Regulatory Toxicology.pdf

Regulatory Toxicology.pdf


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 of research cover studies on cytotoxic, mutagenic, carcinogenic and embryotoxic effects of chemical compounds (e.g. dental materials) in human and animal cells, abrasion of composites and elution of dental composite components during the chewing situation in the chewing simulator MUC/3 and in vitro- and in vivo studies on toxicokinetic and toxicodynamic effects of chemical compounds (e.g. dental materials). He also work on studies on the pathways and on the analysis of intermediates in the metabolism of dental composite components in biological systems and risk assessments of xenobiotics (e.g. dental materials). Michael Schwenk studied Biochemistry and Medicine in Tuebingen, Germany. He then qualifiedas a toxicologist and pharmacologist and worked in universities, industry and a health agency. He initially focused on experimental cell toxicology, but later shifted to the measurement of chemical residues in humans and to study the health effects of such exposures in different populations. He was active in various national regulatory committees, advised the colleagues of the public health service of Baden-Wurttemberg and received practical experience in all major areas of regulatory toxicology.

Aims and mission of regulatory toxicology.- Working areas of regulatory toxicology.- National and international collaboration in regulatory toxicology.- The regulatory process in toxicology.- Quality assurance in regulatory toxicology.- Toxicological risk assessment.- Characterization of physicochemical parameters in toxicology.- Examination of acute and chronic toxicity.- Examination of organ-toxicity.- Specific toxicity tests for neurotoxicity , immunotoxicity, allergy, irritation, reprotoxicity and carcinogenicity.- Toxicity testing in vitro. Regulatory aspects.- New and future toxicological assays and their regulation.- Computer-based prediction models in regulatory toxicology.- Metabolism tests in regulatory toxicology.- Toxicokinetic tests.- Toxicodynamic tests.- Omics in toxicology.- International regulation of toxicological test systems.- Epidemiological methods in regulatory toxicology.- Studies in volunteers and its regulation.- Statistical evaluation methods in toxicology.- Dose-Response analysis, Identification of threshold levels for chemicals.- Extrapolation-procedures for carcinogenic and non-carcinogenic compounds.- Probabilistic methods in toxicology.- Toxicodynamic models.- Toxicokinetic models.- Exposure analysis for indoor contaminants.- Exposure scenarios in toxicology.- Quality criteria for primary literature in toxicology.- Data-mining in toxicology.- Principles of analytical chemistry for toxicology.- Principles of analytical chemistry for toxicology.- Benchmark dose in regulatory toxicology.- Uncertainty analysis in exposure assessment. Relevance for regulatory toxicology.- Do carcinogens have a threshold dose? pro and contra.- Single compounds vs combination effects in toxicology.- Biomolecules vs smaller chemicals in toxicology.- Sensitive humans vs average persons in toxicology.- Extrapolation factors and safety factors in toxicology.- Background exposure vs additional exposure in human biomonitoring.- Adverse effects vs non-adverse effects in toxicology.- Health based threshold ADI vs MOS in toxicology.- Precaution principle vs danger prevention in toxicology.- Hygenic vs toxicological approaches in regulation.- Protected property and protection level in regulatory toxicology.- Ethical issues in Science. Focus on regulatory toxicology.- Current role of the risk concept in regulatory toxicology.- Risk cycles in toxicology.- Risk minimization in drug development. Regulatory aspects.- Importance of physical-chemical properties for toxicological risk assessment.- Importance of intrinsic toxic properties for risk assessment.- Importance of metabolism. Mechanistic considerations relevant for toxicological regulation.- Dose Response Relationship and Extrapolation in Toxicology. Mechanistic and statistical considerations.- Importance of exposure level for risk toxicological assessment.- Risk characterization in regulatory toxicology.- Risk evaluation regulatory toxicology.- Risk comparision in toxicology.- Risk-benefit considerations in toxicology.- Toxicological risk assessment in different jurisdictions.- Purpose of risk management in regulatory toxicology.- Assessment of limit values in regulatory toxicology.- Limit value setting in different areas of regulatory toxicology.- Registration and approval in regulatory toxicology.- Classification and labelling regulatory toxicology.- Human Biomonitoring. Its importance in toxicological regulation.- Restrictions and prohibitions as tools in regulatory toxicology.- Observance of susceptible population groups in regulatory toxicology.- Toxicological report.- Risk managment in toxicological disasters.- Institutionalized participation in regulatory toxicology.- Risk communication.- Dealing with diseases that have been attributed to chemical exposures.- Reach (and CLP). Its role in regulatory toxicology.- Bridging. The regulation of toxic mixtures.- Regulatory aspects of food toxicology.- Notification of Cosmetic Products and dangerous mixtures in regulatory toxicology.- Checklist: Toxicological risk assessment in practice.- Glossary of toxicology and risk terms.- Limit values and guideline values in regulatory toxicology.-

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.


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