List of MAK and BAT values 2018: maximum concentrations and biological tolerance values at the workplace

642 Pages·2018·6.207 MB·English

Deutsche
Forschungsgemeinschaft
List of MAK
and BAT Values
2018
Permanent Senate Commission
for the Investigation
of Health Hazards
of Chemical Compounds
in the Work Area
Report 54
The MAK-Collection for Occupational Health and Safety offers MAK value
documentations, BAT value documentations, air monitoring methods and
biomonitoring methods. It is updated regularly and can be accessed at
www.mak-collection.com
Deutsche
Forschungsgemeinschaft
List of MAK
and BAT Values
2018
Maximum Concentrations
and
Biological Tolerance Values
at the Workplace
Permanent Senate Commission
for the Investigation of Health Hazards
of Chemical Compounds in the Work Area
Report 54
Report 54 of the Permanent Senate Commission for the Investigation of Health Hazards of Chemical
CompoundsintheWorkArea,of1July2018.ThisreportreplacesReport53of1July2017andsupersedes
allpreviousreportsoftheCommission.
DEUTSCHEFORSCHUNGSGEMEINSCHAFT
authorizedandsignedbyProfessorDr.AndreaHartwig
Chair of the PermanentSenate Commission for the Investigation ofHealth Hazards of Chemical Com-
poundsintheWorkArea
DeutscheForschungsgemeinschaft
Kennedyallee40·53175Bonn,FederalRepublicofGermany
Postaladdress:53170Bonn
Phone: [phone]
Telefax: [phone]
[email protected]
www.dfg.de
This book was carefully produced. Nevertheless, authors, editors and publisher do not warrant the information
contained therein to be free of errors. Readers are advised to keep in mind that statements, data, illustration,
proceduraldetailsorotheritemsmayinadvertentlybeinaccurate.
LibraryofCongressCardNo.appliedfor.
DieDeutscheBibliothek–CIP-Cataloguing-in-Publication-Data.
AcataloguerecordforthispublicationisavailablefromDieDeutscheBibliothek.
ISBN:978-3-527-81840-2
© 2018WILEY-VCHVerlagGmbH&Co.KGaA,Weinheim
All rights reserved (including those of translation into other languages). No part of this book may be
reproducedinanyform–byphotoprint,microfilm,oranyothermeans–nortransmittedortranslatedintoa
machinelanguagewithoutwrittenpermissionfromthepublishers.
Registerednames,trademarks,etc.usedinthisbook,evenwhennotspecificallymarkedassuch,arenotto
beconsideredunprotectedbylaw.
CoverDesign:TimWübben,DFG
Composition:KonradTriltsch,PrintunddigitaleMedienGmbH,
97199Ochsenfurt-Hohestadt
Table of Contents
Maximum Concentrations at the Workplace
I Significance, use and derivation of MAK values
Definition................................................. 9
Purpose................................................... 10
Prerequisites ............................................... 10
Derivation of MAK values .................................... 11
a. Selection of substances and collectionof data.................... 11
b. Values based on effectsin man............................... 12
c. Values based on effectson animals............................ 13
d. Exceptional workplaces .................................... 14
e. Odour, irritation and annoyance.............................. 15
f. Habituation ............................................. 15
Documentation ............................................. 16
Publication ................................................ 16
Mixtures ofsubstances ....................................... 16
Analytical controls .......................................... 17
Substances that canoccur simultaneouslyas vapour andaerosol ........ 18
II List ofsubstances
SubstanceswithMAKvaluesandsubstanceslistedinSectionsIIbandIIIto
XV...................................................... 20
Substances for which no MAK value can be establishedat present....... 162
III Carcinogenic substances
Category 1 ................................................ 168
Category 2 ................................................ 170
Category 3 ................................................ 173
Category 3A............................................... 173
Category 3B............................................... 174
Category 4 ................................................ 177
Category 5 ................................................ 179
Groupsof substances requiring specialconsideration................. 179
Carcinogenic medicines.................................... 179
Amines which form carcinogenic nitrosamines on nitrosation........ 180
Monocyclic aromatic amino and nitro compounds ................ 181
Azo colourants........................................... 181
Pyrolysis productsof organicmaterials......................... 182
Fibrousdusts............................................ 184
Classification criteria ................................... 184
Summary ............................................ 186
IV Sensitizing substances ....................................... 187
Criteria for assessmentof contactallergens ........................ 189
ListofMAKandBATValues2018.DFG,DeutscheForschungsgemeinschaft
Copyright©2018WILEY-VCHVerlagGmbH&Co.KGaA,Weinheim
ISBN:978-3-527-81840-2
6 TableofContents
Criteria for assessmentof respiratoryallergens...................... 191
Designation of a substance as anallergen.......................... 193
List of allergens ............................................ 193
Evaluation of members of specific groups of substances............... 201
V Aerosols.................................................. 203
General definitions .......................................... 203
Properties of aerosols which determine their effects.................. 204
Inhalation, deposition andclearance of aerosols inthe respiratorytract.... 205
Conventions for measuring concentrations ofparticles................ 207
Fibrogenic aerosols.......................................... 209
General threshold limit value for dust ............................ 209
Exposures exceedingthe MAK value............................. 210
Ultrafine(aerosol) particles, their agglomeratesandaggregates.......... 210
VI Limitation of exposurepeaks ................................. 212
VII Percutaneous absorption..................................... 213
VIII MAK values and pregnancy .................................. 214
IX Germ cell mutagens......................................... 216
X Substancesrequiring specialconsideration....................... 217
Organicperoxides........................................... 217
Gasolines ................................................. 218
Metal‐working fluids, hydraulicfluids and lubricants................. 218
Metalsand metal compounds................................... 225
Radioactive materials ........................................ 225
Assessment Values in Biological Material
XI Significance anduseof BATvalues............................. 227
Definition................................................. 227
Prerequisites ............................................... 227
Derivation of BATvalues ..................................... 228
Documentation ............................................. 228
Purpose................................................... 229
Correlations between BATandMAKvalues ....................... 229
Surveillance ............................................... 230
Evaluationof analytical data ................................... 230
Allergenic substances ........................................ 231
Carcinogenic substances ...................................... 231
BAR..................................................... 231
Mixtures ofsubstances ....................................... 231
XII List ofsubstances .......................................... 232
TableofContents 7
XIII Carcinogenic substances ..................................... 245
XIV BLW .................................................... 254
XV BAR..................................................... 256
CAS Number Index
CASnumbersofthesubstanceslistedinSectionsIItoXVandontheyellowpages 258
Appendix
Members of theCommission and permanentguest contributors .............. 286
Constitution and procedures of the Commission for the Investigation of Health
Hazards ofChemical Compounds inthe WorkArea..................... 289
Substances inthe lists of MAK and BATvalues reviewed in 2017/2018........ I
Substances being examinedfor the establishmentof MAK and BATvalues ..... V
Procedure of the Commission for the Investigation of Health Hazards of Chemical
Compounds in the Work Area for making changes in or additions to the List of
MAK and BATValues.......................................... XXVIII
★ Indicates a change from the2017 List ofMAKand BATValues
Details of the new threshold values or classifications proposed are listed in the blue
pages(appendix,pageI).TheCommissionhasadoptedtheseproposalsbutputsthemup
for discussion until 31.12.2018. New data or scientific commentary may be submitted to
the Commission’s scientific office (Kommissionssekretariat) until this date. This in-
formation will be examined and taken into consideration in thefinal ratification.
Maximum Concentrations at the Workplace
I Significance, use and derivation of MAK values
Definition
The MAK value (“maximale Arbeitsplatz‐Konzentration”: maximum workplace concen-
tration)isdefinedasthemaximumconcentrationofachemicalsubstance(asgas,vapouror
particulate matter) in the workplace air which generally does not have known adverse
effects on the health of the employee nor cause unreasonable annoyance (e.g. by a
nauseousodour)evenwhenthepersonisrepeatedlyexposedduringlongperiods,usually
for 8 hours daily but assuming on average a 40‐hour working week. Certain aspects of
occupational hygiene associated with liquid substances, e.g. formation of mist with
obscuredvisibility,dampeningofclothing,orcondensationonthefloor,cannotbetaken
intoaccount inestablishing theMAKvalue. Sucheffectshaveawiderangeofvariation,
depending on the industrial process, the procedure, and the physical conditions at the
workplace.Asuitableinstrumentforevaluationisnotyetavailable.Regardlessofthelevel
ofthetoxicologicallybasedMAKvalue,itshouldbeensuredinthesecasesthatsafetyat
the workplace is not placed at risk. This situation is not explicitly mentioned in the
documentations because it isnotknownwhetherthesubstanceexistsasanaerosolatthe
MAKvalue.Asarule,theMAKvalueisgivenasanaverageconcentrationforaperiodof
uptooneworkingdayorshift.MAKvaluesareestablishedonthebasisoftheeffectsof
chemical substances; when possible, practical aspects of the industrial processes and the
resultingexposurepatternsarealsotakenintoaccount.Scientificcriteriafortheprevention
of adverse effectson healthare decisive, not technical andeconomic feasibility.
For the establishmentof a MAK value,
the carcinogenicity (see Section III)
the sensitizing effects (see Section IV)
thecontributiontosystemictoxicityafterpercutaneousabsorption(seeSectionVII)
the risks duringpregnancy (see Section VIII)
the germ cell mutagenicity (see Section IX)
of a substance are evaluated and the substance classified or designated accordingly.
Descriptions of the procedures used by the Commission in the evaluation of these end
pointsmaybefoundintheappropriatesectionsoftheListofMAKandBATValues,inthe
ListofMAKandBATValues2018.DFG,DeutscheForschungsgemeinschaft
Copyright©2018WILEY-VCHVerlagGmbH&Co.KGaA,Weinheim
ISBN:978-3-527-81840-2
10 MaximumConcentrationsattheWorkplace
“Toxikologisch‐arbeitsmedizinischen Begründungen von MAK‐Werten” (available in
EnglishtranslationintheseriesOccupationalToxicants)1andinscientificjournals.2,3,4,5,6
In line with the so‐called “preferred value approach” also used e.g. in the European
Union, MAKvalues areto be establishedpreferentially as thenumerical values 1,2 or 5
ml/m3or, for non‐volatile substances, 1, 2or 5 mg/m3, multiplied by powers often.
IntheuseofMAKvalues,theanalyticalproceduresusedforsamplingandanalysisand
thesampling strategy are ofgreat importance.
Purpose
MAK values promote the protection of health at the workplace. They provide a basis for
judgement of the toxic potential or safety of the concentrations of substances in the
workplaceair.However,theydonotprovideconstantsfromwhichthepresenceorabsence
of a health hazard after longer or shorter periods of exposure can be determined; nor can
provenorsuspecteddamagetohealthbededuced,inanisolatedcase,fromMAKvaluesor
fromtheclassificationofasubstanceascarcinogenic.Suchdeductionscanbemadeonly
on the basis of medical findings, taking into consideration all the circumstances of the
particularcase.Therefore,onprinciple,statementsintheListofMAKandBATValuesare
not to be seen as a priori judgements for individual cases. On principle, observation of
MAK values does not eliminate the necessity for regular medical examination of the
exposed individuals.
MAKvaluesarenotsuitableforprovidingconstantconversionfactorsfordeductionof
health risks associated with long‐term exposure to contaminants in the non‐occupational
atmosphere, e.g., inthe vicinity of industrialplants.
Prerequisites
In principle, the substances are dealt with according to their importance for practical
occupationalhygieneandtheexpertiseofthemembersoftheCommission.Theprerequisite
fortheestablishmentofaMAKvalueistheavailabilityofsufficientdataforthesubstance
from the fields of toxicology, occupational medicine or industrial hygiene. Adequate
documentation is not always available. The List is revised annually and suggestions for
substancestobeaddedandnewinformationonlistedsubstancesarewelcome.7
1 obtainablefromthepublisher:WILEY‐VCH,D‐69451Weinheim,oronlineunder
http://www.mak‐collection.com
2 AdlerID,AndraeU,KreisP,NeumannHG,ThierR,WildD(1999)VorschlägezurEinstufungvonKeim-
zellmutagenen.ArbeitsmedSozialmedUmweltmed34:400–403.
3 DrexlerH(1998)AssignmentofskinnotationforMAKvaluesanditslegalconsequencesinGermany.Int
ArchOccupEnvironHealth71:503–505.
4 Hofmann A (1995) Fundamentals and possibilities of classification of occupational substances as devel-
opmentaltoxicants.IntArchOccupEnvironHealth67:139–145.
5 NeumannHG,ThielmannHW,FilserJG,GelbkeHP,GreimH,KappusH,NorpothKH,ReuterU,Vamvakas
S,WardenbachP,WichmannHE(1998)Changesintheclassificationofcarcinogenicchemicalsinthework
area.(SectionIIIoftheGermanListofMAKandBATValues).JCancerResClinOncol124:661–669.
6 NeumannHG,VamvakasS,ThielmannHW,GelbkeHP,FilserJG,ReuterU,GreimH,KappusH,Norpoth
KH,WardenbachP,WichmannHE(1998)Changesintheclassificationofcarcinogenicchemicalsinthework
area.SectionIIIoftheGermanListofMAKandBATValues.IntArchOccupEnvironHealth71:566–574.
7 PleasecontacttheGeschäftsstellederDeutschenForschungsgemeinschaft,Kennedyallee40,D‐53175Bonn;
ortheSekretariatderKommission:KarlsruherInstitutfürTechnologie(KIT)–Lebensmittelchemie,76131
Karlsruhe.
ISignificance,useandderivationofMAKvalues 11
Derivation of MAK values
MAKvaluesarederivedbythe“DFGCommissionfortheInvestigationofHealthHazards
of Chemical Compounds in the Work Area” exclusively on the basis of scientific
argumentsandarepublishedintheListofMAKandBATValueswhichisissuedannually.
ForthederivationofMAKvalues,certainrulesofprocedurehavebeendevelopedbythe
Commissiononthebasisofestablishedtoxicologicalandoccupationalmedicalconcepts;
answers to at least the more common questions are repeatedly sought in the same way.
ThereforetheusualproceduresandthegeneralprinciplesforthederivationofMAKvalues
are described below. Essentially, these principles correspond with those published by the
European “Scientific Committee onOccupational Exposure Limits, SCOEL”.8
Firstthemostsensitiveparametersdescribedintheavailabledataaretobeidentified,i.
e., those effects which appear first during exposure to increasing concentrations of the
substance.Tobetakenintoaccountinthisprocessarebothlocaleffects,thatis,theresults
of effects on surfaces of the organism which are in contact with the environment (e.g.
mucousmembranesoftherespiratorytractandtheeyes,skin)andalsosystemiceffectsand
effects on the lungs, that is, the results of uptake of the substance into the organism.
Generallytheconcentration‐effectrelationshipsforthesetwokindsofeffectsaredifferent.
ThederivationoftheMAKvalueisbasedonthe“noobservedadverseeffectlevel”forthe
mostsensitiveeffectwithrelevanceforhealth.ANOAELisnotequivalentwithathreshold
which can not be scientifically defined. The NOAEL is a concentration determined by
experimentalconditionsatwhichthegiveneffectissolowthatitdoesnotdifferfromthe
control value. It must be decided whether or not such effects may be considered to be
adverseeffects.Atpresentthereisnogenerallyaccepteddefinitionforan“adverse”effect,
atleastinpartbecauseofthelackofclarityaboutthestillchangingdefinitionforthestate
of being “healthy”;9,10therefore this decision must bemade anew in every case.
Fundamentally, known effects of a substance in man are given highest priority in the
derivation ofthe MAK value.
Intheevaluationofasubstance,knowneffectsofstructuralanaloguesmayalsobetaken
into account.
If no NOAEL may be derived from the available data, a scientifically founded MAK
valuecannotbeestablishedandthesubstanceislistedinSectionIIboftheListofMAKand
BATValues.
a. Selectionofsubstances and collection of data
Forthesubstancesbeingstudied,theepidemiologicaldatapublishedinscientificjournals,
occupational medical reports, toxicological properties and any other potentially useful
information is first assembled by carrying out researches in appropriate databanks. The
referencesfoundintheliteraturesearcharecheckedfortheirrelevancefortheassessment
of the substance in question and the original publications of the selected literature are
examined. When necessary, unpublished internal company data in the form of complete
8 European Commission (Ed.) (1999) Methodology for the derivation of occupational exposure limits: Key
documentationCat.No.CE‐NA‐19253‐EN‐C,ISBN92‐828‐8106‐7,EUR7,OfficeforOfficialPublications
oftheEuropeanCommunities,L‐2985Luxembourg.
9 DFG (Deutsche Forschungsgemeinschaft) (Ed.) (1997) Verhaltenstoxikologie und MAK‐Grenzwertfest-
legungen.WissenschaftlicheArbeitspapiere.Wiley‐VCH,Weinheim.
10 HenschlerD(1992)Evaluationofadverseeffectsinthestandard‐settingprocess.ToxicologyLetters64/65:
53–57.