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, sto...

Full description

Bibliographic Details
Other Authors: Reichl, Franz-Xaver (Editor), Schwenk, Michael (Editor)
Format: eBook
Language:English
Published: Berlin, Heidelberg Springer Berlin Heidelberg 2014, 2014
Edition:1st ed. 2014
Subjects:
Online Access:
Collection: Springer eBooks 2005- - Collection details see MPG.ReNa
LEADER 05992nmm a2200385 u 4500
001 EB000737013
003 EBX01000000000000000588445
005 00000000000000.0
007 cr|||||||||||||||||||||
008 140407 ||| eng
020 |a 9783642353741 
100 1 |a Reichl, Franz-Xaver  |e [editor] 
245 0 0 |a Regulatory Toxicology  |h Elektronische Ressource  |c edited by Franz-Xaver Reichl, Michael Schwenk 
250 |a 1st ed. 2014 
260 |a Berlin, Heidelberg  |b Springer Berlin Heidelberg  |c 2014, 2014 
300 |a 144 illus., 70 illus. in color. eReference  |b online resource 
505 0 |a 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 --  
505 0 |a 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) --  
505 0 |a 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 --  
505 0 |a 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 
653 |a Chemicals / Safety measures 
653 |a Occupational Health 
653 |a Medicine / Research 
653 |a Biology / Research 
653 |a Chemical Safety 
653 |a Occupational health services 
653 |a Biomedical Research 
653 |a Pharmacology 
700 1 |a Schwenk, Michael  |e [editor] 
041 0 7 |a eng  |2 ISO 639-2 
989 |b Springer  |a Springer eBooks 2005- 
028 5 0 |a 10.1007/978-3-642-35374-1 
856 4 0 |u https://doi.org/10.1007/978-3-642-35374-1?nosfx=y  |x Verlag  |3 Volltext 
082 0 |a 615 
520 |a 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