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 risk concept.- 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 in toxicological 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 Skryť popis