Kevin Doughty
      Pages 81-88
    3. Wolfgang Kaufmann, Matt C. Jacobsen
      Pages 89-98
    4. Eckhard von Keutz
      Pages 107-113
    5. Thomas Steger-Hartmann, Scott Boyer
      Pages 123-131
    6. Gert Ulrich Kuerzel, Christine Mauriac
      Pages 133-139
    7. Jürgen Pauluhn
      Pages 141-160
    8. Dieter Schrenk
      Pages 161-172
    9. Heidrun Ellinger-Ziegelbauer, Hans-Juergen Ahr
      Pages 173-179

About this book


This book will be written by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It is the updated and expanded version of a monograph published in German in 2004.  Chemical safety is regulated on various levels including production, storage, transport, handling, disposal or labelling. This book deals comprehensively with the safety-ensuring methods and concepts employed by regulatory agencies, industry and academics. Toxicologists use experimental and scientific approaches for data collection, e.g. about chemical hazards, physicochemical features or toxicokinetics. The respective experimental methods are described in the book. Toxicologists also deal with much insecurity in the exposure and effect scenarios during risk assessment. To overcome these, they have different extrapolation methods and estimation procedures at their disposal. The book describes these methods in an accessible manner. Differing concepts from one regulation area to another are also covered. Reasons and consequences become evident when reading the book. Altogether, the book Regulatory Toxicology will serve as an excellent reference.


environmental and occupational health exposure analysis regulatory toxicology risk assessment risk management and communication toxicological test procedures

Editors and affiliations

  • Franz-Xaver Reichl
    • 1
  • Michael Schwenk
    • 2
  1. 1.Walther-Straub-Institute of Pharmacology and ToxicologyLMU MunichMunichGermany
  2. 2.Formerly Medical SchoolHannoverGermany

About the editors

Franz-Xaver Reichl studied Microbiology and Medicine in Munich, Germany. He is Head of the Department of Dental Toxicology at the Department of Operative/Restorative Dentistry, Periodontology and Pedodontics, LMU Munich and Head of the International Advisory Centre for the toxicology and biocompatibility of dental materials. His field of research cover studies on cytotoxic, mutagenic, carcinogenic and embryotoxic effects of chemical compounds (e.g. dental materials) in human and animal cells, abrasion of composites and elution of dental composite components during the chewing situation in the chewing simulator MUC/3 and in vitro- and in vivo studies on toxicokinetic and toxicodynamic effects of chemical compounds (e.g. dental materials). He also work on studies on the pathways and on the analysis of intermediates in the metabolism of dental composite components in biological systems and risk assessments of xenobiotics (e.g. dental materials). Michael Schwenk studied Biochemistry and Medicine in Tuebingen, Germany. He then qualifiedas a toxicologist and pharmacologist and worked in universities, industry and a health agency. He initially focused on experimental cell toxicology, but later shifted to the measurement of chemical residues in humans and to study the health effects of such exposures in different populations. He was active in various national regulatory committees, advised the colleagues of the public health service of Baden-Württemberg and received practical experience in all major areas of regulatory toxicology.

Bibliographic information

Industry Sectors
Health & Hospitals
Pharmacology & Toxicology
Consumer Packaged Goods