Professional Documents
Culture Documents
Glyphosate
List of information, tests and studies which are considered as relied upon by the RMS for
the evaluation with a view to renew the active substance approval
Version 2 – information, tests and studies relied upon by the RMS and identified in the Renewal
Assessment Report (18 December 2013, rev. 29 January 2015, rev. 31 March 2015), Addendum 1
(31 August 2016) and Addendum 2 (30 March 2017)
B.1 Identity, B.2 Physical and chemical properties, B.3 Data on application and further information, B.4
Proposals for classification and labelling, B.5 Methods of analysis
Codes of owner
AAP Arysta LifeScience S.A.S
AGC AgriChem B.V.
AGT Agro Trade GmbH
ALB Albaugh UK Limited
BCL Barclay Chemicals Manufacturing Ltd.
BRK BROKDEN, SL
CHE Cheminova A/S
DOW Dow AgroSciences GmbH
DPB DuPont de Nemours
EGT European Glyphosate Task Force AIR 2
HEL HELM AG
IMA Imaspro Resources Sdn. Bhd.
INA Industrias Afrasa
JFG Jiangsu Fengshan
JGH Jiangsu Good Harvest
MAH Makhteshim-AGAN Group
MOD Monsanto Europe S.A./N.V.
NUF Nufarm GmbH & Co KG
PUJ Punjab Chemicals and Crop protection Ltd
RTA Rotam Agrochemicals Europe Ltd.
- 15 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.4.1 Li, A. P.; 1988 An evaluation of the genotoxic potential of N LIT
(OECD) Long, T. J. glyphosate, Fundamental and Applied
Toxicology 10 (1988)537 – 546
published: Y,
TOX9500253
KIIA 5.4.1 Rank, J.; 1993 Genotoxicity testing of the herbicide roundup N ---
KIIA 5.4.4 Jensen, A. G.; and its active ingredient glyphosate
(OECD) Skov, B. isopropylamine using the mouse bone
marrow micronucleus test, Salmonella
mutagenicity test, and Allium anaphase-
telephase test
Z82234
KIIA 5.4.1 Rasmussen, E. 1997 Genotoxicity of Roundup/Glyphosate, Danish N LIT
KIIA 5.4.4 S. Environmental Protection Agency,
(OECD) AA036753, 7042-0110
ASB2013-9671
- 41 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.4.4 Kier, L. D.; 1992 Mouse micronucleus study of Roundup N MON
KIIIA1 7.6.3 Flowers, L. J.; herbicide formulation
(OECD) Huffman, M. MSL-11771 ! EHL 91200/91204 ! ML-91-
B. 434/ML-91-437
TOX1999-242
KIIA 5.4 .4 Kier, L. D.; 1992 Glyphosate: Mouse micronucleus study of N MON
(OECD) Flowers, L. J.; DIRECT Herbicide formulation
Huffman, M. MSL-11773 ! EHL 91202/91206 ! ML-91-
B. 436/ML-91-439
TOX1999-322
KIIA 5.4.4 Knopper, L.D., 2004 Carcinogenic and genotoxic potential of turf N LIT
KIIA 5.10 Lean, D.R.S. pesticides commonly used on golf courses
(OECD) Journal of Toxicology and Environmental
Health-Part B-Critical Reviews 7, 267-279
GLP: N, published: Y
2309864 / ASB2012-11871
KIIA 5.4.4 Lebailly, P., 2003 Urine mutagenicity and lymphocyte DNA N LIT
KIIA 5.10 Devaux, A., damage in fruit growers occupationally
(OECD) Pottier, D., De exposed to the fungicide captan
Meo, M., Occupational & Environmental Medicine 60,
Andre, V., 910-917
Baldi, I., GLP: N, published: Y
Severin, F., 2309878 / ASB2012-11878
Bernaud, J.,
Durand, B.,
Henry-Amar,
M.,
Gauduchon, P.
KIIA 5.4.4 Levine, S.L., 2007 Disrupting mitochondrial function with N LIT
KIIA 5.10 Han, Z., Liu, J., surfactants inhibits MA-10 Leydig cell
(OECD) Farmer, D.R., steroidogenesis
Papadopoulos, Cell Biol Toxicol 23, 385-400
V. GLP: N, published: Y
2309890 / ASB2009-9030
KIIA 5.4.4 Li, A. P. 1983 In vivo bone marrow cytogenetics study of N MON
(OECD) glyphosate in Sprague-Dawley rats, Report:
ML-83-236 ! 830083, published: N,
TOX9552375
KIIA 5.4.4 Lioi, M. B.; 1998 Genotoxicity and oxidative stress induced by N LIT
KIIA 5.10 Scarfi, M. R.; pesticide exposure in bovine lymphocyte
(OECD) Santoro, A. cultures in vitro
Mutation Research 403 (1998) 13-20
ASB2013-9836
- 49 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.4.4 Mladinic, M., 2009 Evaluation of genome damage and its relation N LIT
KIIA 5.10 Berend, S., to oxidative stress induced by glyphosate in
(OECD) Vrdoljak, A.L., human lymphocytes in vitro
Kopjar, N., Environmental and Molecular Mutagenesis
Radic, B., 50, 800-807
Zeljezic, D. GLP: N, published: Y
2309942 / ASB2012-11906
KIIA 5.4.4 Mladinic, M., 2009 Characterization of chromatin instabilities N LIT
KIIA 5.10 Perkovic, P., induced by glyphosate, terbuthylazine and
(OECD) Zeljezic, D. carbofuran using cytome FISH assay
Toxicol Lett 189, 130-137
GLP: N, published: Y
2309944 / ASB2012-11907
KIIA 5.4.4 Monroy, C., 2005 Cytotoxicity and genotoxicity of human cells N LIT
KIIA 5.10 Cortes, A., exposed in vitro to glyphosate
(OECD) Sicard, D., de Biomedica 25, 335-345
Restrepo, H. GLP: N, published: Y
2309950 / ASB2012-11910
- 50 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.10 Andreotti, G.; 2012 The Interaction between pesticide use and N LIT
(OECD) Koutros, S.; genetic variants involved in lipid metabolism
Berndt, S. I. et on prostate cancer risk
al. Journal of Cancer Epidemiology
Volume 2012, Article ID 358076,
ASB2014-9198
- 75 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.10 Benachour, N., 2007 Time- and dose-dependent effects of roundup N LIT
(OECD) Sipahutar, H., on human embryonic and placental cells
Moslerni, S., Archives of Environmental Contamination
Gasnier, C., and Toxicology 53, 126-133
Travert, C., GLP: N, published: Y
Seralini, G.E. 2309608 / ASB2009-9018
- 77 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.10 Cattani, D.; de 2014 Mechanisms underlying the neurotoxicity N LIT
(OECD) Liz Oliveira induced by Glyphosate-based herbicide in
Cavalli, V. L.; immature rat hippocampus: Involvement of
Heinz Rieg, C. glutamate excitotoxicity
E. et al. Toxicology 320 (2014) 34–45
ASB2014-3919
KIIA 5.10 Chaufan, G.; 2014 Glyphosate commercial formulation causes N LIT
(OECD) Coalova, I.; cytotoxicity, oxidative effects, and apoptosis
Molina, M. on human cells: Differences with its active
ingredient
International Journal of Toxicology 2014,
Vol. 33(1) 29-38
ASB2014-9314 / ASB2014-7616
KIIA 5.10 Chen, Y. J.; 2009 The epidemiology of Glyphosate-surfactant N LIT
(OECD) Wu, M.-L.; herbicide poisoning in Taiwan, 1986–2007: a
Deng, J.-F.; poison center study
Yang, C.-C. Clinical Toxicology (2009) 47, 670–677
ASB2014-9318
KIIA 5.10 Chen, H.-H.; 2013 Spectrum of corrosive esophageal injury after N LIT
(OECD) Lin, J.-L.; intentional paraquat or Glyphosate-surfactant
Huang, W-H. et herbicide ingestion
al. International Journal of General Medicine
2013:6 677–683
ASB2014-9321
KIIA 5.10 Chien, W.-C.; 2012 Risk and prognostic factors of inpatient N LIT
(OECD) Chung, C.-H.; mortality associated with unintentional
Jaakkola, J. J. insecticide and herbicide poisonings: A
K. et al. retrospective cohort study
PLOS one September 2012 Volume 7 Issue 9
e45627
ASB2014-9326
- 80 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.10 Cocco, P.; 2014 Lymphoma risk and occupational exposure to N LIT
(OECD) Satta, G.; pesticides: results of the Epilymph study
Occup Environ Med 2012;0:1–7
ASB2014-7523
KIIA 5.10 Corsini, E.; 2012 Pesticide induced immunotoxicity in humans: N LIT
(OECD) Sokooti, M.; A comprehensive review of the existing
Galli, C. L.; evidence
Moretto, A.; Toxicology (2012)
Colosio, C. ASB2014-9352
KIIA 5.10 Dai, P.; Hu, 2016 Effect of glyphosate on reproductive organs N LIT
P.; Tang, J.; in male rat
Li, Y.; Li, C.; Acta histochemical Volume 118, Issue 5,
June 2016, Pages 519–526
BVL-3194154, ASB2016-11622
KIIA 5.10 Dallegrave, E., 2003 The teratogenic potential of the herbicide N LIT
KIIIA1 7.6.3 Mantese, F.D., glyphosate-Roundup (R) in Wistar rats
(OECD) Coelho, R.S., Toxicology Letters 142, 45-52
Pereira, J.D., GLP: N, published: Y
Dalsenter, P.R., 2309692 / ASB2012-11600
Langeloh, A.
KIIA 5.10 Dallegrave, E., 2007 Pre- and postnatal toxicity of the commercial N LIT
KIIIA1 7.6.3 Mantese, F.D., glyphosate formulation in Wistar rats
(OECD) Oliveira, R.T., Archives of Toxicology 81, 665-673
Andrade, GLP: N, published: Y
A.J.M., 2309694 / ASB2012-2721
Dalsenter, P.R.,
Langeloh, A.
KIIA 5.10 Defarge, N.; 2016 Co-formulants in Glyphosate-based N LIT
Takacs, E.; herbicides disrupt aromatase activity in
Lozano, V. L. human cells below toxic levels
et al. 10.3390/ijerph13030264
BVL-3194154, ASB2016-2568
KIIA 5.6.1 Dhinsa, N.K., 2007 Glyphosate technical: Dietary Two Y NUF
Watson, P., Generation Reproduction Study in the Rat
Brooks, P.N 2060/0013
GLP: Yes Published: No
BVL-2309418, ASB2012-11494
KIIA 5.10 de Liz Oliveira 2013 Roundup disrupts male reproductive N LIT
(OECD) Cavalli, V. L.; functions by triggering calcium-mediated cell
Cattani, D.; death in rat testis and Sertoli cells
Rieg, C. E. H. FreeRadicalBiologyandMedicine65(2013)335
et al. –346
ASB2014-7495
- 82 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.10 George, J.; 2013 Emptying of intracellular calcium pool and N LIT
(OECD) Shukla, Y.; oxidative stress imbalance are associated with
the Glyphosate-induced proliferation in
human skin keratinocytes HaCaT cells
ISRN Dermatology, Volume 2013, Article ID
825180
ASB2014-8034
KIIA 5.10 Gil, H. W.; 2013 Effect of intravenous lipid emulsion in N LIT
(OECD) Park, J. S.; patients with acute Glyphosate intoxication
Hong; S. Y. Clinical Toxicology (2013), 51, 767–771
ASB2014-9488
- 85 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.10 Hour, B. T.; 2012 Herbicide Roundup intoxication: Successful N LIT
(OECD) Belen, C.; Zar, treatment with continuous renal replacement
T. et al. therapy
The American Journal of Medicine, Vol 125,
No 8, August 2012
ASB2014-9571
KIIA 5.10 Jamkhande, P. 2014 Teratogenicity: A mechanism based short N LIT
(OECD) G.; Chintawar, review on common teratogenic agents
K. D.; Asian Pac J Trop Dis 2014; 4(6): 421-432
Chandak, P. G. ASB2014-9573
KIIA 5.10 Jany, K.-D. 2013 Die Langzeitfütterungsstudie von Seralini et N LIT
(OECD) al. (2012) - eine kritische Replik
Ernährungs Umschau 8/2013
ASB2014-9580
KIIA 5.10 Jasper, R.; 2012 Evaluation of biochemical, hematological and N LIT
(OECD) Locatelli, G. oxidative parameters in mice exposed to the
O.; Pilati, C. et herbicide Glyphosate-Roundup
al. Interdiscip Toxicol. 2012; Vol. 5(3): 133–
140.
ASB2014-9583
KIIA 5.10 Jayasumana, 2014 Glyphosate, hard water and nephrotoxic N LIT
(OECD) C.; Gunatilake, metals: Are they the culprits behind the
S.; Senanayake, epidemic of chronic kidney disease of
P.; unknown etiology in Sri Lanka?
Int. J. Environ. Res. Public Health 2014, 11,
2125-2147
ASB2014-3085
- 88 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.10 Kelce, W.R., 2010 A Critique of prepubertal exposur eto N LIT
(OECD) Lamb, J.C., commercial formulation of the herbicide
DeSesso, J.M. glyphosate
GLP: N, published: Y
2309848 / ASB2012-11867
KIIA 5.10 Kier, L. D.; 2013 Review of genotoxicity studies of Glyphosate N LIT
(OECD) Kirkland, D. J. and Glyphosate-based formulations
Crit Rev Toxicol, 2013; 43(4): 283–315
ASB2014-9587
KIIA 5.10 Kilinc, N.; 2013 Influence of pesticide exposure on carbonic N LIT
(OECD) Isgör, M. M.; anhydrase II from sheep stomach
Sengül, B. et al. Toxicology and Industrial Health 1–8
ASB2014-9588
KIIA 5.10 Kim, J.; Ko, 2013 Depressive symptoms and severity of acute N LIT
(OECD) W.; Lee, W. J. occupational pesticide poisoning among male
farmers
Occup Environ Med 2013;0:1–7
ASB2014-9592
KIIA 5.10 Kim, Y.; Hong, 2013 Mixtures of Glyphosate and surfactant TN20 N LIT
(OECD) J.; Gil, H. et al. accelerate cell death via mitochondrial
damage-induced apoptosis and necrosis
Toxicology in Vitro 27 (2013) 191–197
ASB2014-9591
KIIA 5.10 Kitazawa, T. 2013 IET historical control data on malignant Y ALS
(OECD) lymphoma incidence in control ICR (Crj:CD-
1) mice HR-001: Carcinogenicity study in
mice (IET 94-0151)
13-C015
ASB2014-9146
KIIA 5.10 Knezevic, V.; 2012 Early continuous dialysis in acute N LIT
(OECD) Bozic, D.; Glyphosate-surfactant poisoning
Budosan, I. et Srp Arh Celok Lek. 2012 Sep-Oct;140(9-
al. 10):648-652
ASB2014-9593
- 89 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.10 Krüger, 2012 Visceral botulism at dairy farms in Schleswig N LIT
(OECD) M.;Große- Holstein, Germany - Prevalence of
Herrenthey, A.; Clostridium botulinum in feces of cows, in
Schrödl, W.; animal feeds, in feces of the farmers, and in
Gerlach, A.; house dust
Rodloff, A.; Anaerobe 18 (2012) 221-223
ASB2013-13312
KIIA 5.10 Krüger, M.; 2014 Detection of Glyphosate in malformed piglets N LIT
(OECD) Schrödl, W.; J Environ Anal Toxicol 2014, 4:5
Pedersen, I; ASB2014-8935
Shehata, A. A.
KIIA 5.10 Mesnage, R.; 2014 The need for a closer look at pesticide N LIT
(OECD) Séralini, G.-E. toxicity during GMO assessment
Practical Food Safety: Contemporary Issues
and Future Directions, First Edition.
Edited by Rajeev Bhat and Vicente M.
Gómez-López.
ASB2014-9616
KIIA 5.10 Mink, P. J.; 2012 Epidemiologic studies of Gyphosate and N LIT
(OECD) Mandel, J. S.; cancer: A review
Sceurman, B. Regulatory Toxicology and Pharmacology 63
K. et al. (2012) 440–452
ASB2014-9617
KIIA 5.10 Modesto, K. 2010 Effects of roundup transorb on fish: N LIT
(OECD) A.; Martinez, Hematology, antioxidant defenses and
C. B. R. acetylcholinesterase activity
Chemosphere 81 (2010) 781–787
ASB2012-811
KIIA 5.10 Moreno, N. C.; 2014 Genotoxic effects of the herbicide N LIT
(OECD) Sofia, S. H.; RoundupTransorb®and its active ingredient
Martinez, C. B. glyphosate onthe fish Prochilodus lineatus
R.; Environ. Toxicol. Pharmacol. 37 (2014 )
448–454
ASB2014-7522
KIIA 5.10 Mose, T., 2008 Placental passage of benzoic acid, caffeine, N LIT
(OECD) Kjaerstad, and glyphosate in an ex vivo human perfusion
M.B., system
Mathiesen, L., Journal of Toxicology and Environmental
Nielsen, J.B., Health-Part a-Current Issues 71, 984-991
Edelfors, Sn., GLP: N, published: Y
Knudsen L.E. 2309958 / ASB2012-11914
- 95 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.10 Savitz, D.A., 1997 Male pesticide exposure and pregnancy N LIT
(OECD) Arbuckle, T., outcome
Kaczor, D., American Journal of Epidemiology 146,
Curtis, K.M. 1025-1036
GLP: N, published: Y
2310070 / ASB2012-12022
KIIA 5.10 Schinasi, L.; 2014 Non-Hodgkin lymphoma and occupational N LIT
(OECD) Leon, M. E.; exposure to agricultural pesticide chemical
groups and active ingredients: A systematic
review and meta-analysis
Int. J. Environ. Res. Public Health 2014, 11,
4449-4527
ASB2014-4819
KIIA 5.10 Seneff, S.; 2013 Is encephalopathy a mechanism to renew N LIT
(OECD) Lauritzen, A.; sulfate in autism?
Davidson, R. Entropy 2013, 15, 372-406
M. et al. ASB2014-9729
- 100 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.10 Song, H. Y.; 2012 In vitro cytotoxic effect of glyphosate N LIT
(OECD) Kim, J. H.; mixture containing surfactants
Seok, S. J.; J Korean Med Sci 2012; 27: 711-715
Gil, H. W.; ASB2013-10531
Hong, S, Y.;
- 101 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
KIIA 5.10 Tizhe, E. V.; 2013 Haematogical changes induced by subchronic N LIT
(OECD) Ibrahim, N. D. Glyphosate exposure: Ameliorative effect of
G.; Fatihu, M. zinc in Wistar rats
Y. et al. Sokoto Journal of Veterinary Sciences,
Volume 11 (Number 2). December, 2013
ASB2014-6963
KIIA 5.10 Tizhe, E. V.; 2013 Influence of zinc supplementation on N LIT
(OECD) Ibrahim, N. D. histopathological changes in the stomach,
G.; Fatihu, M. liver, kidney, brain, pancreas and spleen
Y. et al. during subchronic exposure of Wistar rats to
Glyphosate
Comp Clin Pathol (2013)
ASB2014-6965
KIIA 5.10 Tizhe, E. V.; 2013 Serum biochemical assessment of hepatic and N LIT
(OECD) Ibrahim, N. D. renal functions of rats during oral exposure to
G.; Fatihu, M. Glyphosate with zinc
Y. et al. Comp Clin Pathol (2014) 23:1043–1050
ASB2014-6964
KIIA 5.10 Uren Webster, 2014 Effects of Glyphosate and its formulation, N LIT
T. M.; Laing, Roundup, on reproduction in zebrafish
L. V.; Florance, (Danio rerio)
H.; Santos, E.
M. Environmental science & technology.
Volume 48, Number 2, Pages 1271–1279
BVL-3194154, ASB2016-11624
KIIA 5.10 Uren Webster, 2013 Effects of Glyphosate and its formulation, N LIT
T.M.; Laing, Roundup, on reproduction in Zebrafish
L.V.; Florance, (Danio rerio)
H.; Santos, dx.doi.org/10.1021/es404258h
E.M. Environ. Sci. Technol. 2014, 48,
1271−1279
BVL-3194154, ASB2015-8040
KIIA 5.10 Vandenberg, L. 2012 Hormones and endocrine-disrupting N LIT
(OECD) N.; Colborn, chemicals: Low-dose effects and
T.; Hayer, T. B. nonmonotonic dose responses
et al. Endocrine Reviews, June 2012, 33(3):378–
455
ASB2014-9635
- 103 -
Glyphosate List of information, tests and studies relied upon
Version 2 (15 December 2017)
Codes of owner
B.7 Residues
Codes of owner
Codes of owner
B.9 Ecotoxicology
Codes of owner