Regulatory toxicology PDF
Preview Regulatory toxicology
Franz-Xaver Reichl Michael Schwenk Editors Regulatory Toxicology Second Edition Regulatory Toxicology (cid:129) Franz-Xaver Reichl Michael Schwenk Editors Regulatory Toxicology Second Edition With236Figuresand127Tables Editors Franz-XaverReichl MichaelSchwenk DepartmentofOperative/Restorative Formerly:HannoverMedicalSchool Dentistry Hannover,Germany PeriodontologyandPedodontics Tübingen,Germany UniversityHospital,LMU München,Germany Walther-Straub-InstituteofPharmacology andToxicology LMUMunich Munich,Germany ISBN978-3-030-57498-7 ISBN978-3-030-57499-4(eBook) ISBN978-3-030-57500-7(printandelectronicbundle) https://doi.org/10.1007/978-3-030-57499-4 1stedition:©Springer-VerlagBerlinHeidelberg2014 2ndedition:©SpringerNatureSwitzerlandAG2021 Thisworkissubjecttocopyright.AllrightsarereservedbythePublisher,whetherthewholeorpartofthe materialisconcerned,specificallytherightsoftranslation,reprinting,reuseofillustrations,recitation, broadcasting,reproductiononmicrofilmsorinanyotherphysicalway,andtransmissionorinformation storageandretrieval,electronicadaptation,computersoftware,orbysimilarordissimilarmethodology nowknownorhereafterdeveloped. Theuseofgeneraldescriptivenames,registerednames,trademarks,servicemarks,etc.inthispublication doesnotimply,evenintheabsenceofaspecificstatement,thatsuchnamesareexemptfromtherelevant protectivelawsandregulationsandthereforefreeforgeneraluse. Thepublisher,theauthors,andtheeditorsaresafetoassumethattheadviceandinformationinthisbook arebelievedtobetrueandaccurateatthedateofpublication.Neitherthepublishernortheauthorsorthe editorsgiveawarranty,expressedorimplied,withrespecttothematerialcontainedhereinorforanyerrors oromissionsthatmayhavebeenmade.Thepublisherremainsneutralwithregardtojurisdictionalclaims inpublishedmapsandinstitutionalaffiliations. ThisSpringerimprintispublishedbytheregisteredcompanySpringerNatureSwitzerlandAG. Theregisteredcompanyaddressis:Gewerbestrasse11,6330Cham,Switzerland Foreword of the First Edition Regulatory toxicology requires knowledge of aspects related to a number of disci- plines of natural and social sciences, including chemistry, biology, bioinformatics, toxicology, epidemiology,exposureassessmentandnutrition,aswell as sociology, psychologyandcommunication, toname a few.It builds abridge between science anddecision-making.Infact,riskanalysis,thecentrepieceofregulatorytoxicology, isoftenseenasanart,inadditiontoitsbeingascience.Thisexplainswhystandard textbooksonregulatorytoxicologyarerare. Tenyearsafterthepublicationofthefirststandardworkonregulatorytoxicology inGerman,anupdated,expandedversionisnowathandinEnglishlanguage.This major publication addresses questions covering various aspects of risk assessment and risk management in general, paying attention to a number of fields including health protection, occupational health, environmental health and consumer protec- tion. Basic principles are outlined, new developments described, and scientific, social and philosophical questions discussed at length. In times of an increased understanding that risk assessment and management need to be conducted in full transparencyandwithfullinvolvementofallstakeholders,issuesofriskperception andriskcommunicationareaddressed. This breadth of information, complemented by a listing of the newest guidance values, makes this book a standard reference to those involved in the field of regulatory toxicology. It is of interest to risk scientists of various backgrounds, to policymakersandtheiradvisors,andalsotoinformedconsumers. Awelcomeandtimelypublication,indeed. WHO,Geneva,Switzerland MagedYounes IUTOX-president,Aarhus,Denmark HermanAutrup v Preface Basedonthesuccessofthefirstedition(2014)ofthebookRegulatoryToxicology, theeditorsdecidedtocompileasecondedition.Thoughthebasicsoftoxicological risk assessment and risk management experienced only moderate changes, the methodstostudyandevaluateadversechemico-biologicalinteractionswerefurther refinedintheyearssincethefirstedition,notleastduetonumerousnovelinvitrotest systems.Moreover,weexperiencedadecadeofmanyadvancesintheconsolidation ofrulesandguidelinesonnationalandinternationallevels. Thechaptersofthefirsteditionwereupdatedforthissecondedition.Moreover, many new chapters were included, dealing with novel developments, such as regulations of nanoparticles, designer drugs, tattoos, biopharmaceuticals and gene therapy. The chapters were written by experts for all those who are involved in toxicologicaldatagenerationanddecision-makingininstitutionsofpureandapplied regulatorytoxicology. In summary, this handbook deals comprehensively with the management of chemical hazards and risks in regulatory toxicology, with a focus on test systems andtheirinterpretation,andtheconceptsusedtoestimateacuteandchronictoxicity to humans and the environment. Such information supports the work of those involved in risk assessment in academia, industry, government or related agencies. It also serves the superior aim of contributing to the protection of human health, cleanenvironments,andasustainabledevelopmentonearth. Theeditorshavesoughttobringconsistencytothediversityofapproachesandof opinions concerning toxicological risk assessment. Guideline values, regulations anddatamaychangewithtimeandamongjurisdictions.Howeverthebasicprinci- ples and approaches discussed in this handbook will continue to provide a stable basis for future decision finding. Opinions expressed are those of the individual authorsanddonotnecessarilyrepresenttheviewsoftheirinstitutions. September2021 Franz-XaverReichl MichaelSchwenk vii Acknowledgments Theeditorswishtothankallauthorsfortheirvaluablecontributionstothiseditionof RegulatoryToxicology.TheyalsothankKerstinBeckertandBarbaraWolffromthe EditorialteamofSpringerfortheexcellentcooperation. ix Contents Volume 1 PartI The“ModusOperandi”ofRegulatoryToxicology ......... 1 1 AimsandMissionofRegulatoryToxicology ................. 3 HelmutGreim 2 WorkingAreasofRegulatoryToxicology .................... 23 MichaelSchwenkandH.PaulA.Illing 3 NationalandInternationalCollaborationinRegulatory Toxicology ............................................ 35 AlfonsoLampenandKlausE.Appel 4 TheRegulatoryProcessinToxicology ...................... 51 DietrichHenschlerandWolfgangDekant 5 QualityAssuranceinToxicology .......................... 59 Klaus-MichaelWollin,StephenHarston,andWernerLilienblum 6 ToxicologicalRiskAssessment ............................ 69 MagedYounesandNikolaosGeorgiadis PartII TestsandMethods ................................. 81 7 MonoclonalAntibodies:DiscoveryandProteinEngineering ..... 83 WibkeLembkeandMathiasLocher 8 CharacterizationofPhysicochemicalParametersin Toxicology ............................................ 99 MathiasLocher 9 ExaminationofAcuteandRepeated-DoseToxicity ............ 107 VolkerMostert,KarlGeorgHeimann,andKevinDoughty 10 ExaminationofOrganToxicity ............................ 117 WolfgangKaufmannandMattC.Jacobsen xi xii Contents 11 SpecificToxicityTestsforNeurotoxicity,Immunotoxicity, Allergy,Irritation,Reprotoxicity,andCarcinogenicity ......... 129 EckhardvonKeutz 12 ToxicityTestingInVitro:RegulatoryAspects ................ 139 EckhardvonKeutz 13 IntegrationofAdvancedTechnologiesintoRegulatory Toxicology ............................................ 149 HorstSpielmannandHelenaKandarova 14 Computer-BasedPredictionModelsinRegulatoryToxicology ... 163 ThomasSteger-HartmannandScottBoyer 15 MetabolismInvestigationsinDrugDevelopment .............. 177 JensRiedelandAlainKrick 16 ToxicokineticTests ..................................... 189 JürgenPauluhn 17 ToxicodynamicTests .................................... 215 AlexanderCartusandDieterSchrenk 18 OmicsinToxicology .................................... 231 HeidrunEllinger-ZiegelbauerandHans-JuergenAhr 19 EpidemiologicalMethodsinRegulatoryToxicology ............ 245 UlrichRanftandGregoryA.Wellenius 20 EarlyClinicalTrials .................................... 261 SimonJägerandMatthiasSchwab 21 StatisticalEvaluationMethodsinToxicology ................. 273 LudwigA.Hothorn 22 Dose-ResponseAnalysis:IdentificationofThresholdLevels forChemicals ......................................... 285 Hans-KarlHeimandPeterMayer 23 ExtrapolationProceduresforCarcinogenicand NoncarcinogenicCompounds ............................. 299 LutzEdler 24 ProbabilisticMethodsinToxicology ........................ 317 OdileMekelandRainerFehr 25 ExposureAnalysisforIndoorContaminants ................. 325 GerhardVolland 26 BenchmarkDoseApproachinRegulatoryToxicology .......... 339 LutzEdler Contents xiii 27 HumanBiomonitoring:ItsImportanceinToxicological Regulation ............................................ 375 MichaelWilhelm PartIII ApproachesUsed ................................. 395 28 ToxicodynamicModels .................................. 397 LutzEdler 29 ToxicokineticModels .................................... 407 JohannesGeorgFilser 30 ExposureScenariosinToxicology .......................... 419 GerhardHeinemeyer 31 QualityCriteriaforPrimaryLiteratureinToxicology ......... 439 KlausSchneider,SebastianHoffmann,and AgnieszkaKinsner-Ovaskainen 32 DataMininginToxicology ............................... 445 PetraWiedemeierandIngeMangelsdorf 33 PrinciplesofAnalyticalChemistryforToxicology ............. 455 JürgenDurnerandDavidC.Watts 34 UncertaintyAnalysisinExposureAssessment-Relevancefor ToxicologicalRiskAssessment ............................ 499 MichaelSchümann,HalukÖzkaynak,andAlexandreZenié PartIV ParadigmsUsedinRiskEvaluation ................... 523 35 Read-AcrossMethodologyinToxicologicalRiskAssessment .... 525 S.E.EscherandA.Bitsch 36 GreenandSustainableChemistryasRegulatoryLevers ........ 539 MichaelSchwenk 37 DoCarcinogensHaveaThresholdDose?TheProsandCons .... 555 BerndKaina,AdamD.Thomas,HartwigVisser,JanG.Hengstler,and RolandFrötschl 38 SingleSubstancesVersusCombinedEffects:Problemsin MixtureToxicology ..................................... 575 ThomasR.H.Büch,EvaA.M.Büch,IngridBoekhoff, JohnH.Duffus,andThomasGudermann 39 BiomoleculesVersusSmallerChemicalsinToxicology: ICH,EU,andUSRecommendations ....................... 581 ManfredRuthsatz,CarloChiavaroli,M.A.Cassar,and EmmanuelleM.Voisin
The list of books you might like
