Review of the earth open source (eos) report " roundup and birth defects: is the public being kept in the dark?"
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- A REVIEW OF THE EARTH OPEN SOURCE (EOS) REPORT
- GLOSSARY OF TERMS AND ABBREVIATIONS
A REVIEW OF THE EARTH OPEN SOURCE (EOS) REPORT “ROUNDUP AND BIRTH DEFECTS: IS THE PUBLIC BEING KEPT IN THE DARK?” This Report was prepared for the APVMA by
July 2013 © Australian Pesticides and Veterinary Medicines Authority 2013 ISBN: 978-1-922188-42-7 (electronic) 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 and other elements specifically identified, 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:
In referencing this document the Scitox Assessment Services 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 may contain 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: communications@apvma.gov.au
“ROUNDUP AND BIRTH DEFECTS: IS THE PUBLIC BEING KEPT IN THE DARK?” Prepared for the APVMA by Scitox Assessment Services Canberra, ACT, Australia July 2013 TABLE OF CONTENTSTABLE OF CONTENTS 4 1. SUMMARY 7 1.1 The association between glyphosate / glyphosate-based herbicides and developmental malformations 7 1.2 The association between glyphosate / glyphosate-based herbicides, endocrine disruption and reproductive toxicity 9 1.3 Evidence for the genotoxicity and carcinogenicity of glyphosate / glyphosate-based herbicides 10 1.4 Neurotoxicity of glyphosate / glyphosate-based herbicides 11 1.5 Human exposure to glyphosate 11 1.6 Overseas assessment activity 12 Conclusions 12 2. MAIN BODY OF THE REVIEW 14 2.1 The association between glyphosate / glyphosate—based herbicides and developmental malformations 14 2.1.1 Effects in toad and bird embryos 14 2.1.2 Effects in laboratory animals 15 2.1.3 Epidemiological evidence 18 2.2 The association between glyphosate / glyphosate-based herbicides, endocrine disruption and reproductive toxicity 22 2.2.1 Reproductive effects of glyphosate in vivo 23 2.2.2 Evidence of endocrine modulation in other studies 24 2.2.3 Testicular carcinogenicity 24 2.3 Evidence for the genotoxicity of glyphosate / glyphosate-based herbicides 28 2.4 Carcinogenicity of glyphosate / glyphosate-based herbicides 31 2.4.1 Evidence from studies in laboratory animals 31 2.4.2 Evidence from human populations 34 2.5 Neurotoxicity of glyphosate / glyphosate-based herbicides 36 BIBLIOGRAPHY 38 APPENDIX 1: ASSESSMENTS OF DEVELOPMENTAL STUDIES IN RATS 50 APPENDIX 2: ASSESSMENTS OF DEVELOPMENTAL STUDIES IN RABBITS 53 APPENDIX 3: ASSESSMENTS OF REPRODUCTIVE TOXICITY STUDIES 60 A3.1 Rats 60 APPENDIX 4: STUDY ASSESSMENTS PERFORMED BY MARK JENNER, SCITOX ASSESSMENT SERVICES 62 A4.1 Effects of a glyphosate-based herbicide formulation on gene expression in vitro 62 A4.2 Cytotoxicity of glyphosate, AMPA and glyphosate-based herbicides in vitro 63 A4.3 Cytotoxicity, anti-estrogenic and anti–androgenic activity, and genotoxicity of glyphosate and glyphosate-based herbicides in vitro 67 A4.4 Developmental and reproductive effects of glyphosate-based herbicide in amphibians and birds 71 A4.5 Developmental and reproductive effects of a glyphosate-based herbicide in rats 74 A4.6 Reproductive effects of glyphosate in male rabbits 83 A4.7 Dermal carcinogenicity of a glyphosate-based herbicide in mice 85 A4.8 Epidemiological Study 88
GLOSSARY OF TERMS AND ABBREVIATIONS AChE acetylcholinesterase ADD/ADHD attention deficit disorder / attention deficit and hyperactivity disorder ADI acceptable daily intake AMPA aminomethyl sulphonic acid APVMA Australian Pesticides and Veterinary Medicines Authority BNMN binucleated cells with micronuclei BVL (German) Bundesamt fur Verbraucherschutz und Lebensmittelsicherheit bw body weight CFR conditional fecundability ratio ChE cholinesterase CI confidence interval DoHA Department of Health and Ageing DSEWPaC Department of Sustainability, Environment, Water, Population and Communities EOS Earth Open Source EU European Union g gram GBHF glyphosate-based herbicide formulation GC gas chromatography GD gestation day g/L grams per litre GLP good laboratory practice GM genetically modified h hour ha hectare hAR human androgen receptor hER human oestrogen receptor HC historical control HCL hairy cell leukaemia IC50 concentration inhibiting a chemical reaction by 50% IP intraperitoneal route of administration IPA isopropylamino IV intravenous route of administration JMPR Joint FAO/WHO Meeting on Pesticide Residues kg kilogram km kilometre L litre
lb/gal pounds per gallon LC50 lethal concentration to 50% of test cells or animals LD50 lethal dose to 50% of test animals LH luteinising hormone LOD limit of detection LOEL lowest observed effect level µg microgram M molar (concentration) mg milligram mg/kg bw/d milligrams per kilogram bodyweight per day mL millilitre min minute mM millimolar (concentration) MM multiple myeloma mo month
MRL maximum residue limit or level MTT 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide NEDI national estimated daily intake ng nanogram NHL non-Hodgkin’s lymphoma NOAEL no observed adverse effect level NOEL no observed effect level NTP US National Toxicology Program OECD Organisation for Economic Cooperation and Development OR odds ratio PND post natal day PO oral route of administration POEA polyoxyethylene tallow amine ppb parts per billion ppm parts per million RBC red blood cell RNA ribonucleic acid RR relative risk s second
SCE sister chromatid exchange StAR steroidogenic acute regulatory protein TTP time to pregnancy US EPA United States Environmental Protection Agency WHO World Health Organization wk week
yr year Directory: news media news media -> Reducing the business costs of regulation*1 news media -> Structural reform Australian-style: lessons for others? *1 news media -> Gary Banks and Bill Carmichael *1 Introduction news media -> Health costs and policy in an ageing Australia news media -> Gary Banks Chairman, Productivity Commission news media -> Overcoming Indigenous Disadvantage in Australia news media -> Gaining from trade liberalisation: some reflections on Australia’s experience news media -> Indigenous disadvantage: assessing policy impacts Download 0.79 Mb. Share with your friends:
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