LEADER 07102nam 22007455 450 001 9910298317503321 005 20230810210756.0 010 $a3-642-35374-6 024 7 $a10.1007/978-3-642-35374-1 035 $a(CKB)3710000000095033 035 $a(DE-He213)978-3-642-35374-1 035 $a(SSID)ssj0001185975 035 $a(PQKBManifestationID)11675874 035 $a(PQKBTitleCode)TC0001185975 035 $a(PQKBWorkID)11218106 035 $a(PQKB)10041973 035 $a(MiAaPQ)EBC3095731 035 $a(Au-PeEL)EBL3095731 035 $a(CaPaEBR)ebr10968927 035 $a(OCoLC)881306368 035 $a(PPN)177820683 035 $a(EXLCZ)993710000000095033 100 $a20140317d2014 u| 0 101 0 $aeng 135 $aurnn|008mamaa 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aRegulatory Toxicology /$fedited by Franz-Xaver Reichl, Michael Schwenk 205 $a1st ed. 2014. 210 1$aBerlin, Heidelberg :$cSpringer Berlin Heidelberg :$cImprint: Springer,$d2014. 215 $a1 online resource (XXIV, 946 p. 144 illus., 70 illus. in color. eReference.) 300 $aBibliographic Level Mode of Issuance: Monograph 311 $a3-642-35375-4 311 $a3-642-35373-8 327 $aForeword -- 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. 330 $aThis 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. 606 $aPharmacology 606 $aOccupational health services 606 $aMedicine$xResearch 606 $aBiology$xResearch 606 $aChemicals$xSafety measures 606 $aPharmacology 606 $aOccupational Health 606 $aBiomedical Research 606 $aChemical Safety 615 0$aPharmacology. 615 0$aOccupational health services. 615 0$aMedicine$xResearch. 615 0$aBiology$xResearch. 615 0$aChemicals$xSafety measures. 615 14$aPharmacology. 615 24$aOccupational Health. 615 24$aBiomedical Research. 615 24$aChemical Safety. 676 $a615 702 $aReichl$b Franz-Xaver$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aSchwenk$b Michael$4edt$4http://id.loc.gov/vocabulary/relators/edt 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910298317503321 996 $aRegulatory toxicology$9970600 997 $aUNINA