BENTONITE, KAOLIN, AND SELECTED CLAY MINERALS

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This report contains the collective views of an international group ofexperts and does not necessarily represent the decisions or the stated policyof the United Nations Environment Programme, the International LabourOrganization, or the World Health Organization.Environmental Health Criteria 231BENTONITE, KAOLIN, ANDSELECTED CLAY MINERALSFirst draft prepared by Dr Zoltán Adamis, József Fodor NationalCenter for Public Health, National Institute of Chemical Safety,Budapest, Hungary; and Dr Richard B. Williams, US EnvironmentalProtection Agency, Washington, DC, and Regional Office for theAmericas of the World Health OrganizationThe layout and pagination of this pdf file and of the printed EHCare not identicalPublished under the joint sponsorship of the United NationsEnvironment Programme, the International LabourOrganization, and the World Health Organization, andproduced within the framework of the Inter-OrganizationProgramme for the Sound Management of Chemicals.World Health OrganizationGeneva, 2005

The International Programme on Chemical Safety (IPCS), established in 1980, is ajoint venture of the United Nations Environment Programme (UNEP), the International LabourOrganization (ILO), and the World Health Organization (WHO). The overall objectives of theIPCS are to establish the scientific basis for assessment of the risk to human health and theenvironment from exposure to chemicals, through international peer review processes, as aprerequisite for the promotion of chemical safety, and to provide technical assistance instrengthening national capacities for the sound management of chemicals.The Inter-Organization Programme for the Sound Management of Chemicals(IOMC) was established in 1995 by UNEP, ILO, the Food and Agriculture Organization ofthe United Nations, WHO, the United Nations Industrial Development Organization, theUnited Nations Institute for Training and Research, and the Organisation for Economic Cooperation and Development (Participating Organizations), following recommendations madeby the 1992 UN Conference on Environment and Development to strengthen cooperation andincrease coordination in the field of chemical safety. The purpose of the IOMC is to promotecoordination of the policies and activities pursued by the Participating Organizations, jointlyor separately, to achieve the sound management of chemicals in relation to human health andthe environment.WHO Library Cataloguing-in-Publication DataBentonite, kaolin, and selected clay minerals.(Environmental health criteria ; 231)1.Bentonite - toxicity 2.Kaolin - toxicity 3.Aluminum silicates - toxicity4.Environmental exposure 5.Risk assessment I.International Programme for ChemicalSafety II.SeriesISBN 92 4 157231 0ISSN 0250-863X(LC/NLM classification: QV 65) World Health Organization 2005All rights reserved. Publications of the World Health Organization can be obtained fromMarketing and Dissemination, World Health Organization, 20 Avenue Appia, 1211 Geneva27, Switzerland (tel: 41 22 791 2476; fax: 41 22 791 4857; email: bookorders@who.int).Requests for permission to reproduce or translate WHO publications — whether for sale or fornoncommercial distribution — should be addressed to Marketing and Dissemination, at theabove address (fax: 41 22 791 4806; email: permissions@who.int).The designations employed and the presentation of the material in this publication do notimply the expression of any opinion whatsoever on the part of the World Health Organizationconcerning the legal status of any country, territory, city or area or of its authorities, orconcerning the delimitation of its frontiers or boundaries. Dotted lines on maps representapproximate border lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers’ products does not implythat they are endorsed or recommended by the World Health Organization in preference toothers of a similar nature that are not mentioned. Errors and omissions excepted, the names ofproprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by WHO to verify the information containedin this publication. However, the published material is being distributed without warranty ofany kind, either express or implied. The responsibility for the interpretation and use of thematerial lies with the reader. In no event shall the World Health Organization be liable fordamages arising from its use.This document was technically and linguistically edited by Marla Sheffer, Ottawa,Canada, and printed by Wissenchaftliche Verlagsgesellschaft mbH, Stuttgart, Germany.

CONTENTSENVIRONMENTAL HEALTH CRITERIA FORBENTONITE, KAOLIN, AND SELECTED CLAY MINERALSPREAMBLEviiiACRONYMS AND ABBREVIATIONSxvi1.SUMMARY1.1 Identity, physical and chemical properties, andanalytical methods1.2 Sources of human and environmental exposure1.3 Environmental levels and human exposure1.4 Kinetics and metabolism in laboratory animalsand humans1.5 Effects on laboratory mammals and in vitro testsystems1.6 Effects on humans1.7 Effects on other organisms in the laboratory and field1.8 Evaluation of human health risks and effects on theenvironment2.IDENTITY, PHYSICAL AND CHEMICALPROPERTIES, AND ANALYTICAL METHODS2.1 Introduction2.2 Identity2.2.1 Bentonite2.2.2 Kaolin2.2.3 Other clays2.3 Physical and chemical properties2.3.1 Bentonite2.3.2 Kaolin2.3.3 Other clays2.3.4 Surface chemistry2.3.5 Trace elements in clays2.4 Analytical methods2.4.1 Quantitative measurement of dust2.4.2 Identification of iii

EHC 231: Bentonite, Kaolin, and Selected Clay Minerals3.4.5.6.ivSOURCES OF HUMAN AND ENVIRONMENTALEXPOSURE233.1 Natural occurrence3.1.1 Bentonite3.1.2 Kaolin3.1.3 Other clays3.2 Anthropogenic sources3.2.1 Production levels and sources3.2.1.1 Bentonite3.2.1.2 Kaolin3.2.1.3 Other clays3.2.2 Uses3.2.2.1 Bentonite3.2.2.2 Kaolin3.2.2.3 Other clays23232324252525273031313437ENVIRONMENTAL LEVELS AND HUMANEXPOSURE404.1 General population exposure4.1.1 Bentonite4.1.2 Kaolin and other clays4.2 Occupational exposure4.2.1 Bentonite4.2.2 Kaolin4.2.3 Other clays40404042424554KINETICS AND METABOLISM IN LABORATORYANIMALS AND HUMANS56EFFECTS ON LABORATORY MAMMALS ANDIN VITRO TEST SYSTEMS596.1 Single exposure6.1.1 Bentonite6.1.2 Kaolin6.1.2.1 Intratracheal administration6.1.2.2 Parenteral administration6.1.3 Other clays6.2 Repeated exposure59597070777778

6.36.46.56.66.77.8.9.6.2.1 Bentonite6.2.2 KaolinGenotoxicityReproductive effectsAdministration with other agents6.5.1 Kaolin and microbes and microbe-derivedfactors6.5.2 Kaolin and quartzIn vitro test systems6.6.1 Bentonite6.6.2 Kaolin6.6.2.1 Haemolysis6.6.2.2 Macrophage studies6.6.2.3 Other tissue cultures and in vitrosystems6.6.3 Other clays6.6.4 Relationships between in vivo and in vitrostudiesSummary of the effects of quartz7882838384848585859797108109110110110EFFECTS ON HUMANS1127.1 General population7.2 Occupational exposure7.2.1 Bentonite7.2.2 Kaolin7.2.2.1 Kaolin workers, United Kingdom7.2.2.2 Kaolin workers, USA7.2.2.3 Kaolin workers, other countries7.2.2.4 Brick and tile workers and others7.3 Summary of the effects of quartz112112112118119128130130131EFFECTS ON OTHER ORGANISMS IN THELABORATORY AND FIELD133EVALUATION OF HUMAN HEALTH RISKS ANDEFFECTS ON THE ENVIRONMENT1359.1 Evaluation of human health risks9.2 Evaluation of effects on the environment135137v

EHC 231: Bentonite, Kaolin, and Selected Clay Minerals10. CONCLUSIONS AND RECOMMENDATIONS FORPROTECTION OF HUMAN HEALTH AND THEENVIRONMENT13811. FURTHER RESEARCH13912. PREVIOUS EVALUATIONS BY N168vi

NOTE TO READERS OF THE CRITERIA MONOGRAPHSEvery effort has been made to present information in the criteriamonographs as accurately as possible without unduly delaying theirpublication. In the interest of all users of the Environmental HealthCriteria monographs, readers are requested to communicate any errorsthat may have occurred to the Director of the International Programmeon Chemical Safety, World Health Organization, Geneva, Switzerland,in order that they may be included in corrigenda.vii

Environmental Health CriteriaPREAMBLEObjectivesIn 1973 the WHO Environmental Health Criteria Programme wasinitiated with the following objectives:(i)(ii)(iii)(iv)to assess information on the relationship between exposure toenvironmental pollutants and human health, and to provideguidelines for setting exposure limits;to identify new or potential pollutants;to identify gaps in knowledge concerning the health effects ofpollutants;to promote the harmonization of toxicological and epidemiological methods in order to have internationally comparableresults.The first Environmental Health Criteria (EHC) monograph, onmercury, was published in 1976, and since that time an ever-increasingnumber of assessments of chemicals and of physical effects have beenproduced. In addition, many EHC monographs have been devoted toevaluating toxicological methodology, e.g., for genetic, neurotoxic,teratogenic and nephrotoxic effects. Other publications have beenconcerned with epidemiological guidelines, evaluation of short-termtests for carcinogens, biomarkers, effects on the elderly and so forth.Since its inauguration the EHC Programme has widened its scope,and the importance of environmental effects, in addition to healtheffects, has been increasingly emphasized in the total evaluation ofchemicals.The original impetus for the Programme came from World HealthAssembly resolutions and the recommendations of the 1972 UNConference on the Human Environment. Subsequently the workbecame an integral part of the International Programme on ChemicalSafety (IPCS), a cooperative programme of UNEP, ILO and WHO. Inthis manner, with the strong support of the new partners, theimportance of occupational health and environmental effects was fullyrecognized. The EHC monographs have become widely established,used and recognized throughout the world.viii

The recommendations of the 1992 UN Conference on Environmentand Development and the subsequent establishment of theIntergovernmental Forum on Chemical Safety with the priorities foraction in the six programme areas of Chapter 19, Agenda 21, all lendfurther weight to the need for EHC assessments of the risks ofchemicals.ScopeThe criteria monographs are intended to provide critical reviews onthe effect on human health and the environment of chemicals and ofcombinations of chemicals and physical and biological agents. Assuch, they include and review studies that are of direct relevance forthe evaluation. However, they do not describe every study carried out.Worldwide data are used and are quoted from original studies, not fromabstracts or reviews. Both published and unpublished reports areconsidered, and it is incumbent on the authors to assess all the articlescited in the references. Preference is always given to published data.Unpublished data are used only when relevant published data areabsent or when they are pivotal to the risk assessment. A detailedpolicy statement is available that describes the procedures used forunpublished proprietary data so that this information can be used in theevaluation without compromising its confidential nature (WHO (1990)Revised Guidelines for the Preparation of Environmental HealthCriteria Monographs. PCS/90.69, Geneva, World Health Organization).In the evaluation of human health risks, sound human data,whenever available, are preferred to animal data. Animal and in vitrostudies provide support and are used mainly to supply evidencemissing from human studies. It is mandatory that research on humansubjects is conducted in full accord with ethical principles, includingthe provisions of the Helsinki Declaration.The EHC monographs are intended to assist national and international authorities in making risk assessments and subsequent riskmanagement decisions. They represent a thorough evaluation of risksand are not, in any sense, recommendations for regulation or standardsetting. These latter are the exclusive purview of national and regionalgovernments.ix

EHC 231: Bentonite, Kaolin, and Selected Clay MineralsContentThe layout of EHC monographs for chemicals is outlined below. Summary — a review of the salient facts and the risk evaluation ofthe chemicalIdentity — physical and chemical properties, analytical methodsSources of exposureEnvironmental transport, distribution and transformationEnvironmental levels and human exposureKinetics and metabolism in laboratory animals and humansEffects on laboratory mammals and in vitro test systemsEffects on humansEffects on other organisms in the laboratory and fieldEvaluation of human health risks and effects on the environmentConclusions and recommendations for protection of human healthand the environmentFurther researchPrevious evaluations by international bodies, e.g., IARC, JECFA,JMPRSelection of chemicalsSince the inception of the EHC Programme, the IPCS hasorganized meetings of scientists to establish lists of priority chemicalsfor subsequent evaluation. Such meetings have been held in Ispra,Italy, 1980; Oxford, United Kingdom, 1984; Berlin, Germany, 1987;and North Carolina, USA, 1995. The selection of chemicals has beenbased on the following criteria: the existence of scientific evidence thatthe substance presents a hazard to human health and/or the environment; the possible use, persistence, accumulation or degradation of thesubstance shows that there may be significant human or environmentalexposure; the size and nature of populations at risk (both human andother species) and risks for environment; international concern, i.e., thesubstance is of major interest to several countries; adequate data on thehazards are available.If an EHC monograph is proposed for a chemical not on thepriority list, the IPCS Secretariat consults with the CooperatingOrganizations and all the Participating Institutions before embarkingon the preparation of the monograph.x

ProceduresThe order of procedures that result in the publication of an EHCmonograph is shown in the flow chart on p. xii. A designated staffmember of IPCS, responsible for the scientific quality of the document,serves as Responsible Officer (RO). The IPCS Editor is responsible forlayout and language. The first draft, prepared by consultants or, moreusually, staff from an IPCS Participating Institution, is based onextensive literature searches from reference databases such as Medlineand Toxline.The draft document, when received by the RO, may require aninitial review by a small panel of experts to determine its scientificquality and objectivity. Once the RO finds the document acceptable asa first draft, it is distributed, in its unedited form, to well over 150 EHCcontact points throughout the world who are asked to comment on itscompleteness and accuracy and, where necessary, provide additionalmaterial. The contact points, usually designated by governments, maybe Participating Institutions, IPCS Focal Points or individual scientistsknown for their particular expertise. Generally some four months areallowed before the comments are considered by the RO and author(s).A second draft incorporating comments received and approved by theDirector, IPCS, is then distributed to Task Group members, who carryout the peer review, at least six weeks before their meeting.The Task Group members serve as individual scientists, not asrepresentatives of any organization, government or industry. Theirfunction is to evaluate the accuracy, significance and relevance of theinformation in the document and to assess the health and environmental risks from exposure to the chemical. A summary and recommendations for further research and improved safety aspects are alsorequired. The composition of the Task Group is dictated by the rangeof expertise required for the subject of the meeting and by the need fora balanced geographical distribution.xi

EHC 231: Bentonite, Kaolin, and Selected Clay MineralsEHC PREPARATION FLOW CHARTCommitmentCommitment toto draftdraft EHCEHCDocument preparation initiatedRevision asnecessaryDraft sent to IPCS Responsible Officer (RO)Possible meetingof a few expertsto resolvecontroversial issuesResponsible Officer, Editor check for coherence of text andResponsible Officer, Editor check for coherence of text andreadability (not language editing)readability (not language editing)FirstFirst DraftDraftInternational circulation to Contact Points (150 )Comments to IPCS (RO)Review of comments, reference cross-check;preparation of Task Group (TG) draftEditorWorking group,if requiredTask Group meetingInsertion of TG changesPost-TG draft; detailed reference nslations of SummaryWord-processingLibrary forCIP DataCamera-ready copyFinal editingApproval by Director, IPCSWHO Publication Officeroutine procedureoptional procedurexiiPrinterProofsPublicationPublication

The three cooperating organizations of the IPCS recognize theimportant role played by nongovernmental organizations. Representatives from relevant national and international associations may beinvited to join the Task Group as observers. Although observers mayprovide a valuable contribution to the process, they can speak only atthe invitation of the Chairperson. Observers do not participate in thefinal evaluation of the chemical; this is the sole responsibility of theTask Group members. When the Task Group considers it to be appropriate, it may meet in camera.All individuals who as authors, consultants or advisers participatein the preparation of the EHC monograph must, in addition to servingin their personal capacity as scientists, inform the RO if at any time aconflict of interest, whether actual or potential, could be perceived intheir work. They are required to sign a conflict of interest statement.Such a procedure ensures the transparency and probity of the process.When the Task Group has completed its review and the RO issatisfied as to the scientific correctness and completeness of thedocument, it then goes for language editing, reference checking andpreparation of camera-ready copy. After approval by the Director,IPCS, the monograph is submitted to the WHO Office of Publicationsfor printing. At this time a copy of the final draft is sent to the Chairperson and Rapporteur of the Task Group to check for any errors.It is accepted that the following criteria should initiate the updatingof an EHC monograph: new data are available that would substantiallychange the evaluation; there is public concern for health orenvironmental effects of the agent because of greater exposure; anappreciable time period has elapsed since the last evaluation.All Participating Institutions are informed, through the EHCprogress report, of the authors and institutions proposed for the draftingof the documents. A comprehensive file of all comments received ondrafts of each EHC monograph is maintained and is available onrequest. The Chairpersons of Task Groups are briefed before eachmeeting on their role and responsibility in ensuring that these rules arefollowed.xiii

WHO TASK GROUP ON ENVIRONMENTAL HEALTHCRITERIA FOR BENTONITE, KAOLIN, ANDSELECTED CLAY MINERALSA WHO Task Group on Environmental Health Criteria forBentonite, Kaolin, and Selected Clay Minerals met at BradfordUniversity, Bradford, United Kingdom, from 18 to 22 October 2004.The meeting was opened by Professor Jeffrey Lucas on behalf of theUniversity of Bradford and Dr A. Aitio, Programme for the Promotionof Chemical Safety, WHO, on behalf of the IPCS and its three cooperative organizations (UNEP/ILO/WHO). The Task Group reviewedand revised the draft monograph and made an evaluation of the risksfor human health and the environment from exposure to bentonite,kaolin, and other clays.The first draft was prepared by Dr Zoltán Adamis from the JózsefFodor National Center for Pu

The International Programme on Chemical Safety (IPCS), established in 1980, is a joint venture of the United Nations Environment Programme (UNEP), the International Labour Organization (ILO),

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