Risk Assessment of Chemicals: An Introduction PDF
Preview Risk Assessment of Chemicals: An Introduction
RISK ASSESSMENT OF CHEMICALS RISK ASSESSMENT OF CHEMICALS An Introduction Edited by c.J. van Leeuwen Ministry of Housing, Spatial Planning and Environment, The Hague & Research Institute of Toxicology, University of Utrecht, The Netherlands and J.L.M. Hermens Research Institute of Toxicology, University of Utrecht, The Netherlands Springer-Science+Business Media, B.V. Library of Congress Cataloging-in-Publication Data RiSk assessment of chemicals an introduction / edited by C. J. van Leeuwen and J.L.M. Hermens. p. cm. Inc ludes index. ISBN 978-94-015-8522-4 ISBN 978-94-015-8520-0 (eBook) DOI 10.1007/978-94-015-8520-0 1. Health rlsk assessment. 2. Pollutlon--Environmental aspects. 3. TOXlcology. I. Leeuwen. C. J. van. II. Hermens. Joop L. M. RA566.27.R575 1995 615.9·02--dc20 95-33375 06-0104-300 ts Printed on acid-Iree paper First published 1995 Reprinted 1996, 1997,2000,2001,2004 AII Rights Reserved © 1995 Springer Science+Business Media Dordrecht Originally published by Kluwer Academic Publishers in 1995 Softcover reprint ofthe hardcover Ist edition 1995 No part of the material protected by this copyright notice may be reproduced Of utilized in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without written permission from the copyright owners. v This book presents information obtained from various sources. Reprinted material is quoted with permission and the sources have been indicated. A wide variety of references is given. Every reasonable effort has been made to provide reliable data and information, but the authors, editors and the publisher cannot assume responsibility for the validity of all the material or for the consequences of its use. The publication of this book was made possible with the financial support provided by The Netherlands' Ministry of Housing, Spatial Planning and Environment (VROM). It was approved by the Directorate for Chemicals, External Safety and Radiation Protection of VROM. Approval does not necessarily signify that the contents reflect the views and policies of VROM, nor does the mention of trade names or commercial products constitute endorsement or recom mendation for their use. Neither this book nor any part of it may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming and recording, or any information storage and retrieval system, without the prior written permission of the publisher. vii PREFACE In recent years many developments have taken place in promote co-operation between governments and other the field of risk assessment of chemicals. Many reports parties involved in chemical safety and to provide policy have been published by national authorities, industries guidance with emphasis on regional and subregional co and scientific researchers as well as by international bod operation. The Inter-Organization Programme for the ies such as the European Union, the Organization of Sound Management of Chemicals (IOMC) was estab Economic Cooperation and Development (OECD) and lished in 1995 and provides a mechanism for the six par the joint International Programme on Chemical Safety ticipating organizations (UNEP, ILO, FAO, UNIDO,WHO (IPCS) of the World Health Organization (WHO), the and OECD) to better co-ordinate policies and activities in International Labour Organization (lLO), and the United the field of chemical risk management. Nations Environment Programme (UNEP). The present book is an introduction to risk assessment of The development and international harmonization of risk chemicals. It contains basic background information on assessment methods is an important challenge. In sources, emissions, distribution and fate processes for Agenda 21 of the United Nations Conference on exposure estimation. It includes dose-effects estimation Environment and Development (UNCED), chapter 19 is for both human health related toxicology and ecotoxicol entirely devoted to the management of chemicals. For ogy as well as information on estimation methodologies. one of its recommendations, i.e. the expansion and accel It describes the basic principles and methods of risk eration of the international assessment of chemical risks, assessment in their legislative framework. Most of the mutual acceptance of hazard and risk assessment is a risk assessment methods described are part of the so pre-requisite. Another very important recommendation called Uniform System for the Evaluation of Substances of chapter 19 is that national capabilities and capacities (USES), a computerized risk assessment system which in the management of chemicals should be strengthened. has been developed in The Netherlands. UNEP as the Task Manager of Chapter 19 reports for the The book is intended to be used by students in health and Commission on Sustainable Development (CSD), on environmental sciences and as backgroud material for progress in the implementation of the recommendations those who are involved in risk assessment. I hope that of Chapter 19 (by international organizations). Two this book will help to bridge the gaps between science important arrangements for co-operation and co-ordina and application and, particularly, that it will serve to tion of national and international activities with regard build capacity in many developed and developing coun to chemical safety have been established since UNCED. tries in order to increase understanding and thus prevent The Intergovernmental Forum on Chemical Safety man and the environment being exposed to unacceptable (IFCS) was established in April 1994 in Stockholm to risks due to toxic chemicals and hazardous waste. Hans Alders UNEP Regional Director for Europe Vlll EDITORS Cornelis Johannes (Kees) Van Leeuwen studied biology at Josephus Ludovicus Maria (Joop) Hermens studied chem the University of Utrecht, where he also obtained his Ph.D. istry at the University of Utrecht. He received his Ph.D. in in ecotoxicology. He began his career in 1980 as plant ecol 1983 for a thesis on quantitative structure-activity relation ogist at the University of Groningen and, shortly thereafter, ships. Since then he has lead a research group and is now became head of the Laboratory of Ecotoxicology at the associate professor at the Research Institute of Toxicology Ministry of Transport and Public Works. He served in a (RITOX) at the University of Utrecht, working in the field research and advisory role in the implementation of The of environmental toxicology. His major research interests Netherlands' Pollution of Surface Waters Act. In 1987 he are the development of structure-activity relationships in joined the Ministry of Housing, Spatial Planning and environmental toxicology, the study of the environmental Environment (VROM) as a senior expert and deputy head effects of mixtures of chemicals and the development of of the Chemicals Division. In 1991 he became head of the group parameters for measuring mixture toxicity. In 1987 Risk Assessment and Environmental Quality Division of he spent six months as a research scientist at the EPA VROM. In addition to his work at VROM, he holds a part Environmental Research Laboratory in Duluth, Min time professorship in biological toxicology at the Research nesota, U.S. In 1990, he organized the Fourth International Institute of Toxicology (RITOX) at the University of Workshop on QSAR in Environmental Toxicology in The Utrecht. He has been member of various policy and expert Netherlands. He is now actively involved in the develop groups in the European Union, the International Rhine ment and application of estimation methodologies and Committee, the Organization for Economic Co-operation monitoring tools for the European Union. and Development, the European and Mediterranean Plant Protection Organization and the Council of Europe. He was chairman of the OECD Hazard Assessment Advisory Body and is vice-chairman of the OECD Joint Committee on Chemicals. ix CONTRIBUTORS AND REVIEWERS CONTRIBUTORS Research Institute of Toxicology University of Utrecht Dr. M. Van Den Berg Utrecht, The Netherlands Research Institute of Toxicology University of Utrecht Dr. Ir. D. Van De Meent Environmental Toxicology Section National Institute of Public Health and Environmental Utrecht, The Netherlands Protection Laboratory for Ecotoxicology Dr. J.H.M. De Bruijn Bilthoven, The Netherlands Ministry of Housing, Spatial Planning and Environment Risk Assessment and Environmental Quality Division Dr. M. Nendza The Hague, The Netherlands Analytisches Laboratorium fiir Umweltuntersuchungen und Auftragsforschung Dr. J.L.M. Hermens Luhnstedt, Germany Research Institute of Toxicology University of Utrecht Drs. AC.M. De Nijs Environmental Toxicology Section National Institute of Public Health and Environmental Utrecht, The Netherlands Protection Laboratory for Water and Drinking Water Drs. D.T. Jager Bilthoven, The Netherlands National Institute of Public Health and Environmental Protection Dr. Ir. W. Peijnenburg Laboratory for Ecotoxicology National Institute of Public Health and Environmental Bilthoven, The Netherlands Protection Department of Environmental Chemistry Prof. Dr. R. Kroes Laboratory for Ecotoxicology National Institute of Public Health and Environmental Bilthoven, The Netherlands Protection Board of Directors Ing. P. Van Der Poel Bilthoven, The Netherlands National Institute of Public Health and Environmental & Protection Research Institute of Toxicology Laboratory for Emission and Waste University of Utrecht Bilthoven, The Netherlands Utrecht, The Netherlands Drs. J.P.M. Ros Dr. F.AAM. De Leeuw National Institute of Public Health and Environmental National Institute of Public Health and Environmental Protection Protection Laboratory for Emission and Waste Air Research Laboratory Bilthoven, The Netherlands Bilthoven, The Netherlands Dr. D.T.H.M. Sijm Prof. Dr. C.J. Van Leeuwen Research Institute of Toxicology Ministry of Housing, Spatial Planning and Environment University of Utrecht Risk Assessment and Environmental Quality Division Environmental Chemistry Group The Hague, The Netherlands Utrecht, The Netherlands & x Dr. J. Struijs Prof. Dr. H.A.J. Govers National Institute of Public Health and Environmental University of Amsterdam Protection Laboratory of Environmental and Toxicological Department of Environmental Chemistry Chemistry Laboratory for Ecotoxicology Amsterdam, The Netherlands Bilthoven, The Netherlands Dr. K. Grein Dr. W. Tas Commission of the European Communities National Institute of Public Health and Environmental DG XI/C/6 Protection Brussels, Belgium Advisory Centre for Toxicology Bilthoven, The Netherlands Prof. Dr. M. Matthies University of Osnabrock Drs. T.G. Vermeire Institute of Environmental Systems Research National Institute of Public Health and Environmental Osnabrock, Germany Protection Advisory Centre for Toxicology Dr. A. Opperhuizen Bilthoven, The Netherlands Ministry of Transport, Public Works and Water Management Ir. P.T.J. Van Der Zandt Tidal Waters Division Ministry of Housing, Spatial Planning and Environment The Hague, The Netherlands Risk Assessment and Environmental Quality Division The Hague, The Netherlands Prof. Dr. W. Seinen Research Institute of Toxicology REVIEWERS University of Utrecht Utrecht, The Netherlands Dr. B.J. Blaauboer Research Institute of Toxicology Dr. W. Slooff University of Utrecht National Institute of Public Health and Environmental Biochemical Toxicology Protection Utrecht, The Netherlands Environmental Forecasting Bureau Bilthoven, The Netherlands Drs. P.F.H. Bont Resources Planning Consultants B.Y. Prof. Dr. N.M. Van Straalen Delft, The Netherlands Vrije Universiteit Faculty of Biology Prof. Dr. F. Bro-Rasmussen Amsterdam, The Netherlands Danish Technical University Faculty of Environmental Science and Ecology Prof. Dr. H.A. Udo De Haes Lyngby, Denmark University of Leiden Centre of Environmental Science Dr. Ir. T.C.J. Fey tel Leiden, The Netherlands Procter & Gamble Strombeek-Bever, Belgium Dr. Ir. C.A.M. Van Gestel Vrije Universiteit Department of Ecology & Ecotoxicology Amsterdam, The Netherlands xi ACKNOWLEDGEMENTS This book is the result of a joint effort between the Special thanks are due to those who reviewed one or Ministry of Housing, Spatial Planning and Environment more chapters of this book. For the correction of English (VROM), RPC Resources Planning Consultants B.V and we would like to thank Mrs. A. Oostenbrink and Mrs. S. various experts in the field of risk assessment and the Hunt. We would also like to thank Prof. Dr. VI. Feron management of chemicals at the National Institute of for his contribution to Section 5.5.3, Prof. Dr. P. W.l. Public Health and Environmental Protection (RIVM), the Peters, Prof. Dr. G. R. Mohn, Drs. 1. Bol and Ms. 1. Research Institute of Toxicology (RITOX), and various Smink and the secretary of the Research Institute of other organizations. The editors would like to thank RPC Toxicology for their contributions. Resources Planning Consultants B.V for their technical assistance and VROM for its financial support for this project. xii EXPLANATORY NOTES Prefixes to the names of units Other abbreviations M mega (106) a.i. active ingredient k kilo (103) b.p. boiling point d deci (101) bw body weight c centi (10-2) c.v. coefficient of variation m milli (10-3) Cyt cytochrome J1 micro (10-6) Eh electrode potential n nano (10-9) F variance ratio p pico (10-12) GC-MS gas chromatography-mass spectrometry f femto (10-15) GLC gas-liquid chromatography HPLC high performance liquid chromatography Chemical prefixes k rate constant 0 ortho K equilibrium constant m meta log logarithm (common, base 10) p para In logarithm (natural, base e) n normal mol.wt. molecular weight sec secondary m.p. melting point tert tertiary MS mass spectrometry norN total number of individuals or variates Units No. number (in tables and parentheses) A Angstrom (0.1 mm) p level of significance (probability of atm atmosphere wrongfully rejecting the null hypothesis) °C degree Ce1cius or centigrade ppb parts per billion cal calorie ppm parts per million d day r coefficient of correlation g gram R coefficient of multiple correlation h hour s2 sample variance ha hectare (J standard deviation of population J Joule SD standard deviation of series K degree absolute (Kelvin) SE standard error of mean kg kilogram sp. species (when part of a bionomial) L litre t1l2 half-life m metre TLC thin layer chromatography M molar (moillitre) UV ultraviolet mIll minute m mean of population Pa pascal (unit of pressure; 100kPa = 1 bar) v/v volume/volume (concentration) s second w/v weight/volume (concentration) V Volt W Watt y year
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