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.

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.