NN二甲基甲酰胺.docx

NN二甲基甲酰胺.docx

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NN二甲基甲酰胺

N,N-DIMETHYLFORMAMIDE

Firstdraftpreparedby

G.LongandM.E.Meek,EnvironmentalHealthDirectorate,HealthCanada,and

M.Lewis,CommercialChemicalsEvaluationBranch,EnvironmentCanada

PublishedunderthejointsponsorshipoftheUnitedNationsEnvironmentProgramme,theInternationalLabourOrganization,andtheWorldHealthOrganization,andproducedwithintheframeworkoftheInter-OrganizationProgrammefortheSoundManagementofChemicals.

WorldHealthOrganization

Geneva,2001

TheInternationalProgrammeonChemicalSafety（IPCS）,establishedin1980,isajointventureoftheUnitedNationsEnvironmentProgramme（UNEP）,theInternationalLabourOrganization（ILO）,andtheWorldHealthOrganization（WHO）.TheoverallobjectivesoftheIPCSaretoestablishthescientificbasisforassessmentoftherisktohumanhealthandtheenvironmentfromexposuretochemicals,throughinternationalpeerreviewprocesses,asaprerequisiteforthepromotionofchemicalsafety,andtoprovidetechnicalassistanceinstrengtheningnationalcapacitiesforthesoundmanagementofchemicals.

TheInter-OrganizationProgrammefortheSoundManagementofChemicals（IOMC）wasestablishedin1995byUNEP,ILO,theFoodandAgricultureOrganizationoftheUnitedNations,WHO,theUnitedNationsIndustrialDevelopmentOrganization,theUnitedNationsInstituteforTrainingandResearch,andtheOrganisationforEconomicCo-operationandDevelopment（ParticipatingOrganizations）,followingrecommendationsmadebythe1992UNConferenceonEnvironmentandDevelopmenttostrengthencooperationandincreasecoordinationinthefieldofchemicalsafety.ThepurposeoftheIOMCistopromotecoordinationofthepoliciesandactivitiespursuedbytheParticipatingOrganizations,jointlyorseparately,toachievethesoundmanagementofchemicalsinrelationtohumanhealthandtheenvironment.

WHOLibraryCataloguing-in-PublicationData

N,N-Dimethylformamide.

（Conciseinternationalchemicalassessmentdocument;31）

1.Dimethylformamide-toxicity2.Riskassessment3.Environmentalexposure

I.InternationalProgrammeonChemicalSafetyII.Series

ISBN9241530316（NLMClassification:

QV633）

ISSN1020-6167

TheWorldHealthOrganizationwelcomesrequestsforpermissiontoreproduceortranslateitspublications,inpartorinfull.ApplicationsandenquiriesshouldbeaddressedtotheOfficeofPublications,WorldHealthOrganization,Geneva,Switzerland,whichwillbegladtoprovidethelatestinformationonanychangesmadetothetext,plansforneweditions,andreprintsandtranslationsalreadyavailable.

©WorldHealthOrganization2001

PublicationsoftheWorldHealthOrganizationenjoycopyrightprotectioninaccordancewiththeprovisionsofProtocol2oftheUniversalCopyrightConvention.Allrightsreserved.

ThedesignationsemployedandthepresentationofthematerialinthispublicationdonotimplytheexpressionofanyopinionwhatsoeveronthepartoftheSecretariatoftheWorldHealthOrganizationconcerningthelegalstatusofanycountry,territory,city,orareaorofitsauthorities,orconcerningthedelimitationofitsfrontiersorboundaries.

Thementionofspecificcompaniesorofcertainmanufacturers’productsdoesnotimplythattheyareendorsedorrecommendedbytheWorldHealthOrganizationinpreferencetoothersofasimilarnaturethatarenotmentioned.Errorsandomissionsexcepted,thenamesofproprietaryproductsaredistinguishedbyinitialcapitalletters.

TheFederalMinistryfortheEnvironment,NatureConservationandNuclearSafety,Germany,providedfinancialsupportfortheprintingofthispublication.

TABLEOFCONTENTS

FOREWORD

1.EXECUTIVESUMMARY

2.IDENTITYANDPHYSICAL/CHEMICALPROPERTIES

3.ANALYTICALMETHODS

3.1DMFinworkplaceair

3.2DMFandmetabolitesinbiologicalmedia

4.SOURCESOFHUMANANDENVIRONMENTALEXPOSURE

4.1Naturalsources

4.2Anthropogenicsources

4.3Uses

5.ENVIRONMENTALTRANSPORT,DISTRIBUTION,ANDTRANSFORMATION

5.1Air

5.2Surfacewaterandsediment

5.3Soilandgroundwater

5.4Environmentaldistribution

6.ENVIRONMENTALLEVELSANDHUMANEXPOSURE

6.1Environmentallevels

6.1.1Ambientair

6.1.2Surfacewaterandsediment

6.1.3Soilandgroundwater

6.2Humanexposure

6.2.1Drinking-water

6.2.2Food

6.2.3Multimediastudy

6.2.4Exposureofthegeneralpopulation

6.2.5Occupationalexposure

7.COMPARATIVEKINETICSANDMETABOLISMINLABORATORYANIMALSANDHUMANS

7.1Experimentalanimals

7.2Humans

7.2.1Studiesinhumanvolunteers

7.2.2Occupationalenvironment

7.2.3Otherrelevantdata

7.3Interspeciescomparisons

8.EFFECTSONLABORATORYMAMMALSANDINVITROTESTSYSTEMS

8.1Singleexposure

8.2Irritationandsensitization

8.3Short-termexposure

8.4Medium-termexposure

8.4.1Inhalation

8.4.2Oral

8.5Long-termexposureandcarcinogenicity

8.5.1Inhalation

8.5.2Oral

8.5.3Injection

8.6Genotoxicityandrelatedend-points

8.7Reproductivetoxicity

8.7.1Effectsonfertility

8.7.2Developmentaltoxicity

8.8Neurologicaleffects

9.EFFECTSONHUMANS

9.1Effectsontheliver

9.2Cardiaceffects

9.3Cancer

9.4Genotoxicity

10.EFFECTSONOTHERORGANISMSINTHELABORATORYANDFIELD

10.1Aquaticenvironment

10.2Terrestrialenvironment

11.EFFECTSEVALUATION

11.1Evaluationofhealtheffects

11.1.1Hazardidentificationanddose–responseassessment

Effectsinhumans

Effectsinexperimentalanimals

11.1.2Criteriaforsettingtolerableconcentrationsorguidancevalues

11.1.3Sampleriskcharacterization

11.1.4Uncertaintiesanddegreeofconfidenceinhumanhealthriskcharacterization

11.2Evaluationofenvironmentaleffects

11.2.1Terrestrialassessmentend-points

11.2.2Sampleenvironmentalriskcharacterization

11.2.3Discussionofuncertainty

12.PREVIOUSEVALUATIONSBYINTERNATIONALBODIES

REFERENCES

APPENDIX1—SOURCEDOCUMENT

APPENDIX2—CICADPEERREVIEW

APPENDIX3—CICADFINALREVIEWBOARD

APPENDIX4—BENCHMARKDOSECALCULATIONS

INTERNATIONALCHEMICALSAFETYCARD

RÉSUMÉD’ORIENTATION

RESUMENDEORIENTACIÓN

FOREWORD

ConciseInternationalChemicalAssessmentDocuments（CICADs）arethelatestinafamilyofpublicationsfromtheInternationalProgrammeonChemicalSafety（IPCS）—acooperativeprogrammeoftheWorldHealthOrganization（WHO）,theInternationalLabourOrganization（ILO）,andtheUnitedNationsEnvironmentProgramme（UNEP）.CICADsjointheEnvironmentalHealthCriteriadocuments（EHCs）asauthoritativedocumentsontheriskassessmentofchemicals.

InternationalChemicalSafetyCardsontherelevantchemical（s）areattachedattheendoftheCICAD,toprovidethereaderwithconciseinformationontheprotectionofhumanhealthandonemergencyaction.Theyareproducedinaseparatepeer-reviewedprocedureatIPCS.TheymaybecomplementedbyinformationfromIPCSPoisonInformationMonographs（PIM）,similarlyproducedseparatelyfromtheCICADprocess.

CICADsareconcisedocumentsthatprovidesummariesoftherelevantscientificinformationconcerningthepotentialeffectsofchemicalsuponhumanhealthand/ortheenvironment.TheyarebasedonselectednationalorregionalevaluationdocumentsoronexistingEHCs.BeforeacceptanceforpublicationasCICADsbyIPCS,thesedocumentsundergoextensivepeerreviewbyinternationallyselectedexpertstoensuretheircompleteness,accuracyinthewayinwhichtheoriginaldataarerepresented,andthevalidityoftheconclusionsdrawn.

TheprimaryobjectiveofCICADsischaracterizationofhazardanddose–responsefromexposuretoachemical.CICADsarenotasummaryofallavailabledataonaparticularchemical;rather,theyincludeonlythatinformationconsideredcriticalforcharacterizationoftheriskposedbythechemical.Thecriticalstudiesare,however,presentedinsufficientdetailtosupporttheconclusionsdrawn.Foradditionalinformation,thereadershouldconsulttheidentifiedsourcedocumentsuponwhichtheCICADhasbeenbased.

Riskstohumanhealthandtheenvironmentwillvaryconsiderablydependinguponthetypeandextentofexposure.Responsibleauthoritiesarestronglyencouragedtocharacterizeriskonthebasisoflocallymeasuredorpredictedexposurescenarios.Toassistthereader,examplesofexposureestimationandriskcharacterizationareprovidedinCICADs,wheneverpossible.Theseexamplescannotbeconsideredasrepresentingallpossibleexposuresituations,butareprovidedasguidanceonly.ThereaderisreferredtoEHC1701foradviceonthederivationofhealth-basedtolerableintakesandguidancevalues.

WhileeveryeffortismadetoensurethatCICADsrepresentthecurrentstatusofknowledge,newinformationisbeingdevelopedconstantly.Unlessotherwisestated,CICADsarebasedonasearchofthescientificliteraturetothedateshownintheexecutivesummary.IntheeventthatareaderbecomesawareofnewinformationthatwouldchangetheconclusionsdrawninaCICAD,thereaderisrequestedtocontactIPCStoinformitofthenewinformation.

Procedures

TheflowchartshowstheproceduresfollowedtoproduceaCICAD.Theseproceduresaredesignedtotakeadvantageoftheexpertisethatexistsaroundtheworld—expertisethatisrequiredtoproducethehigh-qualityevaluationsoftoxicological,exposure,andotherdatathatarenecessaryforassessingriskstohumanhealthand/ortheenvironment.TheIPCSRiskAssessmentSteeringGroupadvisestheCo-ordinator,IPCS,ontheselectionofchemicalsforanIPCSriskassessment,whetheraCICADoranEHCisproduced,andwhichinstitutionbearstheresponsibilityofthedocumentproduction,aswellasonthetypeandextentoftheinternationalpeerreview.

Thefirstdraftisbasedonanexistingnational,regional,orinternationalreview.Aut