link to page 1 link to page 1
- 1 -
EUROPEAN COMMISSION
HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL
Directorate E – Food Safety: plant health, animal health and welfare, international questions
E1 - Plant health
Glyphosate
6511/VI/99-final
21 January 2002
COMMISSION WORKING DOCUMENT - DOES NOT NECESSARILY REPRESENT THE
VIEWS OF THE COMMISSION SERVICES
Review report for the active substance
glyphosate
Finalised in the Standing Committee on Plant Health at its meeting on 29 June 2001
in view of the inclusion of
glyphosate in Annex I of Directive 91/414/EEC
1.
Procedure followed for the re-evaluation process
This review report has been established as a result of the re-evaluation of glyphosate, made in the
context of the work programme for review of existing active substances provided for in Article 8(2)
of Directive 91/414/EEC concerning the placing of plant protection products on the market, with a
view to the possible inclusion of this substance in Annex I to the Directive.
Commission Regulation (EEC) No 3600/92(
1) laying down the detailed rules for the
implementation of the first stage of the programme of work referred to in Article 8(2) of Council
Directive 91/414/EEC, as last ame
nded by Regulation (EC) No 1972/99(2), has laid down the
detailed rules on the procedure according to which the re-evaluation has to be carried out.
Glyphosate is one of the 90 existing active substances covered by this Regulation.
In accordance with the provisions of Article 4 of Regulation (EEC) No 3600/92, Feinchemie
Schwebda on 11 June 1993, Herbex Produtos Quimicos Ltd on 10 February 1993, Law Offices of
Samuel Pisar on 25 June 1993, Stefes Agro GmbH on 20 July 1993, United Phosphorus Ltd on 26
July 1993, Alkaloida Europe on 23 July 1993, Phytorus SA on 26 July 1993, Marubeni UK plc
(since November 1997 Sinon EU Coorperation) on 23 July 1993, Cequisa on 23 July 1993,
Cheminova Agro A/S on 28 July 1993, Monsanto SA on 19 July 1993, I. Pi. Ci. Industrias Prodotti
Chimici on 30 July 1993, Barclay Chemicals on 27 June 1993, Chimac-Agriphar SA on 27 July
1993, SANC on 23 July 1993, OXON Italia SpA on 20 July 1993, Makhteshim Agan on 20 July
1993, Hermoo Belgium NV on
30 July 1993, Industrial Kern Espag on 26 July 1993, Tessenderlo
Chemie on 27 July 1993, Iberotam on 26 July 1993, Industrias Quimicas del Valles on 28 July
1 OJ No L 366, 15.12.1992, p.10.
2 OJ No L 244, 16.09.1999, p.41.
link to page 2 link to page 2
- 2 -
1993, Aragonesas Agro SA on 27 July 1993, Stefes Research GmbH on 9 July 1993, Pilar Iberica
SL Juan Amich Gail on 23 July 1993, AgriChem on 15 July 1993, Elf Atochem on 26 July 1993,
Portman Agrochemicals on 26 July 1993, Helm AG on 23 July 1993, Calliope on 21 July 1993,
Industrias Afrasas on 27 July 1993, Grower on 29 July 1993, K.C.S. Products on 23 July 1993, B.
V. Luxan on 21 July 1993 and Sanachem GmbH (subsequently Dow AgrowScience) on 25 April
1995 notified to the Commission of their wish to secure the inclusion of the active substance
glyphosate (isopropylamin-, natrium-, ammonium-salts) in Annex I to the Directive.
In accordance with the provisions of Article 4 of Regulation (EEC) No 3600/92, Zeneca Agrochemicals
(subsequently Syngenta) on 27 July 1993 notified to the Commission of their wish to secure the
inclusion of the active substance glyphosate (trimesium-salt) in Annex I to the Directive.
Three glyphosate task forces were formed. AgriChem on behalf of the tulip task force, comprising
AgriChem, Aragonesas Agro SA, Industrias Afrasas, Calliope, Sundat and TKI Pinus Race
submitted a dossier on 20 April 1995. Monsanto and Cheminova formed a task force and jointly
submitted a dossier to the rapporteur Member State on 24 April 1995. Barclay Chemicals and
Portman Agrochemicals formed a task force and jointly submitted a dossier to the rapporteur
Member State on 25 April 1995. Further dossiers were submitted by Feinchemie Schwebda on
27 April 1995, Marubeni UK plc (Sinon EU Coorperation) on 28 April 1995, Herbex Produtos
Quimicos Ltd on 28 April 1995, Luxan on 3 May 1995, I. Pi. Ci. Industrias Prodotti Chimici on
2 May 1995, Nufarm Limited on 17 May 1995, Alkaloida on 2 May 1995 and Sanachem
(subsequently Dow AgroScience) on 9 April 1996, Zeneca Agrochemicals (Syngenta) on
19 December 1994. Nufarm and Alkaloida officially withdrew their notifications on 21 July 1999 and
14 February 2001, respectively.
In accordance with the provisions of Article 5 of Regulation (EEC) No 3600/92, the Commission,
by its Regulation (EEC) No 933/94(3), as last amended by Regulation (EC) No 2230/95(
4),
designated Germany as rapporteur Member State to carry out the assessment of glyphosate on the
basis of the dossiers submitted by the notifiers. In the same Regulation, the Commission specified
furthermore the deadline for the notifiers with regard to the submission to the rapporteur Member
States of the dossiers required under Article 6(2) of Regulation (EEC) No 3600/92, as well as for
other parties with regard to further technical and scientific information; for glyphosate this deadline
was 30 April 1995. For the dossier from Sanachem the deadline was extended to 31 October 1995.
The task force Monsanto/Cheminova as well as Feinchemie Schwebda were considered main data
submitters (glyphosate), with a dossier which did not contain substantial data gaps, taking into
account the supported uses. Sinon EU Corporation (Marubeni), Herbex Produtos Quimicos Ltd,
AgriChem, Aragonesas Agro SA, Industrias Afrasas, Sundat, Calliope, TKI Pinus Race, B. V.
Luxan, I. Pi. Ci. Industrias Prodotti Chimici, Nufarm, Barclay Chemicals, Portman Agrochemicals,
Alkaloida Europe and Dow AgroScience (Sanachem) did not submit complete dossiers. With regard
to glyphosate, additional information has been submitted by third parties including publications
provided by the responsible authorities in other Member States (Denmark, Sweden) and data
obtained from the German National Poisoning Information Centre.
Syngenta (Zeneca Agrochemicals) was main data submitter (glyphosate trimesium), with a dossier
which did not contain substantial data gaps, taking into account the supported uses. With regard to
glyphosate trimesium, some additional (published) information was submitted by the Finnish
3 OJ No L 107, 28.04.1994, p.8.
4 OJ No L 225, 22.09.1995, p.1.
- 3 -
authorities and data on poisoning incidents were provided by the German National Poisoning
Information Centre.
In accordance with the provisions of Article 7(1) of Regulation (EEC) No 3600/92, Germany submitted
on 1 February 1999 to the Commission the report of its examination, hereafter referred to as the draft
assessment report, including, as required, a recommendation concerning the possible inclusion of
glyphosate in Annex I to the Directive. Moreover, in accordance with the same provisions, the
Commission and the Member States received also the summary dossier on glyphosate from Feinchemie
Schwebda and Monsanto/Cheminova and glyphosate trimesium from Syngenta (Zeneca
Agrochemicals), on 2 March 1999.
In accordance with the provisions of Article 7(3) of Regulation (EEC) No 3600/92, the Commission
forwarded for consultation the draft assessment report to all the Member States as well as to Monsanto
being the designated representative of the glyphosate task force
and to
Feinchemie Schwebda and
Syngenta (Zeneca Agrochemicals) being main data submitters, on 11 January 1999.
The Commission organised an intensive consultation of technical experts from a certain number of
Member States, to review the draft assessment report and the comments received thereon (peer
review), in particular on each of the following disciplines:
-
identity and physical /chemical properties ;
-
fate and behaviour in the environment ;
-
ecotoxicology ;
-
mammalian toxicology ;
-
residues and analytical methods ;
-
regulatory questions.
The meetings for this consultation were organised on behalf of the Commission by the Pesticide
Safety Directorate (PSD) in York, United Kingdom, from March to October 1999.
The reports of the peer review (i.e. full report) were circulated, for further consultation, to Member
States on 17 March 2000 (glyphosate) and on 24 March 2000 (glyphosate trimesium) and the main data
submitters on 21 March 2000 (glyphosate) and on 24 March 2000 (glyphosate trimesium) for
comments and further clarification.
In accordance with the provisions of Article 7(3) of Regulation (EEC) No 3600/92, the dossiers, the
draft assessment report, the peer review reports (i.e. full report) and the comments and clarifications on
the remaining issues, received after the peer review were referred to the Standing Committee on Plant
Health, and specialised working groups of this Committee, for final examination, with participation of
experts from the 15 Member States. This final examination took place from December 1999 to June
2001, and was finalised in the meeting of the Standing Committee on 29 June 2001.
The present review report contains the conclusions of this final examination; given the importance of
the draft assessment report, the peer review reports (i.e. full report) and the comments and clarifications
submitted after the peer review as basic information for the final examination process, these documents
are considered respectively as background documents A, B and C to this review report and are part of
it.
These documents were also submitted to the Scientific Committee for Plants. No specific questions
were addressed to the Committee. Following an exchange of views the Committee noted that there
link to page 4 link to page 4
- 4 -
were no issues that it wished to raise regarding the active substances in the context of a possible
inclusion in Annex I to the Directive5. The Committee reiterated its earlier statements that absence of
comment should only be interpreted as an indication of no obvious reasons necessitating comment.
2.
Purposes of this review report
This review report, including the background documents and appendices thereto, have been developed
and finalised in support of Commission Directive 2001/99
/EC concerning the inclusion of glyphosate in
Annex I to Directive 91/414/EEC, and to assist the Member States in decisions on individual plant
protection products containing glyphosate they have to take in accordance with the provisions of that
Directive, and in particular the provisions of article 4(1) and the uniform principles laid down in Annex
VI.
This review report provides also for the evaluation required under Section A.2.(b) of the above
mentioned uniform principles, as well as under several specific sections of part B of these principles. In
these sections it is provided that Member States, in evaluating applications and granting authorisations,
shall take into account the information concerning the active substance in Annex II of the directive,
submitted for the purpose of inclusion of the active substance in Annex I, as well as the result of the
evaluation of those data.
In accordance with the provisions of Article 7(6) of Regulation (EEC) No 3600/92, Member States will
keep available or make available this review report for consultation by any interested parties or will
make it available to them on their specific request. Moreover the Commission will send a copy of this
review report (not including the background documents) to all operators having notified for this active
substance under Article 4(1) of this Regulation.
The information in this review report is, at least partly, based on information, which is confidential
and/or protected under the provisions of Directive 91/414/EEC. It is therefore recommended that this
review report would not be accepted to support any registration outside the context of Directive
91/414/EEC, e.g. in third countries, for which the applicant has not demonstrated to have regulatory
access to the information on which this review report is based.
3.
Overall conclusion in the context of Directive 91/414/EEC
The overall conclusion from the evaluation is that it may be expected that plant protection products
containing glyphosate will fulfil the safety requirements laid down in Article 5(1)(a) and (b) of
Directive 91/414/EEC. This conclusion is however subject to compliance with the particular
requirements in sections 4, 5, 6 and 7 of this report, as well as to the implementation of the provisions
of Article 4(1) and the uniform principles laid down in Annex VI of Directive 91/414/EEC, for each
glyphosate containing plant protection product for which Member States will grant or review the
authorisation.
Furthermore, these conclusions were reached within the framework of the following uses, which were
proposed and supported by the main data submitter:
-
herbicide against terrestrial annual weeds, perennial weeds and shrubs in fruit, vegetables,
forestry, grassland, ornamentals and arable crops as well as non-crop uses
6.
5 Minutes of the plenary of the Scientific Committee on Plants from March 7, 2001
- 5 -
Extension of the use pattern beyond those described above will require an evaluation at Member State
level in order to establish whether the proposed extensions of use can satisfy the requirements of Article
4(1) and of the uniform principles laid down in Annex VI of Directive 91/414/EEC.
With particular regard to residues, the review has established that the residues arising from the
proposed uses, consequent on application consistent with good plant protection practice, have no
harmful effects on human or animal health. The Theoretical Maximum Daily Intake (TMDI; excluding
water and products of animal origin) for a 60 kg adult is 15 % of the Acceptable Daily Intake (ADI),
based on the FAO/WHO European Diet (August 1994). Additional intake from water and products of
animal origin are not expected to give rise to intake problems.
The review has identified several acceptable exposure scenarios for operators, workers and
bystanders, which require however to be confirmed for each plant protection product in accordance
with the relevant sections of the above mentioned uniform principles.
The review has also concluded that under the proposed and supported conditions of use there are no
unacceptable effects on the environment, as provided for in Article 4 (1) (b) (iv) and (v) of Directive
91/414/EEC, provided that certain conditions are taken into account as detailed in section 6 of this
report.
4.
Identity and Physical/chemical properties
The main identity and the physical/chemical properties of glyphosate/glyphosate trimesium are given in
Appendix I.
The active substance shall comply with the FAO specification and there seems not to be reasons for
deviating from that specification; the FAO specification is given in Appendix I of this report.
The review has established that for the active substance notified by the main data submitters
Feinchemie Schwebda, Monsanto
and Syngenta (Zeneca Agrochemicals), none of the
manufacturing impurities considered are, on the basis of information currently available, of
toxicological or environmental concern. Regarding glyphosate, the Syngenta product was evaluated
by FAO and WHO and the decision on the proposal to the FAO Group on Specifications to accept
the Syngenta product as equivalent will be taken at the meeting of the FAO Group end of June
2001.
In accordance with the provisions of Article 13(5) of Directive 91/414/EEC, Germany is also
satisfied, on the basis of the information currently available, that the substance notified by the other
data submitters Sinon EU Corporation, Herbex Produtos Quimicos Ltd, AgriChem, Aragonesas
Agro SA, Industrias Afrasas, Sundat, TKI Pinus Race, B. V. Luxan, I. Pi. Ci. Industrias Prodotti
Chimici, Barclay Chemicals, Portman Agrochemicals, Alkaloida Europe and Dow AgroScience do
not, in the meaning of Article 13(2) and (5) of the Directive, differ significantly in degree of purity
and nature of impurities from the composition registered in the dossiers submitted by the main data
submitters. Only the substances of Nufarm and Calliope deviated significantly from the impurity
profiles of Monsanto/Cheminova.
6 The term non-crop uses is defined as proposed by the EPPO guideline for the efficacy evaluation of herbicides (PP
1/117(2): Weeds in Non-Agricultural Land)
- 6 -
5.
Endpoints and related information
In order to facilitate Member States, in granting or reviewing authorisations, to apply adequately the
provisions of Article 4(1) of Directive 91/414/EEC and the uniform principles laid down in Annex VI
of that Directive, the most important endpoints as identified during the re-evaluation process are set out
under point 1 above. These endpoints are listed in Appendix II.
6.
Particular conditions to be taken into account on short term basis by Member States in
relation to the granting of authorisations of plant protection products containing
glyphosate
On the basis of the proposed and supported uses, the following particular issues have been identified as
requiring particular and short term attention from all Member States, in the framework of any
authorisations to be granted, varied or withdrawn, as appropriate:
-
Groundwater: Member States must pay particular attention to the protection of the
groundwater in vulnerable areas, in particular with respect to non-crop uses.
7.
List of studies to be generated
No further studies were identified which were at this stage considered necessary in relation to the
inclusion of glyphosate in Annex I under the current inclusion conditions. Some endpoints may still
require the generation or submission of additional studies to be submitted to the Member States in order
to ensure authorisations for use under certain conditions.
Extension of the use pattern beyond the uses described in Section 3 above may require the generation or
submission of additional studies to the Member States. This will be the case in particular for uses of the
substance related to the control of aquatic weeds.
8.
Information on studies with claimed data protection
For information of any interested parties, Appendix III gives information about the studies for which
the main data submitter have claimed data protection and which during the re-evaluation process were
considered as essential with a view to Annex I inclusion. This information is only given to facilitate the
operation of the provisions of Article 13 of Directive 91/414/EEC in the Member States. It is based on
the best information available to the Commission services at the time this review report was prepared;
but it does not prejudice any rights or obligations of Member States or operators with regard to its uses
in the implementation of the provisions of Article 13 of the Directive 91/414/EEC neither does it
commit the Commission.
9.
Updating of this review report
The technical information in this report may require to be updated from time to time in order to take
account of technical and scientific developments as well as of the results of the examination of any
information referred to the Commission in the framework of Articles 7, 10 or 11 of Directive
- 7 -
91/414/EEC. Such adaptations will be examined and finalised in the Standing Committee on Plant
Health, in connection with any amendment of the inclusion conditions for glyphosate in Annex I of the
Directive.
- 8 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX I
Identity, physical and chemical properties
11 May 2001
APPENDIX I
Identity, physical and chemical properties
GLYPHOSATE / GLYPHOSATE TRIMESIUM
Common name (ISO)
Glyphosate
Glyphosate trimesium
Chemical name (IUPAC) N-(phosphonomethyl)-glycin
N-(phosphonomethyl)-glycin
trimesium salt
Chemical name (CA)
glycin,
N-(phosphonomethyl)-
glycin,
N-(phosphonomethyl)-
trimethylsulfonium salt
CIPAC No
0284
0284.114
CAS No
1071-83-6
81591-81-3
EEC No
213-997-4
---
FAO SPECIFICATION
FAO 284 (2000)
FAO 284 (2000) (acid)
Minimum Purity
950 g/kg
950 g/kg (acid)
Molecular formula
C3H8NO5P
C6H16NO5PS
Molecular mass
169
245.2
Structural formula
O
O
-
OH
+
O
O
CH
O
3
NH
P
NH
P
HC
S
3
HO
CH
CH
2
2
O
H
CH
CH
OH
2
2
OH
CH3
Melting point
189.5 °C (999 g/kg)
Decomposition.
Boiling point
Decomposition
Decomposition.
Appearance
colourless crystalls
White solid (pure as)
Relative density
1.705 (995 g/kg)
1.42 (pure as)
Vapour pressure
1.31 ⋅ 10-5 Pa (25 °C, acid)
< 1 ⋅ 10-11 Pa (20 °C)
Henry's law constant
2.1 ⋅ 10-7 Pa ⋅ m3 ⋅mol-1
< 2 ⋅ 10-9 Pa ⋅ m3 ⋅mol-1
Solubility in water
pH 2: 10.5 ± 0.2 g/l (20 °C, 995 pH 5- 9: 1050 g/l at 20°C
g/kg)
- 9 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX I
Identity, physical and chemical properties
11 May 2001
Solubility in organic
acetone:
0.078 g/l
acetone:
<0.05 g/l
solvents
(20°C)
dichloro-
0.233 g/l
xylene:
<0.05 g/l
methane:
(20°C)
ethyl acetate:
0.012 g/l
1,2-dichlorothene:
<0.05 g/l
(20°C)
hexane:
0.026 g/l
heptane:
<0.05 g/l
(20°C)
methanol:
0.231 g/l
methanol:
174 g/l
(20°C)
n-octanol:
0.020 g/l
n-octanol:
<0.05 g/l
(20°C)
propan-2-ol:
0.020 g/l
ethanol:
<0.05 g/l
(20°C)
toluene:
0.036 g/l
---
---
Partition co-efficient
pH 5 – 9: - 3.2 at 25 °C (999 g/kg)
- 2.9, pH and temperature not
(log Pow)
stated
Hydrolytic stability
pH 5: stable (25 °C)
pH 5: stable; 25 and 40 °C
(DT50)
(glyphosate and TMS)
pH 7 : stable (25 °C)
pH 7: stable; 25 and 40 °C
(glyphosate and TMS)
pH 9: stable (25 °C)
pH 9: stable; 25 and 40 °C
(glyphosate and TMS)
Dissociation constant
pKa: 2.34 (20 °C), 5.73 (20 °C),
Glyphosate-trimesium is a salt
10.2 (25 °C)
which is fully dissociated in water.
Glyphosate acid has 4 dissociation
constants: < 2, 2.25, 5.5 and 10.34
(0.1 M at 20 °C).
Quantum yield of direct
Not determined.
Not determined.
photo-transformation in
water at ε
>290 nm
Flammability
Not highly flammable.
Not flammable.
Explosive properties
Not explosive.
Not explosive.
UV/VIS absorption
ε: 0.086 (295 nm)
ε is less than 10 at wavelengths >
(max.)
290 nm.
Photostability in water
33 d (pH 5), 69 d (pH 7), 77 d
DT50: 81 d (pH 7) 37°N for
(DT50)
(pH 9) (Xenon lamp).
glyphosate anion and stable for the
cation.
- 10 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
1. Toxicology and metabolism
11 May 2001
APPENDIX II
END POINTS AND RELATED INFORMATION
GLYPHOSATE/GLYPHOSATE TRIMESIUM
1 Toxicology and metabolism
Absorption, distribution, excretion and metabolism in mammals
Glyphosate
Glyphosate Trimesium
Rate and extent of
Rapidly but only to a limited
Rapidly; only moderate absorption
absorption:
extent (approx. 30%).
of phosphonomethylglycine (i.e.
glyphosate, PMG) anion (40 - 60
%); trimethylsulphonium (TMS)
cation nearly completely absorbed
(> 90%)
Distribution:
Generally low residues occurring
Generally low residues in all
in all tissues.
tissues.
Potential for
No evidence of accumulation
No evidence of accumulation (for
accumulation:
(< 1% after 7 days).
PMG anion < 3% after 5 days, for
TMS cation much less).
Rate and extent of
Rapid and nearly complete
Rapid and nearly complete; PMG:
excretion:
(approx. 30% via urine).
36 - 63% via urine and 35 - 58%
via feaces, TMS: 91 - 99% via
urine and 1 - 7% via faeces.
Toxicologically
Parent compound; main plant
Parent compound;
significant compounds:
metabolite, aminomethyl-
aminomethylphosphonic acid
phosphonic acid(AMPA), also
(AMPA, up to 8.5% in female rats
detected in rats (< 0.5%).
receiving multiple doses), i.e. the
main plant metabolite also
occurring in water and soil.
Metabolism in animals:
Very limited (< 0.5%) if occurring
Limited, confined to the PMG
at all.
anion (<10%)
- 11 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
1. Toxicology and metabolism
11 May 2001
Acute toxicity
Glyphosate
Glyphosate Trimesium
Rat LD50 oral:
> 2000 mg/kg bw
464 mg/kg bw (a.i.); R 22
748 mg/kg bw (technical)
Rat LD50 dermal:
> 2000 mg/kg bw
> 1240 mg/kg bw (a.i.; intact skin)
> 2000 mg/kg bw (technical;
intact skin)
Rat LC50 inhalation:
> 5 mg/l air (4-hour exposure)
> 5.1 mg/l air (a.i.; 4-hour
exposure)
> 9.0 mg/l air (technical; 4-hour
exposure)
Skin irritation:
Not irritating
Not irritating.
Eye irritation:
Acid: moderately to severely
Not irritating.
irritating.
Salts: slightly or not irritating, no
classification
Skin sensitization (test
Not sensitizing (M&K test,
Not sensitizing (Buehler as well as
method used and result):
Buehler test).
Magnusson & Kligman test).
Short term toxicity
Glyphosate
Glyphosate Trimesium
Target / critical effect:
Liver, gastrointestinal mucosa,
Clinical signs and mortality in
salivary glands
dogs;
body weight gain↓ in rats.
Lowest relevant oral
90 days, rat: 2000 ppm (equal to
NOAEL / NOEL:
150 mg/kg bw/d)
90 days, dog: 25 mg/kg bw/d
Lowest relevant dermal
21 days, rat: >1000 mg/kg bw/d
21 days, rabbit (systemic):
NOAEL / NOEL:
573 mg/kg bw/d (a.i.);
1000 mg/kg bw/d (technical)
Lowest relevant
2 weeks, rat: >3.8 mg/l
inhalation NOAEL /
Not required.
NOEL:
Genotoxicity
Glyphosate
Glyphosate Trimesium
Not genotoxic.
Not genotoxic.
- 12 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
1. Toxicology and metabolism
11 May 2001
Long term toxicity and carcinogenicity
Glyphosate
Glyphosate Trimesium
Target / critical effect:
Liver (organ weight↑, clinicial
Body weight (gain) and food
chemistry, histology); salivary
consumption↓; chronic mucosal
glands (organ weight↑, histology); inflammation in nasopharynx and
stomach mucosa and bladder
larynx in rats
epithelium (histology); eye
(cataracts)
Lowest relevant NOAEL: 2 years, rat: 31 mg/kg bw/d
2 years, rat: 500 ppm (about 21
mg/kg bw/d)
Carcinogenicity:
No evidence of carcinogenicity.
No evidence of carcinogenicity.
Reproductive toxicity
Glyphosate
Glyphosate Trimesium
Target / critical effect -
Reduced pup weight at parentally
Litter size and pup body weight
Reproduction:
toxic doses.
gain↓ at parentally toxic doses.
Lowest relevant
10000 ppm (equal to 700 mg/kg
reproductive NOAEL /
bw/d)
150 ppm (approx. 7.5 mg/kg bw/d)
NOEL:
Target / critical effect -
Lower number of viable fetuses
Developmental toxicity:
and reduced fetal weight; retarded Post-implantation losses↑, fetal
ossification, higher incidence of
weight↓, slightly higher incidence
skeletal and/or visceral anomalies; of rib variations; effects confined
effects confined to maternally
to maternally toxic doses
toxic doses.
Lowest relevant
Rat: 300 mg/kg bw/d
developmental NOAEL /
Rabbit: 40 mg/kg bw/d
NOEL:
Delayed
neurotoxicity
Glyphosate
Glyphosate Trimesium
No relevant effects.
No relevant effects.
- 13 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
1. Toxicology and metabolism
11 May 2001
Other toxicological
studies
Glyphosate
Glyphosate Trimesium
Toxicological studies on AMPA
revealing the metabolite to be less
toxic than the parent compound,
Studies on the metabolite AMPA:
no evidence of mutagenicity and
low acute oral toxicity in the rat
teratogenicity; toxicity studies in
(LD50>5000 mg/kg bw); Ames
farm animals: no risk to be
test: negative.
expected; mechanistic study on
salivary gland findings
Medical data
Glyphosate
Glyphosate Trimesium
Comprehensive database, mainly
No evidence of adverse health
related to accidental or intentional
effects upon manufacturing; few
oral intake of glyphosate products. reports of poisonings following
oral ingestion confined to cases of
clear misuse.
Summary of Toxicology
Glyphosate
Glyphosate trimesium
Value
Study
Safety
Value
Study
Safety
factor
factor
ADI:
0.3 mg/kg
Long-term
100
0.2 mg/kg
Long-term
100
bw
studies in
bw
study in rats
rats
AOEL
0.2 mg/kg
Rabbit
100
0.1 mg/kg
90-day study
100
systemic:
bw/day
teratogeni-
bw/d
in dogs (40%
(systemic)
city study,
oral
NOEL for
absorption)
mater-nal
toxicity
(30% oral
absorption)
ARfD (acute
Not
0.25 mg/kg
28-day and
100
reference
allocated
bw
90-day
dose):
(not
studies in
necessary).
dogs
Dermal
Less than 3%
≤ 1 %
absorption
- 14 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
11 May 2001
2 Fate and behaviour in the environment
2.1 Fate and behaviour in soil
Route of degradation
Aerobic:
Glyphosate
Glyphosate trimesium
Mineralization after
different periods of time
3 soils, 3 different 14C labels: 46.8
Glyphosate
(%):
– 55.3 (28 d); 5.8 – 9.3 (112 d);
2 soils: 37 (21 d), 75 (150 d)
34.7 – 41.4 (84 d)
TMS:
2 soils: 69.7 – 80.1 (150 d)
2 soils: 46 (9 d), 74 (150 d)
1 soil: 32.7 (112 d)
1 soil: 79.6 (100 d)
Non-extractable residues
3 soils, 3 different 14C labels: 8.5
Glyphosate
after different periods of
– 40.3 (28 d); 4.6 – 13.5 (112 d);
2 soils: 32 (21 d), 20 (150 d)
time (%):
16.7 – 33.9 (84 d)
TMS:
2 soils: 5.1 – 8.8 (150 d)
2 soils: 26 (9 d), 10 (150 d)
1 soil: 13.9 (112 d)
1 soil: 8.4 (100 d)
Major metabolites above
Aminomethylphosphonic acid
Aminomethylphosphonic acid
10 % of applied, name
(AMPA) 26-29% after 14 days
(AMPA) 15.4% after 21 days
and/or code,
(only in one study detected), no
% of applied (range and
further degradation within 70
maximum)
days.
Supplemental studies
Glyphosate
Glyphosate trimesium
Anaerobic degradation
Mineralization after different
Mineralization after different
periods of time (%):
periods of time (%):
3 soils, 3 different 14C labels: 33.5
Glyphosate: 43 (63 d)
– 51.4 (28 d); 1.4 – 5.0 (112 d);
TMS: 57 (63d)
24.2 – 38.6 (84 d)
1 soil, < 1 (120 d)
Non-extractable residues after
different periods of time (%):
Non-extractable residues after
Glyphosate: 24 (63 d)
different periods of time (%):
TMS: 16 (63d)
3 soils, 3 different 14C-labels: 12.8
– 29.7 (28d); 0.4 – 12.0 (112 d);
15.1 – 31.6 (84d)
1 soil, 20 (120 d)
Soil photolysis:
DT50: 96 (90 d dark); 101 d
DT50 200 hours (50 ° N)
(1236 d dark)
AMPA: max. 24 % DT50 200
hours;No metabolites of TMS
detected.
- 15 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
11 May 2001
Remarks:
None.
None.
Rate of degradation
Laboratory studies
Glyphosate
Glyphosate trimesium
DT
Glyphosate: 3- 62 d , mean 29 d,
50lab (20 °C, aerobic):
DT50lab (20°C, aerobic): 4 – 180 d
(20°C), mean 49 d, n=7 (first order n=8 (first order kinetic)
kinetic)
TMS: 3-15 d, mean 7 d, n=8 (first
order kinetic)
DT90lab (20 °C, aerobic):
DT90lab (20°C, aerobic): 40 – 280 d Glyphosate: 81- 207 d n= 4(first ord
(20°C), mean 159 d,n=4 (first order kinetic)
kinetic)
TMS: 37-85 d (TMS anion), n= 4 (f
order kinetic)
DT
Glyphosate:67d
50lab (10 °C, aerobic):
DT50lab (10°C, aerobic):
not submitted (see field studies)
TMS: 70 d (8°C)
DT
No significant degradation.
50lab (20°C, anaerobic)
DT50lab (20°C, anaerobic):
comparable to aerobic (study one);
(waterphase) 3 d, (system) 1699 d
(study two)
Field studies (country or
Glyphosate
Glyphosate trimesium
region)
DT
DT
DT
50f from soil
50f (best fit):
50f (best fit):
dissipation studies:
Germany 5;12 d; Switzerland7;
Germany: 9, 15, 17, 23, 34,34d;
21d; USA: 1 d (Texas), 7 d
USA: 1.5, 1.8, 15 and 17 d
(Ohio), 9 d (Georgia), 12 d
(California), 17 d (Arizona), 31 d
(Minnesota), 106 d (New York),
130 d (Iowa); Canada: 11 d
(Manitoba), 16 d (Ontario), 63 d
(Alberta)
AMPA DT50f (best fit):
AMPA DT50f (first order kinetic) :
Germany 218 d (Menslage);
Germany: 134, 242, 316, 362,
Switzerland 135; 139 d;
449, 875 d ;
USA: 76 d (Ohio), 93 d (Texas),
USA: 13, 23, 37,147d .
103 d (Arizona), 145 d (New York)
170 d (Georgia), 174 d (Minnesota)
240 d (California); Canada: 128 d
(Manitoba), 185 d (Ontario)
- 16 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
11 May 2001
DT
not calculated; see DT
90f from soil
50f
DT90f:
dissipation studies:
Germany: 76, 89, 113, 124, 166,
326 d;
USA: 24, 48, 61, 68 d
AMPA DT90f:
Germany: 445, 804, 1050, 1203,
1491, 2907 d;
USA: 42, 77, 124, 489d
Glyphosate
Glyphosate trimesium
Soil accumulation and
plateau concentation
Plateau concentration for AMPA:
Plateau concentration for AMPA:
5.62 mg/kg (mean DT50f: 697 d
0.91 mg/kg (mean DT50f
(first order kinetic))
(Germany): 396 d (first order
kinetic))
Remarks:
None.
None.
e.g. effect of soil pH on
degradation rate
- 17 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
11 May 2001
Adsorption/desorption
Glyphosate
Glyphosate trimesium
K
soil type
1/n
K
f / Koc:
oc
Kd
soil type 1/n
Kd
Koc
Kd
K
K
1/n
d
oc
silty clay
1.16 60000
900
silt
0.98
25100
427
0.89
1179
20
loam
loam
silt loam
0.8
3800
34
loam
0.93
2860
66
0.89
530
12
loamy sand 0.92 22300
245
sandy
0.88
7880
39
0.84
1758
9
loam
sand
*)
32830
263
clay
1.1
180000
2340
0.93
1659
22
sand loam
*)
50660
810
sandy clay
*)
3598
50
loam
loamy sand *)
884
5.3
silt loam
*)
3404
47
loam
*)
17819
510
(sediment)
*)The advanced adsorption
isotherm test wasn't conducted
because in the screening test
equilibrium was not reached after
72 hours
pH
No pH-dependence
No pH dependence.
dependence:
AMPA
Kf / Koc:
soil type
1/n
Koc
Kd
Kd
clay loam 0.786
3640
76
sand
0.904
8310
1554
sand
0.752
1160
15
clay loam 0.791
3330
30
loamy
0.769
6920
111
sand
sand
0.788
24800
74
pH
No pH-dependence
dependence:
- 18 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
11 May 2001
Mobility
Glyphosate
Glyphosate trimesium
Column leaching:
1. 0.12 – 1.45% as of applied in
< 2 % as in leachate
leachate (3 soils)
(BBA standard soils)
2. 0.03 – 6.56% as of applied in
leachate (7 soils)
14
Aged residue leaching:
1.56, 0.22 and 0.02 % 14C-activity
C distribution after 30 days:
in leachates
Glyphosate-14C: 52 % extractable
65.2, 59.0 and 2.1 % evolved as
(AMPA 26 %), 12 %
CO2
unextractable, 33 % CO2; TMS-
30.3, 40.4 and 97.5 % 14C in the
14C: 10 % extractable, 21 %
upper 2 cm of columns
unextractable, 57 % CO2
0.1 % Glyphosate and 0.5% TMS in
leachate, total radioactivity in
leachate not given.
Lysimeter/Field leaching
Not submitted.
Not submitted.
studies:
Remarks:
None.
None.
- 19 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
11 May 2001
2.2 Fate and behaviour in water
Abiotic degradation
Glyphosate
Glyphosate trimesium
Hydrolytic degradation:
pH__5____: stable (25°C)
pH___5___: stable; 25 and 40 °C
(glyphosate and TMS)
pH__7____: stable (25°C)
pH___7___: stable; 25 and 40 °C
(glyphosate and TMS)
pH__8____: stable (25°C)
pH___9___: stable; 25 and 40 °C
(glyphosate and TMS)
Photolytic degradation:
DT50: 33 d (pH 5), 69 d (pH 7),
Glyphosate:
77 d (pH 9).
DT50: 81 d (pH 7) 37°N
TMS: stable
Biological degradation
Glyphosate
Glyphosate trimesium
Readily biodegradable:
No.
No.
Water/sediment study:
DT50 water:
1 and 4 days (Möllerfeld and
Glyphosate: 14 and 24 d;
Römbke)
TMS: 4 and 3 d
DT90 water:
Glyphosate: 46 and 80 d;
not calculated
TMS: 13 and11 d
DT50 whole system:
27 and 146 days (Möllerfeld and
Glyphosate: 21 and
Römbke),
202 (extrapol.) d;
31 and 124 days (Muttzall)
TMS: 5 and 7 d
DT90 whole system:
Glyphosate: 69 d;
2.1.4.1.1 not calculated
TMS: 18 and 23 d
Mineralization
18 and 24 % after 100 days
Glyphosate: 48 and 6 % after 100
(Möllerfeld and Römbke),
days;
6 and 26 % after 91 days
TMS: 67 and 68 % after 100 days
(Muttzall)
Non-extractable residues
14 and 22 % after 100 days
Glyphosate: 14 and 17 % after 100
(Möllerfeld and Römbke),
days;
31 and 35 % after 91 days
TMS: 7 and 8 % after 100 days
(Muttzall)
Distribution in water /
after 1 day: 47-64% in water, 31-
Glyphosate water: 1 and 5 %;
- 20 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
11 May 2001
Glyphosate
Glyphosate trimesium
sediment systems
44% in sediment;
sediment: 4 and 58 %
(active substance)
after 100 days 3% in water, 29-
TMS water: < 1%; sediment: 2
44% in sediment.
and 5 %
In sediment: maximum 50-60% afte
and 14 days, resp.
and 30-50% after 100 days.
Distribution in water /
AMPA: if found, only in the water
AMPA water: 4 and < 1 %:
sediment systems
phase: maximum 16% after
AMPA sediment: 18 and 3 %
(major metabolites)
14 days and 0.5 % after 100 days.
Water/sediment studies with 14C-
AMPA (Knoch and Spirlet):
1 st system:
waterphase:
101% day 0; 4% day 100;
sediment:
max. 41% day 59; 20% day 100;
2 nd system
waterphase:
100% day 0; 1% day 59;
sediment:
max. 46% day 14; 32% day 100
Accumulation in water
No accumulation
No accumulation
and/or sediment:
Degradation in the
saturated zone
Glyphosate
Glyphosate trimesium
Not submitted.
Not submitted.
Remarks:
None.
None.
- 21 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
11 May 2001
2.3 Fate and behaviour in air
Volatility
Glyphosate
Glyphosate trimesium
Vapour pressure:
1.31 ⋅ 10-5 Pa (25 °C, acid)
< 1 ⋅ 10-11 Pa (20 °C)
Henry's law constant:
2.1 ⋅ 10-7 Pa m3 mol-1
< 2 ⋅ 10-9 Pa m3 mol-1
Photolytic degradation
Glyphosate
Glyphosate trimesium
Direct photolysis in air:
No absorption for wavelengths
No absorption for wavelengths
> 290 nm.
> 290 nm.
DT50 (water):33d (pH 5), 69 d (pH DT50 (water): 81 d (pH 7) 37°N
7), 77 d (pH 9)
(stable for TMS)
Glyphosate
Glyphosate trimesium
Photochemical oxidative
DT50: 1.6 d (Atkinson estimation)
DT50: about 1.4 hours
degradation in air
DT50:
Volatilisation:
from plant surfaces: no significant from plant surfaces: negligible
volatilization
(glyphosate and TMS)
from soil: no significant
from soil: negligible (glyphosate
volatilization
and TMS)
Remarks:
None.
None.
- 22 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
3. Ecotoxicology
11 May 2001
3 Ecotoxicology
Terrestrial Vertebrates
Glyphosate
Glyphosate-trimesium
Acute toxicity to mammals:
2.1.6 LD50 > 2000 mg/kg bw
lowest LD50 748 mg/kg bw
Acute toxicity to birds:
LD50 > 2000 mg/kg bw
lowest LD50 950 mg/kg bw
Dietary toxicity to birds:
LC50 > 4640 ppm
LC50 > 5000 ppm
Reproductive toxicity to
NOEC 200 ppm
NOEC 712 ppm
birds:
Short term oral toxicity to
NOAEL/NOEL 150 mg/kg bw/d
NOAEL/NOEL 25 mg/kg bw/d
mammals:
(90 d, rat)
(90 d, rat)
Aquatic Organisms
Glyphosate-IPA
Glyphosate-
Glyphosate acid
trimesium
(1st metabolite)
Acute toxicity fish: EC50
>1000 mg /L
1800 mg/L
38 mg/L
Long term toxicity fish: NOEC
917 mg /L
50 mg/L
25 mg/L
Bioaccumulation fish:
Not relevant
Not relevant
Not relevant
Acute toxicity invertebrate: EC50
930 mg /L
12 mg/L
40 mg/L
Chronic toxicity invertebrate:
455 mg /L
1.1 mg/L
30 mg/L
NOEC
Chronic toxicity algae EC50
72.9 mg/L
0.72 mg/L
0.64 mg/L (168 h)
Chronic toxicity sediment
Not tested
Not tested
Not tested
dwelling organism:
Long-term toxicity aquatic plants:
53.6 mg/L
1.0 mg/L
12 mg/L
EC50
Honeybees
Glyphosate
Glyphosate-trimesium
Acute oral toxicity:
LD50: 100 µg as/bee
LD50: > 400 µg as/bee
Acute contact toxicity:
LD50: > 100 µg as/bee
LD50: > 400 µg as/bee
22
- 23 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
3. Ecotoxicology
11 May 2001
Other arthropod species
Test species
Glyphosate
Glyphosate-trimesium
% Effect
% Effect
Test method
Typhlodromus pyri
Lifecycle: 100 % mortality (3.6
Lifecycle: 100 % mortality (5.760
Lab on inert substrate
kg as/ha)
kg as/ha)
LR50: 0.211 kg as/ha
Typhlodromus pyri
Lifecycle: 89 % mortality (7.720
LR50: 5.089 kg as/ha
Lab natural substrate on
kg as/ha)
leaves
Typhlodromus pyri
Lifecycle: 30 % mortality; 0 %
---
Lab natural substrate on
effect on fertility (3.708 kg as/ha)
plants
Aphidius rhopalosiphi
Adult: 100 % mortality
Adults: 100 % mortality (5.76 kg
Lab on inert substrate
as/ha)
LR50: 0.043 kg as/ha
Aphidius rhopalosiphi
Adult: 25 % mortality; 6 % effect
---
Lab natural substrate on
on fertility (3.720 kg as/ha)
plants
Aphidius rhopalosiphi
---
LR50:> 8.4 kg as/ha
Lab natural substrate on
leaves
Orius insidiosus
---
Lifecycle: 95 % mortality (5.760
Lab on inert substrate
kg as/ha)
Chrysoperla carnea
Larval stage: 53 % mortality
---
Lab on inert substrate
(0.712 kg as/ha)
Chrysoperla carnea
Larval stage: 59 % mortality; 20 %
---
Lab on inert substrate
effect on fertility (3.708 kg as/ha)
Drino inconspicua
---
Adults: 56 % mortality; 76 %
Lab on inert substrate
effect on parasitization (2.4 kg
as/ha)
Pterostichus melaniarius
---
Adults: 26.7% mortality (3.6 kg
Lab on inert substrate
as/ha)
Adults: 10% mortality (7.2 kg
as/ha)
Aleochara bilineata
Lifecycle: 1% parasitation
---
Lab on inert substrate
capacity (1.63 kg as/ha)
Bembidion lampros
Adult: 0% mortality (4,890 kg
---
Semifield
as/ha)
Poecilus cupreus
Adult: 0% mortality; 31% effect
---
Lab on inert substrate
on food uptake (3.6 kg as/ha)
23
- 24 -
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX II
END POINTS AND RELATED INFORMATION
3. Ecotoxicology
11 May 2001
Test species
Glyphosate
Glyphosate-trimesium
% Effect
% Effect
Test method
Trechus quadristriatus
Adult: 14% mortality (3.6 kg
---
Lab on inert substrate
as/ha)
Pardosa spp.
Adult: 56% mortality (3.7 kg
Adults: 4 % mortality (3.6 kg
Lab on inert substrate
as/ha)
as/ha)
Adults: 0% mortality (7.2 kg
as/ha)
Earthworms
Glyphosate
Glyphosate trimesium
Acute toxicity:
LC50 > 480 mg as/kg
LC50 > 1000 mg as/kg
Reproductive toxicity:
NOEC 28.79 mg/kg (IPA-salt)
NOEC 28.79 mg/kg (IPA-salt)
Soil micro-organisms
Glyphosate
Glyphosate-trimesium
Nitrogen mineralization:
No effects up to 18 kg as/ha
No effects up to 18 kg as/ha
Carbon mineralization:
No effects up to 18 kg as/ha
No effects up to 18 kg as/ha
24
link to page 25
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 25 -
List of studies
7 November 2001
APPENDIX III A
GLYPHOSATE
List of studies for which the main submitters have claimed data protection and which
during the re-evaluation process were considered as essential for the evaluation with a
view to Annex I inclusion
1.
B.1 Identity, B.2 Physical and chemical properties, B.3 Data on application and further
information, B.4 Proposals for classification and labeling, B.5 Methods of analysis
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-2.1;
Cowlyn, T.C.
1993
Glyphosate, ammonium salt: Determination of
Germany 1995
IIA-2.11;
physico-chemical properties.
IIA-2.13;
Source: Monsanto
IIA-2.14;
Report no. 93/MON032/0343
IIA-2.2;
IIA-2.4;
IIA-2.5;
IIA-2.6;
IIA-2.8
II A-2.1
Dommrose, A.M.
1989
Determination of the melting point of the test
Germany 1995
sample Glyphosate acid 99.9% pure acc. to
OECD Guideline 102.
Source: Monsanto
Report no. NA 89 9641/I
IIA-2.1
Krips, H.J.
1995
Determination of the melting temperature of
Germany 1995
MON 77209 Pure.
Source: Monsanto
Report no. 134145
IIA-2.2
Bates, M.L.
1992
Glyphosate ipa salt: determination of relative
Germany 1995
density.
Source: Monsanto
Report no. 7067-676/7-1
IIA-2.4
Roels, M.
1999
Odour of glyphosate isopropylamine salt
Germany 1999
Source: Monsanto/Cheminova
Report no. 205-15750/2
IIA-2.4
Dieudonne, M.
1999
Appearance of an active ingredient: a sodium
Germany 1999
salt of glyphosate.
Source: Monsanto/Cheminova
Report no. F-99-Na_gly-01
1 List based on an analysis from Germany (background document C).
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 26 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-2.4
Dieudonne, M.
1999
Appearance of an active ingredient: an
Germany 1999
ammonium salt of glyphosate.
Source: Monsanto/Cheminova
Report no. F-99-NH4_gly-01
IIA-2.4
Krips, H.J.
1995
Determination of appearance of MON 77209
Germany 1995
(tech) and Pure.
Source: Monsanto
Report no. 134145
IIA-2.5
Krips, H.J.
1995
Determination of the H-NMR Spectrum of
Germany 1995
MON 77209 Pure (IPA salt).
Source: Monsanto
Report no. 134167
IIA-2.5
Snoddy, C.B.; La
1992
Analytical standard data package for N-nitroso, Germany 1995
Monica, R.
N-(phosphonomethyl) glycine.
Source: Cheminova
Report no.Lot no. NPD-9205-4204-A
IIA-2.5
Søensen
, E.V.;
1992
Characterisation of glycine, N-nitroso-
Germany 1995
Bjorholm, T.
(phosphonomethyl)mono sodium salt
Report No: REF 026-01
IIA-2.5
Verhoeven, S.G.L. 1995
Determination of the IR-Spectrum of MON
Germany 1995
77209 Pure (IPA salt)
Source: Monsanto
Report no. 134156
IIA-2.6
Vogel, W.
1990
Solubility determination of glyphosate (pmg)
Germany 1995
in water at different pH values
Source: Cheminova
Report no. 240963
IIA-2.6
Vogels, M.P.W.
1995
Determination of the water solubility of MON
Germany 1995
77209 (Pure)
Source: Monsanto
Report no. 134191
IIA-2.6
Verbist, F.
1999
Preparation of sodium glyphosate and
Germany 1999
elemental analysis
Source: Monsanto
Report no. none
IIA-2.7
Bates, C.
1999
The solubility of sodium and ammonium
Germany 1999
glyphosate salts in organic solvents.
Source: Monsanto/Cheminova
Report no. MLL31266
IIA-2.9
Cowlyn, T.C.
1993
Glyphosate, ammonium salt: Determination of
Germany 1995
hydrolysis as a function of pH
Source: Monsanto
Report no. 93/MON033/0344
IIA-2.9;
Schneider, E.
1993
Glyphosate isopropylamine salt, Hydrolysis in
Germany 1995
IIA-7.2.1
water at 3 different pH-Values
Source: Feinchemie
Report no. PR93/009 (Proj./lab-no) ! B/7-28
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 27 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-2.10
Anonym
1995
Estimation of the photochemical-oxidative
Germany 1995
degradation of Glyphosate in the atmosphere
Source: Agrichem
Report no. 136384
IIA-2.11;
Gibson, A.,
1993
Glyphosate, sodium salt (MON 8722):
Germany 1995
IIA-2.13
Jackson, W.
Determination of physico-chemical properties.
Addendum to final report.
Source: Monsanto
Report no. 93/MON023/0146
IIA-2.11
Krips, H.J.
1995
Determination of the flammability of MON
Germany 1995
77209 (technical) (IPA salt).
Source: Monsanto
Report no. 134235
IIA-2.11
Krips, H.J.
1995
Determination of the relative self-ignition
Germany 1995
temp-erature of MON 77209 (technical) (IPA
salt).
Source: Monsanto
Report no. 134257
IIA-2.13
Garnett, R.P.
1999
Thermal stability of glyphosate and its salts:
Germany 1999
review of differential thermal analysis,
accelerated rate calorimetry and differential
scanning calorimetry
Source: Monsanto/Cheminova
Report no. 12/21/99
IIA-2.13
Krips, H.J.
1995
Determination of explosive properties of MON
Germany 1995
77209 technical (IPA salt).
Source: Monsanto
Report no. 134246
IIA-2.14
Krips, H.J.
1995
Determination of the surface tension of an
Germany 1995
aqueous solution of MON 77209 technical
(IPA salt).
Source: Monsanto
Report no. 134268
IIA-2.15
Krips, H.J.
1995
Determination of the oxidising properties of
Germany 1995
MON 77209 technical (IPA salt).
Source: Monsanto
Report no. 134279
IIIA-2.8.4
Toussaint, M.
1995
Dilution stability of MON 52276, a water
soluble concentrate (SL) formulation of
glyphosate.
Source: Monsanto
Report no. F-95-52276-01
IIIA-2.7
Campbell, C.N.,
1997
MON 44068: long term storage stability of
Calierno, A.
MON 44068 (metallised sachet)
Source: Monsanto
Report no. 10499
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 28 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIIA-2.7
Campbell, C.N.,
1997
MON 44068: long term storage stability of
Calierno, A.
MON 44068 (cardboard box and
polyester/SiO2/PE foil liner)
Source: Monsanto
Report no. 10498
IIA-4.2.1
Schneider, E.
1992
Analyseverfahren auf behandelte Pflanzen,
Germany 1995
pflanzliche Erzeugnisse, Nahrungsmittel,
Futtermittel
Source: Feinchemie
Report no.
IIA-4.2.3
Egloff, K.
1996
Bestimmung der Konzentration an Glyphosat
Germany 1996
und AMPA in Trink- wasserproben
Source: Feinchemie
Report no. IF-95/26884-00
IIA-4.2.3
Jonas, W.
1996
Analytische Konzentrationsbestimmungen;
Germany 1996
NATEC Institut
Source: Feinchemie
Report no. NA 96 9402
IIA-4.2.3
Klumpp, M.
1996
Residue analysis of glyphosate and
Germany 1996
aminomethylphosphonic Acid in water;
Arbeitsgemeinschaft GAB & IFU;
Source: Feinchemie
Report no. 95208/01-RW
IIA-4.2.3
Schneider, E.
1996
Determination of glyphosate residues and
Germany 1996
AMPA residues in drinking water;
Source: Feinchemie
Report no. 95/014
IIA-4.2.3
Schulz, M.,
1996
Determination of the residues of glyphosate
Germany 1996
Ullrich-Mitzel, A.
and its metabolite AMPA in drinking water;
Source: Feinchemie
Report no. RCC 615071
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 29 -
List of studies
7 November 2001
B.6 Toxicology and metabolism
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-5.2.1
Dreher, D.M.
1994
Glyphosate premix: Acute oral toxicity (limit
Germany 1995
test) in the rat.
Source: Cheminova
Project no. 545/37
IIA-5.2.1
Reagan, E.L.
1987
Acute oral toxicity study of MON 8750 in
Germany 1995
Sprague-Dawley rats
Source: Monsanto
FDRL study no. 9308A
IIA-5.2.3
Blagden, S.M.
1994
Glyphosate premix: Acute inhalation toxicity
Germany 1995
study four-hour exposure (nose only) in the rat.
Source: Cheminova
Project no.. 545/39
IIA-5.2.4
Dreher, D.M.
1994
Glyphosate premix: Acute dermal irritation test Germany 1995
in the rabbit.
Source: Cheminova
Project no. 545/40
AIIA-5.2.3
Bechtel, C.L.
1988
Acute inhalation study of MON 8750 technical
Germany 1995
Source: Monsanto
PROJ. No. EHL 87147
AIIA-5.2.4
Busch, B.
1987
Primary dermal irritation study of MON 8750
Germany 1995
in New Zealand white rabbits
Source: Monsanto
FDRL study no. 9308A
IIA-5.2.5
Dreher, D.M.
1994
Glyphosate premix: Acute eye irritation test in
Germany 1995
the rabbit.
Source: Cheminova
Project no. 545/41
AIIA-5.2.5
Busch, B.
1987
Primary eye irritation study of MON 8750 in
Germany 1995
New Zealand white rabbits
Source: Monsanto
FDRL study no. 9307A
IIA-5.2.5
Kuhn, J.O.
1996
Primary eye irritation study in rabbits.
Germany 1999
Source: Cheminova
Report no. 2981-96
IIA-5.2.6
Dreher, D.M.
1994
Glyphosate premix: Magnusson & Kligman
Germany 1995
maximisation study in the guinea pig.
Source: Cheminova
Project no. 545/42
IIA-5.4.1
Kier, L.D.,
1992
Ames/S
almonella mutagenicity assay of MON
Germany 1998
Stegeman, S.D.,
2139 (Roundup herbicide formulation).
Costello, J.G.,
Source: Monsanto
Schermes, S.
Project no. EHL 91183 ! MSL-11729
IIA-5.4.1
Stegeman, S.D.,
1990
Ames/
Salmonella mutagenicity assay of MON
Germany 1998
Li, A.P.
0818.
Source: Monsanto
Project no. EHL 89178 ! MSL-10625
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 30 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-5.4.1
Vargas, A.A.T.
1996
The
Salmonella typhimurium reverse mutation
Germany 1999
by Glifos.
Source: Cheminova
Report no. G.1.1 - 050 / 96
IIA-5.4.2
Kier, L.D.
1992
Mouse micro-nucleus study of Rodeo herbicide Germany 1995
formulation
Source: Monsanto
Report no. MLL-91-438
IIA-5.4.2
Zaccaria, C.B.
1996
A micro-nucleus study in mice for the product
Germany 1999
Glifos.
Source: Cheminova
Report no. G.1.2 - 60 / 96
IIA-5.8.1
Bakke, J.P.
1991
Evaluation of the potential of AMPA to induce
Germany 1995
unscheduled DNA synthesis in the in vitro
hepatocyte DNA repair assay using the male F-
344 rat.
Source: Monsanto
Study no. 2495-V01-91
IIA-5.8.1
Estes, F.L.,
1979
90 day sub-acute rat toxicity study.
Germany 1995
Jefferson, N.D.,
Source: Monsanto
Blair, M.,
Report no. 401-050 ! IRD-78-174
Goldenthal, E.I.
IIA-5.8.1
Cuthbert, J.A. and
1992
AMPA: Magnusson-Kligman maximisation
Germany 1995
Jackson, D.
test in guinea pigs.
Source: Cheminova
Project no. 552409
IIA-5.8.1
Cuthbert, J.A. and
1992
AMPA: Acute dermal toxicity (limit) test in
Germany 1995
Jackson, D.
rats.
Source: Cheminova
Project no. 552409
IIA-5.8.1
Holson, J.F.
1991
A developmental toxicity study of AMPA in
Germany 1995
rats.
Source: Monsanto
Project no. WIL-50159
IIA-5.8.1
Lauer, R., Blount,
1979
Analysis of animal feed diets in the
Germany 1995
L.M., Kramer,
aminomethylphosphonic acid (AMPA) 90-day
R.M.
sub-acute rat toxicity study.
Source: Monsanto
Report no. MSL-0682
IIA-5.8.1
Stout, L.D.
1991
One month study of AMPA administered by
Germany 1995
capsule to beagle dogs.
Source: Monsanto
Report no. ML-90-186/EHL 90074
IIA-5.8.1
Tompkins, E.C.
1991
90-day oral (capsule) toxicity study in dogs
Germany 1995
with AMPA.
Source: Monsanto.
Project no. WIL-50173
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 31 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-5.8.2
Rowe, L.D.,
1987
The sub-acute toxicity of the isopropylamine
Germany 1995
Lovering, S.L.,
salt of glyphosate (Mon-0139) in female cattle.
Martin, B.W.,
Source: Monsanto
Harvey, R.B.,
Report no. VT-80-451
Peterson, H.D.,
Farr, F.M. Moore,
E.G.
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 32 -
List of studies
7 November 2001
B.7 Residue data
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-6.1/6.9
McMullen, P.C.,
1990
Confined rotational crops study of glyphosate:
Germany 1999
Honneger, J.L.,
part II: quantitation, characterization and
Logusch, E.W.
identification of glyphosate and its metabolites
in rotational crops.
Source: Monsanto
Report no. MSL-9811
IIA-6.1
Hattermann, D.R.
1998
(Glyphosate technical) Confined rotational
crop study on lettuce, radish, and wheat in
California.
Source: Cheminova
Report no. 91233/9028
IIA-6.1
Mehrsheikh, A.
2000
Metabolism of glyphosate in Roundup Ready
Germany 2000
sugar beet.
Source: Monsanto/Cheminova
Report no. MSL-16247
IIA-6.3
Balasubramanian
1999
Studies on the residues of glyphosate
M.
(Roundup CT – 41%SL) in processed tea,
decoction and soil (three seasons, Assam)
Source: Monsanto/Cheminova
Report no. 6482
IIA-6.3
Bleeke, M.S.
1997
Nature of Glyphosate residues in cotton plants
Germany 1999
tolerant to Roundup herbicide.
Source: Monsanto
Report No. MSL-14113
IIA-6.3
George, C.
1995
Nature of Glyphosate residues in corn plants
Germany 1999
which are tolerant to Roundup herbicide.
Source: Monsanto
Report No. MSL-14018
IIA-6.3
Hontis, A.M.
1992
Residues of glyphosate/AMPA in olives and
Germany 1999
olive oil following use of Sting SE – Spanish
field trials
Source: Monsanto
Report no. MLL 30.297
IA-6.3
Hontis, A.M.
1993
Residues of glyphosate/AMPA in olives and
Germany 1999
olive oil following soil treatment with MON
65040 herbicide. Field trials in Italy
Source: Monsanto
Report no. MLL 30.319
IIA-6.3
Hontis, A.M.
1996
Residues of glyphosate and AMPA in field
Germany 1999
beans (Vicia faba) treated preharvest with
MON 52276 herbicide. UK and Belgian field
trials, 1995.
Source: Monsanto
Report No. MLL 30463
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 33 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-6.3
Hontis, A.M.
1996
Residues of glyphosate and AMPA in peas
Germany 1999
treated preharvest with MON 52276 herbicide.
UK and Belgian field trials, 1995.
Source: Monsanto
Report No. MLL 30464
IIA-6.3
Hontis, A.M.
1996
Residues of glyphosate and AMPA in olives
Germany 1999
and olive oil, following a soil treatment with
Roundup heribicide. Spanish field trials,
1995.
Source: Monsanto
Report No. MLL 30469
IIA-6.3
Hontis, M.A.
1997
Residues of Glyphosate and AMPA in cotton
treated preharvest with Roundup (MON
2139), Roundup Plus (MON 60612) and
MON 52276 herbicide. Spanish field trials,
1996.
Source: Monsanto
Report no. MLL 30611
AII-6.3
Hontis, M.A.
1998
Residues of Glyphosate and AMPA in cotton
treated preharvest with Roundup (MON
2139), Roundup Plus (MON 60612) and
MON 52276 herbicide. Spanish field trials,
1997.
Source: Monsanto
Report no. MLL 30763
AII-6.3
Hontis, M.A.
1998
Residues of Glyphosate and AMPA in cotton
Germany 1999
containing Roundup Ready genes, after
multiple treatment with MON 52276 herbicide.
Spanish field trials, 1997.
Source: Monsanto
Report no. MLL 30762
AII-6.3
Hontis, M.A.
1999
Residues of Glyphosate and AMPA in sugar
Germany 1999
beet, B
eta vulgaris spp., containing Roundup
Ready genes, after multiple treatment with
MON 52276 herbicide. Belgian field trial,
1998.
Source: Monsanto
Report no. MLL 30919
AII-6.3
Hontis, M.A.
1999
Residues of Glyphosate and AMPA in sugar
Germany 1999
beet, B
eta vulgaris spp., containing Roundup
Ready genes, after multiple treatment with
MON 52276 herbicide. UK and French field
trial, 1998.
Source: Monsanto
Report no. MLL 30918
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 34 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
AII_6.3
Hubbard, N.S.
1993
Determination of Glyphosate in soybean raw
agricultural commodities (RAC), stability
report: analytical phase final report.
Source; Cheminova
Report no. 91210
AII-6.3
Hubbard, NS.
1993
Determination of glyphosate in pasture grasses,
stability report: analytical phase final report.
Source: Cheminova
Report no. 91212
AII-6.3
Morgenroth, U.
1995
Storage stability of Glyphosate and AMPA in
wheat grain and straw and in rye grain and
straw.
Source: Cheminova
Report no. 303614
IIA-6.3
Mueth, M.G.
1991
Storage stability of glyphosate residues in crop
Germany 1999
commodities
Source: Monsanto
Report no. MSL-10843
IIA-6.3
Oppenhuizen,
1994
Magnitude of glyphosate residues in milo
M.E.
processed commodities following preharvest
use of Roundup herbicide.
Source: Monsanto
Report No. MSL-13038
IIA-6.3
Oppenhuizen,
1995
Magnitude of glyphosate residues in
Germany 1999
M.E.
glyphosate tolerant cotton raw agricultural and
processed commodities.
Source: Monsanto
Report No. MSL-13884
IIA-6.3
Oppenhuizen,
1995
Magnitude of glyphosate residues in corn raw
Germany 1999
M.E.
agricultural commodities following pre-harvest
application of Roundup herbicide.
Source: Monsanto
Report No. MSL-13654
IIA-6.3
Oppenhuizen,
1995
Magnitude of glyphosate residues in corn
Germany 1999
M.E.
processed commodities following pre-harvest
application of Roundup herbicide.
Source: Monsanto
Report No. MSL-13655
IIA-6.3
Oppenhuizen,
1995
Magnitude of glyphosate residues in
Germany 1999
M.E.
glyphosate tolerant corn raw agricultural
commodities.
Source: Monsanto
Report No. MSL-13882
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 35 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
winter oats (grain and straw). Treatment with
either CHE 3607 or CHE 3607/Frigate - UK,
season 1993.
Source: Cheminova
Report no. IF-94/01227-01
IIA-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
grass (grass and silage). Treatment with CHE
3607 - UK, season 1993.
Source: Cheminova
Report no. IF-94/01236-01
IIA-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
winter field beans (seed and haulm).
Treatment with CHE 3607 - UK, season 1993.
Source: Cheminova
Report no. :IF-94/01230-01
IIA-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
linseed. Treatment with CHE 3607 - UK,
season 1993.
Source: Cheminova
Report no. IF-94/01233-01
AII-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
winter sown oilseed rape. Treatment with
CHE 3607 - UK, season 1993.
Source: Cheminova
Report no. IF-94/01229-01
AII-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
grass (grass and hay). Treatment with CHE
3607 - UK, season 1993.
Source: Cheminova
Report no. IF-94/01235-01
AII-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
peas (peas and haulm). Treatment with CHE
3607 - UK, season 1993.
Source: Cheminova
Report no. IF-94/01231-01
AII-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
winter sown oilseed rape (seed and pods).
Treatment with CHE 3607 - UK, season 1993.
Source: Cheminova
Report no. IF-94/01240-01
AII-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
winter field beans (seed and haulm).
Treatment with CHE 3607 - UK, season 1993.
Source: Cheminova
Report no. IF-94/01242-01
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 36 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
AII-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
peas (peas and haulm). Treatment with CHE
3607 - UK, season 1993.
Source: Cheminova
Report no. IF-94/01241-01
AII-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
grass (grass and silage). Treatment with CHE
3607 - UK, season 1993.
Source: Cheminova
Report no. IF-94/01244-01
AII-6.3
Schulz, H.
1995
Determination of residues of glyphosate in
grass (grass and hay). Treatment with CHE
3607 - UK, season 1993.
Source: Cheminova
Report no. IF-94/01243-01
AII-6.3
Schulz, H.
1994
Determination of residues of glyphosate in
winter oats (grain, straw and whole plant).
Treatment with either CHE 3607 or CHE
3607/Frigate - UK, season 1993.
Source: Cheminova
Report no. IF-94/01239-01
AII-6.3
Schulz, H.
1995
Determination of the dissipation of glyphosate
in oranges following treatment with Glifos
under field conditions in Portugal, 1994
Source: Monsanto/Cheminova
Report no. IF-94/10285-00
AII-6.3
Schulz, H.
1995
Determination of the dissipation of glyphosate
in oranges following treatment with Glifos
under field conditions in Portugal 1994.
Source: Monsanto/Cheminova
Report no. IF-94/10285-00
AII-6.3
Schultz, H.
1997
Determination of the storage stability of
Glyphosate in beans, oilseed rape and linseed.
Source: Cheminova
Report no. IF-94/13882-00
AII-6.5
Zietz, E.
1995
Determination of residues of Glyphosate in
products of the processing of barley to beer
and whisky following treatment with Glyfos -
England, season 1993.
Source: Cheminova
Report no. IF-94/00451-01
AII-6.5
Zietz, E.
1995
Determination of residues of Glyphosate in
products of the processing of oats to rolled oats
following treatment with Glyfos - England,
season 1993.
Source: Cheminova
Report no. IF-94/00453-01
3
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 37 -
List of studies
7 November 2001
4 B.8 Environmental fate and behaviour
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-7.1.1
Matla, YA.
1993
Rate of degradation and metabolism of [14C]-
Germany 1995
Vonk, JW.
Glyphosate in soil under aerobic conditions
Source: Luxan, Agrichem
Report no. IMW-R 93/047 ! IMW-92-0022-01
IIA-7.1.1
Schneider, E.
1991
Behaviour of Glyphosate in water and soil, Part Germany 1995
5 Degradation in soil
Source: Feinchemie
Report no. PR90/002
IIA-7.1.1.2.1
Keirs, D.C.,
2000
The degradation of [14C]- glyphosate in soil
Germany 2000
Mackie, J.A.
under anaerobic conditions.
Source: Monsanto/Cheminova
Report no. MSL-16796
IIA-7.1.1.2.2
Harnish, W.N.
1998
Terrestrial field dissipation of glyphosate and
Germany 1999
its metabolite, AMPA, in soil.
Source: Cheminova
Report no. 91205
IIA-7.1.1.2.2
Oppenhuizen, ME.
1993
The terrestrial field dissipation of Glyphosate:
Germany 1995
Final Report
Source: Monsanto
Report no. MSL-12651
IIA-7.1.1.2.2
Oppenhuizen,
1993
The terrestrial field dissipation of Glyphosate
Germany 1995
ME.
in Canadian soil
Source: Monsanto
Report no. MSL-12605
IIA-7.1.2
Weeden, DM.
1993
Aminomethylphosphonic acid – Determination
Germany 1995
of the sorption and desorption properties.
Source: Monsanto
Report no. MSL-12703
IIA-7.2.1.3.2
Morgenroth, U.
1995
Storage stability of glyphosate and AMPA in
Germany 1995
soil.
Source: Cheminova
Report no. 303625
IIA-7.2.1.3.2
Oppenhuizen, ME.
1993
Storage stability of Glyphosate and AMPA in
Germany 1995
soil and stream sediment
Source: Monsanto
Report no. MSL-12682
IIA-7.2.1
Heintze, A.
1996
Degradation and Metabolism of glyphosate in
Germany 1997
two Water/Sediment Systems under Aerobic
Conditions - Laboratory Test
Source: Monsanto/Cheminova
Study no. 96138/01-CUWS
IIA-7.2.1
Knoch, E., Spirlet,
1999
Aminomethylphosphonic acid: water/ sediment Germany 1999
M.
metabolism
Source: Monsanto/Cheminova
Lab project no. IF-98/14727-00
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 38 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-7.2.1
Muttzall, PI.
1993
Water/sediment biodegradation of [14C]-
Germany 1995
glyphosate
Source: Feinchemie, Agrichem, Luxan
Report no. IMW-92-0022-
IIA-7.2.1
Schneider, E.
1993
Glyphosate isopropylamine salt, hydrolysis in
Germany 1995
water at 3 different pH values.
Source: Feinchemie
Report no. PR93/009
IIA-7.2.1.3.2
Steginsky, CA.
1995
Determination of the degradability and
FIN: 1.3.1995
Powell, JM.
persistence of 14C-Glyphosate in the
Germany 1998
water/sediment-system (Amendment)
Source: Cheminova
Report no. ET01SE01
IIA-7.2.2
Schulz, J.
1995
Final report – About testing the volatilization
Germany 1996
behaviour of TAIFUN forte in bush beans
under field conditions
Source: Feinchemie
Report no. AGR/RV-95/FSG
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 39 -
List of studies
7 November 2001
B.9 Ecotoxicology
Annex
Author(s)
Year
Title
Reports2 on
point/
source (where different from company)
previous use in
reference
report no.
granting national
number
GLP or GEP status (where relevant),
authorizations
published or not
IIA-8.1.1
Campbell, S.M.,
1991
AMPA: An acute oral toxicity study with the
Grimes, J., Lynn,
northern bobwhite.
St.P., Smith, G.J.
Source: Monsanto
Report no. 139-277 ! WL 90-397
IIA-8.1.2
Long, R.D.,
1991
AMPA: A dietary LC50 study with the
Beavers, J.B.,
mallard.
Smith, G.J., Lynn,
Source: Monsanto
S.P.
Report no. 139-276
IIA-8.1.2
Long, R.D.,
1991
AMPA: A dietary LC50 study with the
Beavers, J.B.,
northern bobwhite.
Smith, G.J., Lynn,
Source: Monsanto
S.P.
Report no. 139-275 ! WL-90-398
IIA-8.2.6
Thun, S.
1993
Algae growth inhibition test.Test article:
Germany 1993
"Glyphosate isopropylamine salt".
Source: Feinchemie
Report no. 80-91-2328-01-93
IIA-8.3.1
Kock
1991
Testing on bee toxicity for the registration
Germany 1995
procedure, laboratory test: test substance:
Taifun 360.
Source: Feinchemie
Report no.
IIA-8.3.1
Schulz
1991
Testing on bee toxicity for the registration
UK:
procedure, laboratory test, test substance:
Submitted to PSD
Taifun 360.
14 May 1993 and
Source: Feinchemie
recorded as having
Report no.
being used as part
of a regulatory
decision for a
product approval
dated 25 April
1995.
Germany 1995
IIA-8.3.1
Warnke U.
1991
Testing on bee toxicity for the registration
UK:
procedure, laboratory test: test substance:
Submitted to PSD
Taifun 360.
14 May 1993 and
Source: Feinchemie
recorded as having
Report no.
being used as part
of a regulatory
decision for a
product approval
dated 25 April
1995.
Germany 1995
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 40 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
source (where different from company)
previous use in
reference
report no.
granting national
number
GLP or GEP status (where relevant),
authorizations
published or not
IIA-8.4.1
Klenner, Bathelt,
1995
Acute toxicity of glyphosate to Eisenia fetida –
Germany 1995
A.
laboratory test
Source: Feinchemie
Report no. RL502
IIIA-10.6.1.1
Hänisch, D.
1991
Auswirkungen von FSG 03090 H (Taifun 360)
Germany 1991
auf Regenwürmer im Labor
Source: Feinchemie
Report no. WL 102
IIA-8.6
Bohn, J.A.
1987
An evaluation of the pre-emergence herbicidal
Germany 1995
activity of CP 70139 (glyphosate)
Source: Monsanto
Report no. MSL-6574
IIA-8.6
Chetram, R.S.
1994
Tier2 Vegetative Vigor non-target
Germany 1995
Lucash, K.J..
phytotoxicity study using Glyphosate
Source: Monsanto
Report no. MSL-13320
IIA-8.4.2
Hayward, J.C.,
2000
A laboratory investigation of the effects of
Germany 2000
Mallett, M.J.,
glyphosate and its breakdown product AMPA
on reproduction in the earthworm,
Eisenia
fetida.
Source: Monsanto/Cheminova
Report no. CEMR-1173
IIA-8.3.2
Barton, R.
1999
A laboratory evaluation of the effects of MON
Germany 1999
IIIA-10.5.1
52276 on the green lacewing
Chrysoperla
carnea.
Source: Monsanto
Report no. MON-99-3
IIA-8.3.2
Kleiner, R.
1995
Roundup Ultra: testing toxicity to beneficial
Germany ???
IIIA-10.5.1
arthropods. Carabid beetles –
Poecilius
cupreus.
Source: Monsanto
Report no. 95 10 48 055
IIA-8.3.2
Kleiner, R.
1995
Testing toxicity to beneficial arthropods Spider Germany ???
IIIA-10.5.1
-
Pardosa spp.
Source Monsanto
Report no. 95 10 48 053
IIA-8.3.2
Kleiner, R.
1995
Testing toxicity to beneficial arthropods Cereal Germany ???
IIIA-10.5.1
aphid parasitoid -
Aphidius rhopalosiphi
(DESTEFANI-PEREZ) Imagines.
Source: Monsanto
Report no. 95 10 48 054
IIA-8.3.2
Kleiner, R.
1995
Roundup Ultra: Testing toxicity to beneficial
Germany ???
IIIA-10.5.1
arthropods Predacious mite -
Typhlodromus
pyri (SCHEUTEN).
Source: Monsanto
Report no. 95 10 48 056
•
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 41 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
source (where different from company)
previous use in
reference
report no.
granting national
number
GLP or GEP status (where relevant),
authorizations
published or not
IIA-8.3.2
Kleiner, R.
1998
MON 52276: Testing toxicity to beneficial
Germany 1999
IIIA-10.5.1
arthropods Cereal aphid parasitoid -
Aphidius
rhopalosiphi (Destefani-Perez) (extended
laboratory test
Source: Monsanto
Report no. XX-98-196 / 98 10 48 066
IIA-8.3.2
Kleiner, R.
1998
MON 52276: Testing toxicity to beneficial
Germany 1999
IIIA-10.5.1
arthropods Predatory mite
- Typhlodromus pyri
(Scheuten) (extended laboratory test
Source: Monsanto
Report no. XX-98-195 / 98 10 48 065
IIA-8.3.2
Vinall, S.
1999
An extended laboratory test to determine the
Germany 1999
IIIA-10.5.1
effects of MON 52276 on the predatory mite,
Typhlodromus pyri (Phytoseiidae).
Source: Monsanto
Report no. MON-99-092
AIIA-8.5
Andre, W.
1991
Auswirkung auf die Aktivität der
Germany 1991
AIIIA-10.7.1
Bodenmikroflora nach Richtlinie Teil VI 1-1
Report no: BMF9500060
not GLP
unpublished
•
link to page 42
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 42 -
List of studies
7 November 2001
APPENDIX III B
GLYPHOSATE TRIMESIUM
List of studies for which the main submitter has claimed data protection and
which during the re-evaluation process were considered as essential for
the evaluation with a view to Annex I inclusion1.
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
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-2.3
Wollerton, C. and
1995
Glyphosate-trimesium: physico-chemical study Austria 1998
Husband, R.
on pure active ingredient.
Netherlands 1998
RJ1724B
Germany 1994
GLP or GEP : yes Unpublished
IIA-2.9
Ericson, L.J.
1992
Glyphosate-Trimesium - Aqueous Photolysis
Germany 1994
RR 91-065B
GLP or GEP : no Unpublished
IIA-2.10
Hayes, S.E.
1995
Glyphosate-Trimesium - Calculation Of Half-
Germany 1995
Life By Reaction With Atmosheric Hydroxyl
Austria 2000
Radicals
Netherlands 1998
GLP or GEP : no Unpublished
IIA-1.10;
Farina, L.S.
1990
Analysis And Certification Of Product
Netherlands 1998
IIA-4.1
Ingredients In Icia0224, Non-Selective
Germany 1994
Herbicide (Wrc-90-410).
GLP or GEP : no Unpublished
IIA-4.2.1
Alferness, P. L.
1993
Touchdown: Determination Of Glyphosate
Germany 1994
And Aminomethylphosphonic Acid In Corn
Grain, Corn Forage, And Corn Fodder By Gas
Chromatography And Mass-Selective
Detection (Wrc-92-061) RR 92-042B
GLP or GEP : yes Unpublished
IIA-4.2.1
Alferness, P.L.
1996
Touchdown: Determination Of Glyphosate [N-
Austria 1998
(Phosphonomethyl)Gly- Cine] In Crops By
Netherlands 1998
Gas Chromatography And Mass-Selective
Germany 1997
Detection;
Report No. RR 92-042B RES2
GLP or GEP : no Unpublished
IIA-4.2.1
Hill, S. and Veal,
1996
Residues Analytical Method For The Analysis
Austria 1998
P.
Of N-(Phosphonomethyl)Glycine (Pmg) In
Netherlands 1998
Crops; RAM 245/03
Germany 1997
GLP or GEP : no Unpublished
1 List based on a detailed analysis from the rapporteur Member State.
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 43 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-4.2.1
Iwata, Y.
1993
Touchdown: Determination Of Residue Of The Netherlands 1998
Trimethylsulfonium Cation In Agricultural
Germany 1994
Crops By Gas Chromatography (Wrc-93-199)
(WINO 12690) RR 93-105B
GLP or GEP : yes Unpublished
IIA-4.2.1
Iwata, Y.
1996
Touchdown: Determination Of Residues Of
Austria 1998
The Trimethylsulfonium Cation In Agricultural Netherlands 1998
Crops By Gas Chromatography;
Germany 1997
Report No. RR 93-105B RES2
GLP or GEP : no Unpublished
IIA-4.2.1
McGinley, A.
1994
N-(Phosphonomethyl)Glycine (Pmg):
Germany 1994
Validation Of The Residue Analytical Method
In Crops
RJ 1599B
GLP or GEP : yes Unpublished
IIA-4.2.1
Tummon, O. J.
1994
Validation Of A Residue Analytical Method
Germany 1994
For The Determination Ofthe
Trimethylsulphonium Cation (Tms+) Of
Glyphosate-Trimesium In Crops Report
RJ1601B
GLP or GEP : yes Unpublished
IIA-4.2.1;
Veal, P.;
1997
Glyphosate-trimesium: validation of an
Austria 1998
IIA-4.2.2
Robinson, N.J. and
analytical method for the determination of the
Germany 1997
Hargreaves, S.L.
trimethylsulphonium cation (tms+) in apples,
grapes, mushrooms, pea seed, soil and wheat
grain using ion chromatography with mass
spectrometry in the selected reaction
monitoring mode
RJ2236B
GLP or GEP : no Unpublished
IIA-4.2.2
Alferness, P L.
1994
Touchdown: Determination Of Glyphosate
Germany 1994
And Aminomethylphosphonic Acid In Soil By
Gas Chromatography And Mass-Selective
Detection RR 92-010b
GLP or GEP : yes Unpublished
IIA-4.2.2;
Iwata, Y.
1994
Touchdown: Determination of residues of the
Germany 1994
IIA-4.2.3
trimethylsulfonium cation in soil and water by
gas chromatography (WRC-94-015) (WINO
10517) RR 94-010B
GLP or GEP : yes Unpublished
AIIA-4.2.2
Wood, B.
1998
ILV Determination of PMG and AMPA in soil
France 2000
by GC-MS
Germany 1999
RR 98-042B, GLP, unpublished
AIIA-4.2.2
James, J.W.
1998
ILV Determination of TMS in soil and water
Germany 1999
Ervin, R.L.
by GC
Germany 1999
RR 98-043B, GLP, unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 44 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-4.2.3
Davy, G. S.
1993
Glyphosate Trimesium: Development and
Germany 1994
validation of a method for the determination of
N-phosphonomethyl glycine in water
RJ1372B
GLP or GEP : yes Unpublished
IIA-4.2.3
Klumpp, M.
1995
Residue analysis of N-
Austria 1998
phosphonomethylglycine and
Netherlands 1998
aminomethylphos- phonic acid in water;
Germany 1996
Report no. 95059/95060/01-RW
GLP or GEP : no Unpublished
IIA-4.2.3
Klumpp, M.
1995
Residue analysis of trimethylsulfonium ion in
Austria 1998
water; Report no. 95061/01-RW
Netherlands 1998
GLP or GEP : no Unpublished
Germany 1996
IIA-4.2.3
Mich, G. and
1995
Quantitative determination of
Austria 1998
Seiler, H.
trimethylsulfonium cation in water; Project no.
Germany 1996
EF 95-59-02
GLP or GEP : no Unpublished
IIA-4.2.3
Pelz, S.
1995
Determination of residues of
Netherlands 1998
trimethylsulfonium cation (TMS+) in tap
Germany 1996
water; Report no. ZEN-9506, AZ. 36535/95
GLP or GEP : no Unpublished
IIA-4.2.3
Roth, A.
1995
Quantitative determination of glyphosate and
Austria 1998
AMPA in water; EF 95-59-01
Germany 1996
GLP or GEP : no Unpublished
IIA-4.2.3
Schulz, H.
1995
Determination of N-(phosphonomethyl)glycine Austria 1998
(PMG) and aminomethyl-phosphonic acid
Germany 1996
(AMPA) in water - Validation of the DFG
method - - Determination of PMG and AMPA
in fortified water samples -; Study no. 95 JH
007
GLP or GEP : no Unpublished
IIA-4.2.3
Schulz, H.
1995
Determination of trimethylsulfonium cation
Austria 1998
(TMS+) in water - Validation of the method
Germany 1996
SOP RAM/229/02 by Zeneca Agrochemicals -
Determination of trimethylsulfonium cation
(TMS+) in fortified water samples -; Study no.
95 JH 007
GLP or GEP : no Unpublished
IIA-4.2.3
Tummon, O.J.
1993
Validation of an analytical residue method for
Germany 1993
the trimethylsulphonium cation (TMS+) in
water RJ 1393B
GLP or GEP : yes Unpublished
AIIA-4.2.3
Crook, S.J.
1999
Analytical method for the determination of
France 2000
residues of PMG and AMPA in water
Germany 1999
TL 49290/01, not GLP, unpublished
AIIA-4.2.3
Bolygo, E.
1999
Analytical method for the determination of
Germany 1999
TMS in water
TL 49291/01, not GLP, unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 45 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-4.2.3
Weber, H.
1995
Determination of residues of glyphosate
Austria 1998
(PMG) and AMPA in tap water; Study no.
Netherlands 1998
95JH007
Germany 1996
GLP or GEP : no Unpublished
IIA-4.2.4
Tummon, O. J.;
1994
Glyphosate Trimesium: Validation of a model
Germany 1994
Freeman, B. L.
to determine residues in air RJ 1665B
GLP or GEP : yes Unpublished
IIA-4.2.5
Iwata, Y.
1993
Touchdown: Determination of residues of the
Germany 1994
trimethylsulphonium cation in milk, eggs, and
animal tissues by gas chromatography (WRC-
93-184) (WINO 12732) RR 93-100B
GLP or GEP : yes Unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 46 -
List of studies
7 November 2001
B.6 Toxicology and metabolism
Annex
Author(s)
Year
Title
Reports2 on
point/
source (where different from company)
previous use in
reference
report no.
granting national
number
GLP or GEP status (where relevant),
authorizations
published or not
AIIA-5.2.2
Johnson, I.R.
2000
Glyphosate-trimesium: Acute dermal toxicity
Germany 2000
in rats
CTL/CR3536
GLP, unpublished
AIIA-5.2.6
Lees, D. and Leah,
1995
Glyphosate trimesium: Skin sensitisation to the
Netherlands 1998
A.M.
guinea pig.
Germany 1998
REPORT NO.: CTL/P/4723
GLP, unpublished
AIIA-5.2.6
Robinson, P.
1994
Glyphosate trimesium: Skin sensitisation to the
Germany 1998
guinea pig.
FI: 21.12.1999
REPORT NO.: CTL/P/4339
GLP, unpublished
AIIA-5.3.2
Pinto, P.J.
1993
Glyphosate trimesium: 90 day oral toxicity
study in dogs.
REPORT NO.: CTL/P/3962
GLP, unpublished
AIIA-5.4.1
Callander, R.D.
1990
ICIA0224 - An evaluation of mutagenic
FI: 01.12.1993
potential using S. typhimurium and E. coli.
REPORT NO.: CTL/P/3129
GLP, unpublished
AIIA-5.4.2
Kennelly, J.C.
1990
ICIA0224: Assessment for the induction of
BE: 19.11.1991
unscheduled DNA synthesis in rat hepatocytes
FI: 02.12.1993
in vivo.
REPORT NO.: CTL/P/2789
GLP, unpublished
AIIA-5.7
Horner, S.A.
1993
Glyphosate trimesium: Acute neurotoxicity
Germany 1999
study in rats.
CTL/P/3813
GLP, unpublished
AIIIA-7.2
Anonym
1999
Operator exposure assessment according to
Germany 1999
german and UK POEM models.
not GLP, unpublished
AIIIA-7.2
Ward, R.J. and
1991
Fluazifop-p-butyl: In vitro absorption from a
Scott, R.C.
125g/l EC formulation trough human
epidermis.
REPORT NO.: CTL/P/3494
GLP, unpublished
AIIIA-7.3
Somers, K.A. and
1995
The dermal absorption of [14C]-anion
Netherlands 1998
Speirs, G.C.
glyphosate trimesium in rats.
CTL/C/2992
GLP, unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 47 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
source (where different from company)
previous use in
reference
report no.
granting national
number
GLP or GEP status (where relevant),
authorizations
published or not
AIIIA-7.3
Ward, R.J. and
1995
Glyphosate-trimesium: In vitro absorption from Germany 1995
Thornton, H.Y.
a 480 g/l SL formulation through rat skin.
CTL/P/4574
GLP, unpublished
AIIIA-7.3
Ward, R.
1994
ICIA0224: In vitro absorption from a 480g/l
Netherlands 1998
SL formulation through human epidermis.
REPORT NO.: CTL/P/4345
GLP, unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 48 -
List of studies
7 November 2001
B.7 Residue data
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-6.1
Parker, S. and
1991
Glyphosate-trimesium: Uptake and metabolism Germany 2000
Harris, M.
in USA grape vines.
RJ 1002B
GLP, UNPUBLISHED
IIA-6.1
Spillner, C.J.
1993
[14C -Anion] Glyphosate-Trimesium: Confined
Germany 2000
Accumulation Studies On Rotational Crops.
RR92-096B.
GLP, UNPUBLISHED
IIA-6.1
Subba-Rao, R.V.
1994
[14C-TMS] Glyphosate-Trimesium: Confined
and Tamichi, E.H.
Accumulation Studies On Rotational Crops.
RR93-045B
GLP, UNPUBLISHED
IIA-6.1
Tambling, D.R.
1992
[14C -ANION] ICIA0224: NATURE OF THE
Germany 2000
RESIDUE: SOYBEANS.
RR91-092B
GLP, unpublished
IIA-6.1
Wilkinson, M.J.
1990
Icia0224: uptake and metabolism in grape
BE: 19.11.1991
and Joseph, R.S.I.
vines.
Germany 2000
RJ 0815B
GLP, UNPUBLISHED
IIA-6.1
Tambling, D.R.
1989
Metabolism of 14C anion ICIA0224 in corn
Burnett, T.J.
and supplement
RR 89-010B,
GLP, unpublished
IIA-6.1
Tambling, D.R.
1989
Metabolism of 14C cation ICIA0224 in corn
Burnett, T.J.
and supplement
RR 89-011B,
GLP, unpublished
IIA-6.2;
Bowler, D.T.
1994
[14c-Pmg] Glyphosate-Trimesium: Nature Of
Germany 2000
IIA-6.4
The Residue In Tissues And Eggs Of Laying
Hens.
RR93-064B
GLP, UNPUBLISHED
IIA-6.2;
Corden, M.T. and
1994
Glyphosate-trimesium: metabolism in hens
IIA-6.4
Skidmore, M.W.
following dosing at 20 mg/kg in the diet.
Rj 1606b
GLP, UNPUBLISHED
IIA-6.2;
Ericson, J.L.
1994
The nature of residues of orally administered
Germany 2000
IIA-6.4
[phosphonomethylene-14c] glyphosate-
trimesium in goat tissues and milk.
RR93-062B
GLP, UNPUBLISHED
IIA-6.2;
Hand, L.H. and
1994
Glyphosate-trimesium: metabolism in lactating
IIA-6.4
Skidmore, M.W.
goats following dosing at 25 mg/kg in the diet.
RJ 1608B
GLP, UNPUBLISHED
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 49 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-6.3
Anderson, L.
1996
Glyphosate-trimesium: residue levels in oil
seed rape from a trial carried out in Denmark
during 1995.
RJ 2148B
GLP, UNPUBLISHED
IIA-6.3
Anderson, L., Ely,
1997
Glyphosate-trimesium: residue levels in olives
Germany 2000
S.V., Alevra, E.
and processed fractions from trials carried out
in Greece during 1996.
RJ2397B
GLP, UNPUBLISHED
IIA-6.3
Anderson, L., Ely,
1997
Glyphosate-trimesium: residue levels in olives
Germany 2000
S.V., Volpi, E.
and processed fractions from trials carried out
in Italy during 1996.
RJ2383B
GLP, UNPUBLISHED
IIA-6.3
Anderson, L.,
1997
Glyphosate-trimesium: residue levels in spring
Leek, S.
oil seed rape from trials carried out in the
united kingdom during 1996.
RJ2316B
GLP, UNPUBLISHED
IIA-6.3
Anderson, L.,
1997
Residue Levels in Woodland Mushrooms from
Germany 1997
Sanderson, D.J.
Trials carried out in Germany during 1996.
RJ 2347B
GLP, unpublished
IIA-6.3
Jones, R.N.
1996
Residue Levels in Field Peas from Trials
carried out in Germany during 1995.
RJ2207B
GLP, unpublished
IIA-6.3
Jones, R.N.,
1996
Glyphosate-trimesium: Residue Levels in
Alevra, E.
Olives from Trials carried out in Greece during
1995.
RJ2217B
GLP, unpublished
IIA-6.3
Jones, R.N., Ely,
1995
Residue Levels in Field Peas from Trials
V., Sanderson, D.
carried out in Denmark during 1994.
RJ1968B
GLP, unpublished
IIA-6.3
Jones, R.N., Hall,
1997
Glyphosate-trimesium: Residue Levels in
G.
Winter Oilseed Rape from Trials carried out in
the United Kingdom during 1995.
RJ2171B
GLP, unpublished
IIA-6.3
Jones, R.N.,
1995
Residue Levels in Field Peas from Trials
Sanderson, D.
carried out in Germany during 1994.
RJ1969B
GLP, unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 50 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-6.3
Jones, R.N., Volpi, 1996
Glyphosate-trimesium: Residue Levels in
E.
Olives from Trials carried out in Italy during
1995.
RJ2218B
GLP, unpublished
IIIA-8.2
Ely, S.V. and
1993
Glyphosate-trimesium: Residue levels in
Runnalls, J.K.
oranges from a field trial carried out in Greece
during 1991.
RJ 1376B
GLP, unpublished
IIIA-8.2
Hill, S.E.
1993
Glyphosate-trimesium: Residue levels in
Germany 1993
cereals (barley, wheat, rye and oats) from a
field study carried out in Germany during
1991.
RJ 1396B
GLP, unpublished
IIIA-8.2
Hill, S.E. and
1992
Glyphosate-trimesium: Residue levels in winter Germany 1992
Runnalls, J.K.
wheat from a trial carried out in Denmark
during 1989.
RJ 1180B
GLP, unpublished
IIIA-8.2
Hill, S.E. and
1992
Glyphosate-trimesium: Residue levels in spring Germany 1992
Runnalls, J.K.
barley from trials carried out in Denmark
during 1989.
RJ 1181B
GLP, unpublished
IIIA-8.2
Hill, S.E. and
1993
Glyphosate-trimesium: Residue levels in winter
Runnalls, J.K.
wheat from trials carried out in France during
1991.
RJ 1463B
GLP, unpublished
IIIA-8.2
Iwata, Y.
1992
Touchdown: Magnitude-of-the-residue study
on grapes.
RR 92-015B
GLP, unpublished
IIIA-8.2
Jones, R.N. and
1995
GLYPHOSATE-TRIMESIUM: Residue levels
Netherlands 1998
Freeman, B.L.
in pome fruit from trials carried out in
Germany 1995
Germany during 1994.
RJ 1831B
GLP, unpublished
IIIA-8.2
Jones, R.N., Cross, 1994
Glyphosate-trimesium: Residue levels in winter
R.C. and
wheat straw from trials carried out in France
Sanderson, D.J.
during 1992.
RJ 1622B
GLP, unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 51 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIIA-8.2
Jones, R.N., Ely,
1996
GLYPHOSATE-TRIMESIUM: Residue
Germany 1996
V.
Levels in Woodland Mushrooms from trials
carried out in Germany during 1995.
RJ 2157B
GLP, unpublished
IIIA-8.2
Jones, R.N., Ely,
1994
Glyphosate-trimesium: Residue levels in
Germany 1994
V. and Sanderson,
grapes from trials carried out in Germany
D.
during 1993.
RJ 1707B
GLP, unpublished
IIIA-8.2
Jones, R.N., Ely,
1995
GLYPHOSATE-TRIMESIUM: Residue levels
Germany 1995
V., Sanderson, D,
in grapes from trials carried out in Germany
and Hill, S.
during 1994.
RJ 1853B
GLP, unpublished
IIIA-8.2
Lant, M.S. and
1994
Glyphosate-trimesium: Residue levels in pome
Germany 1994
McGinley, A.
fruit from trials carried out in Germany during
1993.
RJ 1712B
GLP, unpublished
IIIA-8.2
Lant, M.S. and
1993
Glyphosate-trimesium: Residue levels in winter
Tummon, O.J.
barley from a field trial carried out in the UK
during 1990.
RJ 1437B
GLP, unpublished
IIIA-8.2
Lant, M.S. and
1993
Glyphosate-trimesium: Residue levels in
Germany 1993
Tummon, O.J.
following crops from a field study carried out
in Germany during 1991/2.
RJ 1450B
GLP, unpublished
IIIA-8.2
Lant, M.S. and
1993
Glyphosate-trimesium: Residue levels in winter
Tummon, O.J.
wheat from trials carried out in the UK during
1990.
RJ 1438B
GLP, unpublished
IIIA-8.2
McGinley, A. and
1992
Glyphosate-trimesium: Residue levels in winter Germany 1993
Runnalls, J.K.
cereals (wheat and barley) from trials carried
out in Germany during 1990.
RJ 1287B
GLP, unpublished
IIIA-8.2
McKay, J.C.
1990
ICIA-0224: Magnitude-of-the-residue study on
grapes.
RR 90-411B
GLP, unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 52 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIIA-8.2
Runnalls, J.K.
1993
Glyphosate-trimesium: Residue levels in
grapes from a field trial carried out in Greece
during 1991.
RJ 1375B
GLP, unpublished
IIIA-8.2
Runnalls, J.K. and
1993
Glyphosate-trimesium: Residue levels in spring Germany 1993
Hill, S.E.
crops (maize, peas, sugarbeet and sunflowers)
from trials carried out in Germany during
1990.
RJ 1369B
GLP, unpublished
IIIA-8.2
Runnalls, J.K. and
1993
Glyphosate-trimesium: Residue levels in spring Germany 1993
McGinley, A.
barley from a field study carried out in Sweden
during 1991.
RJ 1314B
GLP, unpublished
IIIA-8.2
Sadler, J.K.
1991
Glyphosate-trimesium: Residue levels in spring Germany 1992
barley from field trials carried out in Denmark
during 1988.
RJ 1013B
GLP, unpublished
IIIA-8.2
Sadler, J.K.
1991
Glyphosate-trimesium: Residue levels in winter BE: 21.09.1992
wheat from trials carried out in Denmark
Germany 1992
during 1988.
RJ 1012B
GLP, unpublished
IIIA-8.2
Sadler, J.K.
1991
Glyphosate-trimesium: Residue levels in spring Germany 1992
barley from trials carried out in Sweden during
1988.
RJ 1001B
GLP, unpublished
IIIA-8.2
Sadler, J.K.
1991
Glyphosate-trimesium: Residue levels in peas
from trials carried out in Denmark during
1988.
RJ 1007B
GLP, unpublished
IIIA-8.2
Sanderson, D.J.
1991
Phosphonomethylglycine: Residues in olive
and Austin, D.J.
from ICIA0224 trials carried out in Italy during
1988.
M 5354B
GLP, unpublished
IIIA-8.2
Sanderson, D.J.
1991
Trimethylsulphonium Cation: Residues in olive
and Austin, D.J.
from ICIA0224 trials carried out in Italy during
1989.
M 5120B
GLP, unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 53 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIIA-8.2
Tummon, O.J. and
1993
Glyphosate-trimesium: Residue levels in olive
Lant, M.S.
from a field trial carried out in Greece during
1991.
RJ 1414B
GLP, unpublished
IIIA-8.2
Wiebe, L.A.
1993
Touchdown: Magnitude-of-the-residue study
for residues of glyphosate-trimesium on
almonds, pecans and walnuts from trials
conducted in the USA during 1990.
RR 93-058B
GLP, unpublished
IIIA-8.4
Hill, S.E. and Lant, 1994
Glyphosate-trimesium: Residue levels in winter Germany 2000
M.S.
wheat processed fractions from a trials carried
out in France during 1991.
RJ 1572B
GLP, unpublished
IIIA-8.4
Hill, S.E. and Lant, 1993
Glyphosate-trimesium: Residue levels in winter Germany 1993
M.S.
wheat and common oat processed fractions
from trials carried out in Germany during
1992.
RJ 1492B
GLP, unpublished
IIIA-8.4
Lant, M.S. and
1995
Glyphosate-Trimesium: Storage Stability of
Hill, S.E.
Residue of N-(phosphonomethyl)glycine
(PMG) and Trimethylsulphonium Cation
(TMS) (both derived from Glyphosate-
trimesium) in Processed Fractions of Winter
Wheat and Common Oats.
RJ2030B
GLP, unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 54 -
List of studies
7 November 2001
B.8 Environmental fate and behaviour
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-7.1.1.2.1
Runnalls, J.K.,
1991
Glyphosate-Trimesium: Laboratory degradation in
Germany 1994
four soils.
RJ1064B
GLP, Unpublished
IIA-7.1.1.2.2
Hill, S.E.
1992
Glyphosate-Trimesium: Soil dissipation study
Netherlands 1998
(Germany 1990-1992).
Germany 1994
RJ1294B
GLP, Unpublished
IIA-7.1.2
Subba-Rao, R.V.
1992
[14C-TMS] Glyphosate-Trimesium:
Germany 1994
Adsorption/desorption in four soils.
RR92-017B
Not GLP, Unpublished
IIA-7.1.2
Subba-Rao, R.V.
1992
[14C-PMG] Glyphosate-Trimesium:
Germany 1994
and McGowan,
Adsorption/desorption in four soils.
N.G.
RR 92-016B
Not GLP, Unpublished
IIA-7.1.3.1
McGinley, A.M.
1992
Glyphosate-Trimesium: Leaching of material
Germany 1994
in soil columns.
RJ1247B
GLP, Unpublished
AIIA-
Bowler, D.T.
1999
Glyphosate-trimesium: Degradation of 14C
Germany 1999
7.2.1.3.2
Johnson, J.A.
PMG labelled compound in natural water
France 2000
sediment systems under laboratory conditions.
RR 99-039B, GLP, Unpublished
AIIA-
Shi, C-T.
1999
Glyphosate-trimesium: Degradation of 14C
Germany 1999
7.2.1.3.2
Ericson, J.L.
TMS labelled compound in natural water
sediment systems under laboratory conditions.
RR 99-040B, GLP, Unpublished
IIA-7.2.2
Hand, L.H.
1992
Glyphosate-trimesium: Volatilization from soil
Germany 1998
and leaf surfaces.
Netherlands 1998
RJ 1237B
GLP, Unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 55 -
List of studies
7 November 2001
B.9 Ecotoxicology
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-8.1.3
Marselas, G.,
1990
ICIA0224: A one-generation reproduction
Germany 1992
Beavers, J.B. and
study with the mallard (Anas platyrhynchos).
Jaber, M.J.
123-151
GLP, unpublished
IIA-8.1.3
Marselas, G.,
1990
ICIA0224: A one-generation reproduction
Germany 1992
Beavers, J.B. and
study with the bobwhite quail (Colinus
Jaber, M.J.
virginianus).
123-150
GLP, unpublished
IIA-8.2.2
Tapp, J.F., Sankey, 1991
GLYPHOSATE TRIMESIUM: The 21 day
Germany 1992
S.A., Caunter, J.E.,
LC50 to rainbow trout (Oncorhynchus mykiss).
Grinell, A.J. and
BL4178/B
Adams, D.S.
GLP, unpublished
IIA-8.2.4
Anonym
1993
AMPA: Acute toxicity to Daphnia magna.
Germany 1993
BL5061/B
GLP, unpublished
AIIA-8.2.6
Smyth, D.V., Kent, 1997
Glyphosate-Trimesium: Toxicity to blue-green
Germany 1998
S.J. and Shillabeer,
alga Anabaena flos-aquae .
Austria 1998
N.
BL5962/B
Netherlands 1998
GLP, unpublished
IIA-8.2.8
Smyth, D.V., Kent, 1997
Glyphosate-Trimesium: Toxicity to duckweed
Germany 1998
S.J. and Shillabeer,
(Lemna gibba).
Austria 1998
N.
BL5965/B
Netherlands 1998
not GLP, unpublished
IIA-8.3.2
Canning, L.,
1992
GLYPHOSAT-TRIMESIUM - Investigation of Netherlands 1998
IIIA-10.5
Lloyd, E.J. and
the Toxicity of a 400 g/l SL Formulation to the
Germany 1994
Lewis, G.B.
Carabid Beetle Pterostichus melanarius and a
Lycosid Spider.
RJ 1066B
GLP, unpublished
IIA-8.3.2
Turner, C. R.
1995
The effects of Glyphosat-Trimesium on the
Austria 1998
predatory mite Typhlodromus pyri.
Netherlands 1998
REPORT NO: 95.02
Germany 1995
GLP, unpublished
IIA-8.3.2
Austin, H.M.
1995
The effect of glyphosate-trimesium on the
Austria 1998
IIIA-10.5.1
heteropteran bug Orius laevigatus
Netherlands 1998
ER 95-13
Germany ???
GLP, unpublished
IIA-8.3.2
Kleiner, R.
1995
Testing toxicity to beneficial arthropods Tachid Austria 1998
IIIA-10.5.1
- Drino inconspicua
Netherlands 1998
95-10-48-001, GLP, unpublished.
Germany 1996
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
GLYPHOSATE/GLYPHOSATE TRIMESIUM
APPENDIX III
- 56 -
List of studies
7 November 2001
Annex
Author(s)
Year
Title
Reports2 on
point/
Source (where different from company)
previous use in
reference
Company, Report No.
granting national
number
GLP or GEP status (where relevant)
authorizations
Published or not
IIA-8.3.2
Coulson, M.J.
1995
Glyphosate-trimesium: Investigation into the
Austria 1998
IIIA-10.5.1
Fleming, T.M.
toxicity of a 480 g/l soluble concentrate
Netherlands 1998
Yearsdon, H.A.
formulation on the cereal aphid parasitoid
Germany ???
Farrelly, L.C.
Aphidius rhopalosiphi
RJ1962B, GLP, unpublished.
IIA-8.3.2
Mead-Briggs, M.
1999
A laboratory test to determine the effects of
Netherlands 1998
IIIA-10.5.1
glyphosate-trimesium 480 g/l SL on the
Germany 1999
parasitoid Aphidius rhopalosiphi,
France 2000
ZEN-98-2, GLP, unpublished
IIA-8.3.2
Gough, H.J.
1999
Glyphosate-trimesium: An extended laboratory Netherlands 1999
IIIA-10.5.1
Hargreave, N.J.
study to determine the ffects of an SL
Germany 1999
Travis, A.
formulation of the cereal aphid parasitoid
France 2000
Yearsdon, H.M.
Aphidius rhopalosiphi
RJ2852B, GLP, unpublished
Austria 2000
IIA-8.3.2
Bakker, F.M.
1999
A laboratory dose response study to evaluate
Netherlands 1999
IIIA-10.5.1
the effects of glyphosate-trimesium on the
Germany 199
predaceous mite Typhlodromus pyri.
France 2000
Z003TPL-CV, GLP, unpublished
IIA-8.3.2
Aldershof, S.A.
1999
An extended laboratory dose response study to
Netherlands 1999
IIIA-10.5.1
evaluate the effects of glyphosate-trimesium on Germany 1999
the predaceous mite Typhlodromus pyri
France 2000
Z006TPE-CV, GLP, unpublished
Austria 2000
AIIA-8.4.2
Hayward, J.C.
2000
A laboratory investigation of the effects of
Germany 2000
Mallett, M.J.
glyphosate and its breakdown product AMPA
Austria 2000
on reproduction in the earthworm, Eisenia
fetida
CEMR-1173, GLP, unpublished
Smyth, D.V. Tapp, 1991
Glyphhosate-trimesium: Toxicity to the green
Germany 1994
IIIA-10.2.1
J.F. Sankey, S.
alga Selenastrum capricornutum of a 480 g/l
Grinnell,A.J.
SL formulation
FT38/91, GLP, unpublished
IIIA-10.6.1
Yearsdon, H.
1991
Glyphosate-trimesium: Toxicity to the
Germany 1992
Smith, D.L.
earthworm Eisenia fetida of a 480 g/l SL
Jackson, D.
formulation
Wilson, A.
RJ1061B
Coulson,M.J.
GLP, unpublished
2 Reports received from Member States at the date of finalisation of the present review report (not exhaustive);
Dates referring to Germany indicate the submission for the national authorization.
Document Outline
