Regulatory Toxicology by Franz-Xaver ReichlRegulatory Toxicology by Franz-Xaver Reichl

Regulatory Toxicology

EditorFranz-Xaver Reichl, Michael Schwenk

Hardcover | March 27, 2014

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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.
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 ...
Title:Regulatory ToxicologyFormat:HardcoverDimensions:1000 pagesPublished:March 27, 2014Publisher:Springer Berlin HeidelbergLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:3642353738

ISBN - 13:9783642353734

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Table of Contents

Foreword.- Introduction.-Operation mode of regulatory toxicology.- Aims and institutions.-Aims and mission.- Applicationareas.- National and international collaboration.- Procedures and standards.- Theregulatory process.- Quality assurance in regulatory toxcicology.- Toxicologicalrisk assessment.- Methodological repertoire.- Toxicological tests.- Characterizationof physicochemical parameters.- Examination of acute and chronic toxicity.- Examinationof organ-toxicity and of laboratory parameters.- Specific tests for neurotox ,immunotox, allergy, irritation, reprotox and carcinogenicity.- Toxicity testingin vitro.- New and future toxicological assays.- Computer-based predictionmodels.- Metabolism tests.- Toxicokinetic tests.- Toxicodynamic tests.- Omics.-International regulation for toxicological test procedures.- Data acquisitionin humans.- Epidemiological methods.- Studies in volunteers.- Chemical analysisin toxicology (New).- Toxicostatistics and models.- Statistical evaluation methods.- Dose-responseanalysis, identification of threshold levels.- Extrapolation-procedures forcarcinogenic and non-carcinogenic compounds.- Probabilistic methods.- Toxicodynamicmodels.- Toxicokinetic models.- Estimation of exposure.- Exposure analysis forindoor contaminants.- Exposure scenarios.- Use of toxiological data.- Qualitycriteria for primary literature.- Data-mining.- Paradigms use in riskevaluation.- Toxicological paradigms.- Do carcinogens have a threshold dose? proand contra.- Single compounds vs combination effects.- Biomolecules vs smallerchemicals.- Sensitive humans vs average persons.- Assessment paradigmas.- Extrapolationfactors and safety factors.- Background exposure vs additional exposure inhuman biomonitoring.- Adverse effects vs non-adverse effects.- ADI vs MOSprinciple.- Precaution principle vs hazard control.- Hygienic vs toxicologicalapproaches.- Protected property and protection level.- Risk characterizationand risk evaluation.- The risk concept.- Current  role of the term "risk".- Riskcycles.- Risk minimization in drug development.- Data required for riskevaluation.- Importance of physical-chemical properties.- Importance ofintrinsic toxic properties.- Importance of metabolism and of mechanism ofaction.- Importance of the extrapolation to lower doses in risk assessment.- Importanceof exposure level for risk assessment.- Risk characterization.- Riskassessment.- Elements of risk assessment.- Risk comparison.- Risk-benefitconsiderations.- Risk assessment in different jurisdictions.- Reach as aregulatory instrument (New).- Risk management and risk communication.- Riskmanagement.- Purpose of risk management.- Assessment of limit values.- Deductionof limit values in different areas.- Registration and approval.- Classificationand labelling.- Monitoring unwanted exposures and effects.- Restrictions andprohibitions.- Observance of susceptible population groups.- The toxicologicalexpert report.- Risk management in toxicological emergencies.- Riskcommunication and participation of affected people.- Institutionalizedparticipation.- The technique of risk communication.- Dealing with diseasesthat have been attributed to chemical exposures.- Addendum: tables and lists.- Checklist:Toxicological risk assessment in practice.- Glossary and risk terms.- Limitvalues, guideline values, tables.-Proposed additional chapters on Ethicsin toxicology? and expansion of the chapter dealing with Immunotoxicology