Properties Thiram PDF
Properties Thiram PDF
Properties Thiram PDF
Thiram
6507/VI/99-Final
27 June 2003
1.
This review report has been established as a result of the re-evaluation of thiram, 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 amended by Regulation (EC) No 2266/2000(2), has laid down the detailed rules
on the procedure according to which the re-evaluation has to be carried out. Thiram 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, JCS
International on 28 June 1993, Uniroyal Chemical Company, Inc. on 15 July 1993, Bayer AG on
21 July 1993, ACI International on 30 July 1993, UCB SA. on 20 July 1993, FMC-foret S.A. on
23 July 1993; Calliope S.A. on 21 July 1993, and B.V. Luxan on 21 July 1993 notified to the
Commission of their wish to secure the inclusion of the active substance thiram in Annex I to the
Directive. A thiram task force, comprising UCB SA and Uniroyal Chemical Company Ltd, now
Crompton Europe Ltd was formed.
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
Belgium as rapporteur Member State to carry out the assessment of thiram 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
3
4
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with regard to further technical and scientific information; for thiram this deadline was 31 October
1995.
Only UCB-Uniroyal on behalf of the thiram task force, submitted in time a dossier to the rapporteur
Member State which did not contain substantial data gaps, taking into account the supported uses
and therefore was considered to be the main data submitter. The seed treatment uses are supported by
Uniroyal and UCB, the foliar uses are only supported by UCB.
In accordance with the provisions of Article 7(1) of Regulation (EEC) No 3600/92, Belgium
submitted on 15 January 1998 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 thiram 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 thiram from UCBUniroyal, on 21 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 UCBUniroyal being the designated representative of the thiram task force, on 25 March 1998.
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:
-
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 report of the peer review (i.e. full report) was circulated, for further consultation, to Member
States on 17 March 2000 and the main data submitter on 21 March 2000 for comments and further
clarification.
In accordance with the provisions of Article 6(4) of Directive 91/414/EEC concerning
consultation in the light of a possible unfavourable decision for the active substance the
Commission organised a tripartite meeting with the main data submitter and the rapporteur
Member State for this active substance on 22 June 2000.
According to Commission Decision of 14 February 2001 concerning the decision on the possible
inclusion of certain active substances into Annex I to Council Directive 91/414/EEC5 a deadline
of 31.12.2001 for submission of further studies was established.
In accordance with the provisions of Article 7(3) of Regulation (EEC) No 3600/92, the dossier, the
draft assessment report, the peer review report (i.e. full report) and the comments and clarifications
5
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on the remaining issues, received after the peer review were referred to the Standing Committee on
the Food Chain and Animal 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 October 2000 to July 2003, and was finalised in the meeting of the Standing Committee
on 4 July 2003.
The review did not reveal any open questions or concerns which would have required a
consultation of the Scientific Committee on Plants.
The present review report contains the conclusions of the final examination; given the importance of
the draft assessment report, the peer review report (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.
2.
This review report, including the background documents and appendices thereto, has been
developed and finalised in support of the Directive 2003/81/EC6 concerning the inclusion of thiram
in Annex I to Directive 91/414/EEC, and to assist the Member States in decisions on individual plant
protection products containing thiram 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.
The overall conclusion from the evaluation is that it may be expected that plant protection products
containing thiram will fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive
6
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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 thiram
containing plant protection product for which Member States will grant or review the authorisation.
Furthermore, these conclusions were reached within the framework of the uses which were proposed
and supported by the main data submitter and mentioned in the list of uses supported by available
data (attached as Appendix IV to this Review Report).
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 89% 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.
The main identity and the physical/chemical properties of thiram are given in Appendix I.
The active substance shall comply with the FAO specification and there seem 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 submitter, the task
force UCB-Uniroyal, none of the manufacturing impurities considered are, on the basis of
information currently available, of toxicological or environmental concern.
In accordance with the provisions of Article 13(5) of Directive 91/414/EEC, Belgium is also
satisfied, on the basis of the information currently available, that the substances notified by the
other data submitters (FMC-foret) 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 dossier submitted by the main data submitter.
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5.
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 were identified during the re-evaluation process.
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
thiram
On the basis of the proposed and supported uses (as listed in Appendix IV), 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:
-
Member States should pay particular attention to the protection of aquatic organism. Risk
mitigation measures should be applied, where appropriate.
Member States should pay particular attention to the protection of small mammals and birds
when the substance is used as a seed treatment in spring uses. Risk mitigation measures
should be applied, where appropriate.
7.
No further studies were identified which were at this stage considered necessary in relation to the
inclusion of thiram in Annex I under the current inclusion conditions.
Some endpoints however may 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.
This may particularly be the case for:
-
processing studies on the intended crops (with special attention to metabolite M1).
8.
For information of any interested parties, Appendix III gives information about the studies for which
the main data submitter has 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.
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9.
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
91/414/EEC. Such adaptations will be examined and finalised in the Standing Committee on the
Food Chain and Animal Health, in connection with any amendment of the inclusion conditions for
thiram in Annex I of the Directive.
-7Thiram
APPENDIX I
Identity, physical and chemical properties
07 April 2003
APPENDIX I
Identity, physical and chemical properties
THIRAM
Thiram
tetramethylthiuram disulfide or
bis (dimethylthiocarbamoyl)-disulfide
tetramethylthioperoxydicarbonic diamide
CIPAC No
CAS No
24
137-26-8
EEC No
205-286-2
FAO SPECIFICATION
24/1/S/18 (1979)
Minimum purity
Molecular formula
C6H12N2S4
Molecular mass
240.4
Structural formula
S
CH3
N
CH3
S
S
CH3
N
CH3
-8Thiram
APPENDIX I
Identity, physical and chemical properties
07 April 2003
Melting point
144 - 146C
Boiling point
Appearance
Relative density
Vapour pressure
Solubility in water
Solubility in organic solvents
Dissociation constant
= 2.97 x 10-3
Flammability
Explosive properties
not explosive
-9Thiram
APPENDIX II
END POINTS AND RELATED INFORMATION
1. Toxicology and metabolism
07 April 2003
APPENDIX II
END POINTS AND RELATED INFORMATION
THIRAM
83-87% within 96 h
Distribution:
Acute toxicity
Rat LD50 oral:
Skin irritation:
non irritant
Eye irritation:
irritant
Skin sensitization (test method used and sensitizer (Split Adjuvant Test)
result):
Supporting evidence for humans
Liver (dog)
Non glandular stomach (rat)
Lowest relevant dermal NOAEL / NOEL: Rabbit, 21 days: 300 mg/kg bw/d (systemic)
- 10 Thiram
APPENDIX II
END POINTS AND RELATED INFORMATION
1. Toxicology and metabolism
07 April 2003
Genotoxicity
Reproductive toxicity
Target / critical effect - Reproduction:
Delayed neurotoxicity
Medical data
Summary
Value
Study
Safety factor
ADI:
100
AOEL systemic:
2 year rat
supported by the
findings in dogs
90 day dog,
supported by the
1 year findings
100
- 11 Thiram
APPENDIX II
END POINTS AND RELATED INFORMATION
1. Toxicology and metabolism
07 April 2003
AOEL inhalation:
Not applicable.
Use systemic
value
AOEL dermal:
Not applicable.
Use systemic
value
0.6 mg/kg bm/d
Acute
neurotoxicity rat
100
Dermal absorption
Default value of 10 %
- 12 Thiram
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
07 April 2003
Route of degradation
Aerobic:
Mineralization after 100 days:
Supplemental studies
Anaerobic:
Not submitted
Soil photolysis:
Remarks:
None
Rate of degradation
Laboratory studies
DT50lab (20 C, aerobic):
Not required
Not required
- 13 Thiram
Remarks:
e.g. effect of soil pH on degradation rate
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
07 April 2003
None
- 14 Thiram
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
07 April 2003
Adsorption/desorption
Kf / Koc:
Kd:
pH dependence:
Mobility
Laboratory studies:
Column leaching:
No studies performed
No studies performed
Field studies:
Lysimeter/Field leaching studies:
No studies performed
Remarks:
None
- 15 Thiram
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
07 April 2003
Major metabolites:
Photolytic degradation:
Major metabolites:
Biological degradation
Readily biodegradable:
Water/sediment study:
DT50 water:
DT90 water:
DT50 whole system:
DT90 whole system:
31.78-46.07 h
105.57-153.03 h
Not relevant
- 16 Thiram
APPENDIX II
END POINTS AND RELATED INFORMATION
2. Fate and behaviour in the environment
07 April 2003
Photolytic degradation
Direct photolysis in air:
Not required
DT50:
Volatilisation:
Remarks:
None
- 17 Thiram
APPENDIX II
END POINTS AND RELATED INFORMATION
3. Ecotoxicology
07 April 2003
3 Ecotoxicology
Terrestrial Vertebrates
Acute toxicity to mammals:
Aquatic Organisms
Acute toxicity fish:
Bioaccumulation fish:
Not required
- 18 Thiram
APPENDIX II
END POINTS AND RELATED INFORMATION
3. Ecotoxicology
07 April 2003
Honeybees
Acute oral toxicity:
Test
Substance
Dose
Endpoint
% Effect
Vitavax 200 FF
400 ml
formulation/10
0 kg seeds
Parasistism
efficiency
21.5 %
Vitavax 200 FF
400 ml
formulation
/100 kg seeds
Mortality
0%
Aatiram
300 g
formulation
/100 kg seeds
Parasistism
efficiency
28.3 %
Aatiram
Mortality
0%
Thiram 80WG
300 g
formulation
/100 kg seeds
3kg
Mortality
87 %
Mortality
95 %
Mortality
0%
7.69 %
Mortality
52 %
55 %
Laboratory tests
formulation
/ha
Aphidius rhopalosiphi
(adults)
Thiram 80WG
6 kg
formulation /ha
3kg
formulation /ha
6 kg
formulation /ha
3kg
formulation /ha
Reproduction
6 kg
formulation /ha
Coccinella septempunctata
(larvae)
Thiram 80WG
3kg
formulation /ha
6 kg
Reproduction
Mortality
89 %
- 19 Thiram
Aphidius rhopalosiphi
(adults)
Coccinella septempunctata
(larvae)
APPENDIX II
END POINTS AND RELATED INFORMATION
3. Ecotoxicology
07 April 2003
Thiram 80WG
Thiram 80WG
Thiram 80WG
(fresh)
Thiram 80WG
(28 d aged
residue)
formulation /ha
2X 0.28 and
2X0.15 kg
a.s./ha
4X 1.92 kg
a.s./ha
Mortality
Mortality
80 %
0%
Mortality
2.56 %
2X 0.28 and
2X0.15 kg
a.s./ha
4X 1.92 kg
a.s./ha
2X 0.28 and
2X0.15 kg
a.s./ha
4X 1.92 kg
a.s./ha
Reproduction
21 %
Reproduction
16 %
Mortality
16.33 %
Mortality
33.36 %
2X 0.28 and
2X0.15 kg
a.s./ha
4X 1.92 kg
a.s./ha
2X 0.28 and
2X0.15 kg
a.s./ha
4X 1.92 kg
a.s./ha
Reproduction
0%
Reproduction
0%
Mortality
25 %
Mortality
91.67 %
2X 0.28 and
2X0.15 kg
a.s./ha
4X 1.92 kg
a.s./ha
Reproduction
42%
Reproduction
not
determined
2X 0.28 and
2X0.15 kg
a.s./ha
4X 1.92 kg
a.s./ha
Mortality
2%
Mortality
23.78%
2X 0.28 and
2X0.15 kg
a.s./ha
4X 1.92 kg
a.s./ha
Reproduction
0%
Reproduction
0%
Typhlodromus pyri
Typhlodromus pyri
- 20 Thiram
APPENDIX II
END POINTS AND RELATED INFORMATION
3. Ecotoxicology
07 April 2003
Earthworms
Acute toxicity:
Reproductive toxicity:
Not required.
Soil micro-organisms
Nitrogen mineralization:
Carbon mineralization:
- 21 Thiram
APPENDIX III
List of studies
07 April 2003
APPENDIX IIIA
THIRAM
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 inclusion.
The evaluation of thiram is based on the dossier which has been submitted by the task
force UCB (now: Taminco) and Uniroyal (now: Crompton). Except a few studies submitted
by FMC, all the studies of this list were submitted by the task force or one of its Members.
Thiram task force I and thiram task force II are equivalent to task force UCB-Uniroyal.
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
Reports7 on
Author(s)
Year Title
Annex
Source (where different from company) previous use in
point/
Company, Report No.
granting
reference
GLP or GEP status (where relevant)
national
number
Published or not
authorizations
IIA 1.10
IIA 4.1.2
IIA 1.11
Comb, A.L.
1997
IIA 1.11/01
Demuynck M.
1999
Entries are based on information received from the Notifier(s) and in certain cases Member States. Neither the Commission nor
the Member States are responsible for the completeness or validity of this information received.
- 22 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 1.11/02
Forbes P.J.,
Mertz J.L.
1997
1994
IIA 2.2/01
1993
Tutty, D.G.
1995
1994
1994
Reports7 on
previous use in
granting
national
authorizations
- 23 Thiram
APPENDIX III
List of studies
07 April 2003
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1994
1994
1995
IIA 2.6/01
Tutty, D.G.
1993
IIA 2.6
IIA 2.11.2
IIA 2.14
Flack, I.
1997
IIA 2.7/01
Tutty, D.G.
1993
Annex
point/
reference
number
Author(s)
Reports7 on
previous use in
granting
national
authorizations
- 24 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 2.7/04
Baele, G.,
Van De Putte, M.,
Demuynck, M.
1997
IIA 2.8/01
Lemal, R.
1983
1991
1991
1994
1995
Reports7 on
previous use in
granting
national
authorizations
- 25 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA
2.11.1/01
Tremain S P
1999
IIA 2.13
Krips H.J.
2000
1993
1994
1992
Reports7 on
previous use in
granting
national
authorizations
- 26 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 4.2.2
Blaszczynski E.
2001
IIA 4.2.3
Blaszczynski E.
2000
Analytical
method
for
determining
Thiram in soil
AGVISE Laboratories, Inc.
Generated by: UCB S.A., Uniroyal
Chemical Limited
Submitted by: UCB S.A., Uniroyal Chemical
Limited (on 26/12/2001)
Study Nr.: 2000-187
Date: 23 February 2001
GLP
Unpublished
Analytical method for determination of thiram
in pond water
AGVISE Laboratories, Inc.
Generated by: UCB S.A., Uniroyal
Chemical Company Inc.
Submitted by: UCB S.A., Uniroyal Chemical
Company Inc. (on 17/11/2000)
Study Nr.: 99188
Date: 27 March 2000
GLP
Unpublished
2001
Reports7 on
previous use in
granting
national
authorizations
- 27 Thiram
APPENDIX III
List of studies
07 April 2003
Author(s)
IIA 5.1/02
Nomeir, A.A.,
Markham, P.
1990
IIA 5.1/03
Norris, K.J.
1991
Year
1992
2001
IIA 5.7/01
Driscoll, C.D.,
Hurley, J.M.
1993
IIA 5.7/02
Driscoll, C.D.,
Hurley, J.M.
1993
IIA 5.8.1
Anon
2001
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Disposition and metabolism of Thiram in rats
after pretreatment with Thiram for 14 days.
Company file No.: Uniroyal Project No. 9049
(T.8.3.4)
GLP
unpublished
Identification and comparison of urinary
metabolite profiles of 14C-Thiram in
subchronic vs single oral dose in rats.
Company file No.: Uniroyal Project No. 8833
(T.8.3.8)
GLP
unpublished
Thiram Technical - Twenty-one day dermal
toxicity study in rabbits.
Huntingdon Research Centre (HRC)
Company file No.: UCB 421/920767
GLP
unpublished
Thiram: Acute investigative study in rats
Central Toxicology Laboratory
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Study Nr.: AR7090
Date: 19 November 2001
GLP
Unpublished
Thiram single exposure peroral (gavage)
neurotoxicity study in rats.
Bushy Run Research Center (BRRC)
Company file No.: T.7.5.1
GLP
Unpublished
Thiram: Ninety day dietary neurotoxicity
study in Sprague-Dawley rats.
Bushy Run Research Center (BRRC)
Company file No.: T.7.5.2
GLP
Unpublished
TOPKAT toxicity assessment report (DMCS)
Accelerys Inc USA
Submitted by Crompton Europe Ltd
Not GLP
Unpublished
Submitted Dec 2001
Reports on
previous use in
granting
national
authorizations
- 28 Thiram
APPENDIX III
List of studies
07 April 2003
Author(s)
Year
IIA 6.1/05
Liu, D.D.W.,
Robinson, R.A.
1994
IIA 6.1/06
Liu, D.D.W.,
Robinson, R.A.
1994
IIA 6.1/07
Liu, D.D.W.,
Robinson, R.A.
1994
IIA 6.1/08
Wyss-Benz, M.
1994
IIA 6.1/09
Morgenroth, U.,
Wyss-Benz, M.
1995
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Distribution and metabolism of 14C Thiram in
plants from treated sugarbeet seed.
XenoBiotic Laboratories Inc.
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: Uniroyal Study No. 92252
Date: November 1, 1994
GLP
unpublished
Uptake and translocation of [14C]-Thiram in
plants from treated wheat seed.
XenoBiotic Laboratories Inc.
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: Uniroyal Project No.
91181
Date: November 4, 1994
GLP
unpublished
Uptake and translocation of [14C]-Thiram in
plants from treated soybean seed.
XenoBiotic Laboratories Inc.
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: Uniroyal Project No.
92161
Date: November 1, 1994
GLP
unpublished
14
C-Thiram: Plant metabolism study in field
grown apple.
RCC
Generated by: UCB Chemicals
Submitted by: UCB Chemicals
Company file No.: RCC Project 319588
Date: November 23, 1994
GLP
unpublished
14
C-Thiram: Plant metabolism study in field
grown grapes
RCC
Generated by: UCB Chemicals
Submitted by: UCB Chemicals (30/10/96)
Company file No.: RCC Project 319590
Date: July 4, 1995
GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 29 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.1/10
Robinson, R.A.
1996
IIA 6.1/13
Womer, J.M.,
Balba, H.M.
1978
IIA 6.2/01
Norris, K.J.
IIA 6.2/02
Norris, K.J.
IIA 6.3/01
Knight, C.
1995
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Investigation of the stability of 14C-3(Dimethyldithiocarbamoyl)-alanine in the
presence of a soybean straw matrix
XenoBiotic Laboratories Inc.
Generated by: Thiram Task Force II
Submitted by: UCB S.A., Uniroyal Chemical
Limited (on 3/11/1997)
Company file No.: Report No. RPT00245 Study No. XBL 95321
Date: 13 September 1996
GLP
Unpublished
Translocation and soil movement of 14C
Thiram from wheat seeds treated with
Vitavax 200
Generated by: Crompton Corporation
Submitted by: Crompton Europe Ltd. (in
12/2001)
Study Nr.: 7846/7850
Date: 1978
Not GLP
Unpublished
Determination of the metabolic fate of [14C]Thiram orally administered to laying hens.
ADC + Colorado State University
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: ADC Report No. 1058-1
Date: September 17, 1993
GLP
Unpublished
Determination of the metabolic fate of [14C]Thiram orally administered to lactating goats.
Analytical Development Corporation
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: ADC Report No. 1057
(T.8.3.11)
Date: February 16, 1993
GLP
Unpublished
Residues of Thiram in combining peas
treated with Vitavax 200FF seed treatment.
Generated by: Uniroyal Chemical, Ltd.
Submitted by: Uniroyal Chemical, Ltd.
Company file No.: V.6.2.11.1
Date: January 10, 1995
GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 30 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/02
Patel, N.P.
1995
IIA 6.3/03
Knight, C.
1995
IIA 6.3/06
Rockwell, J.C.
1992
IIA 6.3/09
Ball, J.O
1988
IIA 6.3/11
Rockwell, J.C.
1992
IIA 6.3/12
Ball, J.O
1988
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Residues of Thiram in linseed treated with
Vitavax 200FF seed treatment.
Generated by: Uniroyal Chemical, Ltd.
Submitted by: Uniroyal Chemical, Ltd.
Company file No.: V.6.2.12.1
Date: January 11, 1995
GLP
unpublished
Residues of gamma-HCH and Thiram in
oilseed rape treated with Vitavax RS seed
treatment.
Generated by: Uniroyal Chemical, Ltd.
Submitted by: Uniroyal Chemical, Ltd.
Company file No.: Uniroyal Project No.
AG/13148
GLP
unpublished
Residues of Thiram and its metabolites in
alfalfa
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: 92-012
Date: June 24, 1992
non-GLP
unpublished
Residues of Thiram and its
monothioglucoside and dithioglucoside in
soybeans (2 volumes).
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: T.6.2.5.2 (89-013)
Date: December 21, 1988
non-GLP
unpublished
Residues of Thiram and its metabolite in
cabbage.
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: Uniroyal Report No. 92013
Date: June 23, 1992
non-GLP
unpublished
Residues of Thiram and its dithioglucoside
and monothioglucoside in sweet corn.
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: T.6.2.4.3
Date: December 19, 1988
non-GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 31 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/13
Rockwell, J.C.
1992
IIA 6.3/14
Rockwell, J.C.
IIA 6.3/15
Rockwell, J.C.
1989
IIA 6.3/16
Rockwell, J.C.
1990
IIA 6.3/17
Rockwell, J.C.
1989
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Residues of Thiram and its metabolites in
cucumbers.
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: Report No. 92-014,
HLA 6111-134D, Gustafson 01774
Date: June 23, 1992
non-GLP
unpublished
Residues of Thiram and its metabolites in
lettuce.
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: Report No. 90-007,
HLA 6111-126K, Gustafson 01488
Date: February 13, 1990
non-GLP
unpublished
Residues of Thiram and its metabolites in
peas.
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: Report No. 90-008,
HLA 6111-126G, Gustafson 01489
Date: October 13, 1989
non-GLP
unpublished
Residues of Thiram and its metabolites in
sugar beets.
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: Report No. 90-010,
HLA 6111-126H, Gustafson 01491
Date: February 13, 1990
non-GLP
unpublished
Residues of Thiram and its metabolites in
table beets.
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: Report No. 90-011
Date: October 13, 1989
non-GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 32 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/18
Rockwell, J.C.
1992
IIA 6.3/19
Ball, J.O
1988
IIA 6.3/20
Rockwell, J.C.
1989
IIA 6.3/21
Christman, P.J.
1992
IIA 6.3/22
Roland, L.
1993
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Residues of Thiram and its metabolites in
fresh and processing tomatoes.
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: Report No. 92-015,
HLA 6111-134F, Gustafson 01775
Date: June 23, 1992
non-GLP
unpublished
Residue of Thiram and its dithioglucoside
and monothioglucoside in cotton (2
volumes).
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: T.6.2.3.2, 89-008,
HLA 6111-126J, Gustafson 01483
Date: December 21, 1988
non-GLP
unpublished
Residues of Thiram and its metabolites in
safflower.
Gustafson + Hazleton Laboratories
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: 90-009, HLA 6111-126L,
Gustafson 01490
Date: October 13, 1989
non-GLP
unpublished
78-Week frozen storage stability of Thiram
and dithioglucoside of Thiram in crops.
Hazleton Laboratories America, Inc.
Generated by: Thiram Task Force II
Submitted by: Thiram Task Force II
Company file No.: HLA 6111-126 A-L
Date: June 23, 1992
GLP
unpublished
Study on the stability of Thiram on frozen
whole plums.
B.E.A.Gx Centre de Recherches de
Phytopharmacie, Gembloux
Generated by: UCB Chemicals
Submitted by: UCB Chemicals
Company file No.: CRP/93/1025
Date: April 23, 1993
non-GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 33 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/23
Roland, L.
1994
IIA 6.3/24
Blaschke, U.
1995
IIA 6.3/25
Blaschke, U.
1995
IIA 6.3/26
IIA 6.3/27
IIA 6.3/28
IIA 6.3/29
Weber, H.
1994
IIA 6.3/30
Blaschke, U.
1995
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Rsidus de Thirame sur raisins, mots et
vins.
B.E.A.Gx Centre de Recherches de
Phytopharmacie, Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: FR 7/91 (CRP/94/1295)
Date: August 18, 1994
non-GLP
unpublished
Raw agricultural and processed commodity
study with LX1282-01 (Dirac Express)
applied to grapes in France.
Paragon Global Services
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: UCB-9301A (28203B002)
Date: May 23, 1995
GLP
unpublished
Raw agricultural and processed commodity
study with LX1282-02 (Silbos DF) applied to
grapes in France.
Paragon Global Services
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: UCB 9301c (28203B004)
Date: May 23, 1995
GLP
unpublished
Determination of residues of Thiram in vine
(grapes, must and wine) BASF study
Dr. Specht & Partner
DE/FR/03/92, Trial No. DU2/60/92,
DU2/61/92, DU3/29/92, DU3/30/92.
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: BAS-9302
Date: January 19, 1994
GLP
unpublished
Raw agricultural and processed commodity
study with LX1282-02 (Dirac Express)
applied to grapes in France.
Paragon Global Services
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: UCB-9301b (28203B003)
Date: May 23, 1995
GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 34 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/31
Blaschke, U.
1995
IIA 6.3/32
IIA 6.3/33
Balluff, M.
1995
IIA 6.3/34
Schmidt,
Ohs
1990
IIA 6.3/35
Schmidt,
Ohs
1990
IIA 6.3/36
Roland, L.
1992
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Raw agricultural and processed commodity
study with LX1280-01 (Dirac Express)
applied to grapes in France.
Paragon Global Services
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: UCB-9301 (28203B001)
Date: May 23, 1995
GLP
unpublished
Determination of residues of Thiram 80WG
in grapes under field conditions at two
locations in France.
GAB Biotechnologie GmbH
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: 94020/01-FPWE
Date: April 7, 1995
GLP
unpublished
Field report and analytical data field trial No.
0318/89, residue on apple, (Germany),
80WP formulation
Bayer AG
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: 0318/89
Date: April 9, 1990
non-GLP
unpublished
Field report and analytical data field trial No.
0320/89, residue on apple, (Germany),
80WP formulation
Bayer AG
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: 0320/89
Date: April 9, 1990
non-GLP
unpublished
Residues of Thiram on apples.
B.E.A.Gx Centre de Recherches de
Phytopharmacie, Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: CRP/92/974 (BEVJG1)
Date: November, 1992
non-GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 35 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/37
Roland, L.
1992
IIA 6.3/38
Pigeon, O.
1993
IIA 6.3/39
IIA 6.3/40
Ohs
1995
IIA 6.3/41
Gatti, G
1992
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Residues of Thiram on apples.
B.E.A.Gx Centre de Recherches de
Phytopharmacie, Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: CRP/92/973 BEVJG2)
Date: November, 1992
non-GLP
unpublished
Determination of residues of Thiram (TMTD)
on apples by selective method.
Station de phytopharmacie de lEtat,
Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: UCB/P.J./B.A.7792c
Date: December 30, 1993
GLP
unpublished
Determination of residues of Pomarsol
80WG in/on apple under actual use
conditions in Belgium.
Bayer AG
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: RA-2097/93 (study
numbers 304670 [467/93], 304735 [473/93])
Date: April 13, 1995
GLP
unpublished
Determination of residues of Thiram in
plums, pears, peaches, cherries and
apples in compliance with good laboratory
practice regulations - CS2 headspace
method, liquid chromatography method.
Neotron
Generated by: UCB Chemicals
Submitted by: UCB Chemicals
Company file No.: UCB
201/202/203/204/205
(Laboratory study LN 14/HP, LN 14/HD)
Date: December 11, 1992
GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 36 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/42
Gatti, G.
199192
IIA 6.3/43
IIA 6.3/44
Ohs
1995
IIA 6.3/45
Schmidt,
Ohs
1990
IIA 6.3/46
Schmidt,
Ohs
1990
IIA 6.3/47
Roland, L.
1992
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Field reports and analytical data for 1991
trials in Italy on apples, pears, peaches,
cherries and plums (50WG formulation).
Neotron
Generated by: UCB Chemicals
Submitted by: UCB Chemicals
Company file No.: 58-F91/6009/6010/6011/6012
UCB 911/912/913/914
(Laboratory study LN 12)
Date: 1991-92
GLP
unpublished
Determination of residues of Pomarsol
80WG in/on Apple under under actual use
conditions in France and of Pomarsol 50WG
in/on Apple under actual use conditions in
Italy.
Bayer AG
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: RA-2099/93 (study
numbers 304697, 304700)
Date: April 13, 1995
GLP
unpublished
Field report and analytical data field trial No.
0319/89, residue on pear, (Germany), 80WP
formulation
Bayer AG
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: 0319/89
Date: April 9, 1990
non-GLP
unpublished
Field report and analytical data field trial No.
0321/89, residue on pear, (Germany), 80WP
formulation
Bayer AG
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: 0321/89
Date: April 9, 1990
non-GLP
unpublished
Residues of Thiram on pears
B.E.A.Gx Centre de Recherches de
Phytopharmacie, Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: CRP/92/978 BEVECON
1)
Date: November, 1992
non-GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 37 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/48
Roland, L.
1992
IIA 6.3/49
Pigeon, I.O.
1993
IIA 6.3/53
Balluff, M.
1995
IIA 6.3/57
Balluff, M.
1995
IIA 6.3/60
Balluff, M.
1995
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Residues of Thiram on pears
B.E.A.Gx Centre de Recherches de
Phytopharmacie, Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: CRP/92/977 BEVECON
2)
Date: November, 1992
non-GLP
unpublished
Determination of residues of Thiram (TMTD)
on pears by selective method.
Station de phytopharmacie de lEtat,
Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: BA 7792b (BEWCON)
Date: December 30, 1993
GLP
unpublished
Determination of residues of Thiram 80WG
in pears under field conditions at one
locations in Spain.
GAB Biotechnologie GmbH
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: 94020/01-FBPI
Date: March 27, 1995
GLP
unpublished
Determination of residues of Thiram 80WG
in cherries under field conditions at one
location in Spain.
GAB Biotechnologie GmbH
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: 94020/01-FPKI
Date: March 27, 1995
GLO
unpublished
Determination of residues of Thiram 80WG
in plums under field conditions at one
location in south France.
GAB Biotechnologie GmbH
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: 94020/02-FPPL
Date: March 27, 1995
GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 38 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/64
Ohs
1995
IIA 6.3/65
IIA 6.3/66
Balluff, M.
IIA 6.3/67
IIA 6.3/68
Roland, L.
1992
IIA 6.3/69
Roland, L.
1992
IIA 6.3/70
Roland, L.
1992
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of residues of Pomarsol
80WG in/on peach under actual use
conditions in France.
Bayer AG
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: RA-2083/93 (study
number 304654)
Date: January 20, 1995
GLP
unpublished
Determination of residues of Thiram 80WG
in peaches under field conditions at two
locations in Spain.
GAB Biotechnologie GmbH
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: 94020/01-FPPF
Date: March 27, 1995
GLP
unpublished
Rsidus de Thiram sur fraises. Residues of
Thiram on strawberries.
B.E.A.Gx Centre de Recherches de
Phytopharmacie, Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: CRP/92/864A
(BC/SELVA1, BC/SELVA2) + CRP/92/865A
Date: May, 1992
GLP
unpublished
Rsidus de Thirame sur fraises. Residues of
Thiram on strawberries.
B.E.A.Gx Centre de Recherches de
Phytopharmacie, Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: CRP/92/862A
(BC/VICODA)
Date: May, 1992
non-GLP
unpublished
Rsidus de Thirame sur fraises. Residues of
Thiram on strawberries.
B.E.A.Gx Centre de Recherches de
Phytopharmacie, Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: CRP/92/863 (91/BC
Elsanta)
Date: May, 1992
non-GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 39 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/71
Pigeon, I.O.
1993
IIA 6.3/72
Pigeon, I.O.
1993
IIA 6.3/73
Reynens Ph.,
Doclot Th.,
Dumont de
Chassart Y.
1994
IIA 6.3/74
IIA 6.3/75
Direction rgionale
de lagriculture et
de la fort
1992
IIA 6.3/76
Prevotat M.,
Dumont de
Chassart Y.
1995
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of residues of Thiram (TMTD)
on strawberries (variety Selva) by selective
method.
Station de phytopharmacie de lEtat,
Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: BA 7792a (BCSEL)
Date: December 30, 1993
GLP
unpublished
Determination of residues of Thiram (TMTD)
on strawberries by selective method.
Station de phytopharmacie de lEtat,
Gembloux
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: BA 7792d(BCIRV)
Date: December 30, 1993
GLP
unpublished
Determination of the magnitude of residue
resulting from thiram foliar applications on
strawberries - Ittre Belgium
Redebel
UCB Study N: RU 0493 (Ittre UCB-B-93-3)
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: UCB 93/3
Date: February 5, 1994
GLP
unpublished
Experimentations residues 1992 - (France)
Thianosan ultra dispersible, 80WG
formulation).
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: SPV3301, SPV3302
Date: January 3, 1992
non-GLP
unpublished
Determination of magnitude of residue
resulting from thiram foliar applications on
strawberries
Prestagro
UCB Study n: RU 0493
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: UCB 93-10
Date: April, 1995
GLP
unpublished
Reports on
previous use in
granting
national
authorizations
- 40 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/77
IIA 6.3/78
Balluff, M.
1995
IIA 6.3/85
Perny A.
1998
IIA 6.3/86
Perny A.
1998
IIA 6.3/87
Balluff M.
1999
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of residues of Thiram 80WG
in strawberries under field conditions at two
locations in France.
GAB Biotechnologie GmbH
Generated by: UCB Chemicals
Held on file by: UCB Chemicals
Company file No.: 94020/01-FPEBL
Date: April 7, 1995
GLP
unpublished
Determination of Thiram (as CS2) residues in
apricot raw agricultural commodity following
treatment with the preparation Thianosan
Ultra Dispersible under field conditions in
France in 1997
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 28/05/1999)
Company file No.: R 7057 DE - trial No.
7057 BD1 + BD2
Date: 9 February 1998
GLP
Unpublished
Determination of Thiram (as CS2) residues in
apricot raw agricultural commodity following
treatment with the preparation Thianosan
Ultra Dispersible under field conditions in
France in 1997
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 28/05/1999)
Company file No.: R 7059 DE - trial No.
7059 SA1 + BD1
Date: 3 February 1998
GLP
Unpublished
Determination of residues of Thiram in
strawberries following the application of
Thiram Granuflo 80WG under Greenhouse
conditions at 1 location in France, 1998
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 28/05/1999)
Company file No.: 98053/F2-FGST - trial
codes: F98035R
Date: 2 March 1999
GLP
Unpublished
Reports on
previous use in
granting
national
authorizations
- 41 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/88
Balluff M.
1999
IIA 6.3/89
Balluff M.
1998
IIA 6.3/90
Balluff M.
1998
IIA 6.3/91
Perny A.
2001
IIA 6.3/92
Perny A.
2001
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of residues of Thiram in
strawberries following the application of
Thiram Granuflo 80WG under Greenhouse
conditions at 1 location in France, 1998
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on28/05/1999)
Company file No.: 98053/F2-FGST - trial
codes: F98034R
Date: 2 March 1999
GLP
Unpublished
Determination of residues of Thiram in
strawberries following the application of
Thiram Granuflo 80WG under Greenhouse
conditions in Spain
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 28/05/1999)
Company file No.: 97064/E1-FGST - trial
codes: S97020R
Date: 1 July 1998
GLP
Unpublished
Determination of residues of Thiram in
strawberries following the application of
Thiram Granuflo 80WG under Greenhouse
conditions at 1 location in Spain, 1998
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on28/05/1999)
Company file No.: 98053/S1-FGST - trial
codes: S98018R
Date: 12 November 1998
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in apples at one site in
Northern France, 2001
Andadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1011
Date: 20 November 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in apples at one site in
Northern France, 2001
Andadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1010
Date: 9 November 2001
GLP
Unpublished
Reports on
previous use in
granting
national
authorizations
- 42 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/93
Perny A.
2001
IIA 6.3/94
Perny A.
2001
IIA 6.3/95
Balluff M.
2001
IIA 6.3/96
Balluff M.
2001
IIA 6.3/97
Perny A.
2001
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of residues of Thiram 80 WG
(80% Thiram) in apples at one site in
Southern France, 2001
Andadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1012
Date: 9 November 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in apples at one site in
Southern France, 2001
Andadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1045
Date: 20 November 2001
GLP
Unpublished
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in apples at one site in
Northern Germany, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/G1-FPAP
Date: 22 March 2001
GLP
Unpublished
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in apples at one site in
Southern Germany, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/G2-FPAP
Date: 21 May 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in apples at one site in Italy,
2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1015
Date: 17 December 2001
GLP
Unpublished
Reports on
previous use in
granting
national
authorizations
- 43 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/98
Balluff M.
2001
IIA 6.3/99
Perny A.
2001
IIA 6.3/100
Perny A.
2001
IIA 6.3/101
Perny A.
2001
IIA 6.3/102
Perny A.
2001
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in apples at one site in Spain,
2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 200036003/S1-FPAP
Date: 27 March 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in apples at one site in Spain,
2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (submitted on
26/12/2001)
Company file No.: R A1013
Date: 9 November 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in apples at one site in Spain,
2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1014
Date: 13 November 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in pears at one site in
Northern France, 2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1016
Date: 9 November 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in pears at one site in
Northern France, 2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1017
Date: 9 November 2001
GLP
Unpublished
Reports on
previous use in
granting
national
authorizations
- 44 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/103
Balluff M.
2001
IIA 6.3/104
Perny A.
2001
IIA 6.3/105
Perny A.
2001
IIA 6.3/106
Balluff M.
2001
IIA 6.3/107
Balluff M.
2001
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in pears at one site in
Southern France, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/F1-FPPE
Date: 22 March 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in pears at one site in
Southern France, 2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1018
Date: 13 November 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in pears at one site in
Southern France, 2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1046
Date: 13 November 2001
GLP
Unpublished
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in pears at one site in
Northern Germany, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/G1-FPPE
Date: 31 March 2001
GLP
Unpublished
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in pears at one site in
Southern Germany, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/G2-FPPE
Date: 21 March 2001
GLP
Unpublished
Reports on
previous use in
granting
national
authorizations
- 45 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/108
Perny A.
2001
IIA 6.3/109
Balluff M.
2001
IIA 6.3/110
Perny A.
2001
IIA 6.3/111
Perny A.
2001
IIA 6.3/112
Perny A.
2001
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of residues of Thiram 80 WG
(80% Thiram) in pears at one site in Italy,
2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1021
Date: 17 December 2001
GLP
Unpublished
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in pears at one site in Spain,
2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/S1-FPPE
Date: 27 March 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in pears at one site in Spain,
2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1019
Date: 13 November 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in pears at one site in Spain,
2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1020
Date: 13 November 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in apricots at one site in
France, 2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1026
Date: 19 November 2001
GLP
Unpublished
Reports on
previous use in
granting
national
authorizations
- 46 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/113
Balluff M.
2001
IIA 6.3/114
Perny A.
2001
IIA 6.3/115
Perny A.
2001
IIA 6.3/116
Balluff M.
2001
IIA 6.3/117
Balluff M.
2001
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in apricots at one site in Spain,
2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/S1-FPAC
Date: 27 March 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in apricots at one site in
Spain, 2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1027
Date: 19 November 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in peaches at one site in
France, 2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1022
Date: 13 November 2001
GLP
Unpublished
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in peaches at one site in
Greece, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/GR1-FPPC
Date: 27 March 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in peaches at one site in
Greece, 2001
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: A1024
Date: 20 November 2001
GLP
Unpublished
Reports on
previous use in
granting
national
authorizations
- 47 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/118
Perny A.
2001
IIA 6.3/119
Balluff M.
2001
IIA 6.3/120
Balluff M.
2001
IIA 6.3/121
Perny A.
2001
IIA 6.3/122
Perny A.
2001
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of residues of Thiram 80 WG
(80% Thiram) in peaches at one site in Italy,
2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: A1025
Date: 20 November 2001
GLP
Unpublished
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in peaches at one site in
Spain, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/S1-FPPC
Date: 27 March 2001
GLP
Unpublished
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in peaches at one site in
Spain, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/S2-FPPC
Date: 27 March 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in peaches at one site in
Spain, 2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1047
Date: 13 November 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in peaches at one site in
Spain, 2001
Anadiag
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: R A1023
Date: 13 November 2001
GLP
Unpublished
Reports on
previous use in
granting
national
authorizations
- 48 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/123
Balluff M.
2001
IIA 6.3/124
Balluff M.
2001
IIA 6.3/125
Balluff M.
2001
IIA 6.3/126
Balluff M.
2001
IIA 6.3/127
Perny A.
2001
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in lettuce at one greenhouse
site in France, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/F1-FGLE
Date: 31 May 2001
GLP
Unpublished
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in lettuce at one greenhouse
site in Northern Germany, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/G1-FGLE
Date: 21 May 2001
GLP
Unpublished
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in lettuce at one greenhouse
site in Southern Germany, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/G2-FGLE
Date: 21 May 2001
GLP
Unpublished
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in lettuce at one greenhouse
site in Spain, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/S1-FGLE
Date: 21 May 2001
GLP
Unpublished
Determination of residues of Thiram 80 WG
(80% Thiram) in lettuce under greenhouse in
Northern and Southern Europe, 2001
Generated by: UCB S.A.
Anadiag
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: A1028
Date: 21 November 2001
GLP
Unpublished
Reports on
previous use in
granting
national
authorizations
- 49 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA 6.3/128
Balluff M.
2001
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Final report of the processing part:
Determination of residues of Thiram after
application of Thiram 80 WG (containing
80% Thiram) in apples at one site in
Southern Germany, 2000
GAB Biotechnologie GmbH
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Company file No.: 20003003/G2-FPAP
Date: 21 May 2001
GLP
Unpublished
Morgenroth, U.
1995
IIA
7.1.1.1.1/0
2
2000
IIA
7.1.1.1.2/0
1
Wyss-Benz, M.
1994
14
Reports on
previous use in
granting
national
authorizations
Reports on
previous use in
granting
national
authorizations
- 50 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA
7.1.1.1.2/0
2
Burri, R.
1995
1995
IIA 7.1.3
2001
IIA
7.2.1.3.2/0
2
Mamouni A.
1992
IIA
7.2.1.3.2/0
3
Wyss-Benz, M.
1995
Reports on
previous use in
granting
national
authorizations
- 51 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
IIA
7.2.1.3.2/0
4
Vlkl S.
2000
IIA 7.2.2
Frster B.
1992
B.9 Ecotoxicology
Author(s)
Annex
point/
reference
number
IIA 8.1
Pritchard P.R
IIA 8.1
Pritchard P.R
IIA 8.1
Pritchard P.R
(*)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Reports on
previous use in
granting
national
authorizations
14
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
only some parts of the draft report are submitted (cover page + p. 13-15 + p. 56-57)
Reports on
previous use in
granting
national
authorizations
- 52 Thiram
APPENDIX III
List of studies
07 April 2003
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1999
1998
1995
1995
1995
1995
Annex
point/
reference
number
Author(s)
Reports on
previous use in
granting
national
authorizations
- 53 Thiram
APPENDIX III
List of studies
07 April 2003
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1995
IIA 8.2/01
Peither A.
2000
IIA 8.2/01
Peither, A.
2000
IIA 8.2/05
IIA 8.2/06
Forbis, A.D.
Annex
point/
reference
number
Author(s)
1983
Reports on
previous use in
granting
national
authorizations
- 54 Thiram
APPENDIX III
List of studies
07 April 2003
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1992
IIA 8.2.2.2
Memmert, U.
2001
IIA 8.2.2.2
Memmert U.
2001
Annex
point/
reference
number
Author(s)
1994
1999
Reports on
previous use in
granting
national
authorizations
- 55 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 8.2.5
Memmert U.
2000
IIA 8.2.6
Jennings A.M.,
Jenkins C.
2001
1995
IIA 8.3.1
2000
Kling A.
2000
Reports on
previous use in
granting
national
authorizations
- 56 Thiram
APPENDIX III
List of studies
07 April 2003
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1991
1992
1995
1995
2000
Annex
point/
reference
number
Reports on
previous use in
granting
national
authorizations
- 57 Thiram
APPENDIX III
List of studies
07 April 2003
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
2001
2001
2001
2001
Annex
point/
reference
number
Author(s)
Reports on
previous use in
granting
national
authorizations
- 58 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
point/
reference
number
Author(s)
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 8.5
Wachter S.
2000
IIA 8.7
1999
Reports on
previous use in
granting
national
authorizations
- 59 Thiram
APPENDIX III
List of studies
07 April 2003
APPENDIX IIIB
THIRAM
List of studies which were submitted during the evaluation process and were
not cited in the draft assessment report:
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
point/
Source (where different from company)
reference
Company, Report No.
number
GLP or GEP status (where relevant)
Published or not
IIA 1.10
IIA 4.1.2
IIA 1.11
Comb A.L.
1997
IIA 1.11/01
Demuynck M.
1999
IIA 2.6
IIA 2.11.2
IIA 2.14
Flack I.
1997
- 60 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 2.6/02
Van de Putte M.
1997
IIA
2.11.1/01
Tremain S. P.
1999
IIA 2.13
Krips H.J.
2000
IIA 2.15
Penny H.B.
1995
1996
2001
- 61 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 4.2.2
Blaszczynski E.
2001
IIA 4.2.3
Blaszczynski
Elizabeth
2000
1994
2001
Williams Jackie
2001
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Thiram: Acute investigative study in rats
Central Toxicology Laboratory
Generated by: UCB S.A.
Submitted by: UCB S.A. (on 26/12/2001)
Study Nr.: AR7090
Date: 19 November 2001
GLP
Unpublished
- 62 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 5.8.1
2001
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
Investigation of the stability of 14C-3-(Dimethyldithiocarbamoyl)alanine in the presence of a soybean straw matrix
XenoBiotic Laboratories Inc.
Generated by: Thiram Task Force II
Submitted by: UCB S.A., Uniroyal Chemical Limited (on
3/11/1997)
Company file No.: Report No. RPT00245 - Study No. XBL
95321
Date: 13 September 1996
GLP
Unpublished
The systemic action of dimethyldithiocarbamates on cucumber
scab caused by Cladosporium cucumerinum and the
conversion of these compounds by plants
Neth. J. Plant. Path., 1964, Vol. 70 - Suppl. 1, pp. 1-75
Submitted by: UCB (on 8/9/1999)
Not GLP
Published
Contribution l'tude de l'action systemique du Thiram
(TMTD) chez les plantes l'aide de thiram marqu au 35S
Mededelingen vd Lanbouwhogeschool & de
Opzoekingsstations vd Staat te Gent, 28, (1963), pp. 590-596
Submitted by: UCB S.A. (on 8/9/1999)
not GLP
Published
Translocation and soil movement of 14C Thiram from wheat
seeds treated with Vitavax 200
Generated by: Crompton Corporation
Submitted by: Crompton Europe Ltd. (in 12/2001)
Study Nr.: 7846/7850
Date: 1978
Not GLP
Unpublished
Anon
Robinson, R.A.
1996
IIA 6.1/11
Dekhuijzen
1964
IIA 6.1/12
Massaux F.
1963
IIA 6.1/13
Womer, J.M.,
Balba, H.M.
1978
- 63 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 6.3/85
Perny A.
1998
IIA 6.3/86
Perny A.
1998
IIA 6.3/87
Balluff M.
1999
IIA 6.3/88
Balluff M.
1999
IIA 6.3/89
Balluff M.
1998
- 64 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 6.3/90
Balluff M.
1998
IIA 6.3/91
Perny A.
2001
IIA 6.3/92
Perny A.
2001
IIA 6.3/93
Perny A.
2001
IIA 6.3/94
Perny A.
2001
- 65 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 6.3/95
Balluff M.
2001
IIA 6.3/96
Balluff M.
2001
IIA 6.3/97
Perny A.
2001
IIA 6.3/98
Balluff M.
2001
IIA 6.3/99
Perny A.
2001
- 66 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 6.3/100
Perny A.
2001
IIA 6.3/101
Perny A.
2001
IIA 6.3/102
Perny A.
2001
IIA 6.3/103
Balluff M.
2001
IIA 6.3/104
Perny A.
2001
IIA 6.3/105
Perny A.
2001
- 67 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 6.3/106
Balluff M.
2001
IIA 6.3/107
Balluff M.
2001
IIA 6.3/108
Perny A.
2001
IIA 6.3/109
Balluff M.
2001
IIA 6.3/110
Perny A.
2001
- 68 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 6.3/111
Perny A.
2001
IIA 6.3/112
Perny A.
2001
IIA 6.3/113
Balluff M.
2001
IIA 6.3/114
Perny A.
2001
IIA 6.3/115
Perny A.
2001
- 69 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 6.3/116
Balluff M.
2001
IIA 6.3/117
Balluff M.
2001
IIA 6.3/118
Perny A.
2001
IIA 6.3/119
Balluff M.
2001
IIA 6.3/120
Balluff M.
2001
- 70 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 6.3/121
Perny A.
2001
IIA 6.3/122
Perny A.
2001
IIA 6.3/123
Balluff M.
2001
IIA 6.3/124
Balluff M.
2001
IIA 6.3/125
Balluff M.
2001
- 71 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 6.3/126
Balluff M.
2001
IIA 6.3/127
Perny A.
2001
IIA 6.3/128
Balluff M.
2001
2000
- 72 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
2000
2001
IIA
7.2.1.3.2/0
2
Mamouni A.
1992
IIA
7.2.1.3.2/0
3
Wyss-Benz, M.
1995
IIA
7.2.1.3.2/0
4
Vlkl S.
2000
(*)
only some parts of the draft report are submitted (cover page + p. 13-15 + p. 56-57)
- 73 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 7.2.2
Frster B.
1992
IIIA 9.1.3
Gro R.
1999
IIIA 9.2.1
Schlter W.
1999
IIIA 9.2.1
Moyle J
2001
IIIA
9.2.1/02
Wanner U
2002
B.9 Ecotoxicology
Annex
Author(s)
point/
reference
number
IIA 8.1
Pritchard P.R
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
- 74 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
IIA 8.1
Pritchard P.R
IIA 8.1
Pritchard P.R
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
- 75 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1995
1995
IIA 8.2/01
Peither A.
2000
IIA 8.2/01
Peither A.
2000
IIA 8.2/04
1978
IIA 8.2/05
- 76 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 8.2/06
Forbis A.D.
1983
IIA 8.2.2.2
Memmert U.
2001
IIA 8.2.2.2
Memmert U.
2001
1999
1985
2000
- 77 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
IIA 8.2.6
Jennings A.M.,
Jenkins C.
2001
IIA 8.3.1
Kling A.
2000
2000
1991
1992
1995
- 78 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
1995
2000
2001
2001
2001
- 79 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
2001
IIA 8.5
Wachter S.
2000
IIA 8.7
1999
IIIA 10.1
IIIA 10.3
Grolleau G.
2000
IIIA
10.1.3/01
Beavers J. B.,
1995
Haberlein D.,
Grimes J., Jaber M.
IIIA
10.1.3/02
1995
- 80 Thiram
APPENDIX III
List of studies
07 April 2003
Annex
Author(s)
point/
reference
number
Year
IIIA 10.3.1
Thompson H.M
IIIA
10.3.1/01
Thompson H.M.
IIIA
10.3.1/02
Thompson H.M.
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or not
- 81 Thiram
APPENDIX IV
List of uses supported by available data
07 April 2003
APPENDIX IV
List of uses supported by available data
THIRAM
Crop and/
or situation
Member
State
or
Country
Product
name
(a)
F
G
or
I
(b)
Pests or
Group of pests
controlled
(c)
Formulation
Application
PHI
(days)
(l)
Type
Conc.
of as
method
kind
(d-f)
(i)
(f-h)
growth
stage &
season
(j)
Apple
All Europe
Thiram 80 WG
Venturia
inaequalis
(Scab)
WG
800
foliar
First
application
on young
leaves
Apple
All Europe
Thiram 80 WG
Monilia
WG
800
foliar
First
application
before
flowering
Apple
All Europe
Thiram 80 WG
Gloeosporium
Gloeodes
pomigena
Schizothirium
pomi
WG
800
foliar
First
application
half June
number
min
max
(k)
4
(treatments
agains
t
Monili
a and
Gloeosporiu
m
included)
2
4
(treatments
agains
t
Monili
a and
Gloeosporiu
m
inclu-
interval
between
applications
(min)
kg as/hl
water l/ha
kg as/ha
min max
min max
min max
7-14 days
0.1 to
0.24
2,4
42
7-14 days
0.16 to
0.24
2,4
42
7-14 days
0.16 to
0.2
2,0
42
Remarks:
(m)
- 82 Thiram
APPENDIX IV
List of uses supported by available data
07 April 2003
Crop and/
or situation
Member
State
or
Country
Product
name
(a)
F
G
or
I
(b)
Pests or
Group of pests
controlled
(c)
Formulation
Application
PHI
(days)
(l)
Type
Conc.
of as
method
kind
(d-f)
(i)
(f-h)
growth
stage &
season
(j)
number
min
max
interval
between
applications
(min)
kg as/hl
water l/ha
kg as/ha
min max
min max
min max
(k)
ded)
4
7-14 days
0.1 to
0.24
2,4
42
Pear
All Europe
Thiram 80 WG
Venturia pirina
(Scab)
Stemphylium
vesicarium
WG
800
foliar
First
application
on young
leaves
Pear
All Europe
Thiram 80 WG
Monilia
WG
800
foliar
First
application
before
flowering
7-14 days
0.16 to
0.24
2,4
42
Pear
All Europe
Thiram 80 WG
Gloeosporium
Gloeodes
pomigena
Schizothirium
pomi
WG
800
foliar
First
application
half June
7-14 days
0.16 to
0.2
2,00
42
Almond
South-Europe
Thiram 80 WG
Monilia spp.
Coryneum
Taphrina
WG
800
foliar
Winter
application
and during
flowering
7-14 days
0.16 to
0.24
2,4
150
Apricot
South- Europe
Thiram 80 WG
Coryneum
beijerinckii
Monilia spp.
Fusicladium
WG
800
foliar
First
application
during leaf
fall then
before
flowering
7-14 days
0.16 to
0.24
2,4
42
Peach
All Europe
Thiram 80 WG
Monilia spp
Fusicladium.
WG
800
foliar
First
application
before
flowering
7-14 days
0.16 to
0.24
2,4
42
Peach
All Europe
Thiram 80 WG
Taphrina
deformans
WG
800
foliar
Autumn/
Winter
treatment
0.16 to
0.24
(0.3 to
0.4 kg
a.s./hl
2,4
42
Remarks:
(m)
- 83 Thiram
APPENDIX IV
List of uses supported by available data
07 April 2003
Crop and/
or situation
Member
State
or
Country
Product
name
(a)
F
G
or
I
(b)
Pests or
Group of pests
controlled
(c)
Formulation
Application
PHI
(days)
(l)
Type
Conc.
of as
method
kind
(d-f)
(i)
(f-h)
growth
stage &
season
(j)
number
min
max
interval
between
applications
(min)
kg as/hl
water l/ha
kg as/ha
min max
min max
min max
(k)
for low
volume
spray at
500 l/ha)
Peach
All Europe
Thiram 80 WG
Coryneum
beijerinckii
(Stigmina
carpophila)
Fusicoccum
amygdali
WG
800
foliar
Autumn/
Winter
treatment
0.16 to
0.24
(0.3 to
0.4 kg
a.s./hl
for low
volume
spray at
500 l/ha)
2,4
42
Wine grapes
All Europe
Thiram 80 WG
Botrytis
Colletotrichum
WG
800
foliar
0.16 to
0.32
3,2
35
Strawberry
(indoor &
outdoor)
All Europe
Thiram 80 WG
F
G
Botrytis
Colletorichum
Mycosphaerella
WG
800
foliar
First
application
during
flowering
During
flowering
Repeat
every 7 14 days if
necessary
0.16 to
0.32
1.6-2.4
Ornamentals
(indoor &
outdoor)
Ornamentals
bulbs
All Europe
Thiram 80 WG
F
G
Botrytis
WG
800
foliar
7 days
0.2 to
0.32
3,2
All Europe
Thiram 80 WG
Sclerotinia
WG
800
foliar
after
flowering
7-10 days
0.32
3,2
Peony
All Europe
Thiram 80 WG
Botrytis
WG
800
1.5
Seed
All Europe
Bird repellent
FS
533
rot
soaking
seed
treatment
Seed
dressing
as
neede
d
as
neede
d
1
1
0,2
Remarks:
(m)
- 84 Thiram
APPENDIX IV
List of uses supported by available data
07 April 2003
Crop and/
or situation
Member
State
or
Country
(a)
Product
name
F
G
or
I
(b)
Pests or
Group of pests
controlled
(c)
Formulation
Application
(l)
Type
Conc.
of as
method
kind
(d-f)
(i)
(f-h)
growth
stage &
season
(j)
number
min
max
interval
between
applications
(min)
kg as/hl
water l/ha
min max
min max
g as/100
kg seed
min max
seed
treatment
seed
treatment
(k)
-
160
533
seed
treatment
160
FS
533
seed
treatment
480
FS
533
seed
treatment
400
FS
533
seed
treatment
400
All Europe
FS
533
seed
treatment
400
Grass
All Europe
FS
533
seed
treatment
160
Leek
All Europe
FS
533
seed
treatment
5600
Lettuce
All Europe
FS
533
seed
treatment
400
Linseed
All Europe
FS
533
seed
treatment
300
Lupin
All Europe
FS
533
seed
treatment
160
Maize
All Europe
FS
533
seed
treatment
160
Afalfa
All Europe
Barley
All Europe
Beans
All Europe
Beet (leaf,
sugar)
All Europe
Cabbage
PHI
(days)
FS
533
FS
533
FS
All Europe
Celery
All Europe
Cucumber
160
Remarks:
(m)
- 85 Thiram
APPENDIX IV
List of uses supported by available data
07 April 2003
Crop and/
or situation
Member
State
or
Country
(a)
Product
name
F
G
or
I
(b)
Pests or
Group of pests
controlled
(c)
Formulation
Application
PHI
(days)
(l)
Type
Conc.
of as
method
kind
(d-f)
(i)
(f-h)
growth
stage &
season
(j)
number
min
max
interval
between
applications
(min)
kg as/hl
water l/ha
min max
min max
g as/100
kg seed
min max
Oats
All Europe
FS
533
seed
treatment
(k)
-
Oilseed rape
All Europe
FS
533
440
All Europe
FS
533
seed
treatment
seed
treatment
Onion
400
Parsley
All Europe
FS
533
seed
treatment
400
Peas
All Europe
FS
533
seed
treatment
160
Poppy
All Europe
FS
533
seed
treatment
400
Potato
All Europe
FS
533
80
All Europe
FS
533
seed
treatment
seed
treatment
Radish
400
Rye
All Europe
FS
533
seed
treatment
160
Spinach
All Europe
FS
533
seed
treatment
400
Turnip
All Europe
FS
533
seed
treatment
400
Vetch
All Europe
FS
533
seed
treatment
160
Wheat
All Europe
FS
533
seed
treatment
160
160
Remarks:
(m)
- 86 Thiram
APPENDIX IV
List of uses supported by available data
07 April 2003
Crop and/
or situation
Member
State
or
Country
Product
name
(a)
F
G
or
I
(b)
Pests or
Group of pests
controlled
(c)
Formulation
Application
PHI
(days)
(l)
Type
Conc.
of as
method
kind
(d-f)
(i)
(f-h)
growth
stage &
season
(j)
number
min
max
interval
between
applications
(min)
kg as/hl
water l/ha
min max
min max
Remarks:
(m)
g as/100
kg seed
min max
(k)
Wheat
All Europe
Vitavax 200FF
Soil/seed borne
fungi
FS
200
60
Barley
All Europe
Vitavax 200FF
Soil/seed borne
fungi
FS
200
60
Oats
All Europe
Vitavax 200FF
Soil/seed borne
fungi
FS
200
60
Rye
All Europe
Vitavax 200FF
Soil/seed borne
fungi
FS
200
60
Triticale
All Europe
Vitavax 200FF
Soil/seed borne
fungi
FS
200
60
Remarks:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
For crops, the EU and Codex classifications (both) should be used; where relevant, the
use situation should be described (e.g. fumigation of a structure)
Outdoor or field use (F), glasshouse application (G) or indoor application (I)
e.g. biting and suckling insects, soil born insects, foliar fungi, weeds
e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
GCPF Codes - GIFAP Technical Monograph No 2, 1989
All abbreviations used must be explained
Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between
the plants - type of equipment used must be indicated
(i)
(j)
(k)
(l)
(m)
g/kg or g/l
Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season
at time of application
The minimum and maximum number of application possible under practical
conditions of use must be provided
PHI - minimum pre-harvest interval
Remarks may include: Extent of use/economic importance/restrictions