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  This report contains the collective views of an international group of experts and does notnecessarily represent the decisions or the stated policy of the United Nations EnvironmentProgramme, the International Labour Organisation, or the World Health Organization. Concise International Chemical Assessment Document 6 BIPHENYL First draft prepared by Dr A. Boehncke, Dr G. Koennecker, Dr I. Mangelsdorf, and Dr A.Wibbertmann, Fraunhofer Institute for Toxicology and Aerosol Research, Hanover, Germany Please note that the layout and paginationof this pdf file are not identical to the printedCICAD Published under the joint sponsorship of the United Nations Environment Programme, theInternational Labour Organisation, and the World Health Organization, and produced within theframework of the Inter-Organization Programme for the Sound Management of Chemicals.World Health OrganizationGeneva, 1999  The International Programme on Chemical Safety (IPCS) , established in 1980, is a joint ventureof the United Nations Environment Programme (UNEP), the International Labour Organisation (ILO),and the World Health Organization (WHO). The overall objectives of the IPCS are to establish thescientific basis for assessment of the risk to human health and the environment from exposure tochemicals, through international peer review processes, as a prerequisite for the promotion of chemicalsafety, and to provide technical assistance in strengthening national capacities for the sound managementof chemicals.The Inter-Organization Programme for the Sound Management of Chemicals (IOMC)  wasestablished in 1995 by UNEP, ILO, the Food and Agriculture Organization of the United Nations, WHO,the United Nations Industrial Development Organization, the United Nations Institute for Training andResearch, and the Organisation for Economic Co-operation and Development (ParticipatingOrganizations), following recommendations made by the 1992 UN Conference on Environment andDevelopment to strengthen cooperation and increase coordination in the field of chemical safety. The purpose of the IOMC is to promote coordination of the policies and activities pursued by the ParticipatingOrganizations, jointly or separately, to achieve the sound management of chemicals in relation to humanhealth and the environment.WHO Library Cataloguing-in-Publication DataBiphenyl.(Concise international chemical assessment document ; 6)1.Biphenyl compounds – adverse effects 2.Biphenyl compounds – toxicity3.Environmental exposure I.International Programme on Chemical Safety II.SeriesISBN 92 4 153006 5 (NLM classification: WA 240) ISSN 1020-6167The World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. Applications and enquiries should be addressed to the Office of Publications,World Health Organization, Geneva, Switzerland, which will be glad to provide the latest information onany changes made to the text, plans for new editions, and reprints and translations already available.©World Health Organization 1999Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights reserved.The designations employed and the presentation of the material in this publication do not imply theexpression of any opinion whatsoever on the part of the Secretariat of the World Health Organizationconcerning the legal status of any country, territory, city, or area or of its authorities, or concerning thedelimitation of its frontiers or boundaries.The mention of specific companies or of certain manufacturers’ products does not imply that theyare endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products aredistinguished by initial capital letters.The Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, Germany, provided financial support for the printing of this publication.Printed by Wissenschaftliche Verlagsgesellschaft mbH, D-70009 Stuttgart 10  iii TABLE OF CONTENTS FOREWORD.............................................................................. 11.EXECUTIVE SUMMARY................................................................... 42.IDENTITY AND PHYSICAL/CHEMICAL PROPERTIES........................................ 63.ANALYTICAL METHODS................................................................. 64.SOURCES OF HUMAN AND ENVIRONMENTAL EXPOSURE.................................. 65.ENVIRONMENTAL TRANSPORT, DISTRIBUTION, AND TRANSFORMATION................. 76.ENVIRONMENTAL LEVELS AND HUMAN EXPOSURE....................................... 86.1Environmental levels............................................................... 86.2Human exposure................................................................... 87.COMPARATIVE KINETICS AND METABOLISM IN LABORATORY ANIMALS ANDHUMANS................................................................................ 98.EFFECTS ON LABORATORY MAMMALS AND  IN VITRO  TEST SYSTEMS..................... 98.1Single exposure................................................................... 98.2Irritation and sensitization..........................................................108.3Short-term exposure................................................................108.3.1Oral exposure.............................................................108.3.2Inhalation exposure........................................................108.3.3Dermal exposure..........................................................108.4Long-term exposure................................................................108.4.1Subchronic exposure......................................................108.4.1.1Oral exposure.....................................................108.4.1.2Inhalation exposure................................................128.4.2Chronic exposure and carcinogenicity........................................128.4.2.1Tumour promotion.................................................138.5Genotoxicity and related end-points..................................................158.6Reproductive and developmental toxicity.............................................158.7Immunological and neurological effects...............................................169.EFFECTS ON HUMANS....................................................................1610.EFFECTS ON OTHER ORGANISMS IN THE LABORATORY AND FIELD........................1710.1 Aquatic environment...............................................................1710.2 Terrestrial environment.............................................................1711.EFFECTS EVALUATION...................................................................1811.1 Evaluation of health effects.........................................................18 11.1.1Hazard identification and dose–response assessment..........................18 11.1.2Criteria for setting guidance values for biphenyl...............................19 11.1.3Sample risk characterization.................................................1911.2 Evaluation of environmental effects..................................................1912.PREVIOUS EVALUATIONS BY INTERNATIONAL BODIES....................................20  Concise International Chemical Assessment Document 6 iv13.HUMAN HEALTH PROTECTION AND EMERGENCY ACTION.................................2013.1 Advice to physicians..............................................................2013.2 Health surveillance advice..........................................................2013.3 Spillage..........................................................................2114.CURRENT REGULATIONS, GUIDELINES, AND STANDARDS.................................21INTERNATIONAL CHEMICAL SAFETY CARD..............................................22REFERENCES.............................................................................24APPENDIX 1 — SOURCE DOCUMENTS.....................................................28APPENDIX 2 — CICAD PEER REVIEW......................................................28APPENDIX 3 — CICAD FINAL REVIEW BOARD (Brussels, Belgium)...........................29APPENDIX 4 — SPECIALIZED CICAD PEER REVIEW.........................................30APPENDIX 5 — CICAD FINAL REVIEW BOARD (Washington, DC)............................30RÉSUMÉ D’ORIENTATION................................................................32RESUMEN DE ORIENTACIÓN..............................................................35  Biphenyl 1 FOREWORD Concise International Chemical AssessmentDocuments (CICADs) are the latest in a family of  publications from the International Programme onChemical Safety (IPCS) — a cooperative programme of the World Health Organization (WHO), the InternationalLabour Organisation (ILO), and the United NationsEnvironment Programme (UNEP). CICADs join theEnvironmental Health Criteria documents (EHCs) asauthoritative documents on the risk assessment of chemicals.CICADs are concise documents that providesummaries of the relevant scientific informationconcerning the potential effects of chemicals uponhuman health and/or the environment. They are basedon selected national or regional evaluation documents or on existing EHCs. Before acceptance for publication asCICADs by IPCS, these documents undergo extensive peer review by internationally selected experts to ensuretheir completeness, accuracy in the way in which thesrcinal data are represented, and the validity of theconclusions drawn.The primary objective of CICADs ischaracterization of hazard and dose–response fromexposure to a chemical. CICADs are not a summary of allavailable data on a particular chemical; rather, theyinclude only that information considered critical for characterization of the risk posed by the chemical. Thecritical studies are, however, presented in sufficientdetail to support the conclusions drawn. For additionalinformation, the reader should consult the identifiedsource documents upon which the CICAD has been based.Risks to human health and the environment willvary considerably depending upon the type and extentof exposure. Responsible authorities are stronglyencouraged to characterize risk on the basis of locallymeasured or predicted exposure scenarios. To assist thereader, examples of exposure estimation and risk characterization are provided in CICADs, whenever  possible. These examples cannot be considered asrepresenting all possible exposure situations, but are provided as guidance only. The reader is referred to EHC170 1  for advice on the derivation of health-basedguidance values.While every effort is made to ensure that CICADsrepresent the current status of knowledge, newinformation is being developed constantly. Unlessotherwise stated, CICADs are based on a search of thescientific literature to the date shown in the executivesummary. In the event that a reader becomes aware of new information that would change the conclusionsdrawn in a CICAD, the reader is requested to contactIPCS to inform it of the new information. Procedures The flow chart shows the procedures followed to produce a CICAD. These procedures are designed totake advantage of the expertise that exists around theworld — expertise that is required to produce the high-quality evaluations of toxicological, exposure, and other data that are necessary for assessing risks to humanhealth and/or the environment.The first draft is based on an existing national,regional, or international review. Authors of the firstdraft are usually, but not necessarily, from the institutionthat developed the srcinal review. A standard outlinehas been developed to encourage consistency in form.The first draft undergoes primary review by IPCS toensure that it meets the specified criteria for CICADs.The second stage involves international peer review by scientists known for their particular expertiseand by scientists selected from an international roster compiled by IPCS through recommendations from IPCSnational Contact Points and from IPCS ParticipatingInstitutions. Adequate time is allowed for the selectedexperts to undertake a thorough review. Authors arerequired to take reviewers’ comments into account andrevise their draft, if necessary. The resulting second draftis submitted to a Final Review Board together with thereviewers’ comments.The CICAD Final Review Board has severalimportant functions: –to ensure that each CICAD has been subjected toan appropriate and thorough peer review; – to verify that the peer reviewers’ comments have been addressed appropriately; –to provide guidance to those responsible for the preparation of CICADs on how to resolve anyremaining issues if, in the opinion of the Board, theauthor has not adequately addressed all commentsof the reviewers; and – to approve CICADs as international assessments.Board members serve in their personal capacity, not asrepresentatives of any organization, government, or industry. They are selected because of their expertise inhuman and environmental toxicology or because of their 1  International Programme on Chemical Safety (1994)  Assessing    human health risks of chemicals: derivationof guidance values for health-based exposure limits. Geneva, World Health Organization (Environmental HealthCriteria 170).
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