-1-

Thiophanate-methyl
List of studies relied upon

Introduction
This list was prepared in accordance with Article 60(1) of Regulation (EC) No 1107/2009 and the European Commission
“Guidance Document on preparing lists of tests and study reports according to Article 60 of Regulation (EC) No
1107/2009” (SANCO/12580/2012- rev 3.1, 17 May 2013). It was prepared by the Rapporteur Member State Sweden
after finalisation of the Renewal Assessment Report on Thiophanate-methyl. Studies available for the first approval of
Thiophanate-methyl are shown in grey shade, studies submitted to support the application for renewal of the approval are
not shaded.

Table of contents

1
1 Identity ................................................................................................................................................. 2
2 Physical and chemical properties ......................................................................................................... 3
3 Data on application and efficacy ........................................................................................................ 13
4 Further information ............................................................................................................................ 14
5 Methods of analysis ............................................................................................................................ 15
6 Toxicology and metabolism data........................................................................................................ 38
7 Residue data ....................................................................................................................................... 52
8 Environmental fate and behaviour...................................................................................................... 70
9 Ecotoxicology data ............................................................................................................................. 80
 -2-
Thiophanate-methyl
List of studies relied upon

1 Identity

All studies relied upon that are related to identity are confidential.
 - 13 -
Thiophanate-methyl
List of studies relied upon

3 Data on application and efficacy

No studies referred to in this section.

 - 14 -
Thiophanate-methyl
List of studies relied upon

4 Further information

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCA 3.8/01 Anonymous 2014 Safety data sheet - Thiophanate-methyl TG N N NIPPON
Report No.: Version : 11 (953-003) SODA
Nisso Chemical Europe GmbH, Düsseldorf, Germany
Not GLP, unpublished

KCA 3.10/01 Anonymous 2014 Safety data sheet - Thiophanate-methyl TG N N NIPPON

Report No.: Version : 11 (953-003) SODA
Nisso Chemical Europe GmbH, Düsseldorf, Germany
Not GLP, unpublished
 - 16 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed*
GLP or GEP status
Published or not Y/N Y/N
KCA 4.1.2 Shiotani, H. 2003 Hydrolysis Study of MBC (ID No. 2-9-13) N Y Study is part NIPPON
(a)/02 Report No.: RD-02326 of the SODA
NSM02-020 (711-002) supplementary
Group of Metabolism Chemistry, Department of dossier and
Environmental Science and Toxicology (NSM), Nippon Soda has not been
Co., Ltd., Japan submitted for
GLP, unpublished national
registrations
KCA 4.1.2 2007 Oral (Gavage) Acute Neurotoxicity Study of Thiophanate- Y Y Study is part NIPPON
(c)/01 methyl in Rats of the SODA
Report No.: RD-00828N supplementary
914-006 (541-001) dossier and
has not been
GLP, unpublished submitted for
national
registrations
KCA 4.1.2 2005 Oral (Diet) Subchronic Neurotoxicity Study of Thiophanate- Y Y Study is part NIPPON
(c)/02 methyl in Rats of the SODA
Report No.: RD-00634 supplementary
914-007 (542-001) dossier and
has not been
GLP, unpublished submitted for
national
registrations
KCA 4.1.2 2014 An F1-Extended Two-Generation Reproductive Toxicity Y Y Study is part MBC
(c)/03 Study with Carbendazim in the Wistar Rat of the Technical
Report No.: RD-03246 supplementary Committee
10277 (553-005) dossier and of the
has not been TM/MBC
GLP, unpublished submitted for Task Force
national
registrations
 - 20 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed*
GLP or GEP status
Published or not Y/N Y/N
KCA 4.1.2 Yslan, F. 1999 Thiophanate-methyl and metabolite (Carbendazim) - N Y Study is part NIPPON
(e)/09 Formulation EXP10931A (WG) South - Spain 1998 - 1 of the SODA
Decline study trial Residues in tomato (fruit) Report No.: 98- supplementary
613 RD-00426 (633-2006) Rhône-Poulenc Agro, France GLP, dossier and
unpublished has not been
submitted for
national
registrations
KCA 4.1.2 Baudet, L. 1999 Thiophanate-methyl and metabolite (Carbendazim) - N Y Study is part NIPPON
(e)/10 Formulation EXP10931A (WG) Greenhouse - Spain 1998 - 1 of the SODA
Decline study trial Residues in tomato (fruit) Report No.: 98- supplementary
612 RD-00425 (633-2007) Rhône-Poulenc Agro, France GLP, dossier and
unpublished has not been
submitted for
national
registrations
KCA 4.1.2 Gateaud, L. 2000 Thiophanate-methyl and metabolite (Carbendazim) - N Y Study is part NIPPON
(e)/11 Formulation EXP10931A (WG) Greenhouse - Spain 1999 - 5 of the SODA
Decline study trials Residues in tomato (fruit) Report No.: 99- supplementary
556 RD-00424 (633-2009) Aventis CropScience, France GLP, dossier and
unpublished has not been
submitted for
national
registrations
KCA 4.1.2 Schwarz, T. 2008 Thiophanate-methyl and Carbendazim: Validation of an N Y Study is part NIPPON
(e)/12 enforcement Method for Plant Materials (DRY, OILY and of the SODA
Commodities with high water content)Report No.: RD-01391 supplementary
P/B 1471 G (432-022) PTRL Europe, Germany GLP, dossier and
unpublished has not been
submitted for
national
registrations
 - 21 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed*
GLP or GEP status
Published or not Y/N Y/N
KCA 4.1.2 Boileau, G. 2014 Magnitude of the Residue of Thiophanate-methyl and its N Y Study is part NIPPON
(e)/13 metabolite Carbendazim in Leeks Raw Agricultural Comodity of the SODA
following Soil Application of Thiophanate-Methyl 500 SC - supplementary
Northern and Southern Europe - 2013 Report No.: RD-02793 dossier and
GBU-13-16018 P 2883 G (633-6504) Staphyt, France GLP, has not been
unpublished submitted for
national
registrations
KCA 4.1.2 Fenn, L. 2003 Stability of Thiophanate Methyl in Snap Beans During Frozen N Y Study is part NIPPON
(e)/14 Storage Pending Analysis Report No.: RD-03167 KP-96-11 of the SODA
(645-010) Exygen Research, USA GLP, unpublished supplementary
dossier and
has not been
submitted for
national
registrations
KCA 4.1.2 Ampofo, S.A. 2002 Stability of Thiophanate-Methyl in Cucumbers During Frozen N Y Study is part NIPPON
(e)/15 Storage Pending Analysis Report No.: RD-03110 43512 KP- of the SODA
96-10 BR-011-05 (645-009) ABC Laboratories, USA GLP, supplementary
unpublished dossier and
has not been
submitted for
national
registrations
KCA 4.1.2 Wright, M.C. 1996 Residue Stability Study of MBC (Methyl-2-Benzimidazole N Y Study is part NIPPON
(e)/16 Carbamate) in Snap Beans, Apples, Wheat Grain, Spinach, of the SODA
Sugar Beet Roots, and Tomatoes Report No.: RD-03034 BR- supplementary
87-6 80502 (formerly 88023) (645-008) Elf Atochem North dossier and
America, USA GLP, unpublished has not been
submitted for
national
registrations
 - 22 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed*
GLP or GEP status
Published or not Y/N Y/N
KCA 4.1.2 1998 Magnitude of the residue of Thiophanate-methyl in milk and Y Y Study is part NIPPON
(e)/17 tissue of lactating dairy cattle (including Addendum No. 1) of the SODA
Report No.: RD-9819 KP-96-04 43285 EPA MRID 44232401 supplementary
RD-02854 - Addendum No. 1 (631-003) dossier and
GLP, unpublished has not been
submitted for
national
registrations
KCA 4.1.2 1998 Residues of Thiophanate-methyl and its major metabolites in Y Y Study is part NIPPON
(e)/18 the eggs and tissue of laying hens following daily oral dosing of the SODA
with Thiophanate-methyl (including Addendum No. 1) Report supplementary
No.: RD-9820 KP-96-05 RD-03269 - Addendum No. 1 dossier and
MRID: 44287501 (631-004) has not been
GLP, unpublished submitted for
national
registrations
KCA 4.1.2 Schmidt, J. 2007 Determination of residues of Thiophanate-methyl after one N Y Study is part NIPPON
(e)/19 application of Thiophanate-methyl 500 SC in Leek at 1 site in of the SODA
Northern Europe 2006 Report No.: RD-01341 20064037/B1- supplementary
FPLK B06W001R (633-6501) Eurofins-GAB GmbH, dossier and
Germany GLP, unpublished has not been
submitted for
national
registrations
KCA 4.1.2 Schmidt, J. 2008 Determination of Residues of Thiophanate Methyl after One N Y Study is part NIPPON
(e)/20 Application of Thiophanate Methyl 500 SC in Leek at 3 Sites of the SODA
in Northern Europe 2007 Report No.: RD-01321 supplementary
20074079/E1-FPLK B07W004R B07W005R NL07W026R dossier and
(633-6503) Eurofins-GAB GmbH, Germany GLP, has not been
unpublished submitted for
national
registrations
 - 30 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed*
GLP or GEP status
Published or not Y/N Y/N
KCA 4.1.2 Hisanaga, K. 2017 Robustness of HPLC analysis of thiophanate-methyl N Y Study is part NIPPON
(g)/16 Report No.: RD-10155 of the SODA
17-123 (410-002) supplementary
Nisso Chemical Analysis Service Co., Ltd. (NCAS), dossier and
Kanagawa, Japan has not been
GLP, unpublished submitted for
national
registrations
KCA 4.2 Class, T. 2008 Thiophanate-methyl and Carbendazim: Comparison of N Y Study is part NIPPON
(a)/01 Residue analytical methods and validation of enforcement of the SODA
method for plant material Report No.: RD-01392 P/B 1407 G supplementary
(432-021) PTRL Europe, Germany GLP, unpublished dossier and
has not been
submitted for
national
registrations
KCA 4.2 Schwarz, T. 2008 Thiophanate-methyl and Carbendazim: Validation of an N Y Study is part NIPPON
(a)/02 enforcement Method for Plant Materials (DRY, OILY and of the SODA
Commodities with high water content)Report No.: RD-01391 supplementary
P/B 1471 G (432-022) PTRL Europe, Germany GLP, dossier and
unpublished has not been
submitted for
national
registrations
KCA 4.2 Schwarz, T. 2010 Validation of the Multi-Residue Method QuEChERS for the N Y Study is part NIPPON
(a)/03 Determination of Thiophanate-methyl and Carbendazim in of the SODA
Acidic Crop Types Report No.: RD-02096 P 2014 G (432- supplementary
025) PTRL Europe, Germany dossier and
GLP, unpublished has not been
submitted for
national
registrations
 - 31 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed*
GLP or GEP status
Published or not Y/N Y/N
KCA 4.2 Class, T. 2012 Thiophanate-methyl and Carbendazim: Validation of a N Y Study is part NIPPON
(a)/04 Residue Analytical Method for Crop and Soil Matrices Report of the SODA
No.: RD-02381 P 2435 G (432-031) PTRL Europe, Germany supplementary
GLP, unpublished dossier and
has not been
submitted for
national
registrations
KCA 4.2 Weber, H. 2009 Independent Laboratory Validation of an Analytical Method N Y Study is part NIPPON
(a)/05 for the Determination of Residues of Thiophanate-methyl and of the SODA
Carbendazim in Plant Material Report No.: RD-03350 NIP- supplementary
0901V (432-024) Eurofins Analytik GmbH, Germany GLP, dossier and
unpublished has not been
submitted for
national
registrations
KCA 4.2 Schwarz, T. 2009 Thiophanate-methyl and Carbendazim - Validation of an N Y Study is part NIPPON
(a)/06 Enforcement Method for Foodstuffs of Animal Origin (Milk, of the SODA
Egg, and Meat) Report No.: P/B 1674 G RD-01846 (433-008) supplementary
PTRL Europe, Germany GLP, unpublished dossier and
has not been
submitted for
national
registrations
KCA 4.2 Senciuc, M. 2014 Thiophanate-methyl and Carbendazim: Validation of an N Y Study is part NIPPON
(a)/07 Enforcement Method for Foodstuffs of Animal Origin (Liver of the SODA
or Kidney and Fat) Report No.: RD-02969 P 3130 G (433- supplementary
011) PTRL Europe, Germany GLP, unpublished dossier and
has not been
submitted for
national
registrations
 - 32 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed*
GLP or GEP status
Published or not Y/N Y/N
KCA 4.2 Schernikau, N. 2015 Thiophanate-methyl and Carbendazim: Independent N Y Study is part NIPPON
(a)/08 Laboratory Validation of an Enforcement Method for of the SODA
Foodstuffs of Animal Origin Report No.: RD-03273 S14- supplementary
04472 (433-013) Eurofins Agroscience Services Chem GmbH, dossier and
Germany GLP, unpublished has not been
submitted for
national
registrations
KCA 4.2 Senciuc, M. 2014 5-Hydroxy-Carbendazim: Validation of an Enforcement N Y Study is part NIPPON
(a)/09 Method for Foodstuffs of Animal Origin Report No.: RD- of the SODA
02981 P 3131 G (433-012) PTRL Europe, Germany GLP, supplementary
unpublished dossier and
has not been
submitted for
national
registrations
KCA 4.2 Witte, A. 2015 Independent Laboratory Validation of an Analytical Method N Y Study is part NIPPON
(a)/10 for the Determination of Residues of 5-Hydroxy-Carbendazim of the SODA
in Food Stuff of Animal Origin Report No.: RD-03316 supplementary
15N07153-01-VMAT (433-014) CIP Chemisches Institut dossier and
Pforzheim GmbH, Germany GLP, unpublished has not been
submitted for
national
registrations
KCA 4.2 Engstfeld, C. 2015 Thiophanate-methyl: Statement on the efficiency of extraction N Y Study is part NIPPON
(a)/11 Goerg, J. methods applied within residue analytical methods for plant of the SODA
and animal matricesReport No.: RD-03407 PP146-00062/01 supplementary
(481-003) Scientific Consulting Company, Germany Not GLP, dossier and
unpublished has not been
submitted for
national
registrations
 - 34 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed*
GLP or GEP status
Published or not Y/N Y/N
KCA 4.2 Miya, K. 2004 Validation study of a confirmatory method for the N Y Study is part NIPPON
(b)/02 determination of Thiophanate-methyl and MBC in soil Report of the SODA
No.: NCAS 04-183 RD-00500 (434-005) Nisso Chemical supplementary
Analysis Service Co., Ltd. (NCAS), Japan GLP, unpublished dossier and
has not been
submitted for
national
registrations
KCA 4.2 Jooß, S. 2012 Validation of an Analytical Method for the Determination of N Y Study is part NIPPON
(b)/03 Thiophanate-methyl and Carbendazim in Drinking, Ground of the SODA
and Surface Water Report No.: RD-02458 P 2681 G JAS-226 supplementary
(435-003) PTRL Europe, Germany GLP, unpublished dossier and
has not been
submitted for
national
registrations
KCA 4.2 Witte, A. 2014 Independent Laboratory Validation (ILV) of an Analytical N Y Study is part NIPPON
(b)/04 Method for Determination of Residues of Thiophanate-methyl of the SODA
and its Metabolite Carbendazim in Drinking Water Report supplementary
No.: RD-02894 14N07016-01-VMWA (435-006) CIP dossier and
Chemisches Institut Pforzheim GmbH, Germany GLP, has not been
unpublished submitted for
national
registrations
KCA 4.2 Senciuc, M. 2012 Validation of an Analytical Method for the Determination of N Y Study is part NIPPON
(c)/01 Thiophanate-methyl and Carbendazim in Air Report No.: RD- of the SODA
02566 P 2682 G JAS-226 (436-004) PTRL Europe, Germany supplementary
GLP, unpublished dossier and
has not been
submitted for
national
registrations
 - 35 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed*
GLP or GEP status
Published or not Y/N Y/N
KCA4.2 Gaag.S 2017 Validation of an Analytical Method for the Determination of N Y Study is part of NIPPON
(d)/01 Thiophanate-methyl in Body Fluids Report No.: RD-10149 the SODA
17N07016-01-VMBF (433-020) CIP Chemishces Institut supplementary
Pforzheim GmbH, Pforzheim, Germany dossier and has
not been
GLP, unpublished submitted for
national
registrations
KCA4.2 Whitte, A 2015 Validation of an Analytical Method for the Determination of N Y Study is part of NIPPON
(d)/02 Carbendazim in Body Fluids the SODA
Doc No.: 433-019 supplementary
dossier and has
not been
submitted for
national
registrations
KCA Todd, M. 2002 Validation of methodology for the determination of residues in N Y Study is part of NIPPON
46.10.1/2 oilseed rape honey. the SODA
(2002) Report No. BSF 633/023976 2002/1006300 (432-023) supplementary
Doc. No. 432-023) dossier and has
not been
submitted for
national
registrations
KCP Anonymous 1986 CIPAC analytical method for active ingredient content in N N - NIPPON
5.1.1(a)/01 Thiophanate-methyl technical, wettable powder, suspension SODA
concentrate and dustable powder by HPLC Report No.: RD-8639
(411-002) CIPAC-Handbook, 1D, 1986, 162-168 Not GLP, published
KCP Martijn, A. 1988 CIPAC Handbook Volume D - Analysis of technical and formulated N N - NIPPON
5.1.1(a)/02 Dobrat,W pesticides - Thiophanate-methyl [362], method Report No.: ni (411- SODA
005) CIPAC-Handbook, D, 1988, 162-168 Not GLP, published
 - 36 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed*
GLP or GEP status
Published or not Y/N Y/N
KCP Deguchi, M. 2015 Validation of the Analytical Method for Thiophanate-methyl in N Y Study is part of NIPPON
5.1.1(a)/03 Thiophanate-methyl 500 SC the SODA
Report No.: RD-03258 supplementary
1-1404 (421-005) dossier and has
Nippon Soda, Japan not been
GLP, unpublished submitted for
national
registrations
KCP Deguchi, M. 2015 Validation of the Analytical Method for DAP and HAP in N Y Study is part of NIPPON
5.1.1(b)/01 Thiophanate-methyl 500 SC Report No.: RD-03272 1-1405PTL 1- the SODA
1405 (424-001) Nippon Soda, Japan GLP, unpublished supplementary
dossier and has
not been
submitted for
national
registrations
KCP Mannsfeld, S. 2017 Development and Validation of an Analytical Method for the N Y Study is part of NIPPON
5.1.1(b)/02 Determination of Carbendazim as an Impurity in Thiophanate-methyl the SODA
500 SC supplementary
Report No.: RD-10153 dossier and has
17N10012-01-VMFO (422-003) not been
CIP Chemisches Institut Pforzheim GmbH, Pforzheim, Germany submitted for
GLP, unpublished national
registrations
KCP Kley, A. Wydra, V. 2012 Toxicity of Thiophanate-methyl 500 SC to Pseudokirchneriella N Y Study is part of NIPPON
5.1.2(f)/01 subcapitata in an Algal Growth Inhibition Test Report No.: RD- the SODA
02400 67723210 (823-007) Ibacon GmbH, Rossdorf, GermanyGLP, supplementary
unpublished dossier and has
not been
submitted for
national
registrations
 - 37 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed*
GLP or GEP status
Published or not Y/N Y/N
KCP Sekine, T. Eichler, 2013 Study on the Effect of Thiophanate-methyl 500 SC on Honey Bee N Y Study is part of NIPPON
5.1.2(f)/02 M. Brood (Apis mellifera L.) under Semi-Field Conditions - Tunnel Test the SODA
- Report No.: RD-02704 68421033 (832-005) Ibacon GmbH, supplementary
Rossdorf, GermanyGLP, unpublished dossier and has
not been
submitted for
national
registrations
KCP Stroemel, C. 2006 The effects of TOPSIN M 500 SC (Thiophanate-methyl) after use as N Y Study is part of NIPPON
5.1.2(f)/03 Brockmann, A. a dipping solution for flower bulbs on survival, reproduction and the SODA
Teresiak, H. biomass of earthworms under field conditions (worm field trial) - supplementary
Including Analytical Part dossier and has
Report No.: RD-01036 not been
AC/TNO/04/01 submitted for
RD-02849 national
V5767 (833-017) registrations
Agro-Check, Dr. Teresiak & Erdmann GbR, Lentzke, Germany
GLP, unpublished
 - 39 -
Thiophanate-methyl
List of studies relied upon

national
GLP, unpublished registrations

KCA 5.1.2/03 Shimomura, H. 2017 In Vitro Comparative Metabolism Study of [Phenyl-U- N Y Study is part of NIPPON
14C]Thiophanate-methyl the SODA
Report No.: RD-10097 supplementary
NSM17-002 (514-002) dossier and has
Group of Metabolism Chemistry, Department of Environmental not been
Science and Toxicology (NSM), Nippon Soda Co., Ltd., Kanagawa, submitted for
Japan national
GLP, unpublished registrations

KCA 5.2.1/01 1990 Thiophanate-methyl - Acute oral toxicity study in rats Y N NIPPON
Report No.: TXR 0330 SODA
RD-9083 (521-002)

GLP, unpublished

KCA 5.2.2/01 1990 Thiophanate-methyl - Acute dermal toxicity study in rabbits Y N NIPPON
Report No.: TXR 0331 SODA
RD-9084 (522-001)

GLP, unpublished

KCA 5.2.3/01 1987 Thiophanate-methyl - Acute inhalation toxicity study in rats Y N NIPPON
Report No.: TXR 0219 SODA
RD-8711 (523-001)

GLP, unpublished

KCA 5.2.4/01 1986 Thiophanate-methyl - Primary dermal irritation study in rabbits Y N NIPPON
Report No.: TXR 0218 SODA
RD-8692 (565-002)

GLP, unpublished

KCA 5.2.5/01 1986 Thiophanate-methyl - Primary eye irritation study in rabbits Y N NIPPON
Report No.: TXR 0217 SODA
RD-8691 (566-002)

GLP, unpublished
 - 42 -
Thiophanate-methyl
List of studies relied upon

RD-9065 (557-006)
Nippon Soda Co., Ltd., Japan
GLP, unpublished

KCA 5.4.1/02 McSheehy, T. et al. 1984 Gene mutation in Chinese hamster V 79 cells with Thiophanate- Y N NIPPON
methyl SODA
Report No.: 063013-M-05184
RD-84109 (557-003)
Life Science Research
Not GLP, unpublished

KCA 5.4.1/04 Myhr, B.C. 1981 Evaluation of pure Thiophanate-methyl in the primary rat hepatocyte Y N NIPPON
Brusick, D.J. unscheduled DNA synthesis assay SODA
Report No.: 21191; 7101
RD-8195 (557-005)
Litton Bionetics, USA
GLP, unpublished

KCA 5.4.1/05 Marshall, R. 1996 Thiophanate-methyl technical - induction of micronuclei in cultured N N NIPPON
human peripheral blood lymphocytes SODA
Report No.: 68/151-1052
RD-9728 (557-001)
Corning Hazleton (Europe), United Kingdom
GLP, unpublished

KCA 5.4.1/06 Marshall, R. 1996 Thiophanate-methyl technical - study to determine the threshold of N N NIPPON
action for the induction of aneuploidy in cultured human peripheral SODA
blood lymphocytes
Report No.: 68/154-1052
RD-9729 (557-002)
Corning Hazleton (Europe), United Kingdom
GLP, unpublished

KCA 5.4.2/01 1999 Thiophanate-methyl - Mouse micronucleus test Y N NIPPON

Report No.: NOD 024/983714 SODA
RD-9957 (557-007)

GLP, unpublished

KCA 5.4.2/03 2012 Structural and numerical chromosome aberration inducers in liver N N nr
micronuleus test in rats with partial hepatectomy
Report No.: RD-03420 (592-013)
 - 45 -
Thiophanate-methyl
List of studies relied upon

KCA 5.6.2/01 1981 Teratology study of Thiophanate-methyl in rats Y N NIPPON

Report No.: 449-006 SODA
RD-8126 (551-003)

GLP, unpublished

KCA 5.6.2/02 1981 Pilot teratology study of Thiophanate-methyl in rats Y N NIPPON

Report No.: 449-005 SODA
RD-8125 (551-002)

GLP, unpublished

KCA 5.6.2/05 1997 Oral (stomach tube) developmental toxicity study of Thiophanate- Y N NIPPON
methyl in rabbits SODA
Report No.: 914-002
RD-9770 (551-005)

GLP, unpublished

KCA 5.6.2/06 1997 Oral (stomach tube and dietary) dosage-range developmental toxicity Y N NIPPON
study of Thiophanate-methyl in rabbits SODA
Report No.: 914-002P
RD-9769 (551-004)

GLP, unpublished

KCA 5.6.2/07 1997 Critical review of two developmental (embryo-fetal toxicity / N N NIPPON
teratogenicity) toxicity study of Thiophanate-methyl in rabbits SODA
Report No.: RD-9771 (551-001)

GLP, unpublished

KCA 5.7.1/01 2007 Oral (Gavage) Acute Neurotoxicity Study of Thiophanate-methyl in Y Y Study is part of NIPPON
Rats the SODA
Report No.: RD-00828N supplementary
914-006 (541-001) dossier and has
not been
GLP, unpublished submitted for
national
registrations
KCA 5.7.1/02 2005 Oral (Diet) Subchronic Neurotoxicity Study of Thiophanate-methyl Y Y Study is part of NIPPON
in Rats the SODA
 - 47 -
Thiophanate-methyl
List of studies relied upon

dossier and has

GLP, unpublished not been
submitted for
national
registrations
KCA 5.8.1/09 2017 A Micronucleus Test of 5-OH-MBC in Mice Y Y Study is part of NIPPON
Report No.: RD-10040 the SODA
N-M242 (557-013) supplementary
dossier and has
Not GLP, unpublished not been
submitted for
national
registrations
KCA 5.8.1/10 2017 A Micronucleus Test of 5-OH-MBC in Mice Y Y Study is part of NIPPON
Report No.: RD-10096 the SODA
M-1552 (557-015) supplementary
dossier and has
GLP, unpublished not been
submitted for
national
registrations
KCA 5.8.1/11 Woolley, D.R. 2017 Toxicological analysis of eleven structures using Derek Nexus N Y Study is part of NIPPON
Report No.: RD-10162 the SODA
SSC001drk (581-017) supplementary
ForthTox Limited, Linlithgow, West Lothian, United Kingdom dossier and has
Not GLP, unpublished not been
submitted for
national
registrations
KCA 5.8.1/12 Wildemann, T. 2017 (Q)SAR analysis for mutagenic and carcinogenic endpoints of N Y Study is part of NIPPON
Briese, B.H. Thiophanate-methyl and the metabolites 4-OH-TM, 5-OH-MBC, the SODA
Harder, V. FH-432, HF-73, AV-1951, DX-105, 2-AB, 4-OH-2-AB, 4-OH-TM- supplementary
S, 5-OH-TM-S, 5-OH-2-AB dossier and has
Report No.: RD-10161 not been
PP146-00062 (581-015) submitted for
Scientific Consulting Company, Bad Kreuznach, Germany national
Not GLP, unpublished registrations

KCA 5.8.4/01 Wildemann, T. 2017 Immunotoxicity assessment of the active substance Thiophanate- N Y Study is part of NIPPON
Harder, V. methyl the SODA
Report No.: RD-10092 supplementary
PP146-00062 (581-014) dossier and has
 - 48 -
Thiophanate-methyl
List of studies relied upon

Scientific Consulting Company, Bad Kreuznach, Germany not been

Not GLP, unpublished submitted for
national
registrations
KCA 5.9.1/01 Ota, Y. 2014 Human handling experiences from plant employees manufacturing N Y Study is part of NIPPON
Thiophanate-methyl (No. 4) the SODA
Report No.: RD-02878 (574-004) supplementary
Nippon Soda Co., Ltd., Japan dossier and has
Not GLP, unpublished not been
submitted for
national
registrations
KCA 5.9.1/02 Aizawa, T. 1991 Human handling experiences from plant employees manufacturing N N NIPPON
topsin (3) SODA
Report No.: RD-9153 (574-001)
Nippon Soda Co., Ltd., Japan
Not GLP, unpublished

KCA 5.9.1/03 Ikeda, K. 1978 Human handling experiences from plant employees manufacturing N N NIPPON
topsin (2) SODA
Report No.: RD-73060 (574-002)
Nippon Soda Co., Ltd., Japan
Not GLP, unpublished

KCA 5.9.1/04 Mori, H. 1972 Human handling experiences from plant employees manufacturing N N NIPPON
topsin (1) SODA
Report No.: RD-73061 (574-003)
Nippon Soda Co., Ltd., Japan
Not GLP, unpublished

KCA 8.1.5/01 Delov, V. 2015 Endocrine Disruption Potential of Thiophanate-methyl N Y Study is part of NIPPON
Wirzinger, G. Report No.: RD-03395 the SODA
PP146-00062/02 (881-018) supplementary
Scientific Consulting Company, Bad Kreuznach, Germany dossier and has
Not GLP, unpublished not been
submitted for
national
registrations
KCA 9.1/01 Reisinger, T. 2015 Literature Review Report acc. to EFSA Guidance “Submission of N Y Study is part of NIPPON
Heidemann, A. scientific peer-reviewed open literature for the approval of pesticide the SODA
active substance under Regulation (EC) No 1107/2009; EFSA supplementary
Journal 2011, 9(2):2092” A.S.: Thiophanate-methyl dossier and has
 - 49 -
Thiophanate-methyl
List of studies relied upon

Report No.: RD-03393 not been

PP146-00076 (091-001) submitted for
Scientific Consulting Company, Bad Kreuznach, Germany national
Not GLP, unpublished registrations

KCA 9.1/02 Anonymous 2016 Reply to the request of the Swedish Authorities dated 13.01.2016 on N Y Study is part of NIPPON
the Literature search for Thiophanate-methyl the SODA
Report No.: RD-03613 supplementary
PP146-00076 (091-003) dossier and has
Scientific Consulting Company, Bad Kreuznach, Germany not been
Not GLP, unpublished submitted for
national
registrations
KCA 9.1/03 Reisinger, T. 2016 Literature Review Report acc. to EFSA Guidance “Submission of N Y Study is part of NIPPON
Kranz, J. scientific peer-reviewed open literature for the approval of pesticide the SODA
a. s. under Reg. (EC) No 1107/2009; EFSA Journal 2011, 9(2):2092” supplementary
- Active Substance: Thiophanate-methyl dossier and has
Report No.: RD-03852 not been
PP146-00062/16-05 (091-005) submitted for
Scientific Consulting Company, Bad Kreuznach, Germany national
Not GLP registrations

KCA 9.2/01 Reisinger, T. 2015 Literature Review Report acc. to EFSA Guidance “Submission of N Y Study is part of NIPPON
Heidemann, A. scientific peer-reviewed open literature for the approval of pesticide the SODA
active subst. under Regulation (EC) No 1107/2009; EFSA Journal supplementary
2011, 9(2):2092”- Metabolite: Carbendazim dossier and has
Report No.: RD-03394 not been
PP146-00076 (091-002) submitted for
Scientific Consulting Company, Bad Kreuznach, Germany national
Not GLP, unpublished registrations

KCA 9.2/02 Anonymous 2016 Reply to the request of the Swedish Authorities dated 13.01.2016 on N Y Study is part of NIPPON
the Literature search for the Thiophanate-methyl metabolite the SODA
Carbendazim supplementary
Report No.: RD-03614 dossier and has
PP146-00076 (091-004) not been
Scientific Consulting Company, Bad Kreuznach, Germany submitted for
Not GLP, unpublished national
registrations
KCA 9.2/03 Reisinger, T. 2016 Literature Review Report acc. to EFSA Guidance “Submission of N Y Study is part of NIPPON
Kranz, J. scientific peer-reviewed open literature for the approval of pesticide the SODA
a. s. under Reg. (EC) No 1107/2009; EFSA Journal 2011, 9(2):2092” supplementary
 - 53 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCA 6.1/05 Brewin, S. 2002 Thiophanate-methyl and Carbendazim - The determination of N N NIPPON
Storage Stability in Rape Seed, Dry Peas, Grapes and Wheat Grain SODA
over a 12 Month Period Stored at approximately -18°C
Report No.: NOD 181/023745
NOD/181
RD-II02426 (645-003)
Huntingdon Life Sciences
GLP, unpublished
KCA 6.1/06 Lucas, L.T. 2000 Thiophanate-methyl - Frozen storage stability of residues in/on N N NIPPON
whole apples SODA
Report No.: BR-95-09
RD-IIM067 (645-001)
ABC Laboratories, Columbia, USA
GLP, unpublished
KCA 6.1/07 Pitt, J. L. 1994 Thiophanate-methyl and its Metabolites - Magnitude of the Residue N Y Study is part of NIPPON
in Apples the SODA
Report No.: RD-01098 supplementary
BR-92-16 dossier and has
EPA MRID 43516301 not been
40690 (632-2006) submitted for
ABC Laboratories, Columbia, USA national
GLP, unpublished registrations
KCA 6.1/08 Class, T. 2014 Stability of Thiophanate-methyl and Carbendazim in/on Intact N Y Study is part of NIPPON
Senciuc, M. Strawberries Stored Frozen the SODA
Report No.: RD-02947 supplementary
P 2878 G (645-012) dossier and has
PTRL Europe, Ulm, Germany not been
GLP, unpublished submitted for
national
registrations
 - 54 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCA 6.1/09 Schwarz, T. 2008 Thiophanate-methyl and Carbendazim: Validation of an enforcement N Y Study is part of NIPPON
Method for Plant Materials (DRY, OILY and Commodities with the SODA
high water content) supplementary
Report No.: RD-01391 dossier and has
P/B 1471 G (432-022) not been
PTRL Europe, Ulm, Germany submitted for
GLP, unpublished national
registrations
KCA 6.1/10 Fenn, L. 2003 Stability of Thiophanate Methyl in Snap Beans During Frozen N Y Study is part of NIPPON
Storage Pending Analysis the SODA
Report No.: RD-03167 supplementary
KP-96-11 (645-010) dossier and has
Exygen Research, Pennsylvania, USA not been
GLP, unpublished submitted for
national
registrations
KCA 6.1/11 Ampofo, S.A. 2002 Stability of Thiophanate-Methyl in Cucumbers During Frozen N Y Study is part of NIPPON
Storage Pending Analysis the SODA
Report No.: RD-03110 supplementary
43512 dossier and has
not been
KP-96-10 submitted for
BR-011-05 (645-009) national
ABC Laboratories, Columbia, USA registrations
GLP, unpublished
KCA 6.1/12 Wright, M.C. 1996 Residue Stability Study of MBC (Methyl-2-Benzimidazole N Y Study is part of NIPPON
Carbamate) in Snap Beans, Apples, Wheat Grain, Spinach, the SODA
Sugar Beet Roots, and Tomatoes supplementary
Report No.: RD-03034 dossier and has
not been
BR-87-6 submitted for
80502 (formerly 88023) (645-008) national
Elf Atochem North America, King of Prussia, USA registrations
GLP, unpublished
 - 59 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCA 6.3.2/01 Yslan, F. 1999 Thiophanate-methyl and metabolite (Carbendazim) - Formulation N Y Study is part of NIPPON
EXP10931A (WG) South - Spain 1998 - 1 Decline study trial the SODA
Residues in tomato (fruit) supplementary
Report No.: 98-613 dossier and has
RD-00426 (633-2006) not been
Rhône-Poulenc Agro, Lyon, France submitted for
GLP, unpublished national
registrations
KCA 6.3.2/02 Giraud, J.P. 2000 Thiophanate-methyl and metabolite (Carbendazim) - Formulation N Y Study is part of NIPPON
EXP10931A (WG) South - Spain 1999 - 1 Decline study trial the SODA
Residues in tomato (fruit) supplementary
Report No.: 99-557 dossier and has
RD-00423 (633-2008) not been
Aventis CropScience, Lyon, France submitted for
GLP, unpublished national
registrations
KCA 6.3.2/03 Delmotte, R. 2013 Magnitude of the residue of Thiophanate-methyl and its metabolite N Y Study is part of NIPPON
Carbendazim in Open Field Tomato Raw Agricultural Commodity the SODA
after three drip irrigation applications Southern Europe - 2013 supplementary
Report No.: RD-02742 dossier and has
RDE-13-16019 not been
P 2893G (633-2013) submitted for
Staphyt, Inchy-en-Artois, France national
GLP, unpublished registrations
KCA 6.3.2/04 Schwarz, T. 2008 Thiophanate-methyl and Carbendazim: Validation of an enforcement N Y Study is part of NIPPON
Method for Plant Materials (DRY, OILY and Commodities with the SODA
high water content) supplementary
Report No.: RD-01391 dossier and has
P/B 1471 G (432-022) not been
PTRL Europe, Ulm, Germany submitted for
GLP, unpublished national
registrations
 - 60 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCA 6.3.2/05 Baudet, L. 1999 Thiophanate-methyl and metabolite (Carbendazim) - Formulation N Y Study is part of NIPPON
EXP10931A (WG) Greenhouse - Spain 1998 - 1 Decline study trial the SODA
Residues in tomato (fruit) supplementary
Report No.: 98-612 dossier and has
RD-00425 (633-2007) not been
Rhône-Poulenc Agro, Lyon, France submitted for
GLP, unpublished national
registrations
KCA 6.3.2/06 Gateaud, L. 2000 Thiophanate-methyl and metabolite (Carbendazim) - Formulation N Y Study is part of NIPPON
EXP10931A (WG) Greenhouse - Spain 1999 - 5 Decline study trials the SODA
Residues in tomato (fruit) supplementary
Report No.: 99-556 dossier and has
RD-00424 (633-2009) not been
Aventis CropScience, Lyon, France submitted for
GLP, unpublished national
registrations
KCA 6.3.3/01 Schmidt, J. 2007 Determination of residues of Thiophanate-methyl after one N Y Study is part of NIPPON
application of Thiophanate-methyl 500 SC in Leek at 1 site in the SODA
Northern Europe 2006 supplementary
Report No.: RD-01341 dossier and has
20064037/B1-FPLK not been
B06W001R (633-6501) submitted for
Eurofins-GAB GmbH, Niefern-Öschelbronn, Germany national
GLP, unpublished registrations
KCA 6.3.3/02 Schmidt, J. 2008 Determination of Residues of Thiophanate Methyl after One N Y Study is part of NIPPON
Application of Thiophanate Methyl 500 SC in Leek at 3 Sites in the SODA
Northern Europe 2007 supplementary
Report No.: RD-01321 dossier and has
20074079/E1-FPLK not been
B07W004R submitted for
B07W005R national
NL07W026R (633-6503) registrations
Eurofins-GAB GmbH, Stade, Germany
GLP, unpublished
 - 67 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCA 6.5.3/03 Boileau, G. 2014b Magnitude of the Residue of Thiophanate-methyl and its metabolite N Y Study is part of NIPPON
Carbendazim in Grapevine Raw Agricultural Commodity and the SODA
processed fractions following one foliar Application of Thiophanate- supplementary
Methyl 500 SC - Northern Europe – 2013 dossier and has
Report No.: RD-02825 not been
GBU-13-16020 submitted for
P 2885 G (638-009) national
Staphyt, Inchy-en-Artois, France registrations
GLP, unpublished
KCA 6.5.3/04 Schwarz, T. 2010 Validation of the Multi-Residue Method QuEChERS for the N Y Study is part of NIPPON
Determination of Thiophanate-methyl and Carbendazim in Acidic the SODA
Crop Types supplementary
Report No.: RD-02096 dossier and has
P 2014 G (432-025) not been
PTRL Europe, Ulm, Germany submitted for
GLP, unpublished national
registrations
KCA 6.5.3/05 Brewin, S. 2001a Thiophanate-methyl and Carbendazim - Development and validation N N NIPPON
of methodology for the determination of residues in melon whole SODA
fruit and flesh
Report No.: ERV 005/004237
RD-II01024 (432-009)
Huntingdon Life Sciences
GLP, unpublished
KCA 6.5.3/06 Boileau, G. 2014c Thiophanate-methyl and its metabolite Carbendazim in Grapevine N Y Study is part of NIPPON
Raw Agricultural Commodity and processed fractions following one the SODA
foliar Application of Thiophanate-Methyl 500 SC - Northern Europe supplementary
- 2013 (Amendment) dossier and has
Report No.: RD-02825N not been
GBU-13-16020 submitted for
P 2885 G (638-014) national
Staphyt, Inchy-en-Artois, France registrations
GLP, unpublished
 - 69 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCA Todd, M. 2002 Validation of methodology for the determination of residues in N Y Study is part of BASF
6.10.1/02 oilseed rape honey Report No.: BSF 633/023976 2002/1006300 the
(432-023) Huntingdon Life Sciences GLP, unpublished supplementary
dossier and has
not been
submitted for
national
registrations
*B= Active substance data submitted for an existing active substance (EAS) initially included on Annex I of Directive 91/414/EEC (EAS under Directive 91/414/EEC) - transition measure - Article 80 (2) a.
 - 71 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCA Kiesel, A. 2017b Raw data to the assessment of degradation kinetics for Thiophanate- N Y Study is part of NIPPON
7.1.2.1.1/06 Drechsler, S. methyl based on data of a laboratory soil study according to FOCUS the SODA
Geibel, E. Degradation Kinetics (2006, 2014) related to the Supplementary supplementary
Dossier - M-CA Section 7 dossier and has
Report No.: RD-03369N2 not been
PP146-00062 (782-098) submitted for
Scientific Consulting Company, Bad Kreuznach, Germany national
Not GLP, unpublished registrations

KCA Adam, D. 2014a 14C-Thiophanate-methyl - Route and Rate of Degradation in One N Y Study is part of NIPPON
7.1.1.1/04 Soil under Aerobic Conditions the SODA
Report No.: RD-02985 supplementary
20110080 (722-001) dossier and has
Innovative Environmental Services (IES) Ltd., Switzerland not been
GLP, unpublished submitted for
national
registrations
KCA Adam, D. 2016 14C-Thiophanate-methyl - Route and Rate of Degradation in One N Y Study is part of NIPPON
7.1.1.1/05 Soil under Aerobic Conditions the SODA
Doc. No.: 781-005 supplementary
(RD-03848 20110080) dossier and has
Innovative Environmental Services (IES) Ltd., Witterswil, not been
Switzerland submitted for
Not GLP, unpublished national
registrations
KCA 7.1.1.1 Cycon, M., Wojcik, 2011 Biodegradation kinetics of the benzimidazole fungicide thiophanate - N N -
M. and Piotrowska- methyl by bacteria isolated from loamy sand soil.
Seget, Z Biodegradation, Vol. 3, 22: pp 573-583.
non-GLP, published
KCA 7.1.1.1 Yu Y., Chu X., Pang 2009 Effects of repeated applications of fungicide carbendazim on its N N -
G., Xiang Y. and persistence and microbial community in soil.
Fang H. Journal of Environmental Science 21: pp 179-185.
non-GLP, published
 - 73 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCA Drechsler, S. 2017b Raw data to the assessment of degradation kinetics of Thiophanate- N Y Study is part of NIPPON
7.1.2.2.1/05 Kiesel, A. methyl and derivation of a formation fraction for the metabolite MBC the SODA
Geibel, E. in a terrestrial field dissipation study acc. to the FOCUS Report on supplementary
Degradation Kinetics (2006, 2014) dossier and has
Report No.: RD-10139 not been
PP146-00062 (782-100) submitted for
Scientific Consulting Company, Bad Kreuznach, Germany national
Not GLP, unpublished registrations
KCA Knoch, E. 2015 Determination of the Storage Stability of Thiophanate-methyl and N Y Study is part of NIPPON
7.1.2.2.1/02 Metabolites in Soil the SODA
Report No.: RD-03398 supplementary
IF-14/02997839 (723-004) dossier and has
SGS Institut Fresenius GmbH, Germany not been
GLP, unpublished submitted for
national
registrations
KCA Voelkel, W. 2015 14C-Thiophanate-methyl - Adsorption/Desorption on Four Soils N Y Study is part of NIPPON
7.1.3.1.1/02 Report No.: RD-03301 the SODA
20110081 (731-005) supplementary
Innovative Environmental Services (IES) Ltd., Switzerland dossier and has
GLP, unpublished not been
submitted for
national
registrations
KCA Voelkel, W. 2016 Letter Report - 14C-Thiophanate-methyl - Adsorption/Desorption on N Y Study is part of NIPPON
7.1.3.1.1/03 Four Soils the SODA
Report No.: RD-03900 supplementary
20110081 (731-006) dossier and has
Innovative Environmental Services (IES) Ltd., Witterswil, not been
Switzerland submitted for
Not GLP, unpublished national
registrations
 - 76 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCA Shiotani, H. 2003c Photodegradation of Thiophanate-methyl N Y Study is part of NIPPON
7.2.1.2/02 Report No.: RD-03185 the SODA
(same EC-74-1 (712-002) supplementary
experiment Nippon Soda Co. Ltd., Japan dossier and has
as in Soeda Not GLP, unpublished not been
& Shiotani, submitted for
national
1987c) registrations
KCA Kiesel, A. 2015g Assessment of degradation kinetics of Thiophanate-methyl in a study N Y Study is part of NIPPON
7.2.1.2/03 Geibel, E. on aqueous photochemical degradation according to the the SODA
recommendations of the FOCUS Report on Degradation Kinetics supplementary
(2006, 2014) dossier and has
Report No.: RD-03367 not been
PP146-00062 (782-039) submitted for
Scientific Consulting Company, Germany national
Not GLP, unpublished registrations
KCA Kiesel, A. 2015h Raw data to the assessment of degradation kinetics for Thiophanate- N Y Study is part of NIPPON
7.2.1.2/04 Geibel, E. methyl based on data of an aqueous photolysis study according to the SODA
FOCUS Degradation Kinetics (2006, 2014) related to the supplementary
Supplementary Dossier - M-CA Section 7 dossier and has
Report No.: RD-03368 not been
PP146-00062 (782-045) submitted for
Scientific Consulting Company, Germany national
Not GLP, unpublished registrations
KCA Tsushima, S. 2013 Ready Biodegradability Test of Thiophanate-methyl N Y Study is part of NIPPON
7.2.2.1/01 Report No.: RD-02537 the SODA
NCAS 12-216 (713-003) supplementary
Nisso Chemical Analysis Service Co., Ltd. (NCAS), Japan dossier and has
GLP, unpublished not been
submitted for
national
registrations
 - 78 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCA Kiesel, A. 2015i Assessment of degradation kinetics of Thiophanate-methyl in N Y Study is part of NIPPON
7.2.2.3/02 Geibel, E. water/sediment systems under laboratory conditions according to the the SODA
recommendations of the FOCUS Report on Degradation Kinetics supplementary
(2006, 2014) dossier and has
Report No.: RD-03329 not been
PP146-00062 (782-040) submitted for
Scientific Consulting Company, Germany national
Not GLP, unpublished registrations
KCA Kiesel, A. 2015j Raw data to the assessment of degradation kinetics for Thiophanate- N Y Study is part of NIPPON
7.2.2.3/03 Geibel, E. methyl based on data of a laboratory water/sediment study according the SODA
to FOCUS Degradation Kinetics (2006, 2014) related to the supplementary
Supplementary Dossier - M-CA Section 7 dossier and has
Report No.: RD-03373 not been
PP146-00062 (782-046) submitted for
Scientific Consulting Company, Germany national
Not GLP, unpublished registrations
KCA Moshenberg, K. 2017a Assessment of degradation kinetics of 4-OH-TM and 2-AB in N Y Study is part of NIPPON
7.2.2.3/04 Drechsler, S water/sediment systems under laboratory conditions according to the the SODA
recommendations of the FOCUS Report on Degradation Kinetics supplementary
(2006, 2014) dossier and has
Report No.: RD-10140 not been
PP146-00062/5 (782-092) submitted for
Scientific Consulting Company, Bad Kreuznach, Germany national
Not GLP, unpublished registrations
KCA Moshenberg, K. 2017b Raw data to the assessment of degradation kinetics of 4-OH-TM and N Y Study is part of NIPPON
7.2.2.3/05 Drechsler, S 2-AB based on data of a laboratory water/sediment study according to the SODA
FOCUS Degradation Kinetics (2006, 2014) supplementary
Report No.: RD-10141 dossier and has
PP146-00062/5 (782-093) not been
Scientific Consulting Company, Bad Kreuznach, Germany submitted for
Not GLP, unpublished national
registrations
 - 79 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data Owner
Source (where different from company) claimed protection is
GLP or GEP status claimed
Published or not Y/N Y/N
KCP Stephan, M. 2016b Thiophanate-methyl in drinking water treatment - Amended version N Y Study is part of NIPPON
9.2.4.1/02 Goerg, J. Report No.: RD-03584N PP146-00062/02 (781-006) the SODA
Scientific Consulting Company, Bad Kreuznach, Germany supplementary
Not GLP, unpublished dossier and has
not been
submitted for
national
registrations
KCP Woelk, A. 2017 Raw data to predicted environmental concentrations in groundwater N Y Study is part of NIPPON
9.2.4.1/04 Schlilchting, A (PECgw) for Thiophanate-methyl and its metabolites using FOCUS the SODA
PEARL 4.4.4, FOCUS PELMO 5.5.3 + MACRO 5.5.4 related to the supplementary
EFSA request for the Supplementary Dossier M-CP Section 9 dossier and has
Report No.: RD-03404N2 not been
PP146-00062 (782-102) submitted for
Scientific Consulting Company, Bad Kreuznach, Germany national
Not GLP, unpublished registrations
KCP 9.2.5/04 Bartsch, A. 2017 Raw data to predicted environmental concentrations in surface water N Y Study is part of NIPPON
Weimann, T. (PECsw) for Thiophanate-methyl and its metabolites using FOCUS the SODA
Ziegler, K. models related to the EFSA request for the Supplementary Dossier supplementary
M-CP Section 9 dossier and has
Report No.: RD-03405N3 not been
PP146-00062 (782-101) submitted for
Scientific Consulting Company, Bad Kreuznach, Germany national
Not GLP, unpublished registrations
 - 81 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed
GLP or GEP status
Published or not Y/N Y/N
KCA Anonymous 2017 Historical Control Data for the Reproductive Parameters for the N Y Study is part of NIPPON
8.1.1.3/04 Mallard Duck - from 1990 to 1994 at the SODA
Report No.: RD-10111 (888-002) supplementary
dossier and has
Not GLP, unpublished not been
submitted for
national
registrations
KCA Capriglione, T. et al. 2011 Genotoxic effects of the fungicide thiophanate methyl on Podarcis N N Nr
8.1.4/01 sicula assessed by micronucleus test, comet assay and chromosome
analysis
Report No.: RD-03355 (892-017)
Ecotoxicology, 2011, 20, 885-891
Not GLP, published

KCA 8.1.5/02 Sciarrillo, R. et al. 2008 Morphological and Functional Changes in the Thyroid Gland of N N nr
Methyl Thiophanate-Injected Lizards, Podarcis sicula
Report No.: RD-03356 (892-022)
Arch Environ Contam Toxicol, 2008, 55, 254-261
Not GLP, published

KCA 8.1.5/03 Cardone, A. 2012 Testicular toxicity of methyl thiophanate in the Italian wall lizard N N nr
(Podarcis sicula): morphological and molecular evaluation
Report No.: RD-03357 (892-018)
Ecotoxicology, 2012, 21, 512-523
Not GLP, published

De Falco et al. 2007 The Effects of the Fungicide Methyl Thiophanate on Adrenal Gland
Morphophysiology of the Lizard, Podarcis sicula
Not GLP, published
Arch. Environ. Contam. Toxicol 53, 241-248
 - 87 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed
GLP or GEP status
Published or not Y/N Y/N
KCA Wirzinger, G. 2015 Effects of Thiophanate-methyl on the growth of green algae N Y Study is part of NIPPON
8.2.6.1/03 (Pseudokirchneriella subcapitata) - Re-calculation of toxicity the SODA
endpoints of the algal growth study by Saito (2002, Doc. No. 823- supplementary
003) dossier and has
Report No.: RD-03363 not been
PP146-00061 (882-007) submitted for
Scientific Consulting Company, Germany national
Not GLP, unpublished registrations

KCA Baba, K. 2012 4-OH-TM: Growth Inhibition Study in Pseudokirchneriella N Y Study is part of NIPPON
8.2.6.1/04 subcapitata the SODA
Report No.: RD-02399 supplementary
NCAS 11-177 (823-006) dossier and has
Nisso Chemical Analysis Service Co., Ltd. (NCAS), Odawara not been
Laboratory, Japan submitted for
GLP, unpublished national
registrations
KCA Baba, K. 2012 CM-0237: Growth Inhibition Study in Pseudokirchneriella N Y Study is part of NIPPON
8.2.6.1/05 subcapitata the SODA
Report No.: RD-02398 supplementary
NCAS 11-176 (823-005) dossier and has
Nisso Chemical Analysis Service Co., Ltd. (NCAS), Odawara not been
Laboratory, Japan submitted for
GLP, unpublished national
registrations
KCP 10.2/01 Wirzinger, G. 2016 Estimation of the aquatic toxicity of Thiophanate-methyl metabolites N Y Study is part of NIPPON
Report No. RD-03849 the SODA
PP146-00062/16-04 (882-011) supplementary
Scientific Consulting Company, Germany dossier and has
Non-GLP, unpublished not been
submitted for
national
registrations
 - 89 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed
GLP or GEP status
Published or not Y/N Y/N
KCA 8.4.1/05 Bandow, C. 2017 Thiophanate-methyl: Reproduction toxicity to the earthworm Eisenia N Y Study is part of NIPPON
Senn, L. fetida in artificial soil with 10% peat the SODA
Report No.: RD-10195 17BG6RR (833-021) supplementary
ECT Oekotoxikologie GmbH, Flörsheim, Germany dossier and has
GLP, unpublished not been
submitted for
national
registrations
KCA Schöbinger, U. 2012 Effects of Thiophanate-methyl TG on the Activity of the Soil N Y Study is part of NIPPON
8.5/01 Microflora the SODA
Report No.: RD-02368 supplementary
S11-02767 dossier and has
S11-02767-L1_ABMF (841-005) not been
Eurofins Agroscience Services EcoChem GmbH, Germany submitted for
GLP, unpublished national
registrations
KCA Yu, Y. et al. 2009 Effects of repeated applications of fungicide carbendazim on its N N nr
8.5/02 persistence and microbial community in soil
Report No.: RD-03362 (892-024)
Journal of Environmental Sciences, 2009, 21 (2), 179-185
Not GLP, published

KCA 8.6.2/01 Hoberg, J.R. 1991 (Thiophanate-methyl) - Determination of effects on seed germination, N Y Study is part of NIPPON
seedling emergence and vegetative vigor of ten plant species the SODA
(including 2 supplementals) supplementary
Report No.: 91-7-3854 (RD-02016) dossier and has
91-7-3845 (RD-02017) - supplemental not been
97-7-7033 (RD-02018) - supplemental (851-002) submitted for
Springborn Laboratories, Inc., USA national
GLP, unpublished registrations
 - 90 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed
GLP or GEP status
Published or not Y/N Y/N
KCA Falk, S. 2012 Toxicity Testing of Thiophanate-methyl TGAI - on Microorganisms N Y Study is part of NIPPON
8.8/01 with the Activated Sludge Respiration Inhibition Test the SODA
Report No.: RD-02475 supplementary
S11-02768 dossier and has
S11-02768-L1_AAHT (842-001) not been
Eurofins Agroscience Services EcoChem GmbH, Germany submitted for
GLP, unpublished national
registrations
KCP Selbach, A. 2007 Generic field monitoring of birds in vineyards in France Y Y Study is part of NIPPON
10.1.1.2/01 Report No.: RD-10128 the SODA
RA05223-2 (865-005) supplementary
RIFCON GmbH, Heidelberg, Germany dossier and has
GLP, unpublished not been
submitted for
national
registrations
KCP Wilkens, S. 2009 Generic field monitoring of birds in vegetable fields in Spain Y Y Study is part of NIPPON
10.1.1.2/02 Selbach, A. Report No.: RD-10129 the SODA
Nast, K. R07199 (865-006) supplementary
RIFCON GmbH, Heidelberg, Germany dossier and has
GLP, unpublished not been
submitted for
national
registrations
KCP Barfknecht, R. 2007 Generic Field Monitoring of Birds in Cereal Fields in Spring and Y Y Study is part of NIPPON
10.1.1.2/04 Summer in Germany the SODA
Report No.: RD-10156 supplementary
E 308 2871-9 (865-008) dossier and has
Bayer CropScience AG, Monheim, Germany not been
GLP, unpublished submitted for
national
registrations
 - 91 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed
GLP or GEP status
Published or not Y/N Y/N
KCP Scherer, F. 2015 Determination of Residues of Thiophanate-Methyl and its Metabolite N Y Study is part of NIPPON
10.1.2.2/01 Carbendazim in Ground Vegetation after Two Applications of Topsin the SODA
500 SC in Meadows in Three Different Climatic Zones 2014 supplementary
Report No.: RD-03401 dossier and has
S14-00071 not been
P 2818 G (645-013) submitted for
Eurofins Agroscience Services EcoChem GmbH, Germany national
GLP, unpublished registrations

KCP Barfknecht, R. 2006 Generic Field Monitoring of Mammals in Cereal Fields in Spring and Y Y Study is part of NIPPON
10.1.2.2/02 Summer in Germany the SODA
Report No.: RD-03942 supplementary
E 308 2926-0 (865-001) dossier and has
Bayer CropScience AG, Monheim, Germany not been
GLP, unpublished submitted for
national
registrations
KCP Barfknecht, R. 2013 Voles in fields with leafy vegetables N Y Study is part of NIPPON
10.1.2.2/03 Report No.: RD-03943 the SODA
E 308 4275-9 (865-002) supplementary
Bayer CropScience AG, Monheim, Germany dossier and has
GLP, unpublished not been
submitted for
national
registrations
KCP Staedtler, T. 2007 Generic field monitoring of mammals in vineyards in France Y Y Study is part of NIPPON
10.1.2.2/04 Report No.: RD-03967 the SODA
RA05223-1 (865-003) supplementary
RIFCON GmbH, Heidelberg, Germany dossier and has
GLP, unpublished not been
submitted for
national
registrations
 - 92 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed
GLP or GEP status
Published or not Y/N Y/N
KCP Staedtler, T. 2010 Generic field monitoring of mammals in vineyards in Spain Y Y Study is part of NIPPON
10.1.2.2/05 Funkenhaus, A. Report No.: RD-03997 the SODA
R09123-2 (865-004) supplementary
RIFCON GmbH, Heidelberg, Germany dossier and has
GLP, unpublished not been
submitted for
national
registrations
KCP 10.2.1/02 Elendt-Schneider 1991 Determination of the acute toxicity of BAS 325 10 F on the water flea N N NIPPON
Daphnia magna STRAUS SODA, BASF
Report No.: 1/90/1119/50/1; 1991/10277
RD-00035 (822-001)
BASF AG, Germany
GLP, unpublished

KCP 10.2.1/04 Kley, A. 2012 Toxicity of Thiophanate-methyl 500 SC to Pseudokirchneriella N Y Study is part of NIPPON
Wydra, V. subcapitata in an Algal Growth Inhibition Test the SODA
Report No.: RD-02400 supplementary
67723210 (823-007) dossier and has
Institut für Biologische Analytik und Consulting IBACON GmbH, not been
Germany submitted for
GLP, unpublished national
registrations
KCP 10.2.1/05 Wirzinger, G., 2016 Re-calculation of toxicity endpoints for effects of Thiophanate- N Y Study is part of NIPPON
Ruhnke, H. methyl 500 SC on algae the SODA
Report No. RD-03839 supplementary
PP146-00062/16-01 (882-008) dossier and has
Scientific Consulting Company, Germany not been
Non-GLP, unpublished submitted for
national
registrations
 - 93 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed
GLP or GEP status
Published or not Y/N Y/N
KCP 10.2.1/06 Sewell, I.G. 2002 TOPSIN M 70% WDG: Acute Toxicity to Daphnia magna N Y Study is part of NIPPON
Mullee, D. M. Report No.: 235/402 (822-005) the SODA
Nippon Soda Co. Ltd., Japan supplementary
GLP, unpublished dossier and has
not been
submitted for
national
registrations
KCP 10.2.2/01 Schäfers, C. 2007 Daphnia magna - Reproduction test (OECD 211) with aging test item N Y Study is NIPPON
- TOPSIN-M WDG required for the SODA
Report No.: RD-01133 supplementary
NIS-003/4-21 (827-006) dossier and was
Fraunhofer, Institut Molekularbiologie und Angewandte Oekologie, not submitted
Germany for the
GLP, unpublished inclusion of
Thiophanate-
methyl in
Annex I of
Directive
91/414/EEC
KCP 10.2.2/02 Schäfers, C. 2016 Daphnia magna - Reproduction test (OECD 211) with aging test item N Y Study is part of NIPPON
- TOPSIN-M WDG (including Amendment No. 1) the SODA
Report No.: RD-01133N supplementary
NIS-003/4-21 (827-007) dossier and has
Fraunhofer, Institut Molekularbiologie und Angewandte Oekologie, not been
Germany submitted for
GLP, unpublished national
registrations
 - 94 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed
GLP or GEP status
Published or not Y/N Y/N
KCP 10.2.2/03 Nieslony, C., 2007 Validity of higher tier Daphnia study performed with a Thiophanate- N Y Study is NIPPON
Heidemann, A. methyl containing WDG-formulation for a Thiophanate-methyl required for the SODA
containing SC-formulation supplementary
Report No. RD-01232 dossier and was
146-039/10-07 (881-009) not submitted
Scientific Consulting Company, Germany for the
Non-GLP, unpublished inclusion of
Thiophanate-
methyl in
Annex I of
Directive
91/414/EEC
KCP Kling, A. 2005 Assessment of Side Effects of BAS 325 11 F to the Honey Bee, Apis N Y Study is part of NIPPON
10.3.1.1.1/02 mellifera L. in the Laboratory the SODA
Report No.: RD-01131 20051175/01-BLEU supplementary
(832-003) dossier and has
GAB Biotechnologie GmbH, Germany not been
GLP, unpublished submitted for
national
registrations
KCP Sekine, T. 2013 Study on the Effect of Thiophanate-methyl 500 SC on Honey Bee N Y Study is part of NIPPON
10.3.1.3/01 Eichler, M. Brood (Apis mellifera L.) under Semi-Field Conditions - Tunnel Test the SODA
- supplementary
Report No.: RD-02704 dossier and has
68421033 (832-005) not been
IBACON GmbH, Germany submitted for
GLP, unpublished national
registrations
KCP Sekine, T. 2017 Statement: Thiophanate-methyl 500 SC on Honey Bee Brood Tunnel N Y Study is part of NIPPON
10.3.1.3/02 Test the SODA
Report No.: RD-10023 supplementary
68421033 (881-022) dossier and has
Ibacon GmbH, Rossdorf, Germany not been
Not GLP, unpublished submitted for
national
registrations
 - 98 -
Thiophanate-methyl
List of studies relied upon

Title Vertebrate Data Justification if

Data point Author(s) Year Company Report No study Protection data protection Owner
Source (where different from company) claimed is claimed
GLP or GEP status
Published or not Y/N Y/N
KCP 10.7/02 Anonymous 2008 A Biological Assessment Dossier for the Registration of Topsin M N Y Study is NIPPON
SC 500 for the control of various fungal pests required for the SODA
Scientific Consulting Company, Wendelsheim, Germany supplementary
Report No.: RD-03851 (381-006) dossier and was
Not GLP, unpublished not submitted
for the
inclusion of
Thiophanate-
methyl in
Annex I of
Directive
91/414/EEC