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

ROUNDUP AND BIRTH DEFECTS: IS THE PUBLIC BEING KEPT IN THE DARK?”

This Report was prepared for the APVMA by

Scitox Assessment Services

Canberra, ACT, Australia

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.description: description: description: c:\users\mchandra\desktop\cc.pngdescription: description: description: c:\users\mchandra\desktop\by (2).png

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 Scitox Assessment Services.

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

This publication is available from the APVMA website: www.apvma.gov.au.
A REVIEW OF THE EARTH OPEN SOURCE (EOS) REPORT

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 CONTENTS


TABLE 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

DNA deoxyribonucleic acid

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

GIT gastro-intestinal tract

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

LOQ limit of quantification

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

RA retinoic acid

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
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