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Fumonisin B1 This report contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the United Nations Environment Programme, the International Labour Organisation, or the World Health Organization. Environmental Health Criteria 219 Fumonisin B1 First draft prepared by Professor W.F.O. Marasas (Medical ResearchCouncil, Tygerberg, Douth Africa), Professor J.D. Miller (Carleton University, Ottawa, Canada), Dr.R.T. Riley (US Department of Agriculture, Athens, USA) and Dr A. Visconti (National Research Council, Bari, Italy) Please note that the layout and pagination of this web version are not identical with the printed document Published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organisation, and the World Health Organization, and produced within the framework of the Inter-Organization Programme for the Sound Management of Chemicals. World Health Organization Geneva, 2000 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), and the World Health Organization (WHO). The overall objectives of the IPCS are to establish the scientific basis for assessment of the risk to human health and the environment from exposure to chemicals, through international peer-review processes, as a prerequisite for the promotion of chemical safety, and to provide technical assistance in strengthening 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 of the United Nations, WHO, the United Nations Industrial Development Organization, the United Nations Institute for Training and Research, and the Organisation for Economic Co-operation and Development (Participating Organizations), following recommendations made by the 1992 UN Conference on Environment and Development 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 Participating Organizations, jointly or separately, to achieve the sound management of chemicals in relation to human health and the environment. WHO Library Cataloguing in Publication Data Fumonisin B1. (Environmental health criteria ; 219) 1.Carboxylic acids - toxicity 2.Food contamination 3.Environmental exposure 4.Risk assessment I.Series ISBN 92 4 157219 1 (NLM Classification: QD 341.P5) ISSN 0250-863X The 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 on any changes made to the text, plans for new editions, and reprints and translations already available. ©World Health Organization 2000 Publications 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 the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers’ products does not imply that they are 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 are distinguished by initial capital letters. Computer typesetting by I. Xavier Lourduraj, Chennai, India CONTENTS ENVIRONMENTAL HEALTH CRITERIA FOR FUMONISIN B1 PREAMBLE ............................. viii ABBREVIATIONS ............................. xvii INTRODUCTION .............................. xix 1. SUMMARY, EVALUATION AND RECOMMENDATIONS ................................ 1 1.1 Summary ............................... 1 1.1.1 Identity, physical and chemical properties, and analytical methods .................... 1 1.1.2 Sources of human exposure ................ 1 1.1.3 Environmental transport, distribution and transformation ........................... 1 1.1.4 Environmental levels and human exposure ... 2 1.1.5 Kinetics and metabolism in animals ......... 2 1.1.6 Effects on animals and in vitro test systems . 2 1.1.7 Effects on humans ........................ 3 1.1.8 Effects on other organisms in the laboratory . 3 1.2 Evaluation of human health risks .................. 4 1.2.1 Exposure . 4 1.2.2 Hazard identification ...................... 4 1.2.3 Dose-response assessment ................ 6 1.2.4 Risk characterization ...................... 6 1.3 Recommendations for protection of human health .... 6 2. IDENTITY, PHYSICAL AND CHEMICAL PROPERTIES, AND ANALYTICAL METHODS ........... 8 2.1 Identity ............................... 8 2.2 Physical and chemical properties of the pure substance ............................... 9 2.3 Analytical methods ............................. 10 2.3.1 Sampling and preparation procedures ...... 10 iii EHC 219: Fumonisin B ____________________________________________________1 2.3.2 Extraction .............................. 10 2.3.3 Analysis .............................. 12 3. SOURCES OF HUMAN EXPOSURE .................... 14 4. ENVIRONMENTAL TRANSPORT, DISTRIBUTION AND TRANSFORMATION ........................... 19 5. ENVIRONMENTAL LEVELS AND HUMAN EXPOSURE .............................. 20 6. KINETICS AND METABOLISM IN ANIMALS .......... 24 6.1 Absorption .............................. 24 6.2 Distribution .............................. 25 6.3 Elimination, excretion and metabolic transformation .............................. 26 6.4 Retention and turnover .......................... 28 6.5 Reaction with body components .................. 29 7. EFFECTS ON LABORATORY MAMMALS AND IN VITRO TEST SYSTEMS ....................... 30 7.1 Laboratory animals and in vitro test systems ....... 30 7.1.1 Single exposure ......................... 30 7.1.2 Repeated exposure ...................... 30 7.1.2.1 Body weight loss ............... 30 7.1.2.2 Hepatocarcinogenicity and nephrotoxicity ................. 32 7.1.2.3 Immunotoxicity ................. 36 7.1.3 Skin and eye irritation .................... 37 7.1.4 Reproductive toxicity, embryotoxicity and teratogenicity ....................... 37 7.1.5 Mutagenicity and related end-points ....... 41 7.1.6 Carcinogenicity ......................... 42 7.1.6.1 Carcinogenicity bioassays ....... 42 7.1.6.2 Short-term assays for carcinogenicity ................. 48 7.2 Other mammals .............................. 50 7.2.1 Equine leukoencephalomalacia ............ 50 iv ____________________________________________________ 7.2.2 Porcine pulmonary oedema syndrome ...... 53 7.2.3 Poultry toxicity .......................... 56 7.2.4 Non-human primate toxicity ............... 57 7.2.5 Other species ........................... 57 7.3 Mechanisms of toxicity – mode of action .......... 58 7.3.1 Disruption of sphingolipid metabolism ..... 58 7.3.1.1 Sphingolipids and their metabolism .................... 58 7.3.1.2 Fumonisin-induced disruption of sphingolipid metabolism in vitro . 59 7.3.1.3 Fumonisin disruption of sphingolipid metabolism in vivo .. 64 7.3.1.4 Tissue and species specificity .... 68 7.3.1.5 Fumonisin-induced sphingolipid alterations: effects on growth, differentiation and cell death ..... 69 7.3.1.6 Sphingolipid-mediated cellular deregulation and fumonisin diseases ....................... 74 7.3.2 Altered fatty acid metabolism in liver ....... 76 7.3.3 Other biochemical changes ............... 77 7.4 Factors modifying toxicity; toxicity of metabolites .. 79 8. EFFECTS ON HUMANS .............................. 82 8.1 Transkei, South Africa .......................... 82 8.2 China .............................. 84 8.3 Northern Italy .............................. 85 9. EFFECTS ON OTHER ORGANISMS IN THE LABORATORY .............................. 86 9.1 Microorganisms .............................. 86 9.2 Plants .............................. 86 9.2.1 Duckweed and jimsonweed ............... 86 9.2.2 Tomato .............................. 87 9.2.3 Maize .............................. 87 10. FURTHER RESEARCH .............................. 88 v EHC 219: Fumonisin B ____________________________________________________1 11. PREVIOUS EVALUATIONS BY INTERNATIONAL ORGANIZATIONS ................. 89 REFERENCES .............................. 90 APPENDIX 1. NATIONAL GUIDELINES FOR FUMONISINS ............................. 126 APPENDIX 2. NATURAL OCCURRENCE OF FUMONISIN B1 (FB1) IN MAIZE-BASED PRODUCTS ........ 127 RESUME, EVALUATION ET RECOMMANDATIONS ........ 135 RESUMEN, EVALUACION Y RECOMENDACIONES ......... 143 vi NOTE TO READERS OF THE CRITERIA MONOGRAPHS Every effort has been made to present information in the criteria monographs as accurately as possible without unduly delaying their publication. In the interest of all users of the Environmental Health Criteria monographs, readers are requested to communicate any errors that may have occurred to the Director of the International Programme on
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