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.
