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Review of the Mammalian Toxicology REVIEW OF THE MAMMALIAN TOXICOLOGY AND METABOLISM/TOXICOKINETICS OF FENTHION The APVMA Review of Fenthion © Australian Pesticides and Veterinary Medicines Authority 2012 ISBN 978-0-9873591-5-5 (electronic) This document was originally published in 2005 as part of the preliminary review findings report for Part 1 of the fenthion review. It was subsequently updated in 2007, and revised in 2008. Ownership of intellectual property rights in this publication Unless otherwise noted, copyright (and any other intellectual property rights, if any) in this publication is owned by the Australian Pesticides and Veterinary Medicines Authority (APVMA). Creative Commons licence With the exception of the Coat of Arms, this publication is licensed under a Creative Commons Attribution 3.0 Australia Licence. This is a standard form agreement that allows you to copy, distribute, transmit and adapt this publication provided that you attribute the work. A summary of the licence terms is available from www.creativecommons.org/licenses/by/3.0/au/deed.en. The full licence terms are available from www.creativecommons.org/licenses/by/3.0/au/legalcode. The APVMA’s preference is that you attribute this publication (and any approved material sourced from it) using the following wording: Source: Licensed from the Australian Pesticides and Veterinary Medicines Authority (APVMA) under a Creative Commons Attribution 3.0 Australia Licence. This report was prepared for the APVMA by the Department of Health and Aging Office of Chemical Safety. In referencing this document the Department of Health and Aging Office of Chemical Safety should be cited as the author and the Australian Pesticides and Veterinary Medicines Authority as the publisher and copyright owner. Use of the Coat of Arms The terms under which the Coat of Arms can be used are set out on the Department of the Prime Minister and Cabinet website (see www.dpmc.gov.au/guidelines). Disclaimer The material in or linking from this report contains the views or recommendations of third parties. This material does not necessarily reflect the views of the APVMA, or indicate a commitment to a particular course of action. There may be links in this document that will transfer you to external websites The APVMA does not have responsibility for these websites, nor does linking to or from this document constitute any form of endorsement. The APVMA is not responsible for any errors, omissions or matters of interpretation in this document. Comments and enquiries: The Manager, Public Affairs Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Australia Telephone: +61 2 6210 4701 Email: [email protected] This publication is available from the APVMA website: www.apvma.gov.au. AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES AUTHORITY AUSTRALIA CHEMICAL REVIEW PROGRAM REVIEW OF THE MAMMALIAN TOXICOLOGY AND METABOLISM/TOXICOKINETICS OF FENTHION Prepared by Office of Chemical Safety of Department of Health and Ageing Canberra FINAL April 2007 Revised November 2008 The APVMA Review of Fenthion TABLE OF CONTENTS ABBREVIATIONS .......................................................................................................................................... 5 EXECUTIVE SUMMARY .............................................................................................................................. 7 TOXICOLOGY HAZARD PROFILE ........................................................................................................... 8 SUMMARY TOXICOLOGY REPORT ...................................................................................................... 10 INTRODUCTION ............................................................................................................................................ 10 METABOLISM AND TOXICOKINETICS............................................................................................................ 10 PERCUTANEOUS ABSORPTION ........................................................................................................................ 13 ACUTE TOXICITY ......................................................................................................................................... 14 SHORT-TERM REPEAT-DOSE STUDIES ......................................................................................................... 15 SUBCHRONIC STUDIES ................................................................................................................................. 16 CHRONIC STUDIES........................................................................................................................................ 16 REPRODUCTION STUDIES ............................................................................................................................. 19 DEVELOPMENTAL STUDIES .......................................................................................................................... 19 GENOTOXICITY STUDIES .............................................................................................................................. 20 NEUROTOXICITY STUDIES ............................................................................................................................ 20 HUMAN STUDIES .......................................................................................................................................... 23 HAZARD ASSESSMENT ............................................................................................................................. 25 MECHANISM OF MAMMALIAN TOXICITY ..................................................................................................... 25 METABOLISM AND TOXICOKINETICS............................................................................................................ 25 ACUTE TOXICITY .......................................................................................................................................... 25 REPEAT-DOSE TOXICITY ............................................................................................................................... 26 CARCINOGENICITY ....................................................................................................................................... 26 GENOTOXICITY ............................................................................................................................................ 26 REPRODUCTIVE AND DEVELOPMENTAL TOXICITY ........................................................................................ 26 NEUROTOXICITY .......................................................................................................................................... 27 HUMAN TOXICITY ........................................................................................................................................ 28 OCULAR TOXICITY ....................................................................................................................................... 29 DOSE LEVELS RELEVANT FOR RISK ASSESSMENT ........................................................................ 29 HUMAN EXPOSURE ................................................................................................................................... 30 RESIDUES IN FOOD AND DRINKING WATER ................................................................................................... 30 RESIDENTIAL EXPOSURE CONSIDERATIONS ................................................................................................. 31 CONSIDERATION OF PUBLIC HEALTH STANDARDS ...................................................................... 32 APPROVAL STATUS ...................................................................................................................................... 32 IMPURITY LIMITS ......................................................................................................................................... 32 ACCEPTABLE DAILY INTAKE ........................................................................................................................ 32 ACUTE REFERENCE DOSE (ARFD) ............................................................................................................... 33 HEALTH VALUE FOR AUSTRALIAN DRINKING WATER ................................................................................. 33 POISONS SCHEDULE ..................................................................................................................................... 33 FIRST-AID INSTRUCTIONS ............................................................................................................................ 33 WARNING STATEMENTS AND GENERAL SAFETY PRECAUTIONS .................................................................. 34 SAFETY DIRECTIONS .................................................................................................................................... 34 RECOMMENDATIONS ............................................................................................................................... 40 MAIN TOXICOLOGY REPORT ................................................................................................................ 44 1. INTRODUCTION ................................................................................................................................ 44 1.1 HISTORY OF PUBLIC HEALTH CONSIDERATIONS OF FENTHION IN AUSTRALIA
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