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Review Reports Is a Part of That Process The reconsideration of approvals of the active constituent fenthion, registrations of products containing fenthion and their associated labels Part 1: Uses of fenthion in non-food-producing situations Preliminary Review Findings Volume 2: Technical Reports DECEMBER 2005 Australian Pesticides & Veterinary Medicines Authority Canberra Australia © Australian Pesticides & Veterinary Medicines Authority 2005 This work is copyright. Apart from any use permitted under the Copyright Act 1968, no part may be reproduced without permission from the Australian Pesticides & Veterinary Medicines Authority. This review report for products containing fenthion is published by the Australian Pesticides and Veterinary Medicines Authority. For further information about this review or the Pesticides Review Program, contact: Manager Pesticides Review Australian Pesticides and Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604 Australia Telephone: 61 2 6272 3213 Facsimile: 61 2 6272 3218 Email: [email protected] APVMA web site: http://www.apvma.gov.au Fenthion Review – Preliminary Review Findings, Part 1 non-food producing situations FOREWORD The Australian Pesticides & Veterinary Medicines Authority (APVMA) is an independent statutory authority with responsibility for the regulation of agricultural and veterinary chemicals in Australia. Its statutory powers are provided in the Agvet Codes scheduled to the Agricultural and Veterinary Chemicals Code Act 1994. The APVMA can reconsider the approval of an active constituent, the registration of a chemical product or the approval of a label for a container for a chemical product at any time. This is outlined in Part 2, Division 4 of the Agvet Codes. The basis for the current reconsideration is whether the APVMA is satisfied that continued use of the active constituent fenthion and products containing fenthion in accordance with the instructions for their use: • would not be an undue hazard to the safety of people exposed to it during its handling; and • would not be likely to have an effect that is harmful to human beings; and • would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment. The APVMA also considered whether product labels carry adequate instructions and warning statements. A reconsideration may be initiated when new research or evidence has raised concerns about the use or safety of a particular chemical, a product or its label. The reconsideration process includes a call for information from a variety of sources, a review of that information and, following public consultation, a decision about the future use of the chemical or product. In undertaking reconsiderations (hereafter referred to as reviews), the APVMA works in close cooperation with advisory agencies including the Office of Chemical Safety, the Department of the Environment and Heritage, and state departments of agriculture as well as other expert advisers as appropriate. The APVMA has a policy of encouraging openness and transparency in its activities and community involvement in decision-making. The publication of review reports is a part of that process. The APVMA also makes these reports available to the regulatory agencies of other countries as part of bilateral agreements. The APVMA recommends that countries receiving these reports will not utilise them for registration purposes unless they are also provided with the raw data from the relevant applicant. This document sets out the preliminary review findings relating to all products containing fenthion used in non-food-producing situations that have been nominated for review by the APVMA. The assessment of data for the review of fenthion products used in food-producing situations is still to be complete. It will form Part 2 of the fenthion review. The preliminary review findings and proposed recommendations are based on information collected from a 3 Fenthion Review – Preliminary Review Findings, Part 1 non-food producing situations variety of sources. The information and technical data required by the APVMA to review the safety of both new and existing chemical products must be derived according to accepted scientific principles, as must the methods of assessment undertaken. 4 Fenthion Review – Preliminary Review Findings, Part 1 non-food producing situations ACRONYMS AND ABBREVIATIONS Time Weight d Day bw Body weight h Hour g Gram min Minute kg Kilogram mo Month µg Microgram wk Week mg Milligram s Second ng Nanogram yr Year wt Weight Length Dosing cm Centimetre id Intradermal m Metre im Intramuscular µm Micrometre inh Inhalation mm Millimetre ip Intraperitoneal nm Nanometre iv Intravenous po Oral sc Subcutaneous mg/kg bw/d mg/kg bodyweight/day Volume Concentration L Litre M Molar mL Millilitre ppb Parts per billion µL Microlitre ppm Parts per million Clinical chemistry, haematology, urinalysis A/G Albumin/globulin ratio ALT Alanine Aminotransferase (SGPT) AP Alkaline Phosphatase AST Aspartate Aminotransferase (SGOT) BUN Blood Urea Nitrogen ChE ChE CPK Creatine Phosphatase (phosphokinase) GGT Gamma-Glutamyl Transferase Hb Haemoglobin Hct Haematocrit (packed cell volume) LDH Lactate Dehydrogenase MCH Mean Corpuscular Haemoglobin MCHC Mean Corpuscular Haemoglobin Concentration MCV Mean Corpuscular Volume NTE Neurotoxicity/neuropathy Target Esterase PT Prothrombin Time RBC Red Blood Cell (RBC) WBC White Blood Cell/leucocyte WBC-DC White Blood Cell – Differential Count 5 Fenthion Review – Preliminary Review Findings, Part 1 non-food producing situations Anatomy CNS Central Nervous System GIT Gastro-Intestinal Tract Chemistry BH6 Obidoxime chloride CMC Carboxymethyl Cellulose CO2 Carbon Dioxide DMSO Dimethyl Sulfoxide 2-PAM Pyridine-2-aldoxime methiodide P-2-S 2-Pyridine-aldoxime methyl methanesulfonate TMB-4 (1, 1-trimethylene-bis(4-formyl-pyridinium bromide) dioxime) TOCP Tri-Ortho Cresyl Phosphate Terminology ADI Acceptable Daily Intake ARfD Acute Reference Dose ECG Electrocardiogram FOB Functional Observation Battery gd Gestational day GLP Good Laboratory Practice HPLC High Performance Liquid Chromatography ld Lactational day LOEL Lowest Observed Effect Level MRL Maximum Residue Limit or Level NOEC No Observed Effect Concentration NOEL No Observed Effect Level NZW New Zealand White OP Organophosphorus pesticide OPIDN Organophosphate Induced Delayed Neuropathy PCO Pest Control Operator SCE Sister Chromatid Exchange SD Sprague-Dawley (rats) UDS Unscheduled DNA Synthesis Organisations & publications ACPH Advisory Committee on Pesticides and Health APVMA Australian Pesticides and Veterinary Medicines Authority CRP Chemical Review Program FAO Food and Agriculture Organisation of the United Nations FAISD First Aid Instructions & Safety Directions IPCS International Programme on Chemical Safety JMPR Joint FAO/WHO Meeting on Pesticide Residues NCI National Cancer Institute NDPSC National Drugs and Poisons Schedule Committee NHMRC National Health and Medical Research Council 6 Fenthion Review – Preliminary Review Findings, Part 1 non-food producing situations NOHSC National Occupational Health & Safety Commission SUSDP Standard for the Uniform Scheduling of Drugs and Poisons US EPA United States Environmental Protection Agency WHO World Health Organisation 7 Fenthion Review – Preliminary Review Findings, Part 1 non-food producing situations TABLE OF CONTENTS FOREWORD............................................................................................................................ 3 ACRONYMS AND ABBREVIATIONS ................................................................................ 5 TABLE OF CONTENTS......................................................................................................... 8 9. TOXICOLOGY ASSESSMENT .................................................................................. 10 9.1 SUMMARY TOXICOLOGY REPORT ............................................................................. 10 9.1.1 Introduction...................................................................................................... 10 9.1.2 Metabolism and Toxicokinetics........................................................................ 10 9.1.3 Acute Toxicity................................................................................................... 13 9.1.4 Short-Term Repeat-Dose Studies ..................................................................... 14 9.1.5 Subchronic Studies ........................................................................................... 15 9.1.6 Chronic Studies ................................................................................................ 16 9.1.7 Reproduction Studies........................................................................................ 18 9.1.8 Developmental Studies ..................................................................................... 19 9.1.9 Genotoxicity Studies......................................................................................... 19 9.1.10 Neurotoxicity Studies........................................................................................ 20 9.1.11 Human Studies.................................................................................................. 23 9.2 HAZARD ASSESSMENT .............................................................................................. 23 9.2.1 Mechanism of Mammalian Toxicity ................................................................. 23 9.2.2 Metabolism and Toxicokinetics.......................................................................
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