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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.
List of contents
Foreword.- Introduction.- Operation mode of regulatory toxicology.- Aims and institutions.- Aims and mission.- Application areas.- National and international collaboration.- Procedures and standards.- The regulatory process.- Quality assurance in regulatory toxcicology.- Toxicological risk assessment.- Methodological repertoire.- Toxicological tests.- Characterization of physicochemical parameters.- Examination of acute and chronic toxicity.- Examination of organ-toxicity and of laboratory parameters.- Specific tests for neurotox , immunotox, allergy, irritation, reprotox and carcinogenicity.- Toxicity testing in vitro.- New and future toxicological assays.- Computer-based prediction models.- Metabolism tests.- Toxicokinetic tests.- Toxicodynamic tests.- Omics.- International regulation for toxicological test procedures.- Data acquisition in humans.- Epidemiological methods.- Studies in volunteers.- Chemical analysis in toxicology (New).- Toxicostatistics and models.- Statistical evaluation methods.- Dose-response analysis, identification of threshold levels.- Extrapolation-procedures for carcinogenic and non-carcinogenic compounds.- Probabilistic methods.- Toxicodynamic models.- Toxicokinetic models.- Estimation of exposure.- Exposure analysis for indoor contaminants.- Exposure scenarios.- Use of toxiological data.- Quality criteria for primary literature.- Data-mining.- Paradigms use in risk evaluation.- Toxicological paradigms.- Do carcinogens have a threshold dose? pro and contra.- Single compounds vs combination effects.- Biomolecules vs smaller chemicals.- Sensitive humans vs average persons.- Assessment paradigmas.- Extrapolation factors and safety factors.- Background exposure vs additional exposure in human biomonitoring.- Adverse effects vs non-adverse effects.- ADI vs MOS principle.- Precaution principle vs hazard control.- Hygienic vs toxicological approaches.- Protected property and protection level.- Risk characterization and risk evaluation.- The riskconcept.- Current role of the term "risk".- Risk cycles.- Risk minimization in drug development.- Data required for risk evaluation.- Importance of physical-chemical properties.- Importance of intrinsic toxic properties.- Importance of metabolism and of mechanism of action.- Importance of the extrapolation to lower doses in risk assessment.- Importance of exposure level for risk assessment.- Risk characterization.- Risk assessment.- Elements of risk assessment.- Risk comparison.- Risk-benefit considerations.- Risk assessment in different jurisdictions.- Reach as a regulatory instrument (New).- Risk management and risk communication.- Risk management.- Purpose of risk management.- Assessment of limit values.- Deduction of limit values in different areas.- Registration and approval.- Classification and labelling.- Monitoring unwanted exposures and effects.- Restrictions and prohibitions.- Observance of susceptible population groups.- The toxicological expert report.- Risk management intoxicological emergencies.- Risk communication and participation of affected people.- Institutionalized participation.- The technique of risk communication.- Dealing with diseases that have been attributed to chemical exposures.- Addendum: tables and lists.- Checklist: Toxicological risk assessment in practice.- Glossary and risk terms.- Limit values, guideline values, tables.- Proposed additional chapters on Ethics in toxicology and expansion of the chapter dealing with Immunotoxicology.
About the author
Franz-Xaver Reichl, geboren 1953 in Tegernsee, studierte von 1975 bis 1980 Mikrobiologie an der TU München, 1983 Promotion. Von 1983 bis 1985 studierte er Humanmedizin an der Ludwig-Maximilians-Universität München, 1994 Habilitation für das Fach Pharmakologie und Toxikologie der medizinischen Fakultät der LMU München zum Thema Amalgam. 2002 wurde er zum C3 Univ.-Professor berufen und wurde zugleich Leiter der Abteilung Dental-Toxikologie an der Poliklinik für Zahnerhaltung und Parodontologie der LMU München. Seit 2009 ist Franz-Xaver Reichl stellv. Leiter der Arbeitsgruppe Verträglichkeit von Biomaterialien am Menschen (VERBIO) und seit 2010 Leiter des Beratungszentrums für die Verträglichkeit von Zahnmaterialien (BZVZ) an der LMU München. Er hat zahlreiche Publikationen zum Thema Toxikologie sowie zur Diagnostik und Therapie in der Umweltmedizin veröffentlicht.
Summary
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.
