Regulatory Toxicology

1. Front Matter

   Pages 1-27

   PDF

2. The “Modus Operandi” of Regulatory Toxicology

   1. Front Matter

      Pages 1-2

      PDF

   2. Aims and Mission of Regulatory Toxicology

      • Helmut Greim

      Pages 3-20

   3. Working Areas of Regulatory Toxicology

      • Michael Schwenk, H. Paul A. Illing

      Pages 21-30

   4. National and International Collaboration in Regulatory Toxicology

      • Klaus E. Appel

      Pages 31-47

   5. The Regulatory Process in Toxicology

      • Dietrich Henschler, Wolfgang Dekant

      Pages 49-55

   6. Quality Assurance in Regulatory Toxicology

      • Werner Lilienblum, Stephen Harston

      Pages 57-63

   7. Toxicological Risk Assessment

      • Maged Younes

      Pages 65-71

3. Approaches Used

   1. Front Matter

      Pages 73-74

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   2. Characterization of Physicochemical Parameters in Toxicology

      • Mathias Locher

      Pages 75-80

   3. Examination of Acute and Chronic Toxicity

      • Karl Georg Heimann, Kevin Doughty

      Pages 81-88

   4. Examination of Organ Toxicity

      • Wolfgang Kaufmann, Matt C. Jacobsen

      Pages 89-98

   5. Specific Toxicity Tests for Neurotoxicity, Immunotoxicity, Allergy, Irritation, Reprotoxicity, and Carcinogenicity

      • Eckhard von Keutz

      Pages 99-106

   6. Toxicity Testing In Vitro. Regulatory Aspects

      • Eckhard von Keutz

      Pages 107-113

   7. New and Future Toxicological Assays and Their Regulation

      • Horst Spielmann

      Pages 115-122

   8. Computer-Based Prediction Models in Regulatory Toxicology

      • Thomas Steger-Hartmann, Scott Boyer

      Pages 123-131

   9. Metabolism Tests in Regulatory Toxicology

      • Gert Ulrich Kuerzel, Christine Mauriac

      Pages 133-139

   10. Toxicokinetic Tests

       • Jürgen Pauluhn

       Pages 141-160

   11. Toxicodynamic Tests

       • Dieter Schrenk

       Pages 161-172

   12. Omics in Toxicology

       • Heidrun Ellinger-Ziegelbauer, Hans-Juergen Ahr

       Pages 173-179

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

• Walther-Straub-Institute of Pharmacology and Toxicology, LMU Munich, Munich, Germany

  Franz-Xaver Reichl

• Formerly Medical School, Hannover, Germany

  Michael Schwenk

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.

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