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AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY Application Summary for Application No 60514
Page 1
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 1 of 12
Application Summary 2
Application Details:
Application
Purpose and
Description of
Use:
Approval of Momfluorothrin for use in Agricultural Chemical Products.
Reference
Active/Product Number
Reference Active/Product Name
69332
Active No:
MOMFLUOROTHRIN
Active Name:
SUMITOMO CHEMICAL AUSTRALIA PTY LIMITED
Applicant Name:
Description of Data Provided
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
78966
79023
79022
Chem1
Tox23
Tox22
Foster, B.
Sommer, E.W.
Shutoh, Y.
S-1563PAI: Determination of Physical
State, Colour and Odour
S-1563: 13-Week Neurotoxicity (Feeding)
Study in Rats.
Acute Oral Neurotoxicity Study in Rats.
2012
2011
2012
-
-
-
Applicant
Applicant
Applicant
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
Page 2
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 2 of 12
Application Summary 2
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
79021
79020
79019
79018
79017
79024
79016
Tox21
Tox20
Tox19
Tox18
Tox17
Tox24
Tox16
Tanaka, J.
Kitamato, S.
Wollny, H-E.
Kitamota, S.
Kitamoto, S.
Boobis, A.R.,
Cohen, S.M.,
Dellarco, V.,
McGregor, D.,
Meek, M.E.,
Vickers, C.,
Willcocks, D. and
Farland, W.
Iwashita, K.
In Vivo Unscheduled DNA Synthesis
(UDS) Assay with S-1563 in Rat
Hepatocytes.
Micronucleus Test on S-1563 in Rats.
Gene Mutation Assay in Chinese
Hamster V79 Cells in Vitro (V79/HPRT)
with S-1563.
In vitro chromosomal aberration test on
S-1563 in Chinese hamster lung cells
(CHL/IU).
Reverse mutation test of S-1563 in
bacterial systems.
IPCS Framework for Analyzing the
Relevance of a Cancer Mode of Action
for Humans.
Study for effects on embryo-fetal
development of S-1563 administered
orally to rabbits.
2010
2010
2011
2009
2009
2006
2011
-
-
-
-
-
Critical Review in
Toxicology
-
Applicant
Applicant
Applicant
Applicant
Applicant
Public
Applicant
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
-
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
Page 3
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 3 of 12
Application Summary 2
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
79014
79013
79012
79011
79010
79009
79008
79015
Tox14
Tox13
Tox12
Tox11
Tox10
Tox9
Tox8
Tox15
Pal-Kutas, K.
Rached, E.
Sommer, E.W.
Rached, E.
Braun, L.
Sommer, E.W.
Deguchi, Y.
Izumi, H.
S-1563: Two-Generation Reproduction
Toxicity Study in the Han Wistar Rat.
S-1563: 104-Week Oncogenicity
(Feeding) Study in the Wistar Rat.
S-1563: 52-Week Chronic Toxicity
(Feeding) Study in the Wistar Rat.
S-1563: 78-Week Oncogenicity
(Feeding) Study in the CD-1 Mouse.
S-1563: 52-Week Repeated Dose Oral
(Capsule) Toxicity Study in the Beagle
Dog.
13-Week Repeated Dose Oral (Feeding)
Toxicity Study in the Wistar Rat Followed
by a 6-Week Recovery Period
Four-week repeated inhalation toxicity
study of S-1563 in rats.
Study on the effect of oral administration
of S-1563 on embryo-fetal development
in rats.
2012
2012
2011
2012
2012
2010
2011
2011
-
-
-
-
-
-
-
-
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
Page 4
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 4 of 12
Application Summary 2
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
79007
79025
79027
79043
79042
79041
79040
Tox7
Tox25
Tox27
Tox43
Tox42
Tox41
Tox40
Ogata, H.
Okuda, Y.
Okuda, Y.
Osimitz, T.G. and
Lake, B.G.
Lake, B.G.
Parkinson, A. and
Ogilive, B.W.
Holsapple, M.P.,
Pitot, H.C., Cohen,
S.H., Boobis, A.R.,
Klaunig, J.E.,
Pastoor, T.,
Dellarco, V.L. and
Dragan, Y.P.
A 28-Day Repeated Dose Dermal
Toxicity Study of S-1563 in Rats.
Study for Mode of Action Analysis for
Tumor Formation of S-1563 on Rat Liver
(1) - Time Course Analysis in Male Rats.
Study for Mode of Action Analysis for
Tumor Formation of S-1563 on Rat Liver
(3) - Time Course Analysis at High Dose
of S-1563 in Male Rats.
Mode-of-action analysis for induction of
rat liver tumors by pyrethrins: relevance
to human cancer risk.
Species differences in the hepatic effects
of inducers of CYP2B and CYP4A
subfamily forms: relationship to rodent
liver tumour formation.
Chapter 6: BioTransformation of
Xenobiotics.
Mode of Action in Relevance of Rodent
Liver Tumors to Human Cancer Risk.
2012
2012
2012
2009
2009
unknown
2006
-
-
-
Critical Reviews in
Toxicology
Xenobiotica
Casarett & Doull's
Toxicology: The
Basic Sciences of
Poisons ed. Curtis
D. Klaassen
TOXICOLOGICAL
SCIENCES
Applicant
Applicant
Applicant
Public
Public
Public
Public
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
-
-
-
-
Page 5
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 5 of 12
Application Summary 2
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
79039
79038
79037
79026
79036
79034
79033
Tox39
Tox38
Tox37
Tox26
Tox36
Tox34
Tox33
Whysner, J., Ross,
P.M. and Williams,
G.M.
Olsen, J.J.,
Schulgen, J.H.,
Boice Jr, J.D.,
Whysner, J., Travis,
L.B., Williams,
G.M., Johnson, F.B.
and McGee, J.O'D
Olsen, J.H., Boice
Jr, J.D., Jenson,
J.P.A. and
Fraumeni Jr, J.F.
Okuda, Y.
Yamada, T.
Yamada, T.
Yamada, T.
Phenobarbital Mechanistic Data and Risk
Assessment: Enzyme Induction,
Enhanced Cell Proliferation, and Tumor
Promotion.
Antiepilectic Treatment and Risk for
Hepatobiliary Cancer and Malignant
Lymphoma.
Cancer Among Epileptic Patients
Exposed to Anticonvulsant Drugs.
Study for Mode of Action Analysis for
Tumor Formation of S-1563 on Rat Liver
(2) - Analysis for Time Course, Dose
Response and Reversibility in Male Rats.
An Evaluation of the Human Relevance
of S-1563-induced Liver Tumors in Rats
Based on Mode of Actin.
Study for Mode of Action Analysis for
Effects of S-1563 on Male Mouse Liver -
Dose Response and Reversibility
Study for Mode of Action Analysis for
Effects of S-1563 on Male Mouse Liver -
Time Course Analysis.
1996
1995
1989
2012
2012
2012
2012
Pharmacol. Ther.
CANCER
RESEARCH
Journal of the
National Cancer
Institute
-
-
-
-
Public
Public
Public
Applicant
Applicant
Applicant
Applicant
-
-
-
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
Page 6
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 6 of 12
Application Summary 2
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
79032
79031
79030
79029
79028
79035
79006
Tox32
Tox31
Tox30
Tox29
Tox28
Tox35
Tox6
Okuda, Y.
Okuda, Y.
Okuda, Y.
Okuda, Y.
Okuda, Y.
Yamada, T.
Ota, M.
Comparison of the effects of S-1563 and
its metabolite Z-CMCA on replicative
DNA synthesis and CYP2B induction in
cultured rat and human hepatocytes.
Study for Mode of Action Analysis for
Tumor Formation of S-1563 on Rat Liver
(6) - In vitro evaluation for Role of
Nuclear Receptor CAR in S-1563 - and
its Metabolite Z-CMCA-induced
CYP/2B1/2 mRNA Expression of
Cultured Rat Hepatocytes.
Study for Mode of Action Analysis for
Effects of S-1563 on Thyroid Gland in
Male Rats.
Study for Mode of Action Analysis for
Tumor Formation of S-1563 on Rat Liver
(5) - Analysis for Time Course and Dose
Response in Female Rats.
Sutdy for Mode of Action Analysis for
Tumor Formation of S-1563 on Rat Liver
(4) - The 2nd Study for Dose Response
Analysis in Male Rats.
Study for Mode of Action Analysis for
Effects of S-1563 on Female Mouse Liver
- Time Course, Dose Response and
Reversibilty.
Skin sensitization test of S-1563 in
guinea pigs (Maximization Test)
2012
2012
2012
2012
2012
2012
2010
-
-
-
-
-
-
-
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
Page 7
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 7 of 12
Application Summary 2
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
79005
79004
78982
78981
78980
78979
78978
78977
Tox5
Tox4
Chem17
Chem16
Chem15
Chem14
Chem13
Chem12
Ota, M.
Ota, M.
Foster, B.
Leslie, S. and
Moseley, R.H.
Moseley, R.H.
Moseley, R.H.
Foster, B.
Foster, B.
Primary skin irritation test of S-1563 in
rabbits.
Primary eye irritation test of S-1563 in
rabbits.
S-1563PAI: Calculation of Henry's Law
Constant
S-1563RTZ: Evaluation of Vapour
Pressure
S-1563RTE: Evaluation of Vapour
Pressure
S-1563: Evaluation of Vapour Pressure
S-1563TGAI: Determination of pH
S-1563PAI: Evaluation of Spectroscopic
Properties
2011
2011
2012
2011
2011
2011
2011
2012
-
-
-
-
-
-
-
-
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
Page 8
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 8 of 12
Application Summary 2
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
78976
78983
78975
78973
78972
78971
78970
78969
Chem11
Chem18
Chem10
Chem8
Chem7
Chem6
Chem5
Chem4
Wright, D.R. and
Mesley, R.H.
Leslie, S. and
Moseley, R.H.
Moseley, R.H.
Moseley, R.H.
Foster, B. and
Moseley, R.H.
Foster, B. and
Moseley, R.H.
Moselely, R.H.
Moseley, R.H.
S-1563RTZ: Evaluation of Dissociation
Constant
S-1563: Development and Validation of
an Analytical Method, and Evaluation of
the Water Solubility
S-1563RTZ: Determination of the
Ultra-violet/Visible Spectrum
S-1563TGAI: Determination of
Ultra-violet/Visible Spectrum
S-1563TGAI: Determination of Relative
Density
S-1563PAI: Determination of Relative
Density
S-1563RTZ: Determination of
Melting/Boiling Point
S-1563RTE: Determination of
Melting/Boiling Point
2011
2010
2011
2011
2012
2012
2011
2011
-
-
-
-
-
-
-
-
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
Page 9
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 9 of 12
Application Summary 2
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
78968
78967
78974
78984
78985
78986
79003
79002
Chem3
Chem2
Chem9
Chem19
Chem20
Chem21
Tox3
Tox2
Moseley, R.H.
Foster, B.
Moseley, R.H.
Leslie, S. and
Moseley, R.H.
Leslie, S. and
Moseley, R.H.
Foster, B.
Deguchi, Y.
Deguchi, Y.
S-1563PAI: Determination of
Melting/Boiling Point
S-1563TGAI: Determination of Physical
State, colour and odour
S-1563RTE: Determination of
Ultra-violet/Visible Spectrum
S-1563RTE: Development and Validation
of an Analytical Method, and Evaluation
of the Water Solubility
S-1563RTZ: Development and Validation
of an Analytical Method, and Evaluation
of the Water Solubility
S-1563TGAI: Determination of Solvent
Solubility
Acute Inhalation Toxicity Study of S-1563
in Rats.
Acute Dermal Toxicity Study of S-1563 in
Rats.
2011
2012
2011
2010
2010
2011
2011
2010
-
-
-
-
-
-
-
-
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
Page 10
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 10 of 12
Application Summary 2
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
79001
79000
78999
78998
78997
78996
78995
78994
Tox1
Chem35
Chem34
Chem33
Chem32
Chem31
Chem30
Chem29
Deguchi, Y.
Tokunaga, T.
Anon
Minamisaki, T.
Hirota, M.
Foster, B. and
Crane, M.
Foster, B. and
Moseley, R.H.
Matoba, Y.
Acute Oral Toxicity Study of S-1563 in
Rats.
Enforcement Analytical Methods of
S-1563 Technical Material
Chromatograms for S-1563 active
ingredient and impurities
Preliminary Analysis of S-1563 Technical
Material
Description of Materials used to Produce
S-1563 Description of Production
PRocess of S-1563 Description of
Formation Impurities of S-1563
S-1563TGAI: Determination of Stability to
Metals and Metal Ions
S-1563TGAI: Determination of Thermal
Stability
Long-term Stability Study of S-1563
2010
2011
2013
2011
2012
2012
2012
2013
-
-
-
-
-
-
-
-
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
Page 11
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 11 of 12
Application Summary 2
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
78993
78992
78991
78990
78989
78988
78987
79044
Chem28
Chem27
Chem26
Chem25
Chem24
Chem23
Chem22
Met1
Foster, B.
Foster, B.
Foster, B.
Foster, B.
Ponte, M.
Wright, D.R. and
Moseley, R.H.
Wright, D.R. and
Moseley, R.H.
Mikata, K. (Tarui, H.
- english translation)
S-1563TGAI: Assessment of Oxidising
Properties
S-1563TGAI: Assessment of Explosive
Properties
S-1563TGAI: Determination of
Flammability and Auto-Flammability
S-1563TGAI: Determination of Surface
Tension
Hydrolysis of [14C]S-1563 in Buffered
Aqueous Solutions
S-1563RTZ: Evaluation of Octanol:water
partition coefficient
S-1563RTE: Evaluation of Octanol:water
partition coefficient
Amended Final Report 1: The Disposition
and Metablism of S-1563RTZ and
S-1563RTZ in Rats (a single
administration).
2011
2012
2012
2011
2011
2011
2011
2010
-
-
-
-
-
-
-
-
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
Applicant
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA
Page 12
AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITY
Application Summary for Application No 60514
Created on: 30 Oct 2013 04:12 PM
Page 12 of 12
Application Summary 2
Data No
Applicants
Reference
Author
Title
Date
Publication
Authorising Party
Auth Party
Contact Address
79045
Met2
Hayashi, K. (Tarui,
H. - English
translation)
Metabolism of S-1563RTZ in Rats -
Distribution, Metabolism and Excretion in
Rats after Repeated Oral Administration
2009
-
Applicant
51 RAWSON
STREET EPPING
NSW 2121
AUSTRALIA