European Commission
Pyraflufen-ethyl
LIST OF INFORMATION, TESTS AND
STUDIES WHICH ARE CONSIDERED
AS RELIED UPON BY THE RMS FOR
THE EVALUATION WITH A VIEW TO
THE RENEWAL OF THE ACTIVE
SUBSTANCE
January 2016
Rapporteur Member State: The Netherlands
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
i
Table of contents
A.1
Identity ........................................................................................................................................... 1
A.2
Physical, chemical and technical properties.................................................................................. 2
A.3
Further Information ........................................................................................................................ 7
A.4
Proposals for classification, packaging and labelling .................................................................... 7
A.5
Analytical methods ........................................................................................................................ 8
A.6
Effects on human health .............................................................................................................. 11
A.7
Residue data ............................................................................................................................... 25
A.8
Fate and behaviour in the environment ....................................................................................... 29
A.9
Effects on non-target organisms ................................................................................................. 37
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
1
A.1
Identity
Confidential information. Included in Volume 4 (Annex C).
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
2
A.2
Physical, chemical and technical properties
References for the active substance
Annex point
/reference
number
Author(s)
Year
IIA, 2.1.1, 2.1.2,
Russell, S.
2.1.3, 2.2, 2.3.1/01,
2.3.2/01, 2.4.1/01,
2.4.2/01, 2.5.1,
2.6/01, 2.8/01 &
2.14/01
IIA 2.3.1/02
Bates, M.
1996a
1996a
IIA 2.3.2/02
1996
Kubiak, R.
IIA, 2.4.1/02,
Russel, S.
2.4.2/02, 2.7,
2.11.1, 2.11.2, 2.13,
2.14/02 & 2.15
IIA, 2.5.1.3/1
IIA, 2.5.2/01
IIA, 2.5.2/02
IIA, 2.5.2/03
IIA 2.6/02
Ihara, T
1996b
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant),
Published or not
ET-751: Determination of physico-chemical
properties of purified active substance
Nihon Nohyaku, Report No.: PC-5005
GLP
Not published
ET-751 E1 metabolite: Determination
of the vapour pressure
Nihon Nohyaku, Report No.: PC-5001
GLP
Not published
Investigation of the volatilization of 14C-ET751 formulated corresponding to EXP31279A
from plant and soil surfaces under laboratory
conditions
Rhône-Poulenc, Report No. RPA22
GLP
Not published
ET-751: Determination of physico-chemical
properties of the substance as manufactured
Nihon Nohyaku, Report No.: PC-5004
GLP
Not published
1
13
2011 NMR spectra ( H and C) ; Report No. PC5122
Nihon Nohyaku Co. Ltd, 345 Oyamadacho,
Kawachi-Nagano, Osaka 586, Japan.
GLP
Not Published
Sakamoto, 1996a Measurement of mass spectra of impurities
presented in ET-751technical
Y and Kudo,
M.
Nihon Nohyaku, Report No.: PC-5007
GLP
Not published
Sakamoto, 1996b Measurement of IR, UV and NMRspectra of
Y and Kudo,
impurities presented inET-751 technical
M.
Nihon Nohyaku, Report No.: PC-5008
GLP
Not published
Sakamoto, 1996c Absorption spectra (UV/VIS, IR, NMR,MS) of
Y and Kudo,
HME-Cl
M.
Nihon Nohyaku, Report No.: PC-5009
GLP
Not published
Bates, M.
1996b ET-751 E-1 metabolite: Determination solubility
in water buffered at specified pH values
Nihon Nohyaku, Report No.: PC-5003
GLP
Not published
Data
Owner*
Protection
Claimed
Y/N
N
NNC
N
NNC
N
RPA
N
NNC
Y
NNC
N
NNC
N
NNC
N
NNC
N
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
3
Annex point
/reference
number
Author(s)
Year
Title
Data
Owner*
Source (where different from company)
Protection
Company, Report No.
Claimed
GLP or GEP status (where relevant),
Y/N
Published or not
IIA 2.6/03
Bates, M.
1996c E-1 soil metabolite of ET-751,
N
NNC
E-2 soil metabolite of ET-751,
E-3 soil metabolite of ET-751,:
Determination of water solubility and
Octanol:water partition coefficient
Nihon Nohyaku, Report No.: PC-5006
GLP
Not published
IIA 2.9.1/01
Ikemoto, Y 1996
Aqueous hydrolysis study of ET-751
N
NNC
Nihon Nohyaku, Report No.: E-5008
GLP
Not published
14
IIA 2.9.1/02
Lewis, C. J. 1996
( C)-E-1: Hydrolytic stability
N
NNC
Nihon Nohyaku, Report No.: E-5024
GLP
Not published
IIA, 2.9.1/1
McKemie,
1999 Hydrolysis of [14C]ET-751 at pH 5, 7 and 9;
Y
NNC
T.H.
Report No. PC-5034
PTRL West, Inc. 4123-B Lakeside Drive,
Richmond, CA 94806
GLP
Not Published
IA 2.9.2 & 2.9.3/01 Ikemoto, Y 1997
Aqueous photolysis study of ET-751
N
NNC
Nihon Nohyaku, Report No.: E-5025
GLP
Not published
IIA 2.9.3/02
Corgier,
1997a ET-751: Calculation of environmental
N
NNC
M.M.
photolytic half-life in water
Nihon Nohyaku, Report No: E-5029
Not to GLP
Not published
IIA, 2.9.5/1
Sarff, P.
2000 Determination of Dissociation Constant for ETY
NNC
and
751 Technical; Report No. PC-5053
Ambroz, J.
ABC Laboratories, Inc.7200 E. ABC Lane,
Columbia, Missouri 65202
GLP
Not Published
IIA 2.10
Corgier,
1997b ET-751: Estimation of the rate of
N
NNC
M.M.
photochemical transformation in the
atmosphere under tropospheric conditions
Nihon Nohyaku, Report No.: E-5028
Not to GLP
Not published
IIA, 2.15/1
Cage. S.
2012 Pyraflufen-ethyl: oxidizing properties;
Y
NNC
Huntingdon Life Sciences, Eye Research
Centre, Eye, Suffolk, IP23 7PX, UK; Report
No. PC-5133
GLP
Not Published
IIA, 2.15/02
Tran Thanh 1999
Determination of the oxidizing properties of
N
RPA
Phong , J.
technical pyraflufen-ethyl
Rhône-Poulenc, Report No.: 99-267-SEC
GLP
Not published
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
4
References for the PPP (OS-169)
Annex point
/reference
number
Author(s)
Year
IIIA 2.1/1
Krips, H.J.
2006a
IIIA 2.1/2
Krips, H.J.
2006i
IIIA 2.2.1/1
Krips, H.J.
2006b
IIIA 2.2.2/1
Krips, H.J.
2006c
IIIA 2.3.1/1
Krips, H.J.
2006d
IIIA 2.3.3/1
Krips, H.J.
2006e
IIIA 2.4.2/1
Krips, H.J.
2006f
IIIA 2.5.2/1
Dardemann, J.
and Frauen, M.
2007
Title
Data
Owner*
Source (where different from company)
Protection
Company, Report No.
Claimed
GLP or GEP status (where relevant),
Y/N
Published or not
Determination of appearance of OS-159
Y
NNC
2.5%EC (N); Report No. PC-5087.
Notox B.V., Hambakenwetering, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Determination of the accelerated storage
Y
stability of OS-159 2.5%(N) by heating; Report
No. PC-5102.
Notox B.V., Hambakenwetering, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Determination of explosive properties of OSY
159 2.5%EC (N); Report No. PC-5091.
Notox B.V., Hambakenwetering 7, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Statement on the oxidizing properties of OSY
159 2.5%(N); Report No. PC-5092.
Notox B.V., Hambakenwetering 7, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Determination of flash point of OS-159
Y
2.5%EC (N); Report No. PC-5093.
Notox B.V., Hambakenwetering 7, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Determination of the auto-ignition temperature
Y
(liquid) of OS-159 2.5%EC (N); Report No. PC5094.
Notox B.V., Hambakenwetering 7, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Determination of the pH of an aqueous
Y
dispersion of OS-159 2.5%EC (N); Report No.
PC-5098.
Notox B.V., Hambakenwetering 7, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Determination of the physical-chemical
Y
properties of OS-159 2,5 EC (N) (ASU 98510
H);
Report No. AB 98510-FO-012A
Stähler International GmbH & Co. KG, Stader
Elbstrasse, 21683 Stade, Germany
GLP
Not Published
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
5
Annex point
/reference
number
Author(s)
Year
IIIA 2.5.3/1
Dardemann, J.
and Frauen, M.
2007
IIIA 2.5.3/2
Krips, H.J.
2006g
IIIA 2.6.1/1
Dardemann, J.
and Frauen, M.
2007
IIIA 2.6.1/2
Krips, H.J.
2006h
IIIA 2.7.1/1
Krips, H.J.
2006i
IIIA 2.7.4/1
Krips, H.J.
2006j
IIIA 2.7.5/1
Brekelmans,
M.J.C.
2007
IIIA 2.8.2/1
Krips, H.J.
2006k
Title
Data
Owner*
Source (where different from company)
Protection
Company, Report No.
Claimed
GLP or GEP status (where relevant),
Y/N
Published or not
NNC
Determination of the physical-chemical
Y
properties of OS-159 2,5 EC (N) (ASU 98510
H);
Report No. AB 98510-FO-012A
Stähler International GmbH & Co. KG, Stader
Elbstrasse, 21683 Stade, Germany
GLP
Not Published
NNC
Determination of the surface tension of an
Y
aqueous solution of OS-159 2.5%EC (N);
Report No. PC-5097
Notox B.V., Hambakenwetering 7, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Determination of the physical-chemical
Y
properties of OS-159 2,5 EC (N) (ASU 98510
H);
Report No. AB 98510-FO-012A
Stähler International GmbH & Co. KG, Stader
Elbstrasse, 21683 Stade, Germany
GLP
Not Published
NNC
Determination of the density (liquid) of OS-159
Y
2.5%EC (N); Report No. PC-5096
Notox B.V., Hambakenwetering 7, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Determination of the accelerated storage
Y
stability of OS-159 2.5%(N) by heating; Report
No. PC-5102.
Notox B.V., Hambakenwetering, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Determination of low temperature stability of
Y
OS-159 2.5%EC(N); Report No. PC-5103.
Notox B.V., Hambakenwetering, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Determination of the stability of OS-159
Y
2.5%(N) over 2 years under ambient
conditions; Report No. PC-5114.
Notox B.V., Hambakenwetering, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
Determination of persistent foaming of OS-159
Y
2.5%(N) in water; Report No. PC-5099.
Notox B.V., Hambakenwetering, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
6
Annex point
/reference
number
Author(s)
IIIA 2.8.7.1/1
Krips, H.J.
IIIA 2.8.7.4/1
Krips, H.J.
IIIA 2.8.7.4/2
Wakaki, K.
IIIA 2.8.7.4/3
Bates, M.
Year
Title
Data
Owner*
Source (where different from company)
Protection
Company, Report No.
Claimed
GLP or GEP status (where relevant),
Y/N
Published or not
NNC
2006l Determination of the stability of a dilute
Y
emulsion of OS-159 2.5%(N); Report No. PC5101.
Notox B.V., Hambakenwetering, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
2006m Determination of the stability of a dilute
Y
emulsion of OS-159 2.5%(N); Report No. PC5100.
Notox B.V., Hambakenwetering, 5231 DD ‘sHertogenbocsh, The Netherlands
GLP
Not Published
NNC
2011
Determination of the stability of a dilute
Y
emulsion of OS-169 2.5% EC (N)
Nihon Nohyaku Co. Ltd.
Report number: PC-5131
Not GLP
unpublished
NNC
1999
OS-159 2.5% EC(N): Determination of the Two
N
Year Storage Stability of the Plant Protection
Product.
Nihon Nohyaku Co. Ltd.
Report No. 608/53-D2141
GLP
Unpublished
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
7
A.3
Further Information
References for the active substance
None
References for the PPP (OS-169)
Annex point
/reference number
Author(s)
AIII 4.2.2/01
Lee, S.
A.4
Year
2005
Title
Data
Owner*
Source (where different from company)
Protection
Company, Report No.
Claimed
GLP or GEP status (where relevant),
Y/N
Published or not
Determination of residual Pyraflufen-Ethyl
Y
NNC
within a spray tank chamber after spraying with
‘OS-159 EC (N)’{an emulsifiable concentration
formulation} and washing of the tank chamber,
in compliance with Good Laboratory Practise.
Oxford Analytical Ltd, A3 Telford Road,
Bicester, OX26 4LD Oxford, UK
Study no. OA01370
GLP
Not published
Proposals for classification, packaging and labelling
The proposed classification and labelling is based on the physical-chemical, toxicological and
ecotoxicological evaluation as presented in section B.2, B.6 and B.9, respectively.
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
8
A.5
Analytical methods
References for the active substance
Annex point
/reference
number
Author(s)
Year
IIA, 4.2.1/1
Ohira, Ch.
2008
IIA, 4.3/1
Wolf, S
2005
IIA, 4.3/2
Motoba, K
2008
IIA, 4.3/3
Jones, S.
2007
IIA, 4.3/4
Solé, C.
2007
IIA, 4.3/5
Weber, H.
2008
Title
Data
Source (where different from company)
Protection
Company, Report No.
Claimed
GLP or GEP status (where relevant),
Y/N
Published or not
Validation of the Analytical Method for Active
Y
Ingredient in Pyraflufen-ethyl Technical; Report
No. A-5057
Nihon Nohyaku Co. Ltd, 345 Oyamadacho,
Kawachi-Nagano, Osaka 586, Japan.
GLP
Not Published
Development & Validation of a residue
Y
analytical method for Pyraflufen-ethyl and its
metabolite E-1 in apples, pears & grapes;
Report number A-5067.
RCC Ltd Environmental Chemistry
&Pharmanalytics
Zelgliweg 1 CH-4452 Itingen I Switzerland
GLP
Not Published
Independent laboratory validation of analytical
Y
method for Pyraflufen-ethyl and its metabolite
(E-1) in/on apple, pear, grapes and oilseed
rape; Report No. A-5061.
Nihon Nohyaku Co. Ltd, 345 Oyamadacho,
Kawachi-Nagano, Osaka 586, Japan.
GLP
Not Published
To conduct a validation of the analytical
Y
method described in RCC study number
A25986 for the analysis of pyraflufen-ethyl and
its
Metabolite E1 in potato (2007). Report No. A5054
Agrisearch UK Ltd. Slade Iane, Wilson
DE731AG
GLP
Not Published
Independent laboratory validation of a residue
Y
analytical method for Pyraflufen-ethyl and its
metabolite (E-1) for the determination of
residues in potato; Report No. A-5055
ADME bioanalyses75, chemin de sommieres
30310 Vergeze France.
GLP
Not Published
Validation of Multiresidue Method DFG S 19
Y
for the Determination of Residues of
Pyraflufen-ethyl and Metabolite E-1
(Pyraflufen) in Cucumber, Wheat (Grain),
Orange and Sunflower Seed; Report No. A5065.
Eurofins Analytik GmbH, Dr. Specht
Laboratorien, Grossmoorbogen 25, D-21079
Hamburg, Germany.
GLP
Not Published
Owner
NNC
NNC
NNC
NNC
NNC
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
9
Annex point
/reference
number
Author(s)
IIA 4.3/6
Schlewitz, P.
2012a
IIA 4.3/7
Schlewitz, P.
2012b
IIA 4.3/8
Baker F.C. &
Arndt, T.
2000b
IIA, 4.4/1
Tanaka T.
2012
IIA, 4.5/1
Nishimura, Y.
IIA, 4.5/2
IIA, 4.5/3
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant),
Published or not
Independent laboratory validation of the
analytical method for the determination of
pyraflufen-ethyl and its metabolite E-1
(pyraflufen) in cucumber (fruit), wheat (grain),
orange (whole fruit) and sunflower seeds;
Report No. B2077.
Anadiag, 16 Rue Ampère, 67500 Hagenau,
France.
GLP
Not Published
Validation of the analytical method for the
determination of pyraflufen-ethyl and its
metabolite E-1 (pyraflufen) in milk, eggs, meat
(bovine), fat (bovine) and liver or kidney
(bovine); Report No. B2078.
Anadiag, 16 Rue Ampère, 67500 Hagenau,
France.
GLP
Not Published
Method Validation for Determination of
Pyraflufen-Ethyl (ET-751) and Its Acid
Metabolite (E-1) in Potato Matrices, and
Storage Stability of these Analytes in Potato,
Report no.: A-5041
PTRL West, Inc. 4123-B Lakeside Drive,
Richmond, CA 94806, USA
GLP
Not Published
Validation of Analytical Method for Pyraflufenethyl and its Metabolite E-1 in soil; Report No.
LSRC-A12-032A
Nihon Nohyaku Co. Ltd, 345 Oyamadacho,
Kawachi-Nagano, Osaka 586, Japan.
GLP
Not Published
2011 Validation of an Analytical Method for
Pyraflufen-ethyl and its metabolite E-1 in
water; Report No. A-110097A
Nihon Nohyaku Co. Ltd, 345 Oyamadacho,
Kawachi-Nagano, Osaka 586, Japan.
GLP
Not Published
Jones, S.
2008a To conduct a validation of the analytical
method Pyraflufen E-1/water/SJ/08/1 for the
analysis of Pyraflufen E-1 in water; Report No.
A-5062
Agrisearch UK Ltd. Slade Iane, Wilson
DE731AG
GLP
Not Published
Yaginuma, S. 2011 Algal growth inhibition test of the pyraflufenethyl metabolite E-3; Report No. A-110097A
Nihon Nohyaku Co. Ltd, 345 Oyamadacho,
Kawachi-Nagano, Osaka 586, Japan.
GLP
Not Published
Data
Protection
Claimed
Y/N
Owner
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
10
Annex point
/reference
number
Author(s)
IIA, 4.7/1
Jones, S.
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant),
Published or not
2008b To conduct a validation of the analytical
method Pyraflufen ethyl/air/SJ/08/1 for the
analysis of Pyraflufen ethyl in air; Report No.
A-5063
Agrisearch UK Ltd. Slade Iane, Wilson
DE731AG
GLP
Not Published
Data
Protection
Claimed
Y/N
Owner
Y
NNC
Data
Protection
Claimed
Y/N
Owner
Y
NNC
References for the PPP (OS-169)
Annex point
/reference number
Author(s)
IIIA 5.2.1/1
Bates,
M.L.
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant),
Published or not
2008 Pyraflufen-Ethyl 2%SC and Pyraflufen-Ethyl
2.5%EC: Validation of Analytical Procedures
for the Determination of the Active Ingredient;
Report No: A-5064
Covance Laboratories Ltd, Otley Road,
Harrogate, HG3 1PY, UK
GLP
Not Published
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
11
A.6
Effects on human health
References for the active substance (from the original DAR)
Author(s)
Year
Annex IIA Point
GLP Publishe Owne
Title
GEP
Company, Report No.
d
r
or not
Y/N
Y/N
Andant, Ch.,
1998
and Puy, H.
IIA 5.2, IIA 5.5Acute hepatic porphyrias and primary
N
Y
-
N
Y
-
Y
N
NN
Y
N
NN
Y
N
NN
N
N
NN
liver cancer.
Reference: New England J. Medicine, 338 (25),
1853-1854, 1998
Andersson, C., 1996
IIA 5.5The epidemiology of hepatocellular carcinoma
Bjersing, L. and
in patients with acute intermittent porphyria.
Lithner, F.
J. Inter. Med., 240, 1996, 195-201.
Amanuma, T.
1995a IIA, 5.2.1/01
Acute oral toxicity study of ET-751 technical in rat
Nihon Nohyaku, Report No.: T-5019
Amanuma, T.
1995b IIA, 5.2.1/02
Acute oral toxicity study of ET-751 technical in mice
Nihon Nohyaku, Report No.: T-5017
Amanuma, T.
1995c IIA, 5.2.2
Acute dermal toxicity study of ET-751 technical in rat
Nihon Nohyaku, Report No.: T-5018
Amanuma, T.
1996
IIA, 5.8.2/01
Effect of ET-751 on hepatic drug metabolizing
enzymes in mice
Nihon Nohyaku, Report No.: T-5062
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
12
Author(s)
Year
Annex IIA Point
GLP Publishe Owne
Title
GEP
d
r
or not
Company, Report No.
Y/N
Y/N
Bloomer, JR.
1997
IIA 5.2.1Hepatic protoporphyrin metabolism in
N
Y
-
N
N
RPA
Y
N
NN
Y
N
NN
Y
N
NN
patients with advanced protoporphyric liver disease.
Reference : Yale J. Biol. Med, 70(4)323-330, 1997.
Bouvier, G.
1999
IIA 5
ET-751 : Absence of genotoxic hazard, and no
requirement of further test for EU registration.
Rhône-Poulenc Agro, Sophia Antipolis, France. 31
1999
Broadmeadow, 1994a IIA, 5.3.1/01
A.
ET-751: Preliminary toxicity study by dietary
administration to CD rats for four weeks
Nihon Nohyaku, Report No.: T-5001
Broadmeadow, 1994b IIA, 5.3.2/01
A.
ET-751: Toxicity study by dietary administration to
CD rats for 13 weeks followed by an 8 week
reversibility period
Nihon Nohyaku, Report No.: T-5006
Broadmeadow, 1994c IIA, 5.3.2/02
A.
ET-751: Toxicity study by dietary administration to
CD rats for 13 weeks followed by an 8 week
reversibility period -First supplement to Pharmaco
LSR Report No : 93/NHH058/1093, Electron
microscopy reportNihon Nohyaku, Report No.: T-5007
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
13
Author(s)
Year
Annex IIA Point
GLP Publishe Owne
Title
GEP
d
r
or not
Company, Report No.
Y/N
Y/N
Broadmeadow, 1996a IIA, 5.3.2/03
A.
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
N
Y
-
Y
N
NN
ET-751: Toxicity study by oral (capsule)
administration to beagle dogs for 13 weeks
Nihon Nohyaku, Report No.: T-5038
Broadmeadow, 1996b IIA, 5.3.2/04
A.
ET-751: Toxicity study by oral (capsule)
administration to beagle dogs for 52 weeks
Nihon Nohyaku, Report No.: T-5061
Burns, L. M.
1995
IIA, 5.6.2/01
ET-751: Teratology study following oral (gavage)
administration in the rat
Nihon Nohyaku, Report No.: T-5021
Burns, L. M.
1996
IIA, 5.6.2/02
ET-751: Teratology study in the rabbit
Nihon Nohyaku, Report No.: T-5034
Butterworth,
1995
IIA 5
B.E., Conolly,
A strategy for establishing mode of action chemical
R.B. and
carcinogens as a guide for approaches to risk
Morgan, K.T.
assessments. 12 April 1995. Cancer Letters, 93,
129-146
Cracknell, S.
1995
IIA, 5.2.3
ET-751: acute inhalation toxicity study in the rat
Nihon Nohyaku, Report No.: T-5012
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
14
Author(s)
Year
Annex IIA Point
GLP Publishe Owne
Title
GEP
d
r
or not
Company, Report No.
Y/N
Y/N
Dance, C. A.
1994
IIA, 5.4.1/02
Y
N
NN
Y
N
NN
N
Y
-
N
Y
-
Y
N
NN
ET-751: an in vitro test for induction of chromosome
damage: cytogenetic study in cultured human
peripheral lymphocytes
Nihon Nohyaku, Report No.: T-5008
Edwards, C. N. 1994
IIA, 5.4.2
ET-751: mouse micronucleus test
Nihon Nohyaku, Report No.: T-5004
Ellefson, R.D.
1996
and Ford, R.
IIA 5.9.5The polyphyrias : characteristics and
laboratory tests.
Reference: Regul. Toxicol.Pharmacol., 1996, 24,
S119-S125.
Fingar, VH.,
1997
IIA 5.9.3Phtotodynamic therapy using a
Wieman, TJ.,
protoporphyrinogen oxidase inhibitor.
McMahon, KS.,
Reference: Cancer Res., 57(20),4551-4556, 1997.
Halling, BP.,
Yuhas, DA,
Winkelman,
JW.
Fujii, S.
1996
IIA, 5.6.1
ET-751: Two-generation reproduction study in rats
Nihon Nohyaku, Report No.: T-5026
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
15
Author(s)
Year
Annex IIA Point
GLP Publishe Owne
Title
GEP
d
r
or not
Company, Report No.
Y/N
Y/N
Inagaki, K.
1994
IIA, 5.4.1/04
Y
N
NN
Y
N
NN
N
Y
-
N
Y
-
ET-751: DNA repair test (rec-assay) with Bacillus
subtilis
Nihon Nohyaku, Report No.: T-5011
Inagaki, K.
1998
IIA 5.8
Effect of pyraflufen-ethyl dietary adminstration on
lipid peroxidation,
-oxidative activity, catalase
activity and 8-hydroxydeoxyguanosine production in
mouse liver. Research Centre, Nihon Nohyaku Co.,
Ltd., Japan
Report N° LSRC-T98-051A (Draft in English). July
1998. 7 pp.
Kawamura, S., 1996
IIA 5.2Histological changes in rat embryonic blood
Yoshioka, T.,
cells as a possible mechanism for ventricular septal
Kato, T.,
defects produced by an N-phenylimide herbicide.
Matsuo, M.,
Reference: Teratology, 54(5), 237-244, 1996.
Yasuda, M.
Knasmuller, S., 1997
IIA 5 and IIA 5.9.3Reference: Crit. Rev. Toxicol.,
Parzefall,
27(5), 495-537, 1997
W.,Helma Ch.,
Kassie, F.,
Ecker, S., and
SchulteHermann, R.
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
16
Author(s)
Year
Annex IIA Point
GLP Publishe Owne
Title
GEP
d
r
or not
Company, Report No.
Y/N
Y/N
Komatsu, M.
1995a IIA, 5.2.4
Y
N
NN
Y
N
NN
N
Y
-
Y
N
NN
Y
N
NN
Primary dermal irritation study of ET-751 technical in
rabbit
Nihon Nohyaku, Report No.: T-5015
Komatsu, M.
1995b IIA, 5.2.5
Primary eye irritation study of ET-751 technical in
rabbit
Nihon Nohyaku, Report No.: T-5014
Krijt, J.,
1993
IIA 5.2Effect of diphenyl ether herbicides and
Holsteijn, I.,
oxadiazinon on porphyrin biosynthesis in mouse
Hassing, I.,
liver, rat primary hepacyte culture and HepG2 cells.
Vokurka, M.,
Reference: Arch. Toxicol., 67, 255-261, 1993
and Blaauboer,
B.
Kuwahara, M.
1996
IIA, 5.5/02
ET-751: 78-week oral oncogenicity study in mice
Nihon Nohyaku, Report No.: T-5060
Kuwahara, M.
1997
IIA, 5.8.2/02
ET-751: 78-week oral oncogenicity study in mice Additional study of effect on proliferative activity of
hepatic cells
Nihon Nohyaku, Report No.: T-5066
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
17
Author(s)
Year
Annex IIA Point
GLP Publishe Owne
Title
GEP
d
r
or not
Company, Report No.
Y/N
Y/N
Lindal, S.,
1992
IIA 5.3.2Mitochondrial diseases and myopathies : a
Torbergsen, T.,
series of muscle biopsy specimens with
Aasly, J.,
ultrastructural changes in the mitochondria.
Mellgren, SI.,
Reference: Ultrastruct. Pathol., 16 (3), 263-275,
and Monstad,
1992
N
Y
-
Y
N
NN
N
Y
-
Y
N
NN
N
Y
P.
Lloyd, J. M.
1994
IIA, 5.4.1/03
ET-751: L5178Y TK+/- mouse lymphoma mutation
assay using the methodology recommended by the
O.E.C.D. (1984)
Nihon Nohyaku, Report No.: T-5005
Logan , GM.,
1991
IIA 5.2.1Bile porphyrin analysis in the evaluation of
Weimer, MK.,
variegate porphyria.
Ellefson, M.,
Reference: N. Engl.J.Med, 324 (20), 1408-1411,
Pierach, CA.,
1991
Bloomer, JR.
May, K.
1994
IIA, 5.4.1/01
ET-751: Assessment of mutagenic potential in
amino-acid auxotrophs of Salmonella typhimurium
and Escherichia coli (the Ames test)
Nihon Nohyaku, Report No.: T-5003
Meyer,U.A,
1998
IIA 5.2.1Acute porphyrias : pathogenesis of
Schuurmans,
neurological manifestations.
M.M. and
Reference: Semin. Liver Dis. 18, 1998, 43-52.
Lindberg, RL.
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
18
Author(s)
Year
Annex IIA Point
GLP Publishe Owne
Title
GEP
d
r
or not
Company, Report No.
Y/N
Y/N
Meyer, UA.,
1998
IIA 5.3
Schuurmans,
Acute porphyrias : pathogenesis of neurological
MM., and
manifestations.
Lindberg, RL.
Reference: Semin. Liver Dis., 18(1), 43-52, 1998
Moore, MR.
1993
IIA 5.2.1Biochemistry of porphyria.
N
Y
-
N
Y
-
Y
N
NN
Y
N
NN
Y
N
NN
Reference: Int. J. Biochem., 25(10), 1353-1368,
1993.
Motoba, K.
1996a IIA, 5.1/01
Absorption, distribution, metabolism and excretion of
14
[pyrazole-5- C] ET-751 following a single oral
administration to male and female rats
Nihon Nohyaku, Report No.: T-5039
Motoba, K.
1996b IIA, 5.1/02
14
Metabolism and excretion of [phenyl-U- C] ET-751
following a single oral administration to male and
female rats
Nihon Nohyaku, Report No.: T-5059
Motoba, K.
1996c IIA, 5.1/03
Absorption, distribution, metabolism and excretion of
14
a single oral dosing of [pyrazole-5- C] ET-751
following repetitive oral dosing of non-radiolabeled
test substance to rats
Nihon Nohyaku, Report No.: T-5046
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
19
Author(s)
Year
Annex IIA Point
GLP Publishe Owne
Title
GEP
d
r
or not
Company, Report No.
Y/N
Y/N
Motoba, K.
1996d IIA, 5.1/04
Y
N
NN
Y
N
NN
Y
N
NN
N
Y
--
Y
N
NN
14
Metabolism and excretion of [pyrazole-5- C] ET751 into bile following a single oral administration to
rats
Nihon Nohyaku, Report No.: T-5045
Nakatani, M.
1998
IIA 5.8
Studies on the porphyrin accumulation in mice and
rats by pyraflufen-ethyl administration. Research
Centre, Nihon Nohyaku Co., Ltd., Japan (Draft in
English).
Report code T-5095. July 1998. 11 pp.
Nakatani, M.
1998
IIA 5.8
Investigation of liver injury caused by dietary
administration of pyraflufen-ethyl in mice. Research
Centre, Nihon Nohyaku Co., Ltd., Japan (Draft in
English) Report n° LSRC-T98-0046. July 1998. 22
pp.
Omara, F.,
1993
IIA 5.3.2Hepatotoxicity associated with dietary iron
Blakley, B. and
overload in mice.
Wanjala, L.
Reference: Human & Experimental toxicol., 12 , 463467, 1993
Patel, S.
1996
IIA, 5.5/01
ET-751: Combined oncogenicity and toxicity study
by dietary administration to CD rats for 104 weeks
Nihon Nohyaku, Report No.: T-5064
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
20
Author(s)
Year
Annex IIA Point
GLP Publishe Owne
Title
GEP
d
r
or not
Company, Report No.
Y/N
Y/N
Rees, P. B.
1995
IIA, 5.2.6
Y
N
NN
N
Y
-
N
Y
-
Y
N
NN
Y
N
NN
ET-751: Delayed contact hypersensitivity study in
the guinea-pig
Nihon Nohyaku, Report No.: T-5013
Rio B.,
1997
IIA 5.2Effects of a diphenyl-ether herbicide,
D.Parent-
oxyflurfen, on human BFU-E/CFU-E development
Massin, S.
and hemoglobin synthesis
Lautraite and
Reference: Human and Exp.Toxicol. 16, 1997, 115-
H. Hoellinger.
122.
Salonpaa, P.,
1997
IIA 5.2.1Regulation of CYP 2A5 induction by
Kottari, S.,
porphyrogenic agents in mouse primary
Pelkonen, O.
hepatocytes.
And Raunio, H.
Reference: Naunyn Schiedebergs Arch. Parmacol.,
355, 8-13, 1997
Tanaka, N.
1998
II A 5.4.1
Report on mutation Assay of ET-751 Using L5178Y
Mouse Lymphoma Cells. Hatano Research
Institute,Food and Drugs Safety Centre, Japan. HRI
Report N° 10-426. Revised August 18, 1998.
Takahashi, K.
1994
IIA, 5.3.1/02
ET-751: 78-week oral oncogenicity study in mice /
28-day dose range finding study
Nihon Nohyaku, Report No.: T-5002
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
21
Author(s)
Year
Annex IIA Point
GLP Publishe Owne
Title
GEP
d
r
or not
Company, Report No.
Y/N
Y/N
Ye, Q., and
1996
Bodell, W.,
IIA 5Production of 8-hydroxy-2'-deoxyguanosine in
N
Y
-
DNA by microsomal activation of tamoxifen and 4hydroxytamoxifen.
Reference: Carcinogenesis, 17, 1747-1750, 1996
References for the active substance (submitted for renewal of the active)
Annex
Author(s)
Year
point(s)
Title
Source
Report ID
GLP or GEP status
Data
Owner
Protection
Claimed
Y/N
Published or not
IIA, 5.3.7/1
Biegel, L.
2000
28-Day Dermal Toxicity Study with Pyraflufen-ethyl
Y
NNC
Y
NNC
Technical in Rats.
Covance Laboratories Inc. Madison, USA
Report; T-5114
GLP
Not Published
IIA 5.5.4/1
Takanori, H.
2000
ET-751: 78-week oral oncogenicity study in mice Additional histochemical study on porphyrin
accumulation in the liver (T-5060); Report No. T5118
The Institute Of Environmental Toxicology
4321, Uchimoriya-machi, Mitsukaido-shi, Ibaraki
303-0043, JAPAN
GLP
Not Published
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
22
Annex
Author(s)
Year
point(s)
Title
Source
Report ID
GLP or GEP status
Data
Owner
Protection
Claimed
Y/N
Published or not
IIA, 5.8/1
Komatsu. M.
1997
Acute oral toxicity testing of 2-chloro-5-(4-chloro-5-
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Data
Owner
difluoromethoxy-1-methylpyrazol-3-yl)-4fluorophenoxyacetic acid (E-1)
in the rat; Report No. T-5067
Nihon Nohyaku General Research Center
345 Oyamada-cho, Kawachinagano-shi, Osaka
GLP
Not Published
IIA, 5.9.1/1
Motoba, K.
2012
Pyraflufen-ethyl: medical surveillance report for
factory worker
Nihon Nohyaku General Research Center
345 Oyamada-cho, Kawachinagano-shi, Osaka
Non-GLP
Not Published
IIA, 5.9.2/1
Pickering, B.
2012
Statement on clinical cases and poisoning incidents
Nihon Nohyaku Co. Ltd. 2-5 Nihonbashi 1-chome,
Chuo-ku, Tokyo 103-8236, Japan
Non-GLP
Not Published
IIA, 5.9.9/1
Kane, T. J.
2008
Pyraflufen-ethyl comparative in vitro dermal
absorption study using human and rat skin.
Report No. T-5215
Huntingdon life sciences ltd.
GLP
Not Published
NNC = Nihon Nohyaku Co. Ltd
References for the PPP (OS-169)
Annex
point(s)
Author(s)
Year
Title
Source
Report ID
GLP or GEP status
Published or not
Protection
Claimed
Y/N
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
23
Annex
Author(s)
Year
point(s)
Title
Source
Report ID
GLP or GEP status
Data
Owner
Protection
Claimed
Y/N
Published or not
IIIA 7.1.1/1
Janssen,
P.J.M.
2006a
Assessment of Acute Oral Toxicity with OS-159
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
2.5%EC(N) in the Rat (Acute Toxic Class Method);
Report No. T-5205
NOTOX B.V., Hambakenwetering 7, 5231 DD’sHertogenbosch, The Netherlands
GLP
Not Published
IIIA 7.1.2/1
Driscoll, R.
1997
OS-159 2.5%EC(N): Acute Dermal Toxicity (limit
Test) in the Rat; Report No. T-5078
Safepharm Laboratories Limited, P.O. Box No. 45,
Derby, DE1 2BT, UK
GLP
Not Published
IIIA 7.1.3/1
Janssen,
P.J.M.
2006b
Assessment of Acute Inhalatory Toxicity with OS159 2.5%EC(N) in the Rat.
Report No. T-5206
NOTOX B.V., Hambakenwetering 7, 5231 DD’sHertogenbosch, The Netherlands
GLP
Not Published
IIIA 7.1.4/1
Janssen,
P.J.M.
2006c
Primary Skin Irritation/Corrosion Study with OS-159
2.5%EC(N) in the Rabbit; Report No. T-5207
NOTOX B.V., Hambakenwetering 7, 5231 DD’sHertogenbosch, The Netherlands
GLP
Not Published
IIIA 7.1.5/1
Suzuki,
K.M.S.
1998
Primary Eye Irritation Study of OS-159 2.5%EC(N)
in Rabbits; Report No. T-5086.
Nippon Experimental Medical research Institue Co.,
Ltd. Agatsuma-gun, Gunma, Japan.
GLP
Not Published
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
24
Annex
Author(s)
Year
point(s)
Title
Source
Report ID
GLP or GEP status
Data
Owner
Protection
Claimed
Y/N
Published or not
IIIA 7.1.5/2
Van
Sikkelerus,
B.P.C.
2006
Screen for the Eye Irritancy Potential of OS-159
Y
NNC
Y
NNC
2.5%EC(N) using the Bovine Corneal Opacity and
Permeability Test (BCOP Test); Report No. T-5208
NOTOX B.V., Hambakenwetering 7, 5231 DD’sHertogenbosch, The Netherlands
GLP
Not Published
IIIA 7.1.6/1
Bull, A.D.
2007
OS-169 2.5EC Assessment of Skim Sensitisation
Potential using the Local Lymph Node Assay in the
Mouse (Pooled treatment group approach);
Report No. T-5204.
Huntingdon Life Science Ltd, Woolley Road,
Alconbury, Huntingdon,Cambridge, UK
GLP
Not Published
NNC = Nihon Nohyaku Co. Ltd
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
25
A.7
Residue data
References for the active substance
Annex
point(s)
Author(s)
Year
IIA 6.1.1/1
Baker, F &
Arndt, T.
2000b
IIA 6.1.1/2
Gillis, N.
2005
Title
Data
Source
Protection
Report ID
Claimed
GLP or GEP status
Y/N
Published or not
Method validation for determination of pyraflufenY
ethyl (ET-751) and its acid metabolite (E-1) in potato
matrices, and storage stability of these analytes in
potato tubers; Report No. A-5041
PTRL West, Inc. 4123-B Lakeside Drive, Richmond,
CA 94806, USA
GLP
Not Published
Study to determine the stability of pyraflufen-ethyl
and pyraflufen-ethyl metabolite E-1 residues in
potato following frozen storage at ca.-18℃ for 0, 3
and 10 months; Report No. PC-5088
Agrisearch UK Ltd. Slade Iane, Wilson DE73 1AG,
UK
Owner
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
N
NNC
N
NNC
GLP
IIA 6.1.1/3
Class, T.
2002
IIA 6.1.1/4
Baker, F.C.,
Cooley, T. &
Arndt, T.
2000
IIA 6.1.1/5
Takahashi,
Y.
2010
IIA 6.1.1/6
Anding, C.
1997a
IIA 6.1.1/7
Anding, C.
1997b
Not Published
Freezer storage stability of Pyraflufen-ethyl and its
acid metabolite E-1 in cereal samples; A-5049
PTRL Europe. Helmholtzstr. 22, Science Park
D-89081 Ulm, Germany
GLP
Not Published
Magnitude of the residue of ET-751 in/on processed
fractions of potato raw agricultural commodities;
Report No. R-5060
PTRL West, Inc. 4123-B Lakeside Drive, Richmond,
CA 94806
GLP
Not Published
Interim Report to: Storage Stability of PyraflufenEthyl and Its Metabolite (E-1) in/on Grapes; Report
No. LSRC-A10-113A-1.
Nihon Nohyaku General Research Center
345 Oyamada-cho, Kawachinagano-shi, Osaka
GLP
Not Published
Stability study of ET-751 in Wheat (grain, straw and
shoot) after storage in a freezer at about -18/C,
Intermediate Results
Nihon Nohyaku, Report n/ A-5029, 21 April 1997
Non GLP
Not Published
Stability study of E-1 in Wheat (grain, straw) and
barley (shoot) after storage in a freezer at about 18/C, Intermediate Results
Nihon Nohyaku, Report n/ A-5030, 21 April 1997
Non GLP
Not Published
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
26
Annex
point(s)
Author(s)
Year
IIA 6.1.2/1
Schlewitz, P.
2012c
IIA, 6.2.1.1/1
Baker, F.C.,
Bautista,
A.V., &
Kimmel, E.C.
1999a
IIA, 6.2.1.2/1
Baker, F.C.,
Bautista,
A.V., &
Kimmel, E.C.
1999b
IIA, 6.2.1.3/1
Nishizawa,
H.
1995
IIA, 6.2.1.4/1
Goodyear, A.
1995
IIA, 6.2.2/1
Jalali, K. et
al.
2000a
IIA, 6.2.3/1
Jalali, K. et
al.
2000b
IIA, 6.3.1/1
Oxspring, S.
2002a
Title
Source
Report ID
GLP or GEP status
Published or not
Frozen storage stability of residues of pyraflufenethyl metabolite E-1 (pyraflufen) in potato tuber
extracts; Report No. B2081
Anadiag, 16 Rue Ampère, 67500 Hagenau, France.
GLP
Not Published
A metabolism study with [14C]ET-751 on potato;
Report No. R-5051
PTRL West, Inc. 4123-B Lakeside Drive, Richmond,
CA 94806, USA
GLP
Not Published
A metabolism study with [14C]ET-751 on cotton;
Report No. R-5052
PTRL West, Inc. 4123-B Lakeside Drive, Richmond,
CA 94806, USA
GLP
Not Published
Metabolism of [pyrazole-5-14C]ET-751 in mandarin
orange; Report No. R-5002
Nihon Nohyaku General Research Center
345 Oyamada-cho, Kawachinagano-shi, Osaka
GLP
Not Published
14
[ C]-ET-751: Metabolism in spring wheat
Nihon Nohyaku, Report No.: R-5001, April 1995
The Metabolism of C4C]-ET-751 in the laying hen
Report No. R-5026
PTRL West, Inc. 4123-B Lakeside Drive, Richmond,
CA 94806, USA
GLP
Not Published
The Metabolism of [,4C]-ET-751 in the Lactating
Goat. Report No R-5030
PTRL West, Inc. 4123-B Lakeside Drive, Richmond,
CA 94806, USA
GLP
Not Published
To determine the magnitude of Pyraflufen-ethyl
residues at intervals and at harvest in the raw
agricultural commodity potatoes resulting from
sequential overall applications of OS 159 EC(N), in
the Southern France, Spain, Northern France and
the UK, 2000; Report No. R-5081
Agrisearch UK Ltd. Slade Iane, Wilson DE73 1AG,
UK
GLP
Not Published
Data
Protection
Claimed
Y/N
Owner
Y
NNC
Y
NNC
Y
NNC
Y
NNC
N
NNC
Y
NNC
Y
NNC
Y
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
27
Annex
point(s)
Author(s)
Year
IIA, 6.3.1/2
Oxspring, S.
2002b
IIA, 6.3.1/3
Clark, D. E.
2002
Title
Data
Source
Protection
Report ID
Claimed
GLP or GEP status
Y/N
Published or not
To determine the magnitude of Pyraflufen-ethyl
Y
residues at intervals and at harvest in the raw
agricultural commodity potatoes resulting from
sequential overall applications of OS 159 EC(N), in
the Northern France and the UK, 2001; Agrisearch,
Report No. R-5082
Agrisearch UK Ltd. Slade Iane, Wilson DE73 1AG,
UK
GLP
Not Published
To determine the magnitude of Pyraflufen-ethyl
Y
residues at intervals and at harvest in the raw
agricultural commodity potatoes resulting from
sequential overall applications of OS 159 EC(N), in
the UK, 2002; Report No. R-5083
Agrisearch UK Ltd. Slade Iane, Wilson DE73 1AG,
UK
Owner
NNC
NNC
GLP
IIA, 6.3.2/1
Ellis, C.
2009a
Not Published
Determination of residues of Pyraflufen-ethyl after
one and two applications of OS-169 in grapevines at
2 sites in Northern Europe and 2 sites in Southern
Europe; Report No. R-5101
Agrisearch UK Ltd. Slade Iane, Wilson DE73 1AG,
UK
Y
NNC
Y
NNC
Y
NNC
Y
NNC
GLP
IIA, 6.3.2/2
Perny, A.
2013
Not Published
Determination of Pyraflufen-ethyl and its Metabolite
E-1 (pyraflufen) Residues in Grapevines RAC
following Treatment with OS-169 in Northern and
Southern Europe in 2012
ANADIA, 16 rue Ampère, 67500 HAGENAU, France
Report No. R B2079
GLP
IIA, 6.4.2.1
Marin, J. E.
2009
IIA 6.5.3/1
Baker, F.C.,
Cooley, T. &
Arndt, T.
2000
Not Published
Magnitude ofET-751 Residues in Bovine Tissues
and Milk from a 28-Day Feeding Study and
Radiovalidation in Goat Liver and Milk.
Report No. R-5098
PTRL West, Inc. Cresting Facility. 625-B Alfred
Nobel Dr. Hercules, CA 94547, USA
GLP
Not Published
Magnitude of the residue of ET-751 in/on processed
fractions of potato raw agricultural commodities;
Report No. R-5060
PTRL West, Inc. 4123-B Lakeside Drive, Richmond,
CA 94806
GLP
Not Published
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
28
Annex
point(s)
Author(s)
Year
IIA, 6.6.2/1
Clarke, D. E.
1998
IIA, 6.6.3/1
Ellis, C.
2009b
IIA, 6.6.3/2
Oppilliart, S.
2009
Title
Data
Source
Protection
Report ID
Claimed
GLP or GEP status
Y/N
Published or not
[14C]-ET-751: A confined rotational crop study using
Y
radishes, lettuces and barley; Report No. R-5049
Rhone-Poulenc Agriculture Ltd., Fyfield Road,
Ongar, UK.
GLP
Not Published
Determination of residues of Pyraflufen-ethyl after
Y
one application of OS169 to bare soil followed by
planting of various crops at 2 sites in Northern
Europe and 2 sites in Southern Europe 2008; Report
No. S08-01879
Agrisearch UK Ltd. Slade Iane, Wilson DE73 1AG,
UK
GLP
Not Published
Determination of residues of Pyraflufen after one
Y
application of OS169 to bare soil followed by
planting of various crops at 2 sites in Northern
Europe and 2 sites in Southern Europe 2007; Report
No. S08-01879
Eurofins ADME Bioanalysis, 75 Cheminde
Sommières, 30310 Vergèze, France
GLP
Not Published
Owner
NNC
NNC
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
29
A.8
Fate and behaviour in the environment
References for the active substance (from the original DAR)
Annex
point/
reference
number
Author(s)
Year
IIA, 7.1.2/01 Bates, M.
1996
IIA,
Benwell, L. 1997
7.1.1.2.2/01 and
Burden, A.
N.
IIA,
Burden, A. 1997
7.1.1.2.2/02 N. and
Dunn, L
IIA,
7.2.1.1/01
Ikemoto, Y. 1996
IIA, 7.2.1.2
Ikemoto, Y. 1997
IIA, 7.2.1.2
Ikemoto, Y. 1996
IIA, 7.2.1.2
Ikemoto, Y. 1997
IIA, 7.1.3.1
Kimura, Y. 1996a
Title, Source, Company, Report No,
GLP or GEP status (where relevant),
Published or not
ET-751: Determination of adsorption
coefficient on soil (Koc) by HPLC simulation.
Nihon Nohyaku, Report No: E-5005
GLP:Y
Not Published
ET-751 SC (containing 20 g ET-751/l):
Dissipation from four field soils following
spring application.
Nihon Nohyaku, Report No: R-5028
GLP:Y
Not Published
ET-751 SC (containing 20 g ET-751/l):
Dissipation from four field soils following
autumn application.
Nihon Nohyaku, Report No: R-5031
GLP:Y
Not Published
Aqueous hydrolysis study of ET-751.
Nihon Nohyaku Co. Ltd., Report No: E-5008
GLP:Y
Not Published
Aqueous photolysis study of ET-751 using
distilled water and river water .
Nihon Nohyaku Co. Ltd., Report No: LSRCE96-066A (only briefly described in original
DAR, submitted for renewal upon request
RMS)
Aqueous photolysis study of metabolites of
ET-751 using distilled water and river water.
Nihon Nohyaku Co. Ltd., Report No: LSRCE96-059A
GLP:N
Not Published
Aqueous photolysis study of ET-751.
Nihon Nohyaku Co. Ltd., Report No: E-5025
GLP:Y
Not Published
14
Soil column leaching of [pyrazole-5- C] ET751 (Normal study)
Nihon Nohyaku, Report No: E-5009
GLP:Y
Not Published
Data
Owner
Protec-tion
Claimed
Y/N
N
NNC
N
NNC
N
NNC
N
NNC
N
NNC
N
NNC
N
NNC
N
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
30
Annex
point/
reference
number
Author(s)
Year
IIA, 7.1.3.2
Kimura, Y. 1996b
IIA,
Lewis, C. J. 1996a
7.1.1.1.2/02,
7.1.1.2.1/08
IIA, 7.2.1.3.2 Lewis, C. J. 1996b
IIA,
7.2.1.1/02
Lewis, C. J. 1997
IIA,
Purser, D.
7.1.1.2.1/02
1995a
IIA,
Purser, D.
7.1.1.2.1/03
1995b
IIA,
Purser, D.
7.1.1.1.1/01,
7.1.1.2.1/01
1996a
IIA,
Purser, D.
7.1.1.1.2/01,
7.1.1.2.1/05
1996b
IIA,
Purser, D.
7.1.1.1.1/02
1997
IIA,
Yeomans,
7.1.1.2.1/04 P.
1996a
Title, Source, Company, Report No,
GLP or GEP status (where relevant),
Published or not
14
Soil column leaching of [pyrazole-5- C] ET751 (Aged study)
Nihon Nohyaku, Report No: E-5010
GLP:Y
Not Published
14
( C)-ET-751: Photodegradation on a soil
surface.
Nihon Nohyaku, Report No: E-5006
GLP:Y
Not Published
14
( C)-ET-751: Degradation and retention in
water/sediment systems.
Nihon Nohyaku, Report No: E-5011
GLP:Y
Not Published
14
( C)-E-1: Hydrolytic stability.
Nihon Nohyaku, Report No.: E-5024
GLP:Y
Not Published
14
( C)-ET-751: Soil degradation at 20°C.
Nihon Nohyaku, Report No: E- 5001
GLP:Y
Not Published
14
( C)-ET-751: Soil degradation at 10°C
Nihon Nohyaku, Report No: E- 5003
GLP:Y
Not Published
14
( C)-ET-751: Aerobic soil metabolism
Nihon Nohyaku, Report No: E-5018
GLP:Y
Not Published
14
( C)-ET-751: Anaerobic soil metabolism.
Nihon Nohyaku, Report No: E-5004
GLP:Y
Not Published
14
( C)-ET-751: Aerobic soil metabolism Addendum
Nihon Nohyaku, Report No: E-5027
GLP:Y
Not Published (submitted for renewal upon
request of RMS)
14
( C)-E-2 (ET-751 metabolite): Soil
degradation at 20°C.
Nihon Nohyaku, Report No: E-5013
GLP:Y
Not Published
Data
Owner
Protec-tion
Claimed
Y/N
N
NNC
N
NNC
N
NNC
N
NNC
N
NNC
N
NNC
N
NNC
N
NNC
N
NNC
N
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
31
Annex
point/
reference
number
Author(s)
Year
IIA,
Yeomans,
7.1.1.2.1/05 P.
1996b
IIA,
Yeomans,
7.1.1.2.1/07 P.
1996c
IIA, 7.1.2/02 Yeomans,
P.
1996d
IIA, 7.1.2/03 Yeomans,
P.
1996e
IIA, 7.1.2/04 Yeomans,
P.
1996f
Title, Source, Company, Report No,
GLP or GEP status (where relevant),
Published or not
14
( C)-E-3 (ET-751 metabolite): Soil
degradation at 20°C.
Nihon Nohyaku, Report No: E-5014
GLP:Y
Not Published
14
( C)-E-2 (ET-751 metabolite): Anaerobic soil
degradation at 20°C.
Nihon Nohyaku, Report No: E-5012
GLP:Y
Not Published
14
( C)-E-1 (ET-751 metabolite):
Adsorption/desorption in three soils.
Nihon Nohyaku, Report No: E-5016
GLP:Y
Not Published
14
( C)-E-2 (ET-751 metabolite):
Adsorption/desorption in three soils.
Nihon Nohyaku, Report No: E-5017
GLP:Y
Not Published
14
( C)-E-3 (ET-751 metabolite):
Adsorption/desorption in three soils
Nihon Nohyaku, Report No: E-5020
GLP:Y
Not Published
Data
Owner
Protec-tion
Claimed
Y/N
N
NNC
N
NNC
N
NNC
N
NNC
N
NNC
References for the active substance (submitted for renewal of the active)
Annex
point(s)
Author(s)
Year
IIA 7.1.1/1
Shepler, K.
2000
IIA 7.1.3/1
Concha, M.
2000
Title
Source
Report ID
GLP or GEP status
Published or not
Aerobic soil metabolism of [14C]ET-751;
Report No. E-5036
PTRL West, Inc. 4123-B Lakeside Drive,
Richmond, CA 94806, USA
GLP
Not Published
Photodegradation of [14C]ET-751 in/on soil
by artificial sunlight; Report No. E-5038
PTRL West, Inc. 4123-B Lakeside Drive,
Richmond, CA 94806, USA
GLP
Not Published
Data
Owner
Protection
Claimed
Y/N
Y
NNC
Y
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
32
Annex
point(s)
Author(s)
Year
IIA 7.1.1/3/
IIA 7.1.3/3
Callow, B &
Mamouni,
A.
2014
IIA 7.2.1/1
Callow, B & 2012a
Mamouni,
A.
IIA 7.2.2/1
Callow, B & 2012a
Mamouni,
A.
IIA 7.2.3/1
Callow, B & 2012a
Mamouni,
A.
IIA 7.2.3/2
Callow, B & 2012b
Mamouni,
A.
Title
Source
Report ID
GLP or GEP status
Published or not
Consideration of the detections of the
metabolite U1 in the pyraflufen ethyl soil
metabolism and soil photolysis studies
conducted by PTRL
Determination of rates of decline for
pyraflufen-ethyl and its metabolites in soil
according to the guidance within the FOCUS
Kinetics Guidance Document. Report No.
1007738.UK0/EWC0008
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
Determination of rates of decline for
pyraflufen-ethyl and its metabolites in soil
according to the guidance within the FOCUS
Kinetics Guidance Document. Report No.
1007738.UK0/EWC0008
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
Determination of rates of decline for
pyraflufen-ethyl and its metabolites in soil
according to the guidance within the FOCUS
Kinetics Guidance Document. Report No.
1007738.UK0/EWC0008
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
Determination of rates of decline for E-2 and
E-3 (metabolites of pyraflufen-ethyl) in soil
according to the guidance within the FOCUS
Kinetics Guidance Document
Report No. 1007738.UK0/EWC0009
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
Data
Owner
Protection
Claimed
Y/N
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
33
Annex
point(s)
Author(s)
Year
Title
Data
Owner
Source
Protection
Report ID
Claimed
GLP or GEP status
Y/N
Published or not
IIA 7.3.1/1
Callow, B & 2012c Determination of rates of decline for
Y
NNC
Mamouni,
pyraflufen ethyl and its metabolites, E-1 and
A.
E-3, in field dissipation studies according to
the guidance within the FOCUS Kinetics
Guidance Document
Report No. 1007738.UK0/EWC0010
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
IIA 7.3.1/4/
Callow, B & 2014 Determination of rates of decline for
Y
NNC
Hilton, M.
pyraflufen-ethyl and its metabolites in soil in
IIA 7.2.1/9)
response to the EFSA request dated
26 May 2014, according to the guidance
within the FOCUS Kinetics Guidance
Document
IIA 7.7/1
Mead, C.
1998 Et-751: Assessment of ready biodegradability
Y
NNC
CO2 evolution test; Report No. E-5033
Safepharm Laboratories Limited P.O. Box 45
Derby. U.K.
GLP
Not Published
Y
NNC
IIA 7.8.3/1
Callow, B & 2012d Determination of rates of decline for
Mamouni,
pyraflufen and its metabolites in a sedimentA.
water study in soil according to the guidance
within the FOCUS Kinetics Guidance
Document;
Report No. 1007738.UK0/EWC0011
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
NNC = Nihon Nohyaku Co. Ltd
References for the PPP (OS-169)
Annex
point(s)
Author(s)
Year
Title
Source
Report ID
GLP or GEP status
Published or not
Data
Protection
Claimed
Y/N
Owner
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
34
Annex
Author(s)
Year
point(s)
Title
Source
Report ID
GLP or GEP status
Data
Owner
Protection
Claimed
Y/N
Published or not
IIIA 9.6.1/1
Callow, B &
2012e Predicted environmental concentrations in
Mamouni,
groundwater for pyraflufen ethyl and its
A.
metabolites using the FOCUS groundwater
Y
NNC
Y
NNC
Y
NNC
scenarios and the PEARL 4.4.4 model.
Report No. 1007738.UK0/EWC0015
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
IIIA 9.6.2/1
Callow, B &
2012e Predicted environmental concentrations in
Mamouni,
groundwater for pyraflufen ethyl and its
A.
metabolites using the FOCUS groundwater
scenarios and the PEARL 4.4.4 model.
Report No. 1007738.UK0/EWC0015
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
IIIA 9.7.1/1
Callow, B &
2012f
Predicted environmental concentrations of
Mamouni,
pyraflufen ethyl and its metabolites in surface
A.
water after use on potatoes using the FOCUS
surface water scenarios.
Report No. 1007738.UK0/EWC0016
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
35
Annex
Author(s)
Year
point(s)
Title
Source
Report ID
GLP or GEP status
Data
Owner
Protection
Claimed
Y/N
Published or not
IIIA 9.7.1/2
Callow, B &
2012g Predicted environmental concentrations of
Mamouni,
pyraflufen ethyl and its metabolites in surface
A.
water after use on vines using the FOCUS
Y
NNC
Y
NNC
Y
NNC
Y
NNC
surface water scenarios.
Report No. 1007738.UK0/EWC0019
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
IIIA 9.8.1/1
Callow, B &
2012f
Predicted environmental concentrations of
Mamouni,
pyraflufen ethyl and its metabolites in surface
A.
water after use on potatoes using the FOCUS
surface water scenarios.
Report No. 1007738.UK0/EWC0016
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
IIIA 9.8.1/2
Callow, B &
2012g Predicted environmental concentrations of
Mamouni,
pyraflufen ethyl and its metabolites in surface
A.
water after use on vines using the FOCUS
surface water scenarios.
Report No. 1007738.UK0/EWC0019
Exponent International Ltd., The Lenz,
Hornbeam, Business Park, Harrogate, HG2
8RE UK.
Non GLP
Not Published
IIIA 9.7.1/3/
Callow, B &
2014
Predicted Environmental Concentrations
IIIA 9.8.1/3
Montesano,
(PEC) of Pyraflufen ethyl and its metabolites in
V.
surface water after use on potatoes and vines
using the FOCUS surface water scenarios
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
36
NNC = Nihon Nohyaku Co. Ltd
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
37
A.9
Effects on non-target organisms
References for the active substance (from the original DAR)
Author(s)
Year
Candolfi, M.P.
1996a IIA, 8.3.2/01
EXP31279A: Laboratory Toxicity Test with the
Parasitic Wasp Aphidius rhopalosiphi (Hymenoptera:
Braconidae) based on the IOBC Method of Polgar
(1988)
Rhône-Poulenc Agrochimie, Report no: 96-032-1013
1996b IIA, 8.3.2/02
EXP31279A: Laboratory Contact Toxicity Test with
the Predacious Mite, Typhlodromus pyri Scheuten
(Acari: Phytoseiidae), based on the IOBC Approved
Method of Overmeer (1988)
Rhône-Poulenc Agrochimie, Report no: 96-037-1013
1995a IIA, 8.2.1/01
ET-751: Acute toxicity to rainbow trout
(Oncorhynchus mykiss)
Nihon Nohyaku, Report No: W-5003
1995b IIA, 8.2.1/02
ET-751: Acute toxicity to bluegill sunfish (Lepomis
macrochirus)
Nihon Nohyaku, Report No: W-5002
1996a IIA, 8.2.1/03
E-1: Acute toxicity to rainbow trout (Oncorhynchus
mykiss)
Nihon Nohyaku, Report No: W-5017
1996b IIA, 8.2.1/04
E-1: Acute toxicity to bluegill sunfish (Lepomis
macrochirus)
Nihon Nohyaku, Report No: W-5018
1996a IIA, 8.2.2.2
E-1: Chronic toxicity to fathead minnow (Pimephales
promelas) embryos and larvae
Nihon Nohyaku, Report No: W-5029
1996b IIA, 8.2.4/01
ET-751: Acute toxicity to Daphnia magna
Nihon Nohyaku, Report No: W-5020
1996c IIA, 8.2.4/02
E-1: Acute toxicity to Daphnia magna
Nihon Nohyaku, Report No: W-5016
1996d IIA, 8.2.5
E-1: Chronic toxicity to Daphnia magna
Nihon Nohyaku, Report No: W-5026
1997 IIA, 8.5
Assessment of the side effects of ET-751 technical
on the activity of the soil microflora
Nihon Nohyaku, Report No: N-5011
Candolfi, M.P.
Caunter, J.E.
Magor, S.E.
Croudace, C.P.
Caunter, J.E.
Magor, S.E.
Croudace, C.P.
Caunter, J.E.
Johnson, P.A.
Croudace, C.P.
Caunter, J.E.
Cornish, S.K.
Croudace, C.P.
Croudace, C.P.
Caunter, J.E.
Wallace, S.J.
Croudace, C.P.
Banner, A.J.
Johnson, P.A.
Croudace, C.P.
Banner, A.J.
Johnson, P.A.
Croudace, C.P.
Williams, N.J.
Shearing, J.M.
Dengler, D.
Annex IIA Point
Title
Company, Report No.
GLP Publishe Owne
GEP
d
r
or not
Y/N
Y/N
Y
N
RPA
Y
N
RPA
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
38
Author(s)
Year
Annex IIA Point
Title
Company, Report No.
Grinell, A.J.
1996 IIA, 8.2.3
Croudace, C.P.
E-1: Determination of the accumulation and
14
Caunter, J.E.
elimination of [ C]E-1 in rainbow trout
Gillings, E.
(Oncorhynchus mykiss)
Nihon Nohyaku, Report No: W-5030
Morgan, D.J.
1996 IIA, 8.2.6/01
ET-751: Toxicity to the green alga Selenastrum
Croudace, C.P.
capricornutum
Magor, S.E.
Nihon Nohyaku, Report No: W-5024
Nengel, S.
1996 IIA, 8.3.1.1
Assessment of side effects of ET-751 Technical to
the honey bee, Apis mellifera L. in the laboratory
following the EPPO guideline No.170
Nihon Nohyaku, Report No: N-5010
Odin-Feurtet,
1998 IIA 8.2.6
M.
E2 : Freshwater algal growth inhibition study (72 h)
(Selenastrum capricornutum)
Rhône-Poulenc, Report No : 603459
Pascual, J.
1998 IIA 8.2
Position paper : Pyraflufen-ethyl : Risk to fish,
daphnids and algae from metabolite E2
Smyth, D.V.
1996a IIA, 8.2.6/03
ET-751: Toxicity to the freshwater diatom Navicula
Croudace, C.P.
pelliculosa
Johnson, P.A.
Nihon Nohyaku, Report No: W-5021
Smyth, D.V.
1996b IIA, 8.2.6/04
E-1: Toxicity to the green alga Selenastrum
Croudace, C.P.
capricornutum
Wallace, S.J.
Nihon Nohyaku, Report No: W-5015
Smyth, D.V.
1996c IIA, 8.2.6/06
E-1: Toxicity to the freshwater diatom Navicula
Croudace, C.P.
pelliculosa
Johnson, P.A.
Nihon Nohyaku, Report No: W-5022
Smyth, D.V.
1996d IIA, 8.2.8
E-1: Toxicity to duckweed (Lemna gibba)
Croudace, C.P.
Magor, S.E.
Nihon Nohyaku, Report No: W-5025
Smyth, D.V.
1997a IIA, 8.2.6/02
ET-751: Toxicity to the green alga Selenastrum
Croudace, C.P.
capricornutum
Wallace, S.J.
Nihon Nohyaku, Report No: W-5031
Smyth, D.V.
1997b IIA, 8.2.6/05
E-1: Toxicity to the green alga Selenastrum
Croudace, C.P.
capricornutum
Magor, S.E.
Nihon Nohyaku, Report No: W-5034
Standens-Peek, 1997 IIA, 8.1.3
W.M.M.
Reproduction study in mallard duck with ET-751
Leopold, M.A.
techn.
Nihon Nohyaku, Report No.: W-5032
van Dreumel,
1995a IIA, 8.1.1
I.F.
Acute oral toxicity study in bobwhite quail with ETLeopold, M.A.
751 techn.
Nihon Nohyaku, Report No.: W-5010
GLP Publishe Owne
GEP
d
r
or not
Y/N
Y/N
Y
N
NN
Y
N
NN
Y
N
NN
N
N
RPA
N
N
RPA
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
Y
N
NN
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
39
Author(s)
Year
van Dreumel,
I.F.
Leopold, M.A.
1995b IIA, 8.1.2/02
5-day dietary toxicity study in mallard duck with ET751 techn.
Nihon Nohyaku, Report No.: W-5011
1996 IIA, 8.1.2/01
5-day dietary toxicity study in bobwhite quail with ET751 techn.
Nihon Nohyaku, Report No.: W-5019
1996 IIA, 8.4.1
Acute toxicity of ET-751 Technical on earthworms,
Eisenia foetida using an artificial soil test
Nihon Nohyaku, Report No: N-5007
van Dreumel,
I.F. Reijnders,
J.B.J.
Wachter, S.
Annex IIA Point
Title
Company, Report No.
GLP Publishe Owne
GEP
d
r
or not
Y/N
Y/N
Y
N
NN
Y
N
NN
Y
N
NN
References for the active substance (submitted for renewal of the active)
Annex
point(s)
Author(s)
Year
IIA 8.1.4/1
Frieling,
W.J.A.M.
2000
IIA 8.2.1.3/1
Sousa, J.V.
2001a
IIA 8.2.1.3/2
Cafarella,
M.A.
2000a
IIA 8.2.4/1
Sousa, J.V.
2001b
IIA 8.3.1.3/1
Putt, A.E.
2001
Title
Data
Source
Protection
Syngenta ID
Claimed
GLP or GEP status
Y/N
Published or not
Reproduction study in bobwhite quail
Y
With pyraflufen-ethyl technical (by dietary admixture)
Report No. W-5052
NOTOX B.V.Hambakenwetering 35231 DD 'sHertogenbosch, The Netherlands
GLP
Not Published
ET-751 – Acute toxicity to sheepshead minnow
Y
(Cyprinodon variegatus) under flow-through
conditions; Report No. W-5054
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
E-1 – Acute toxicity to sheepshead minnow
Y
(Cyprinodon variegatus) under static conditions;
Report No. W-5049
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 – The toxicity to fathead minnow
Y
(Pimephales promelas) during an early life-stage
exposure; Report No. W-5059
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 – Acute toxicity to Mysids (Americamysis
Y
bahia) under flow-through conditions;
Report No. W-5053
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
Owner
NNC
NNC
NNC
NNC
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
40
Annex
point(s)
Author(s)
Year
IIA 8.3.1.3/2
Cafarella,
M.A.
2000b
IIA 8.3.1.4/1
Dionne, E.
2000a
IIA 8.3.1.4/2
Dionne, E.
2000b
IIA 8.3.2.1/1
Cafarella,
M.A.
2000c
IIA 8.4/1
Yaginuma,
S.
2011
IIA 8.4/2
Ikuta, J
2012
IIA 8.4/3
Wenzel, A.
2012
IIA 8.5.2/1
Odin-Feurtet,
M
1998
Title
Source
Syngenta ID
GLP or GEP status
Published or not
E-1 – Acute toxicity to Mysids (Mysidopsis bahia)
under static conditions;
Report No. W-5048
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 – Acute toxicity to Eastern Oyster
(Crassostrea virginica) under flow-through
conditions; Report No. W-5055
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
E-1 – Acute toxicity to Eastern Oyster (Crassostrea
virginica) under static (recirculated) conditions;
Report No. W-5051
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 – Full life cycle toxicity test with water fleas
(Daphnia magna) under flow-through conditions;
Report No. W-5058
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
Algal growth inhibition test of the pyraflufen-ethyl
Metabolite E-3; Report No. N-5071
Nihon Nohyaku General Research Center
345 Oyamada-cho, Kawachinagano-shi, Osaka
GLP
Not Published
Algal growth inhibition test of the pyraflufen-ethyl
photolysis product, PD-1;
Report No. Gc-13, 12-0038
Nihon Nohyaku General Research Center
345 Oyamada-cho, Kawachinagano-shi, Osaka
GLP
Not Published
Freshwater Alga, Growth Inhibition Test - Effect of
Pyraflufen-ethyl on the growth of several fresh water
algae species; Fraunhofer Institute for Molecular
Biology and Applied Ecology (IME), Auf dem Aberg
1, 57392 Schmallenberg, Germany
IME Study No. NIN-001/4-30
GLP
Not Published
ET-751 Toxicity to the sediment dwelling chironomid
larvae – 28 days – (Chironomus riparius);
Report No. W-5037
Rhone-Poulenc Agrochimie, Centre de Recherche
355, rue Dostoievski, BP 153, F-06903 Sophia
Antipolis Cedex, France
GLP
Not Published
Data
Protection
Claimed
Y/N
Owner
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
41
Annex
point(s)
Author(s)
Year
IIA 8.6/1
Hoffmann, K.
and Wydra,
V.
2012a
IIA 8.6/2
Hoffmann, K.
and Wydra,
V.
2012b
IIA 8.8.1.1/1
Nienstedt,
K.M.
2000a
IIA 8.8.1.2/1
Nienstedt,
K.M.
2000b
IIA 8.8.1.3/1
Nienstedt,
K.M.
2000c
IIA 8.8.1.3/2
Nienstedt,
K.M.
2000d
IIA 8.8.1.4/1
Nienstedt,
K.M.
2001
IIA 8.8.2.1/1
Bruhnke, C.
2002a
Title
Source
Syngenta ID
GLP or GEP status
Published or not
Toxicity of Pyraflufen-ethyl to the aquatic plant
Lemna gibba in a static growth inhibition test
Ibacon Report No. 71621240
IBACON GmbH, Arheilger Weg 17D-64380
Rossdorf, Germany
GLP
Not Published
Toxicity of Pyraflufen-ethyl to the aquatic plant
Myriophyllum aquaticum in a static growth inhibition
test; Ibacon Report No. 71622245
IBACON GmbH, Arheilger Weg 17D-64380
Rossdorf, Germany
GLP
Not Published
ET-751 2.5% EC(N): acute toxicity test with the
parasitic wasp, Aphidius rhopalosiphi (hymenoptera:
braconidae); Report No. N-5016
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5% EC(N): laboratory contact toxicity test
with the predacious mite, Typhlodromus pyri
scheuten (Acari, phytoseidae); Report No. N-5015
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5 % EC(N): laboratory acute toxicity test
with Poecilus cupreus L. (Coleoptera: Carabidae);
Report No. N-5027
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5 % EC(N): acute toxicity test with spider,
Paradosa sp. (Araneae: Lycosidae); Report No. N5031
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5% EC(N): laboratory contact toxicity test
with Chrysoperla carnea steph. (Neuroptera:
Chrysopidae); Report No. N-5032
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5%EC(N): Extended laboratory test on
adults of Aphidius rhopalosiphi, exposed to barley
plants (limit-test); Report No. N-5039
Dr.u.Noack-Laboratorium For angewanote biologie,
Kathe-paulus-str. 1D-31157 Sarstedt, Germany
GLP
Not Published
Data
Protection
Claimed
Y/N
Owner
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
42
Annex
point(s)
Author(s)
Year
IIA 8.8.2.2/1
Bruhnke, C.
2002b
IIA 8.9.1/1
Stabler, D.
2009a
IIA 8.9.1/2
Stabler, D.
2009b
IIA 8.9.2/1
Lührs, U.
1998
IIA 8.9.2/2
Stäbler, D
2009c
IIA 8.10.1/1
Stäbler, D
2009d
IIA 8.10.1/2
Stäbler, D
2009e
IIA 8.10.2/1
Stäbler, D
2009d
IIA 8.10.2/2
Stäbler, D
2009e
Title
Data
Source
Protection
Syngenta ID
Claimed
GLP or GEP status
Y/N
Published or not
ET-751 2.5%EC(N): Extended laboratory test on
Y
Typhlodromus pyri (Acari: Phytoseiidae), exposed to
treated soybean leaves (limit-test); Report No. N5038
Dr.u.Noack-Laboratorium For angewanote biologie,
Kathe-paulus-str. 1D-31157 Sarstedt, Germany
GLP
Not Published
Acute toxicity of E-2 standard on earthworms,
Y
Eisenia fetida, using an artificial soil test; Report No.
N-5064
Eurofins-GAB GmbH, Eutinger Str. 24, D-75223
Niefern-Öshelbronn, Germany
GLP
Not Published
Acute toxicity of E-3 standard on earthworms,
Y
Eisenia fetida using an artificial soil test; Report No.
N-5066
Eurofins-GAB GmbH, Eutinger Str. 24, D-75223
Niefern-Öshelbronn, Germany
GLP
Not Published
Effects of Pyraflufen-ethyl (ET-751) on reproduction
Y
and growth of earthworms Eisenia fetida (Savigny
1826) in artificial soil; Report No. N-5012
IBACON GmbH. Industriestrasse 1D-64380,
Rossdorf, Germany
GLP
Not Published
Sublethal toxicity of E-3 standard to the earthworm
Y
Eisenia fetida in artificial soil; Report No. N-5067
Eurofins-GAB GmbH, Eutinger Str. 24, D-75223
Niefern-Öshelbronn, Germany
GLP
Not Published
Assessment of the side effects of E-2 standard on
Y
the activity of the soil microflora; Report No. N-5065
Eurofins-GAB GmbH, Eutinger Str. 24, D-75223
Niefern-Öshelbronn, Germany
GLP
Not Published
Assessment of the side effects of E-3 standard on
Y
the activity of the soil microflora; Report No. N-5068
Eurofins-GAB GmbH, Eutinger Str. 24, D-75223
Niefern-Öshelbronn, Germany
GLP
Not Published
Assessment of the side effects of E-2 standard on
Y
the activity of the soil microflora; Report No. N-5065
Eurofins-GAB GmbH, Eutinger Str. 24, D-75223
Niefern-Öshelbronn, Germany
GLP
Not Published
Assessment of the side effects of E-3 standard on
Y
the activity of the soil microflora; Report No. N-5068
Eurofins-GAB GmbH, Eutinger Str. 24, D-75223
Niefern-Öshelbronn, Germany
GLP
Not Published
Owner
NNC
NNC
NNC
NNC
NNC
NNC
NNC
NNC
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
43
Annex
point(s)
Author(s)
Year
IIA 8.12/1
Teixeira, D
2000a
IIA 8.12/2
Teixeira, D
2000b
IIA 8.12/3
Teixeira, D
2000c
IIA 8.15/1
Mead C.
1998
Title
Data
Source
Protection
Syngenta ID
Claimed
GLP or GEP status
Y/N
Published or not
ET-751 2.5% EC-determination of effects on
Y
vegative vigor of ten plant species; Report No. N5014
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5% EC(N)-determination on effects on
Y
seedling emergence of ten plant species; Report No.
N-5021.
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5% EC-determination of effects of multiple
Y
applications on early seedling growth of ten plant
species; Report No. N-5013
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
Pyraflufen-ethyl: assessment of the inhibitory effect
Y
on the respiration of activated sewage sludge; SPL,
Report No. W-5038
Rhone-Poulenc Agrochimie, Centre de Recherche
355, rue Dostoievski, BP 153, F-06903 Sophia
Antipolis Cedex, France
GLP
Not Published
Owner
Title
Source
Syngenta ID
GLP or GEP status
Published or not
96-hour acute toxicity study in rainbow trout with
OS-159 2.5%EC(N) (static); Report No. W-5072
NOTOX B.V.Hambakenwetering 35231 DD 'sHertogenbosch, The Netherlands
GLP
Not Published
ET-751 2.5% EC(N) – Acute Toxicity to Rainbow
Trout (Oncorhynchus mykiss) Under Flow-Through
Conditions;
Report No. W-5050
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
Data
Protection
Claimed
Y/N
Owner
Y
NNC
Y
NNC
NNC
NNC
NNC
NNC
References for the PPP (OS-169)
Annex
point(s)
Author(s)
Year
IIIA 10.2.2.1/1
Bouwman,
L.M.
2006a
IIIA 10.2.2.1/2
Sousa, J.V.
2000a
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
44
Annex
point(s)
Author(s)
Year
IIIA 10.2.2.1/3
Sousa, J.V.
2000b
IIIA 10.2.2.2/1
Collins, M.K.
1997
IIIA 10.2.2.2/2
Cafarella,
M.A.
2000d
IIIA 10.2.2.2/3
Bouwman,
L.M.
2006b
IIIA 10.2.2.3/1
Hoberg, J.R.
2000a
IIIA 10.2.2.3/2
Hoberg, J.R.
2000b
IIIA 10.2.2.3/3
Hoberg, J.R.
2000c
IIIA 10.2.2.3/4
Hoberg, J.R.
2000d
Title
Data
Source
Protection
Syngenta ID
Claimed
GLP or GEP status
Y/N
Published or not
ET-751 2.5% EC(N) – Acute Toxicity to Bluegill
Y
Sunfish (Lepomis macrochirus) Under Flow-Through
Conditions;
Report No. W-5046
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
OS-159 2.5%EC (N) - Acute Toxicity to Daphnids
Y
(Daphnia magna) Under Static Conditions; Report
No. W-5036
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5% EC(N) - Acute Toxicity to Water Fleas
Y
(Daphnia magna) Under Flow-Through Conditions
Report No. W-5047
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
Acute Toxicity Study in Daphnia magna with OS-159
Y
2.5%EC(N) (Static); Report No. W-5071
NOTOX B.V.Hambakenwetering 35231 DD 'sHertogenbosch, The Netherlands
GLP
Not Published
ET-751 2.5% EC(N) - Acute Toxicity to the
Y
Freshwater Blue-Green Alga (Anabaena flosaquae); Report No. N-5022
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5% EC(N) - Acute Toxicity to the Marine
Y
Diatom, Skeletonema costatum; Report No. N-5023
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5% EC(N) - Acute toxicity to the
Y
Freshwater Green Alga (Pseudokirchneriella
subcapitata); Report No. N-5024
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5% EC(N) - Acute Toxicity to the
Y
Freshwater Diatom (Navicula pelliculosa); Report
No. N-5025
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
Owner
NNC
NNC
NNC
NNC
NNC
NNC
NNC
NNC
Pyraflufen-ethyl – List of information, tests and studies relied upon – January 2016
45
Annex
point(s)
Author(s)
Year
IIIA 10.2.2.3/5
Bouwman,
L.M.
2006c
IIIA 10.4.2.1/1
Nienstedt,
K.M.
2000e
IIIA 10.4.2.2/1
Nienstedt,
K.M.
2000e
IIIA 10.6.2/1
Teixeira, D.
2000d
IIIA 10.7.1/1
Van der Kolk
2001
IIIA 10.8.2.1/1
Hoberg, J.R.
2000e
Title
Source
Syngenta ID
GLP or GEP status
Published or not
Fresh water algal growth inhibition test with OS-159
2.5% EC(N); Report No. W-5058
NOTOX B.V.Hambakenwetering 35231 DD 'sHertogenbosch, The Netherlands
GLP
Not Published
ET-751 2.5% EC(N): Laboratory acute oral and
contact toxicity test with the honeybee, Apis
mellifera; Report No. N-5028
Springborn Laboratories (Europe) AG, Seestrasse
21, CH-9326 Horn, Switzerland
GLP
Not Published
ET-751 2.5% EC(N): Laboratory acute oral and
contact toxicity test with the honeybee, Apis
mellifera; Report No. N-5028
Springborn Laboratories (Europe) AG, Seestrasse
21, CH-9326 Horn, Switzerland
GLP
Not Published
ET-751 2.5% EC(N): Acute toxicity to earthworms
(Eisenia foetida); Report No. N-5020
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
ET-751 2.5% EC(N): Determination of the effects on
soil microflora activity; Report No. N-5037
Springborn Laboratories (Europe) AG, Seestrasse
21, CH-9326 Horn, Switzerland
GLP
Not Published
ET-751 2.5% EC – Toxicity to Duckweed, Lemna
gibba; Report No. N-5026
Springborn Laboratories Inc., 790 Main Street,
Wareham, Massachusetts, USA
GLP
Not Published
Data
Protection
Claimed
Y/N
Owner
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC
Y
NNC