For many applications, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to publish a summary of the application once the applicant has been notified that the application has been accepted for assessment. The summary will be removed once the application is finalised.

The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.

The summaries include details of the applications as specified in Divisions 2.1 and 2.2 of the regulations.

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Use the filter and links below to find and view application summaries.

Date

Application Date

Application No

Application Number

132222
Product/Active constituent Name

Application Product Name

VICTRATO TYMIRIUM technology Seed Treatment

Application details

Product name:

VICTRATO TYMIRIUM technology Seed Treatment

Product number:

91436

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Approval of cyclobutrifluram for use in agricultural chemical products in conjunction with the registration of a 200 g/L cyclobutrifluram suspension concentrate for seed treatment product for use on wheat and barley seed.

Description of data provided:

Data no
224381
Author
Jenniches, D and Das, R
Title
The Determination of SYN549522 and its Enantiomers, SYN547386 and SYN548941, in Formulation FS (200) by HPLC
Study date
04 September 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224382
Author
Khot, S
Title
A22940D - Validation of Analytical Method ST-70/1
Study date
31 July 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224375
Author
Khot, S
Title
A22940D - Chemical Characterisation of Batch SMU9HP001
Study date
31 July 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224376
Author
Khot, S
Title
A22940D - Physical and Technical Properties of Batch SMU9HP001
Study date
31 July 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224377
Author
Khot, S
Title
A22940D - Physico?chemical Characteristics of Batch SMU9HP001
Study date
31 July 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224378
Author
Jackson, W
Title
A22940D - Safety Study
Study date
13 March 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224379
Author
Khot, S
Title
Report on IR Spectra for A22940D [cyclobutrifluram FS (200)] formulation
Study date
07 August 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224383
Author
Patterson K
Title
A22940D Safety Data Sheets Cyclobutrifluram : 200 g/L FS
Study date
02/06/2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224387
Author
Patterson K
Title
Part 2 ? Chemistry & Manufacture
Study date
July 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224380
Author
Khot, S
Title
A22940D - Storage Stability and Shelf Life Statement (2 Weeks 54?C) in Packaging Made of HDPE according to CIPAC MT 46.3
Study date
08 August 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246903
Author
Treston, A.
Title
CLEO profiling against crown rot in wheat [AUSTRALIA]
Study date
26 January 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246904
Author
Treston, A.
Title
CLEO profiling against crown rot in wheat [AUSTRALIA]
Study date
1 January 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246905
Author
Todd, A.
Title
EXF10670V profiling against crown rot in wheat [AUSTRALIA]
Study date
15 January 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246906
Author
Gentle, J.
Title
CLEO profiling against crown rot in wheat [AUSTRALIA]
Study date
1 January 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246907
Author
Gentle, J.
Title
CLEO profiling against crown rot in wheat [AUSTRALIA]
Study date
16 January 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246908
Author
Schnippenkoetter, G.
Title
CLEO profiling against crown rot in wheat [AUSTRALIA]
Study date
9 February 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246909
Author
Landmeter, D.
Title
EXF10670 profiling against crown rot in wheat [AUSTRALIA]
Study date
20 December 2017
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246910
Author
Landmeter, D.
Title
EXF10670 profiling against crown rot in wheat [AUSTRALIA]
Study date
12 December 2017
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246911
Author
Todd, A.
Title
EXF10670V profiling against crown rot in wheat [AUSTRALIA]
Study date
15 January 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246912
Author
Kelly, M and Harvey, D
Title
CLEO profiling against crown rot in wheat. Bellata, NSW, 2017
Study date
24 January 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246913
Author
Clark, A and Harvey, D
Title
Efficacy and safety of seed applied CLEO for the control of crown rot in wheat. Moree, NSW, 2017
Study date
12 February 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246914
Author
Gentle, J.
Title
CLEO development for the control of crown rot in wheat [AUSTRALIA]
Study date
28 November 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246915
Author
Gentle, J.
Title
CLEO development for the control of crown rot in wheat [AUSTRALIA]
Study date
7 December 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246916
Author
Wherrett, A.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in wheat. Nukarni, WA 2019
Study date
2 November 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246917
Author
Wherrett, A.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in wheat. Yorkrakine, WA 2019
Study date
November 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246918
Author
Schnippenkoetter, G.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
2 May 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246919
Author
Schnippenkoetter, G.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
20 January 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246920
Author
Gentle, J.
Title
CLEO development for the control of crown rot in wheat
Study date
19 November 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246921
Author
Schnippenkoetter, G.
Title
CLEO development for the control of crown rot in wheat
Study date
30 January 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246922
Author
Schnippenkoetter, G.
Title
CLEO development for the control of crown rot in wheat
Study date
1 February 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246923
Author
Burgess, E.
Title
CLEO development for the control of crown rot in wheat. Horsham VIC 2018
Study date
21 February 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246924
Author
Rogan, M.
Title
CLEO development for the control of crown rot in wheat. Mt Tyson QLD 2018
Study date
18 March 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246925
Author
McIntosh, C.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in wheat and barley. Manangatang VIC 2019
Study date
30 January 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246926
Author
Landmeter, D.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
30 December 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246927
Author
Todd, A.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
31 December 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246928
Author
Cockburn, E and Lehmann, A.
Title
Bioequivalence of seed applied treatments for crown rot (Fusarium pseudograminearum) control in durum cv. Aurora
Study date
12 June 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246929
Author
Wherrett, A.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in barley. Nukarni, WA 2019
Study date
23 November 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246930
Author
Wherrett, A.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in barley. Yorkrakine, WA 2019
Study date
November 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246931
Author
Cockburn, E and Lehmann, A.
Title
Efficacy of A22417B 500 FS for the control of Crown Rot (Fusarium pseudograminearum) in barley cv. Scope
Study date
1 July 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246932
Author
Schnippenkoetter, G.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
30 May 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246933
Author
Schnippenkoetter, G.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
20 January 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246934
Author
Winkel, M.
Title
Efficacy and safety of seed applied CLEO for the control of crown rot in barley. Croppa Creek, NSW, 2019
Study date
9 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246935
Author
Gentle, J.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
29 November 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246936
Author
Smith, R.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
16 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246937
Author
Schnippenkoetter, G.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
23 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246938
Author
Allan, C.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
16 November 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246939
Author
Schnippenkoetter, G.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
31 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246940
Author
Landmeter, D.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
23 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246941
Author
Pannu, A.
Title
Efficacy and safety of seed applied treatments for the control of crown rot in cereals
Study date
11 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246942
Author
Clark, A.
Title
Bio-equivalence of seed applied treatments for the control of Crown Rot in wheat and barley. Gunnedah NSW, 2020.
Study date
18 February 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246943
Author
Gardner, M.
Title
Efficacy of seed applied SYN549522 for the control of Crown rot applied at 3 different concentrations in wheat, Rowena NSW
Study date
31 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246944
Author
Rogan, M.
Title
Efficacy and safety of seed applied treatments for the control of a Crown Rot/Root Lesion Nematode complex in wheat. Mt Tyson QLD 2019
Study date
11 February 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246945
Author
Wilson, A.
Title
Efficacy and safety of seed applied treatments for the control of a Crown Rot/Root Lesion Nematode complex in wheat
Study date
15 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246946
Author
Schnippenkoetter, G.
Title
Efficacy and safety of seed applied treatments for the control of Crown Rot and RLN in cereals
Study date
20 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246947
Author
Landmeter, D.
Title
Efficacy and safety of seed applied treatments for the control of Crown Rot and RLN in cereals
Study date
23 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246948
Author
Eulenstein, N.
Title
Efficacy and safety of seed treatments for the control of a Crown Rot/RLN complex in wheat. Mt Tyson QLD 2020
Study date
18 February 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246949
Author
Schnippenkoetter, G.
Title
Efficacy and safety of seed applied treatments for the control of Crown Rot and RLN in cereals
Study date
15 January 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246950
Author
Cockburn, E and Lehmann, A.
Title
Efficacy of A22417B 500 FS for the control of crown rot (Fusarium pseudograminearum) and root lesion nematode (Pratylenchus neglectus) in Durum cv. Spes
Study date
17 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246951
Author
Dababat, M and Orakei, G.
Title
Seed treatment to control the cereal cyst nematodes ?Heterodera filipjevi? and the dry land crown rot ?Fusarium culmorum? on wheat investigated in growth room and large plot studies using artificial infestation
Study date
14 August 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246952
Author
Roberts, S.
Title
VIBRANCE ? Fusarium seedborne disease control in wheat
Study date
31 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246953
Author
Treston, A.
Title
CLEO profiling against lesion and cyst nematodes in wheat [AUSTRALIA]
Study date
25 January 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246954
Author
Schnippenkoetter, G.
Title
CLEO profiling against lesion and cyst nematodes in wheat [AUSTRALIA]
Study date
25 March 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246955
Author
Schnippenkoetter, G.
Title
CLEO profiling against lesion and cyst nematodes in wheat [AUSTRALIA]
Study date
25 March 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246956
Author
Landmeter, D.
Title
EXF10670 profiling against lesion and cyst nematodes in wheat [AUSTRALIA]
Study date
20 December 2017
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246957
Author
Todd, A.
Title
CLEO profiling against lesion and cyst nematodes in wheat [AUSTRALIA]
Study date
23 May 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246958
Author
Todd, A.
Title
CLEO profiling against lesion and cyst nematodes in wheat [AUSTRALIA]
Study date
24 May 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246959
Author
Gentle, J.
Title
CLEO profiling against lesion and cyst nematodes in wheat [AUSTRALIA]
Study date
23 May 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246960
Author
Gentle, J.
Title
CLEO profiling against lesion and cyst nematodes in wheat [AUSTRALIA]
Study date
8 January 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246961
Author
Treston, A.
Title
CLEO evaluation for the control of Root Lesion Nematodes in wheat
Study date
25 January 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246962
Author
Treston, A.
Title
CLEO evaluation for the control of Root Lesion Nematodes in wheat
Study date
25 January 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246963
Author
Treston, A.
Title
CLEO evaluation for the control of Root Lesion Nematodes in wheat
Study date
25 January 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246964
Author
Schnippenkoetter, G.
Title
CLEO evaluation for the control of Root Lesion Nematodes in wheat
Study date
28 January 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246965
Author
Schnippenkoetter, G.
Title
CLEO evaluation for the control of Root Lesion Nematodes in wheat
Study date
23 January 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246966
Author
Landmeter, D.
Title
A-22417-B evaluation for the control of Root Lesion Nematodes in wheat
Study date
21 January 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246967
Author
Landmeter, D.
Title
A-22417-B evaluation for the control of Root Lesion Nematodes in wheat
Study date
31 January 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246968
Author
Todd, A.
Title
CLEO evaluation for the control of Root Lesion Nematodes in wheat
Study date
9 January 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246969
Author
Todd, A.
Title
CLEO evaluation for the control of Root Lesion Nematodes in wheat
Study date
9 January 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246970
Author
Wilson, A.
Title
Efficacy and safety of seed treatments for the control of Root Lesion Nematode in cereals, York, WA 2019
Study date
October 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246971
Author
Landmeter, D.
Title
Efficacy and safety of seed applied treatments for the control of RLN in cereals
Study date
14 December 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246972
Author
Schnippenkoetter, G.
Title
Efficacy and safety of seed applied treatments for the control of RLN in cereals
Study date
4 December 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246973
Author
Schnippenkoetter, G.
Title
Efficacy and safety of seed applied treatments for the control of RLN in cereals
Study date
26 May 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246974
Author
Mills, J and Lehmann, A.
Title
Efficacy of A22417B 500 FS for the control of root lesion nematode (Pratylenchus neglectus) in barley cv. Spartacus CL
Study date
5 August 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246975
Author
Landmeter, D.
Title
Efficacy and safety of seed applied treatments for the control of RLN in cereals
Study date
15 February 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246976
Author
Todd, A.
Title
Efficacy and safety of seed applied treatments for the control of RLN in cereals
Study date
20 November 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246977
Author
Bandano, M.
Title
Efficacy and safety of seed treatments for the control of Root Lesion Nematode in barley, Northam WA 2020
Study date
5 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246978
Author
Mills, J.
Title
Efficacy of various seed treatment formulations for root lesion nematode (Pratylenchus neglectus) control in barley cv. Spartacus CL
Study date
19 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246979
Author
Bandano, M.
Title
Efficacy and safety of seed treatments for the control of Root Lesion Nematode in wheat, Northam WA 2020
Study date
5 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246980
Author
Schnippenkoetter, G.
Title
Efficacy and safety of seed applied treatments for the control of RLN in cereals
Study date
31 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246981
Author
Pannu, A.
Title
Efficacy and safety of seed applied treatments for the control of RLN in cereals
Study date
11 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246982
Author
Eulenstein, N.
Title
Efficacy and safety of seed treatments for the control of Root Lesion Nematodes in cereals. Billa Billa QLD 2020
Study date
3 February 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246983
Author
McKee, K.
Title
Part 8 ? Efficacy and Crop Safety
Study date
8 July 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246833
Author
Roohi A
Title
SYN549522 - Aerobic Soil Metabolism of [Pyridinyl-2-14C-SYN549522
Study date
20 March 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246836
Author
Connor, S
Title
SYN549522 - Anaerobic Soil Metabolism of 14C-SYN549522
Study date
11 September 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246834
Author
Connor S
Title
SYN549522 ? Route and Rate of Degradation of [Phenyl-U-14C]-SYN549522 in Aerobic Soil
Study date
12 November 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246835
Author
Boultwood T and Garrod M
Title
SYN549522 ? Rate of Degradation of [Pyridinyl-2-14C]-SYN549522 on Intact Soil Cores
Study date
01 June 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246838
Author
Crabtree, G.
Title
SYN510275 - Rate of degradation of SYN510275 in aerobic soil
Study date
12 August 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246839
Author
Crabtree, G.
Title
SYN549104 - Rate of degradation of SYN549104 in aerobic soil
Study date
12 August 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246853
Author
Habeeb S.
Title
SYN549522 ? Route and Rate of Degradation of [14C] SYN549522 in Two Aerobic Water/Sediment Systems
Study date
25 April 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246854
Author
Connor, S
Title
SYN549522 ? Route and Rate of Degradation of [14C] SYN549522 in Two Anaerobic Water/Sediment Systems
Study date
23 April 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246840
Author
Gibbs, A., Rebstock, M., and Wiepke, T.
Title
SYN549422 SC (A22011B) - Dissipation of the Nematicide SYN549522 in Soil After an In-Furrow Application at Cotton Planting in the Central Valley of California, USA
Study date
24 November 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246841
Author
Gibbs, A., Rebstock, M., and Wiepke, T.
Title
SYN549422 SC (A22011B) - Dissipation of the Nematicide SYN549522 in Soil After an In-Furrow Application at Peanut Planting in the Coastal Plain of Georgia, USA
Study date
27 October 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246842
Author
Gibbs, A., Rebstock, M., and Wiepke, T.
Title
SYN549422 SC (A22011B) - Dissipation of the Nematicide SYN549522 in Soil After an In-Furrow Application at Potato Planting in the Columbia Basin of Washington State, USA
Study date
15 October 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246843
Author
Harrington, C. R. and Blanchard, D.
Title
SYN549522 SC (450) (A22011B) ? Dissipation Trial to Determine the Persistence and Leaching Movement of SYN549522 and any Significant Soil Degradates in Soil
Study date
01 September 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246844
Author
Gibbs, A., Lizotte, Jr., R., and Wiepke, T.
Title
SYN549522 SC (A22011B) - Dissipation of the Nematicide SYN549522 in Warm-Season Turfgrass in the Central Valley of California, USA
Study date
26 May 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246845
Author
Gibbs, A., Rutt, D., Lizotte, Jr., R., and Wiepke, T.
Title
SYN549522 SC (A22011B) - Dissipation of the Nematicide SYN549522 in a Warm-Season Turfgrass in Georgia, USA
Study date
20 April 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246846
Author
Moate, T.
Title
Frozen Storage Stability of SYN549522 and its Degradation Products in Turfgrass Clippings, Thatch-Sod, and Soil Matrices from a Georgia, Washington, and Canada Terrestrial Field Dissipation Study
Study date
24 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246847
Author
Hawkins T.
Title
SYN549522 ? Adsorption and Desorption of 14C SYN549522
Study date
24 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246848
Author
Habeeb S.
Title
SYN549522 ? Adsorption and Desorption Properties of [14C] SYN549522 in Japanese Volcanic Ash Soil, St Triphon Soil, and Hepler Soil
Study date
13 June 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246849
Author
Sutcliffe, R.
Title
SYN510275? Adsorption and Desorption Properties of [14C] SYN510275
Study date
19 July 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246850
Author
Sutcliffe, R.
Title
SYN549104 ?Adsorption and Desorption Properties of [14C] SYN549104
Study date
03 August 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246851
Author
Habeeb S.
Title
[14C]SYN549522 ? Hydrolysis in Sterile Buffer at pH 4, 7, and 9
Study date
03 May 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246852
Author
Yeomans P
Title
SYN549522 - Aqueous Photolysis of 14C-SYN549522
Study date
30 September 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246837
Author
Habeeb S.B.
Title
SYN549522 ? Soil Photolysis of [14C]-SYN549522
Study date
16 October 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246870
Author
Shaw, A.
Title
SYN549522 ? Acute Toxicity with Water Fleas (Daphnia magna) Under Static Conditions
Study date
3 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246871
Author
Helene Eckenstein
Title
SYN510275 ? Effect on Daphnia magna in a 48-Hour Immobilization Test
Study date
24 November 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246873
Author
Softcheck, K.
Title
SYN549522 ? 96-Hour Toxicity Test with the Freshwater Green Alga, Raphidocelis subcapitata
Study date
3 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246874
Author
Softcheck, K.
Title
SYN549522 ? 96-Hour Toxicity Test with the Freshwater Diatom, Navicula pelliculosa
Study date
17 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246875
Author
Softcheck, K.
Title
SYN549522 ? 96-Hour Toxicity Test with the Cyanobacterium, Anabaena flos-aquae
Study date
31 March 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246876
Author
Helene Eckenstein
Title
SYN510275 ? Effect on Raphidocelis subcapitata in a 96-Hour Algal Growth Inhibition Test
Study date
24 November 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246864
Author
Shaw, A.
Title
SYN549522 ? Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) Under Static Conditions
Study date
3 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246865
Author
Shaw, A.
Title
SYN549522 ? Acute Toxicity to Fathead Minnow (Pimephales promelas) Under Static Conditions
Study date
3 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246866
Author
Shaw, A.
Title
SYN549522 ? Acute Toxicity to Carp (Cyprinus carpio) Under Static Conditions
Study date
3 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246867
Author
Helene Eckenstein
Title
SYN510275 ? Acute Toxicity to Fathead Minnow (Pimephales promelas) in a 96-Hour Test
Study date
24 November 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246880
Author
Softcheck, K.
Title
SYN549522 ? 7-Day Toxicity Test with Duckweed (Lemna gibba)
Study date
31 March 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246892
Author
Shaw, A.
Title
SYN549522 ? Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under Static Conditions
Study date
3 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246893
Author
Ross, T. L., Perkins, K., Schneider, S. Z., Zhang, L.
Title
SYN549522 ? A 96-Hour Static Acute Toxicity Test with the Saltwater Mysid (Americamysis bahia)
Study date
22 July 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246894
Author
Softcheck, K.
Title
SYN549522 ? 96-Hour Toxicity Test with the Marine Diatom, Skeletonema costatum
Study date
3 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246895
Author
Shaw, A.
Title
SYN549522 ? Acute Toxicity Test to Eastern Oyster (Crassostrea virginica) Under Flow-Through Conditions
Study date
25 March 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246896
Author
Snow, B.
Title
SYN549522 ? 10-Day Toxicity Test Exposing Estuarine Amphipods (Leptocheirus plumulosus) to a Test Substance Applied to Sediment Under Intermittent-Renewal Conditions
Study date
6 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246897
Author
Marini, J
Title
SYN549522 ? Early Life-Stage Toxicity Test with Sheepshead Minnow (Cyprinodon variegatus)
Study date
8 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246898
Author
Milligan, A., Perkins, K., Schneider, S. Z., Zhang, L.
Title
SYN549522 ? A Flow-Through Life-Cycle Toxicity Test with the Saltwater Mysid (Americamysis bahia)
Study date
12 November 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246868
Author
Marini, JP
Title
SYN549522 ? Early Life-Stage Toxicity Test with Fathead Minnow (Pimephales promelas)
Study date
8 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246869
Author
Kang, S.
Title
[14C]SYN549522 ? Bioaccumulation in Bluegill Sunfish (Lepomis macrochirus): Aqueous Exposure
Study date
13 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246877
Author
Snow, B.
Title
SYN549522 ? 10-Day Toxicity Test Exposing Midge (Chironomus dilutus) to a Test Substance Applied to Sediment Under Intermittent-Renewal Conditions
Study date
6 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246878
Author
Snow, B.
Title
SYN549522 ? 10-Day Toxicity Test Exposing Freshwater Amphipods (Hyalella azteca) to a Test Substance Applied to Sediment Under Intermittent Renewal Conditions
Study date
6 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246879
Author
Valenti, T., Ma, H.
Title
Cyclobutrifluram (SYN549522) ? Justification for Submission of 10-Day (Sub-chronic) Whole Sediment Toxicity Tests as a Complete Database for Characterizing Potential Risk to Benthic Invertebrates
Study date
8 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246872
Author
Shaw, A.
Title
SYN549522 ? Full Life-Cycle Toxicity Test with Water Fleas (Daphnia magna) Under Static-Renewal Conditions
Study date
10 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246881
Author
Kling, A.
Title
SYN549522 - Acute Oral and Contact Toxicity to the Honey Bee, Apis mellifera L. under Laboratory Conditions
Study date
14 September 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246882
Author
Kling, A.
Title
SYN549522 - Honey Bee (Apis mellifera L.) Chronic Oral Toxicity Test 10 Day Feeding Test in the Laboratory
Study date
14 September 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246883
Author
Kling, A.
Title
SYN549522 - Honey bee (Apis mellifera L.) Larval Toxicity Test (Single Exposure)
Study date
14 September 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246884
Author
Kling, A.
Title
SYN549522 - Honey bee (Apis mellifera L.) 22 Day Larval Toxicity Test (Repeated Exposure)
Study date
14 September 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246888
Author
Friedrich S.
Title
SYN549522 - Acute Toxicity to the Earthworm Eisenia andrei in Artificial Soil.
Study date
3 July 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246889
Author
Friedrich S.
Title
SYN549522 - Sublethal Effects on the Reproduction of the Earthworm Eisenia andrei in Artificial Soil with 5 % Peat.
Study date
4 August 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246890
Author
Friedrich S.
Title
SYN549522 SC (A22011B) - Sublethal Effects on the Reproduction of the Earthworm Eisenia andrei in Artificial Soil
Study date
26 August 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246891
Author
Friedrich S.
Title
SYN549522 FS (A22417C) - Sublethal Effects on the Reproduction of the Earthworm Eisenia andrei in Artificial Soil
Study date
8 October 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246885
Author
Stevens, J.
Title
SYN549522 SC (A22011B) ? A laboratory study of the effects of fresh residues on the parasitic wasp Aphidius rhopalosiphi (Hymenoptera, Braconidae)
Study date
7 November 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246886
Author
Fallowfield L.
Title
SYN549522 SC (A22011B) ? A Rate-Response Laboratory Study to Determine the Effects of Fresh Residues on the Predatory Mite Typhlodromus pyri (Acari: Phytoseiidae)
Study date
11 November 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246887
Author
G?tz, K.
Title
SYN549522 FS (A22417C) - Effects on the Reproduction of the Predatory Mite Hypoaspis aculeifer
Study date
23 September 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
252033
Author
Schulz, L.
Title
SYN549522 - Effects on the Activity of Soil Microflora (Nitrogen and Carbon Transformation Tests)
Study date
01/04/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246899
Author
Bramby-Gunary, J.
Title
SYN549522 SC (A22011B) ? Evaluation of the Phytotoxicity to Non Target Terrestrial Plant Seedling Emergence and Seedling Growth Test
Study date
16 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246900
Author
Bramby-Gunary, J.
Title
SYN549522 SC (A22011B) ? Evaluation of the Phytotoxicity to Non Target Terrestrial Plant Vegetative Vigour Test
Study date
16 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246901
Author
Banman C.
Title
SYN549522 SC (A22011B) ? Determination of Residues in Cucumber Pollen and Nectar Following Soil Application
Study date
31 May 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246902
Author
Patterson, K.
Title
Part 7.2 ? Environmental Toxicology
Study date
June 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246857
Author
Hubbard P.M., Temple D.L.
Title
SYN549522 ? An acute oral toxicity study with the Mallard using a sequential testing procedure
Study date
13 March 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246858
Author
Hubbard P.M., Davies R.J., Temple D.L
Title
SYN549522 ? An Acute Oral Toxicity Study with the Canary Using a Sequential Testing Procedure
Study date
13 March 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246859
Author
Hubbard P.M., Temple D.L.
Title
SYN549522 ? An acute oral toxicity study with the Northern Bobwhite using a sequential testing procedure
Study date
13 March 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246860
Author
Hubbard P.M., Davis R.J., Temple D.L., Lockard L.
Title
SYN549522 ? A Dietary LC50 Study with the Northern Bobwhite
Study date
1 March 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246861
Author
Hubbard P.M., Davis R.J., Temple D.L., Lockard L.
Title
SYN549522 ? A Dietary LC50 study with the Mallard
Study date
1 March 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246862
Author
Hammett, K., Hubbard P.M., Temple D.L., Lockard L., Zhang L.
Title
SYN549522 ? A Reproduction Study with the Northern Bobwhite
Study date
21 February 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246863
Author
Hammett, K., Hubbard P.M., Temple D.L., Lockard L., Zhang L.
Title
SYN549522 ? A Reproduction Study with the Mallard
Study date
21 February 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224891
Author
APVMA
Title
Project Plan - Item 27 Timeshift
Study date
27 April 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224882
Author
M Libberton
Title
SYN549522 - The Absorption and Excretion of [Phenyl-U-14C] and [Pyridinyl-2-14C]-SYN549522 Following Single Oral and Intravenous Administration in the Rat
Study date
22/11/2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224883
Author
M Libberton
Title
SYN549522 - Tissue Depletion and Elimination of [Phenyl-U-14C] and [Pyridinyl-2-14C]-SYN549522 Following Single and Multiple Oral Administration in the Rat
Study date
25/02/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224884
Author
M Libberton
Title
SYN549522 - Pharmacokinetics of [Phenyl-U-14C]-SYN549522 and [Pyridinyl-2-14C]-SYN549522 Following Single Oral and Intravenous Administration in the Rat
Study date
22/11/2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224885
Author
A Strathdee, E Hickman
Title
SYN549522 - Biotransformation of [Phenyl-U-14C]-SYN549522 and [Pyridinyl-2-14C]-SYN549522 in the Rat
Study date
11/06/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224886
Author
M Dick, J Przeorska
Title
SYN549522 - Metabolism of [14C]-SYN549522 in the Lactating Goat
Study date
30/11/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224887
Author
M Dick
Title
SYN549522 - Metabolism of [14C]-SYN549522 in the Laying Hen
Study date
30/11/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224888
Author
K Patterson
Title
Metabolism Database - Cyclobutrifluram
Study date
01/07/21
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224890
Author
K Patterson
Title
Part 4 ? Metabolism & Toxicokinetics
Study date
July 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224878
Author
G Hobbs
Title
SYN549522 - Metabolism of [14C]-SYN549522 in Wheat
Study date
29/10/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224879
Author
M Shankey, K Begley, L Gilmour
Title
SYN549522 - Metabolism of [14C]-SYN549522 in Soybean
Study date
3/11/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224880
Author
M Shankey, K Begley, L Gilmour
Title
SYN549522 - Metabolism of [14C]-SYN549522 in Potatoes
Study date
6/11/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224881
Author
G Hobbs
Title
SYN549522 - Uptake and Metabolism of [14C]-SYN549522 in Confined Rotational Crops at 500g a.i/ha
Study date
26/11/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224384
Author
Stephen C, Kerr M
Title
SYN549522 FS (A22417C) - The In Vitro Percutaneous Absorption of Radiolabelled SYN549522 in Concentrate Formulation and Two In-Use Dilutions Through Human Split-Thickness Skin
Study date
12/10/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224385
Author
Stephen C, Kerr M
Title
SYN549522 FS (A22417C) - The In Vitro Percutaneous Absorption of Radiolabelled SYN549522 in Concentrate Formulation and Two In-Use Dilutions Through Rat Split-Thickness Skin
Study date
12/10/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224386
Author
Anonymous
Title
Safety Data Sheet ? SYN549522 FS (200)
Study date
01/06/2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224388
Author
Patterson K
Title
Part 6 ? Occupational Health and Safety
Study date
July 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246826
Author
L Mayer
Title
SYN549522 - Analytical Method GRM076.07A for the Determination of SYN549522 and its Metabolites SYN510260 and SYN510275 in Crops
Study date
14 October 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246827
Author
L Mayer
Title
SYN549522 - Analytical Method GRM076.08A for the Determination of Conjugated Metabolites SYN549104, SYN552677 (racemate of SYN552301), SYN552678 (racemate of SYN552441), SYN551636 and SYN551829 in Crops
Study date
2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246828
Author
L Mayer
Title
QuEChERS Method GRM076.10A for the Determination of SYN549522 and its Metabolite SYN510275 in Commodities of Animal Origin
Study date
1 September 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246829
Author
Paula Piedade Rabello
Title
SYN549522 - Validation of Analytical Methods GRM076.07A and GRM076.11A for the Determination of Residues of SYN549522 and Its Metabolites SYN510275, SYN510260 and Conjugated SYN549104 in Crops by LC-MS/MS
Study date
23 September 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246830
Author
Emily Vogl
Title
Method Validation of SYN549522 - QuEChERS method GRM076.10A for the Determination of SYN549522 and its Metabolite SYN510275 in Commodities of Animal Origin
Study date
1 September 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258247
Author
L Mayer
Title
SYN549522 - Analytical Method GRM076.14A for the Determination of SYN549522 and its Metabolites SYN510275, SYN549104, SYN552415, SYN552439 and SYN552442 in Commodities of Animal Origin
Study date
07/08/2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258248
Author
A Dwamena
Title
SYN549522 - Analytical Method GRM076.14A Validation of SYN549522 and its Metabolites SYN510275, SYN549104, SYN552415, SYN552439, and SYN552442 in Commodities of Animal Origin
Study date
28/04/2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
255125
Author
E Vogl
Title
Method Validation in Representative Crops of ?SYN549522 ? Analytical Method GRM076.08A for the Determination of Conjugated Metabolites SYN549104, SYN552677 (racemate of SYN552301), SYN552678 (racemate of SYN552441), SYN551636 and SYN551829 in Crops?
Study date
08/09/2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258246
Author
R Smith
Title
Cyclobutrifluram - Magnitude of the Residues in Milk and Tissues of Lactating Dairy Cows Following Oral Administration of SYN549522
Study date
05/07/2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
255126
Author
J Brown, A Ascough
Title
Determination of SYN549522 and metabolite residues in cereal foliage, seed and stubble following seed treatment with A-22940-D or A-22417-B
Study date
20/04/2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246824
Author
N Pinny, M Miller
Title
Determination of residues in cereal forage, grain and straw following the seed treatment with A-22417-B
Study date
16 July 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246825
Author
J Brown, A Ascough
Title
Determination of SYN549522 and metabolite residues in cereal foliage, seed and stubble following seed treatment with A-22940-D or A-22417-B
Study date
2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258249
Author
A Dwamena
Title
Frozen Storage Stability of SYN549522 and its Metabolites SYN510275, SYN549104, SYN552415, SYN552439, and SYN552442 in Milk and Bovine Tissues and Eggs
Study date
31/05/2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258250
Author
P Rabello
Title
SYN549522- Stability of SYN549522 and its metabolites SYN510260, SYN510275 and SYN549104 in Crop Matrices under Freezer Storage Conditions ? Brazil, 2020-2022 ? Final Report
Study date
21/07/2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258251
Author
Patterson K
Title
Part 5A - Residues - additional studies
Study date
August 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246831
Author
Paula Piedade Rabello
Title
SYN549522- Stability of SYN549522 and its metabolites SYN510260, SYN510275 and SYN549104 in Crop Matrices under Freezer Storage Conditions ? Brazil, 2020-2022
Study date
29 July 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246832
Author
Patterson, K.
Title
Part 5A ? Residues
Study date
December 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224808
Author
Y Jia
Title
Acute Dermal Toxicity Study of SYN549522B 200FS (A22940D) in Rats
Study date
21/10/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224800
Author
A Appl
Title
SYN549522 SC (A22011B) - Acute Dermal Toxicity Study in Rats
Study date
16/01/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224802
Author
M Weisz
Title
SYN549522 SC (A22011B) - Acute Eye Irritation Study in Rabbits
Study date
16/01/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224803
Author
I Orosz
Title
SYN549522 SC (A22011B) - In Vitro Eye Irritation Test in Isolated Chicken Eyes
Study date
6/11/2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224809
Author
Y Jia
Title
Acute Eye Irritation/Corrosion Study of SYN549522B 200FS (A22940D) in Rabbits
Study date
21/10/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224801
Author
J Durando
Title
SYN549522 SC (A22011B) - Acute Inhalation Toxicity in Rats
Study date
4/01/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224799
Author
A Appl
Title
SYN549522 SC (A22011B) - Acute Oral Toxicity Study in Rats (Up and Down Procedure)
Study date
3/01/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224807
Author
N Chang
Title
Acute Oral Toxicity Study of SYN549522B 200FS (A22940D) in Rats
Study date
22/07/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224810
Author
Y Jia
Title
Acute Dermal Irritation/Corrosion Study of SYN549522B 200FS (A22940D) in Rabbits
Study date
21/10/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224804
Author
M Weisz
Title
SYN549522 SC (A22011B) - Primary Skin Irritation Study in Rabbits
Study date
16/01/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224805
Author
I Orosz
Title
SYN549522 SC (A22011B) - In Vitro Skin Irritation Test in the EPISKIN TM Model
Study date
24/10/2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224806
Author
J Durando
Title
SYN549522 SC (A22011B) - Local Lymph Node Assay (LLNA) in Mice
Study date
3/01/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224811
Author
N Chang
Title
Skin Sensitisation Study of SYN549522B 200FS (A22940D) in Guinea Pigs (Buehler Method)
Study date
22/07/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224820
Author
B Robertson
Title
SYN549522 - 80 Week Mouse Oral (Dietary) Carcinogenicity Study
Study date
31/08/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224821
Author
H Blunt, C Pottle
Title
SYN549522 - Oral (Dietary) Two-Generation Reproduction Toxicity Study in the Rat
Study date
13/08/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224819
Author
B Robertson
Title
SYN549522 - 104 Week Rat Oral (Dietary) Carcinogenicity Study with a Combined 52 Week Toxicity Study
Study date
27/08/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224822
Author
C Pottle
Title
SYN549522 - Oral (Gavage) Prenatal Developmental Toxicity Study in the Rat
Study date
13/08/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224823
Author
K Fincher, L Britton
Title
SYN549522 - Oral (Gavage) Prenatal Developmental Toxicity Study in the Rabbit
Study date
11/01/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224824
Author
S Chang
Title
SYN549522 - Salmonella typhimurium and Escherichia coli Reverse Mutation Assay
Study date
29/08/2016
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224825
Author
M Schulz
Title
SYN549522 - Salmonella typhimurium and Escherichia coli Reverse Mutation Assay
Study date
16/02/2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224826
Author
S Chang
Title
SYN549522 tech. (batch 05455-ASC-170) - Salmonella typhimurium and Escherichia coli Reverse Mutation Assay
Study date
21/01/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224827
Author
S Chang
Title
SYN549522 tech. (batch 05455-ASC-199) - Salmonella typhimurium and Escherichia coli Reverse Mutation Assay
Study date
21/01/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224828
Author
S Chang
Title
SYN549522 tech. (batch 05455-ASC-237) - Salmonella typhimurium and Escherichia coli Reverse Mutation Assay
Study date
22/01/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224829
Author
S Chang
Title
Cyclobutrifluram - Salmonella typhimurium and Escherichia coli Reverse Mutation Assay
Study date
15/12/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224830
Author
S Chang
Title
SYN549522 - Chromosome Aberration Test in Human Lymphocytes In Vitro
Study date
3/08/2016
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224831
Author
A Sokolowski
Title
SYN549522 - Cell Mutation Assay at the Thymidine Kinase Locus (TKP+/-) in Mouse Lymphoma L5178Y Cells
Study date
22/03/2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224832
Author
H Wollny
Title
SYN549522 - Cell Mutation Assay at the Thymidine Kinase Locus (TK +/-) in Mouse Lymphoma L5178Y Cells
Study date
15/08/2016
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224833
Author
S Naumann
Title
SYN549522 - Micronucleus Test in Human Lymphocytes In Vitro
Study date
16/02/2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224834
Author
S Naumann
Title
SYN549522 tech. - Micronucleus Test in Human Lymphocytes In Vitro
Study date
20/08/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224835
Author
S Naumann
Title
Cyclobutrifluram - Micronucleus Test in Human Lymphocytes In Vitro
Study date
16/12/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224836
Author
J Dunton
Title
SYN549522 - Oral (Gavage) Rat Micronucleus Test
Study date
7/02/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224872
Author
S Naumann
Title
SYN510275 - Micronucleus Test in Human Lymphocytes In Vitro
Study date
24/09/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224838
Author
B Orovecz
Title
CA5879A - In Vitro Skin Corrosivity Test in the EPISKINTM Model
Study date
17/12/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224839
Author
P Thompson
Title
CA5879 tech. - Reverse Mutation Assay ?Ames Test? using Salmonella typhimurium and Escherichia coli
Study date
13/03/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224840
Author
L Flanders
Title
CA5879 tech - V79 HPRT Gene Mutation Assay
Study date
29/09/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224841
Author
A Morris
Title
CA5879 tech.- Micronucleus Test in Human Lymphocytes in vitro
Study date
25/08/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224842
Author
B Orovecz
Title
CA5980A - In Vitro Skin Corrosivity Test in the EPISKINTM Model
Study date
17/12/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224843
Author
S Chang
Title
CA5980 tech. - Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay
Study date
22/04/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224844
Author
C Lowe
Title
CA5876 Acute Oral Toxicity - Up-And-Down Procedure in Rats
Study date
27/11/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224845
Author
J Gijsbrechts
Title
CA5876 - Bovine Corneal Opacity and Permeability Test
Study date
11/02/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224846
Author
B Orovecz
Title
CA5876 - In Vitro Skin Irritation Test in the EPISKIN TM Model
Study date
6/03/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224847
Author
J Reinen
Title
CA5876A - In Chemico Determination of the Skin Sensitization Potential of CA5876A using the Direct Peptide Reactivation Assay (DPRA)
Study date
21/02/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224848
Author
A Aubert
Title
CA5876A - Human-Cell Line Activation Test (h-CLAT)
Study date
11/06/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224849
Author
A Aubert
Title
CA5876 - Keratinosens Test An In Vitro Skin Sensitisation Assay
Study date
17/06/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224850
Author
B Gilby
Title
CA5876 tech. - Bacterial Reverse Mutation Test
Study date
21/11/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224851
Author
B Gilby
Title
CA5876 tech. - In Vitro HPRT Mutation Test Using Chinese Hamster Ovary Cells
Study date
7/01/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224852
Author
B Gilby
Title
CA5876 tech. - In Vitro Micronucleus Test in Human Lymphocytes
Study date
2/12/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224853
Author
A Appl
Title
CA5865A - Acute Oral Toxicity Study in Rats (Up and Down Procedure)
Study date
29/09/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224854
Author
J Gijsbrechts
Title
CA5865A - Bovine Corneal Opacity and Permeability Test
Study date
3/03/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224855
Author
B Orovecz
Title
CA5865A - In Vitro Skin Irritation Test in the EPISKINTM Model
Study date
7/02/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224856
Author
B Orovecz
Title
CA5865A - In Vitro Skin Corrosivity Test in the EPISKINTM Model
Study date
25/06/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224857
Author
J Reinen
Title
CA5865A - In Chemico Determination of the Skin Sensitization Potential of CA5865A using the Direct Peptide Reactivity Assay (DPRA)
Study date
12/03/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224858
Author
A Aubert
Title
CA5865A - Human-Cell Line Activation Test (h-CLAT) an In Vitro Skin Sensitisation Assay
Study date
16/07/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224859
Author
A Aubert
Title
CA5865A - Keratinosens Test An In Vitro Skin Sensitisation Assay
Study date
16/07/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224860
Author
S Chang
Title
CA5865 tech. - Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay
Study date
6/03/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224861
Author
C Lowe
Title
CA5542 - Acute Oral Toxicity - Up-And-Down Procedure in Rats
Study date
10/09/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224862
Author
J Gijsbrechts
Title
CA5542 - Bovine Corneal Opacity and Permeability Test
Study date
28/10/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224863
Author
B Orovecz
Title
CA5542 tech. - In Vitro Skin Irritation Test in the EPISKINTM Model
Study date
8/10/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224864
Author
B Orovecz
Title
CA5542 - In Vitro Skin Corrosivity Test in the EPISKINTM Model
Study date
15/08/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224865
Author
J Reinen
Title
CA5542A - In Chemico Determination of the Skin Sensitization Potential of CA5542A using the Direct Peptide Reactivity Assay (DPRA)
Study date
21/04/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224866
Author
M Grignard-Racinet
Title
CA5542 tech. - Human-Cell Line Activation Test (h-CLAT) an In Vitro Skin Sensitization Assay
Study date
18/08/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224867
Author
M Grignard-Racinet
Title
CA5542 tech. - Keratinosens Test An In Vitro Skin Sensitisation Assay
Study date
29/06/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224868
Author
I Woods
Title
CA5542 tech. - Bacterial Reverse Mutation Test
Study date
5/12/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224869
Author
I Woods
Title
CA5542 tech.- In Vitro Micronucleus Test in Human Lymphocytes
Study date
5/12/2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224870
Author
I Woods
Title
CA5542 tech. - In Vitro HPRT Mutation Test Using Chinese Hamster Ovary Cells
Study date
10/02/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224871
Author
S Chang
Title
SYN510275 - Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay
Study date
1/09/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224877
Author
K Patterson
Title
Toxicological Database - Cyclobutrifluram
Study date
28/05/2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224889
Author
K Patterson
Title
Part 3 ? Toxicology
Study date
July 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224812
Author
B Robertson
Title
SYN547386 - 28 Day Dietary Toxicity Study in Rats
Study date
17/11/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224813
Author
B Robertson
Title
SYN547386 - 28 Day Dietary Toxicity Study in Mice
Study date
1/04/2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224814
Author
L Coleman
Title
SYN549522 - A 28 Day Oral (Capsule) Toxicity Study in the Dog
Study date
6/04/2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224815
Author
S Cooper
Title
SYN549522 tech - Toxicity Study by Dermal Administration to Han Wistar Rats for 4 Weeks
Study date
21/04/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224873
Author
E Murie
Title
Cyclobutrifluram - A 28 Day Dietary Liver Mode of Action Study in Male CD-1 Mice
Study date
18/02/2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224874
Author
S Plummer
Title
Cyclobutrifluram - Mouse Liver Toxicogenomics Study to Test the Dose-Dependency of Pathways Affected by Treatments
Study date
15/01/2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224875
Author
C Omiecinski
Title
SYN549522 - CAR3 Transactivation Assay with Mouse, Rat and Human CAR
Study date
9/03/2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224876
Author
C Haines
Title
SYN549522 - In-Vitro Inhibition or Rat Thyroperoxidase (TPO) - Catalysed Guaiacol Oxidation
Study date
6/05/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224837
Author
J Shearer
Title
SYN549522 - Neurotoxicity Study by a Single Oral Administration to Han Wistar Rats Followed by a 14 Day Observation Period
Study date
8/09/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224816
Author
L Coleman
Title
SYN549522 - 90 Day Oral (Dietary) Toxicity Study in Rats
Study date
23/07/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224817
Author
L Coleman
Title
SYN549522 - 90 Day Oral (Dietary) Toxicity Study in Mice
Study date
8/05/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
224818
Author
B Robertson
Title
SYN549522 - A 13 Week Oral (Capsule) Toxicity Study in Dogs with Toxicokinetics
Study date
13/10/2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246855
Author
Peffer, R.C., Peranginangin, N., Simmons, D., Maul J., Harrington, C., Johnson, D.
Title
Toxicological and Environmental Non-Relevance of Trifluoracetic Acid ? Assessment with Respect to SYN549522
Study date
10 April 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
246856
Author
Patterson, K.
Title
Part 7.1 ? Environmental Chemistry & Fate
Study date
May 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

131144
Product/Active constituent Name

Application Product Name

S-methoprene

Application details

Product name:

S-methoprene

Active name:

S-methoprene

Applicant Name:

AGRO-ALLIANCE (AUSTRALIA) PTY LTD

Application purpose and description of use:

Approval of (S)-methoprene for use in agricultural and veterinary chemical products.

Description of data provided:

Data no
219697
Author
Yeming Zhang
Title
Qualitative and Quantitative Analysis of S-(+)-METHOPRENE Technical
Study date
9 April 2021
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
219698
Author
L Ye
Title
New source of S-(+)-Methoprene technical
Study date
10 May 2021
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
219699
Author
L Ye
Title
S-methoprene - DoC
Study date
28 April 2021
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
233591
Author
Anon
Title
Quantitative Analysis of Cis-methoprene in S-(+)-methoprene Tech.
Study date
15 December 2021
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
233592
Author
Anon
Title
Response to APVMA Queries
Study date
15 December 2021
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
238038
Author
Anon
Title
Explanation - 2022-05-09
Study date
16 May 2022
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date

Application Date

Application No

Application Number

106073
Product/Active constituent Name

Application Product Name

SOMETRIBOVE ZINC

Application details

Product name:

SOMETRIBOVE ZINC

Product number:

82564

Applicant Name:

ELANCO ANIMAL HEALTH A DIV OF ELI LILLY AUST PTY LTD

Reference details:

70120 - ELANCO POSILAC
Date

Application Date

Application No

Application Number

62556
Product/Active constituent Name

Application Product Name

ELANCO POSILAC

Application details

Product name:

ELANCO POSILAC

Product number:

70120

Applicant Name:

ELANCO ANIMAL HEALTH A DIV OF ELI LILLY AUST PTY LTD

Application purpose and description of use:

Registration of a 500 mg/syringe sometribove zinc injection product for increased milk production in lactating dairy cows, in conjunction with approval of sometribove zinc [HASBZ/70120].

Description of data provided:

Data no
95783
Author
Anon
Title
Determination of the appearance of sometribove zinc powder
Study date
2009
Data no
95784
Author
Carroll K, Elmore E
Title
Electrophoretic Profile Gel Densitometry (SDS-PAGE/reduced)
Study date
2010
Data no
95785
Author
Bussey BE
Title
Aqueous size exclusion HPLC assay
Study date
2009
Data no
95786
Author
Mulch A
Title
Kinetic LAL assay of sometribove zinc (ZnbST) bulk powder
Study date
2009
Data no
95787
Author
Anon
Title
Determination of the water content in sometribove zinc bulk powder
Study date
2009
Data no
95788
Author
Pack L
Title
Zinc determination in unbuffered, lyophilized sometribove zinc (ZnbST) by atomic absorption
Study date
2008
Data no
95789
Author
Opfer S
Title
Reduced RP-HPLC assay for bST process streams
Study date
2008
Data no
95790
Author
Anon
Title
Tryptic Map Analysis of Sometribove Zinc Bulk Powder by RP-HPLC
Study date
2009
Data no
95791
Author
Bussey BE
Title
Determination of N-Formyl-BST and Norleucyl 123-BST in Bulk ZnBST Powder by Reversed-Phase HPLC
Study date
2008
Data no
95792
Author
Bussey BE
Title
Spectrophotometric determination of urea in bulk ZnbST or bST
Study date
2009
Data no
95793
Author
Myers S
Title
Modified USP Sterility Testing for Sterile ZnBST Bulk Powder
Study date
2009
Data no
95794
Author
EF Elmore
Title
Certificate of Analysis - Sometribove Zinc Bulk Powder
Study date
7 Nov 2011
Data no
95795
Author
E.F. Elmore
Title
Certificate of Analysis - Sometribove Zinc Bulk Powder
Study date
7 Nov 2011
Data no
95796
Author
E.F. Elmore
Title
Certificate of Analysis - Sometribove Zinc Bulk Powder
Study date
7 Nov 2011
Data no
95797
Author
George D
Title
Examination of the manufacturers working cell bank for purity
Study date
2009
Data no
95798
Author
George D, Elmore E
Title
Adventitious organism screening of recombinant E. coli fermentation samples
Study date
2010
Data no
95799
Author
Anon
Title
Stability Data Summary for Sometribove Zinc bulk powder at -15oC.
Study date
2009
Data no
95800
Author
Anon
Title
Determination of Zinc in Posilac Syringes
Study date
2008
Data no
95801
Author
Hendrix J
Title
Particle Size Determination of Sometribove Zinc Suspension
Study date
2009
Data no
95802
Author
Hendrix J
Title
Viscosity Measurement of Sometribove Zinc Formulated Product by Means of Large-Cone Rotation Viscometry
Study date
2009
Data no
95803
Author
Bussey BE
Title
In Vitro Dissolution of Sometribove Zinc Suspension According to the Disk Method
Study date
2008
Data no
95804
Author
Bussey BE
Title
Non-reduced assay (RP-HPLC) for in process, ZnbST bulk powder and sometribove zinc suspension samples
Study date
2008
Data no
95805
Author
Anon
Title
Determination of the Appearance of Sometribove Zinc Suspension
Study date
2008
Data no
95806
Author
J.J. Triska, J.W. Cagney, M.L.V. Gotangco, T.A. Stanley
Title
Analytical Technology Reference Guide to Summary of Validation Activity
Study date
7 Mar 2005
Data no
95807
Author
J Jeng
Title
Dissolution of ZnBST SO/ALMS formulation using a paddle over Teflon device
Study date
23 June 1994
Data no
95977
Author
Paula L Pettig
Title
Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
23-Aug-1995
Data no
95979
Author
Anon
Title
Appendix H Stability Summary: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
23 Aug 1995
Data no
95980
Author
Anon
Title
Appendix J Freeze/Thaw Stability: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
18 Jul 1994
Data no
95982
Author
Sheri Bensoni, Donnagail Carr, Howard Seligsohn, James Triska
Title
3140.301 RP-HPLC Assay for ZnBST Bulk Powder, Bulk Posilac (r) and Posilac (r) S
Study date
24-Jun-2000
Data no
95983
Author
Sheri Benson, Donnagail Carr, Pam Suemnicht, Kathleen Hieb, Howard Selisohn
Title
Validation Report for Analytical Method 3140.301
Study date
19-Jan-2001
Data no
95984
Author
Paula Pettig
Title
Protocol: Supplement to the Validation Protocol for Monsanto Analytical Method No. 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
15 Mar 1994
Data no
95808
Author
Clark C
Title
Batch 2009600033 Formulation / Filling production batch record
Study date
2009
Data no
95809
Author
E.F. Elmore
Title
Certificate of Analysis - POSILAC 500 mg/unit dose
Study date
1 Nov 2011
Data no
95810
Author
E.F. Elmore
Title
Certificate of Analysis - POSILAC 500 mg/unit dose
Study date
1 Nov 2011
Data no
95811
Author
E.F. Elmore
Title
Certificate of Analysis - POSILAC 500 mg/unit dose
Study date
1 Nov 2011
Data no
95812
Author
Bussey BE
Title
Determination of Content Uniformity and Uniformity of Fill of Sometribove Zinc Suspension Disposable Syringes
Study date
2009
Data no
95813
Author
Myers S
Title
Modified USP Sterility Testing for Posilac (Sterile Sometribove Zinc Suspension) Syringes
Study date
2009
Data no
95976
Author
Richard A Dunbar
Title
Validation Addendum Protocol: Validation Addendum to Method 2-32-403: RP-HPLC for In-Process, ZnbST Bulk Powder and Sometribove Zinc Suspension Syringes
Study date
10-Dec-2012
Data no
95981
Author
Anon
Title
Appendix A: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
23 Aug 1995
Data no
95978
Author
Anon
Title
Figure 8 Accuracy- Weighted Analysis of Variance: Supplement to the Validation Report for Analytical Method 402.305, HPLC Analysis of BST and ZnBST Bulk Powder
Study date
07-Jun-1994
Data no
95814
Author
Anon
Title
Stability data summary for process qualification
Study date
2007
Data no
95841
Author
Dohoo IR, Leslie K, DesCoteaux L, Fredeen A, Dowling P, Preston A, Shewfelt W
Title
A meta-analysis review of the effects of recombinant bovine somatotropin 1. Methodology and effects on production
Study date
2003
Authorising party
Public
Auth party contact address
-
Data no
95842
Author
Dohoo IR, DesCoteaux L, Leslie K, Fredeen A, Shewfelt W, Preston A, Dowling P
Title
A meta-analysis review of the effects of recombinant bovine somatotropin 2. Effects on animal health, reproductive performance, and culling
Study date
2003
Authorising party
Public
Auth party contact address
-
Data no
95843
Author
St-Pierre NR, Miliken GA, Bauman DE, Collier RJ, Hogan JS, Shearer JK, Smith L, Thatcher WW
Title
Production and health effects of sometribove zinc suspension (recombinant bovine somatotropin) in lactating dairy cows
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
95844
Author
McDougall S, Rhodes F
Title
Comparison of New Zealand and Australian production systems, mastitis prevalence, incidence and bacterial pathogens
Study date
2011
Data no
95845
Author
Bauman DE
Title
Bovine somatotropin: review of an emerging animal technology
Study date
1992
Authorising party
Public
Auth party contact address
-
Data no
95846
Author
Thomas JW, Erdman RA, Galton DM, Lamb RC, Arambel MJ, Olson JD, Madsen KS, Samuels WA, Peel CJ, Green GA
Title
Responses by lactating cows in commercial dairy herds to recombinant bovine somatotropin
Study date
1991
Authorising party
Public
Auth party contact address
-
Data no
95847
Author
Bauman DE, Everett RW, Weiland WH, Collier RJ
Title
Production responses to bovine somatotropin in northeast dairy herds
Study date
1999
Authorising party
Public
Auth party contact address
-
Data no
95848
Author
Carriquiry M, Weber WJ, Dahlen CR, Lamb GC, Baumgard LH, Vincini JL, Crooker BA
Title
Production response of multiparous Holstein cows treated with bovine somatotropin and fed n-3 fatty acids in early lactation
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
95849
Author
Lynch JM, Barbano DM, Bauman DE, Hartnell GF, Nemeth MA
Title
Effect of a Prolonged-Release Formulation of N-Methionyl Bovine Somatotropin (Sometribove) on Milk Fat
Study date
1992
Authorising party
Public
Auth party contact address
-
Data no
95850
Author
Sullivan JL, Huber JT, DeNise SK, Hoffman RG, Kung L Jr, Franson SE, Madsen KS
Title
Factors affecting response of cows to biweekly injections of sometribove
Study date
1992
Authorising party
Public
Auth party contact address
-
Data no
95851
Author
VanBaale MJ, Ledwith DR, Thompson JM, Burgos R, Collier RJ, Baumgard LH
Title
Effect of increased milking frequency in early lactation with or without recombinant bovine somatotropin
Study date
2005
Authorising party
Public
Auth party contact address
-
Data no
95852
Author
Fike JH, Staples CR, Sollenberger LE, Moore JE, Head HH
Title
Southeastern pasture-based dairy systems: housing, Posilac, and supplemental silage effects on cow performance
Study date
2002
Authorising party
Public
Auth party contact address
-
Data no
95853
Author
Bargo F, Muller LD, Altman NS
Title
Milk response to bovine somatotropin of high producing dairy cows with three different feeding systems combining pasture and total mixed rations
Study date
2003
Authorising party
Public
Auth party contact address
-
Data no
95854
Author
Bauman DE, Vernon RG
Title
Effects of exogenous bovine somatotropin on lactation
Study date
1993
Authorising party
Public
Auth party contact address
-
Data no
95855
Author
White TC, Eppard PJ, Lanza GM, Ganguli S, Mitchell JW, Duque JA, Hintz RL, Miller MA, Franson SE, Chmielewski MA, Hartnell GF, Ryan RL, Morgan FW
Title
Report MSL 6532: Preliminary Dose Determination for Weekly Administration of the CP115099 Prolonged Release Formulation in Lactating Dairy Cows
Study date
27 April 1987
Data no
95856
Author
Lanza GM, menke PT, Ganguli S, Ribas JL, Hintz RL, Duque JA, Eppard PJ, Mitchell JW, Hartnell GF, Ryan RL, Morgan FW
Title
Report MSL 4936: A preliminary range finding study to determine the dose response profile of the standard CP115099 prolonged release formulation, 40% ZnMBS / 5% ALMS/SO in lactating dairy cows
Study date
25 February 1986
Data no
95857
Author
Menke PT, Lanza GM, Madsen KS, Hartnell GF, Hard DL, White TC, Eppard PJ, Ribas JL, Ganguli S, Mitchell JW, Hintz RL
Title
Report MSL 7051: Initial dose determination of CP115099-F in lactating dairy cows - terminated after seven 14-day treatment cycles
Study date
15 September 1987
Data no
95858
Author
Vincini JL, Eppard PJ, Lanza GM, Hudson S, Miller MA, Cole WJ, White TC, Nemeth MA, Abel, KM, Duque JA, Hintz RL, Hartnell GF, Madsen KS, Ribelin WE
Title
Report MSL 8140: Assessment of the effective range of CP115099-F in lactating primiparous and multiparous dairy cows
Study date
2 September 1988
Data no
95859
Author
Vincini JL, Cole WJ, McCrate MM, Sorbet RH, Madsen KS, Hintz RL, Eppard PJ
Title
Report MSL 8140 (Supplement): Assessment of the effective range of CP115099-F in lactating primiparous and multiparous dairy cows - additional health analyses
Study date
18 January 1990
Data no
95860
Author
Hartnell GF, Franson SE, Bauman DE, Head HH, Huber JT, Lamb RC, Madsen KS, Cole WJ, Hintz RL
Title
Evaluation of Sometribove in a Prolonged-Release system in lactating dairy cows - production responses
Study date
1991
Authorising party
Public
Auth party contact address
-
Data no
95861
Author
Franson SE, Cole WJ, Madsen KS, Hartnel GF, Hoffman RG, Meserole VK, Sprick DM, Dyer SE, Collier RJ, Hintz RL
Title
Report MSL 9607: Response of Cows Throughout Lactation to Sometribove, in a Prolonged Release System. A Dose Titration Study, conducted at four US sites
Study date
18 January 1991
Data no
95862
Author
Hard DL, Franson SE, Huber JT, Bauman DE, Samuels WA, Lamb RC, Cole WJ, Hartnell GF, Hintz RL
Title
Report MSL 7183: Long term evaluation of zinc methionyl bovine somatotropin treatment in a prolonged release system for lactating cows at four US clinical trial sites - 252 days of treatment
Study date
30 September 1987
Data no
95863
Author
Cole WJ, Franson SE, Hintz RL, Hoffman RG, Meserole VK, Hartnell GF, Madsen KS, Hudson S, Collier RJ, Babcock DS, Sprick DM, Swenson GH
Title
Report MSL 8193: Long term evaluation of Zinc Treatment in a Prolonged Release System for Lactating Primaparous Cows at Four U.S. Clinical Trial Sites
Study date
1 August 1988
Data no
95864
Author
Cole WJ, Franson SE, Madsen KS, Hartnell GF, Collier RJ
Title
Supplement to MSL 8193: Long term evaluation of Zinc Treatment in a Prolonged Release System for Lactating Primaparous Cows at Four U.S. Clinical Trial Sites
Study date
21 June 1989
Data no
95865
Author
Cole WJ, Franson SE, Hintz RL, Hoffman RG, Meserole VK, Hartnell GF, Madsen KS, Hudson S, Collier RJ, Babcock DS, Sprick DM, Swenson GH
Title
Report MSL 9664: Long Term Evaluation of Zinc Methionyl Bovine Somatotropin Treatment in a Prolonged Release System for Lactating Multiparous Cows at Four U.S. Clinical Trial Sites
Study date
15 December 1989
Data no
95866
Author
White TC, Ribelin WE, Eppard PJ, Lanza GM, Chatel MGT, Chmielewski MA, Cole WJ, Duque JA, Franson SE, Ganguli S, Hintz RL, Miller MA, Mitchell JW, Tor
Title
Report MSL 6594: Galactopoietic response and injection site resolution of CP115099-F administered intramuscularly or subcutaneously to lactating Holstein cows
Study date
27 March 1987
Data no
95867
Author
Eppard PJ, Lanza GM, Hudson S, Chmielewski MA,Miller MA, Menke PT, Cole WJ, White TC, Abel KM, Duque JA, Hintz RL, Hartnell GF, Madsen KS, Ribelin WE
Title
Report MSL 7118: Assessment of the effective range of CP115099-F in lactating primiparous and multiparous dairy cows: report covering 312 days of lactation
Study date
23 September 1987
Data no
95868
Author
White TC, Collier RJ, Hartnell GF, Dyer SE, Hudson S, Miller MA, Metzger LE, Hintz RL, Sorbet RH, Curran TL, Schurter KL
Title
Report MSL 9646: Comparison of the effectiveness of intramuscular and subcutaneous administration of CP115099-F
Study date
22 January 1990
Data no
95869
Author
Meserole VK, Franson SE, Cole WJ, Pell AN, Hartnell GF
Title
Report MSL 8734: Long Term Evaluation of Zinc Methionyl Bovine Somatotropin Treatment in a Prolonged Release System for Lactation Jersey Cows
Study date
5 January 1985
Data no
95870
Author
Delgado-Elorduy A
Title
Study T4UME0702: Lactation performance of dairy cows treated at different dose and injection interval of bovine somatotropin (Lactropina and Lactropina Plus)
Study date
2002
Data no
95871
Author
Schockmel LR, Vedeau F, Lamy P, Peel CJ, de Kerchove G, Madsen K, Hartnell GF
Title
Report MLL 90376: Efficacy and Safety of CP115099-F in Dairy Cows. Report on lactations 1 and 2 of the French Clinical Trials performed at Sanders Experimental Centre, Saint Symphorien
Study date
29 July 1988
Data no
95872
Author
Phipps RH, Weller RF, Craven N, Peel CJ, de Kerchove G, Meserole VK, Madsen K, Hartnell GF
Title
Report MLL 90329: Efficacy and safety of CP115099-F in dairy cows. Report on UK clinical trial performed under Animal Test Certificate No 5997/0001
Study date
10 July 1987
Data no
95873
Author
Adriaens F, Craven N, Phipps RH, Weller RF, de Kerchove G, Hard DL, Madsen K, Hartnell GF
Title
Report MLL 90413: Efficacy and safety of CP115099-F (Sometribove) in dairy cows through three consecutive lactations of treatment in the UK. Report on the clinical trial performed under Animal Test Certificate NO. 5997/0001
Study date
May 1989
Data no
95874
Author
Gravert HO, Pabst K, Weber T, Wollny C, Peel CJ, de Kerchove G, Meserole VK, Madsen K, Hartnell GF
Title
Report MLL 90330: Efficacy and safety of CP115099-F in dairy cows. Report on German clinical trial (one lactation) performed at the Bundesforschungsanstalt fur Milcherzeugung
Study date
10 July 1987
Data no
95875
Author
Gravert HO, Pabst K, Hard DL, De Kerchove G, Madsen KS, Peel CJ, Wollny C
Title
Report MLL 90406: Safety and Efficacy of CP115099-F (sometribove) in dairy cows through three consecutive lactations of treatment. Report on the German Clinical Trial performed at Bundesanstalt fur Milchforschung, Kiel
Study date
19 April 1989
Data no
95876
Author
Rijpkema YS, van Reewijk L, Peel CJ, Mol EPJC, de Kerchove G, Meserole VK, Madsen K, Hartnell GF
Title
Report MLL 90328: Efficacy and safety of CP115099-F in dairy cows. Report on Netherlands clinical trial performed at Instituut voor Veevoedingsonderzoek (I.V.V.O.)
Study date
10 July 1987
Data no
95877
Author
Rijpkema YS, van Reeuwijk L, Hard DL, de Kerchove G, Madsen K, Peel CJ
Title
Report MLL 90402: Safety and Efficacy of CP115099-F (Sometribove) in Dairy Cows through Three Consecutive Lactations of Treatment. Report on the Netherlands Clinical Trial performed at INstituut voor Veevoedingsonderzoek (I.V.V.O.)
Study date
20 March 1989
Data no
95878
Author
Collier RJ, Byatt JC, Denham SC, Eppard PJ, Fabellar AC, Hintz RL, McGrath MF, McLaughlin CL, Shearer JK, Veenhuizen JJ, Vicini JL
Title
Effects of sustained release bovine somatotropin (Sometribove) on animal health in commercial dairy herds
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
95879
Author
Huber JT, Wu Z, Fontes C Jr, Sullivan JL, Hoffman RG, Hartnell GF
Title
Administration of recombinant bovine somatotropin to dairy cows for four consecutive lactations
Study date
1997
Authorising party
Public
Auth party contact address
-
Data no
95880
Author
Vicini JL, Hudson S, Cole WJ, Miller MA, Eppard PJ, White TC, Collier RJ
Title
Effect of acute challenge with an extreme dose of somatotropin in a prolonged release formulation on milk production and health of dairy cattle
Study date
1990
Authorising party
Public
Auth party contact address
-
Data no
95884
Author
Eppard PJ, Hudson S, Cole WJ, Hintz RL, Hartnell GF, Hunter TW, Metzger LE, Torkelson AR, Hammond BG, Collier RJ, Lanza GM
Title
Response of dairy cows to high doses of a sustained - release bovine somatotropin administered during two lactations. 1. Production response
Study date
1991
Authorising party
Public
Auth party contact address
-
Data no
95885
Author
Cole WJ, Eppard PJ, Boysen BG, Madsen KS, Sorbet RH, Miller MA, Hintz RL, White TC, Ribelin WE, Hammond BG, Collier RJ, Lanza GM
Title
Response of dairy cows to high doses of a sustained - release bovine somatotropin administered during two lactations. 2. Health and Reproduction
Study date
1992
Authorising party
Public
Auth party contact address
-
Data no
95886
Author
Eppard PJ, Rogan GJ, Boysen BG, Miller MA, Hintz RL, Hammond BG, Torkelson AR, Collier RJ, Lanza GM
Title
Effect of high doses of a sustained-release bovine somatotropin on antibody formation in dairy cows
Study date
1992
Authorising party
Public
Auth party contact address
-
Data no
95895
Author
Pell AN, Tsang DS, Howlett BA, Huyler MT, Meserole VK, Samuels WA, Hartnell GF, Hintz RL
Title
Effect of dietary energy and previous bovine somatotropin on milk yield, mastitis, and reproduction in dairy cows
Study date
1992
Authorising party
Public
Auth party contact address
-
Data no
95903
Author
Garcia S, Jhajj RK, Thomson P, House J, Celi P
Title
Study GN4AU090012: Confirmation of lactation performance and animal safety of dairy cows treated with a lactation enhancer
Study date
December 2012
Data no
95904
Author
Vedeau F, Lamay P, Schockmel LR, Peel CJ, de Kerchove G, Meserole VK, Madsen KS, Hartnell GF
Title
Report MLL 90336: Efficacy and safety of CP115099-F in dairy cows. Report on the French clinical trial performed at Sanders Experimental Centre, Saint Symphorien
Study date
30 September 1987
Data no
95905
Author
Meserole VK, Duque JA, Hintz RL, Peel CJ
Title
Report MSL 12207: Evaluation of the galactopoietics response of bovine somatotropin (sometribove (CP115099-F), 500 mg and CP115400-P, 260 mg) when administered subcutaneously to lactating jersey cows in a commercial dairy herd
Study date
8 September 1992
Data no
95906
Author
Capuco AV & Akers
Title
Galactopoiesis. Effect of treatment with somatotropin
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
95907
Author
West JW, Mullinix BG, Johnson JC Jr, Ash KA, Taylor VN
Title
Effects of bovine somatotropin on dry matter intake, milk yield, and body temperature in Holstein and Jersey cows during heat stress
Study date
1990
Authorising party
Public
Auth party contact address
-
Data no
95908
Author
Anon
Title
Freedom of Information Summary: Posilac 1Step
Study date
27 Dec 2001
Authorising party
Public
Auth party contact address
-
Data no
95896
Author
Judge LJ, Erskine RJ, Bartlett PC
Title
Recombinant bovine somatotropin and clinical mastitis: Incidence, discarded milk following therapy and culling
Study date
1997
Authorising party
Public
Auth party contact address
-
Data no
95897
Author
Cole et al
Title
Effect of recombinantly-derived bovine somatotropin on reproductive performance of dairy cattle
Study date
1991
Authorising party
Public
Auth party contact address
-
Data no
95839
Author
Anon
Title
Freedom of Information Summary 1: Posilac
Study date
5 Nov 1993
Authorising party
Public
Auth party contact address
-
Data no
95840
Author
Anon
Title
Freedom of Information Summary, Supplemental New Animal Drug Application: Posilac
Study date
11 Nov 2003
Authorising party
Public
Auth party contact address
-
Data no
95889
Author
Baker DE
Title
Final response to Citizens Petition. CVM, FDA
Study date
2000
Authorising party
Public
Auth party contact address
-
Data no
95956
Author
Vicini J, Etherton T, Kris-Etherton P, Ballam J, Denham S, Staub R, Goldstein D, Cady R, McGrath M, Lucy M
Title
Survey of retail milk composition as affected by label claims regarding farm-management practices.
Study date
2008
Authorising party
Public
Auth party contact address
-
Data no
95957
Author
Peel CJ, Fronk TJ, Bauman DE, Gorewit RC
Title
Effect of exogenous growth hormone in early and late lactation on lactational performance of dairy cows.
Study date
1983
Authorising party
Public
Auth party contact address
-
Data no
95958
Author
Eppard PJ, Bauman DE, Bitman J, Wood DL, Akers RM, House WA
Title
Effect of dose of bovine growth hormone on milk composition: Alpha-lactalbumin, fatty acids and mineral elements.
Study date
1985
Authorising party
Public
Auth party contact address
-
Data no
95959
Author
Bitman J, Wood DL, Tyrrell HF, Bauman DE, Peel CJ, Brown ACG, Reynolds PJ
Title
Blood and milk lipid responses induced by growth hormone administration to lactating cows.
Study date
1984
Authorising party
Public
Auth party contact address
-
Data no
95960
Author
Peel CJ, Bauman DE, Gorewit RC, Sniffen CJ
Title
Effect of exogenous growth hormone on lactational performance in the high yielding dairy cow.
Study date
1981
Authorising party
Public
Auth party contact address
-
Data no
95961
Author
Bines JA, Hart IC, Morant SV
Title
Endocrine control of energy metabolism in the cow: The effect on milk yield and levels of some blood constituents of injecting growth hormone and growth hormone fragments.
Study date
1980
Authorising party
Public
Auth party contact address
-
Data no
95962
Author
Eppard PJ, Bauman DE, McCutcheon SN
Title
Effect of dose of bovine growth hormone on lactation of dairy cows.
Study date
1985
Authorising party
Public
Auth party contact address
-
Data no
95963
Author
Fronk TJ, Peel CJ, Bauman DE, Gorewit RC
Title
Comparison of different patterns of exogenous growth hormone administration on milk production in Holstein cows.
Study date
1983
Authorising party
Public
Auth party contact address
-
Data no
95964
Author
Peel CJ, Fronk TJ, Bauman DE, Gorewit RC
Title
Lactational response to exogenous growth hormone and abomasal infusion of a glucose-sodium caseinate mixture in high-yielding dairy cows.
Study date
1982
Authorising party
Public
Auth party contact address
-
Data no
95965
Author
Bauman DE, Eppard PJ, DeGeeter MJ, Lanza GM
Title
Responses of high-producing dairy cows to long-term treatment with pituitary somatotropin and recombinant somatotropin.
Study date
1985
Authorising party
Public
Auth party contact address
-
Data no
95966
Author
Peel CJ, Sandles LD, Quelch KJ, Herington AC
Title
The effects of long-term administration of bovine growth hormone on the lactational performance of identical twin dairy cows.
Study date
1985
Authorising party
Public
Auth party contact address
-
Data no
95967
Author
Hartnell GF.
Title
Report MSL 542: Sensory and chemical evaluation of milk produced from cows treated with CP115099 in a prolonged release system - a preliminary study.
Study date
10 February 1986
Data no
95968
Author
ODonnell AM, Spatny KP, Vicini JL, Bauman DE
Title
Survey of the fatty acid composition of retail milk differing in label claims based on production management practices.
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
95969
Author
Kindstedt PS, Pell AN, Rippe JK, Tsang DS, Hartnell GF
Title
Effect of long-term bovine somatotropin (sometribove) treatment on nitrogen (protein) distribution in Jersey milk.
Study date
1991
Authorising party
Public
Auth party contact address
-
Data no
95970
Author
Torkelson AR, Whitehead TL, Dwyer KA, Rogan GJ, Eppard PJ, Ryan RL.
Title
Report MSL 6600: Somatotropin and antibodies in milk from cows on study no. 100-DDC-COW-PJE-010 (Toxicity Study): First lactation study final report.
Study date
11 May 1987
Data no
95971
Author
Richard AL, McCutcheon SN, Bauman DE
Title
Responses of dairy cows to exogenous bovine growth hormone administered during early lactation.
Study date
1985
Authorising party
Public
Auth party contact address
-
Data no
95972
Author
Lenoir J, Schockmel LR.
Title
Report MLL 90311: Composition and processing characteristics of milk from cows in the French Clinical trial.
Study date
2 February 1987
Data no
95973
Author
Hartnell GF.
Title
Report MSL 7031: Evaluation of vitamins in milk produced from cows treated with placebo and CP115099 in a prolonged release system.
Study date
29 May 1987
Data no
95974
Author
Van den Berg G, de Jong E.
Title
Report MLL 90310: The influence of the treatment of lactating cows with methionyl bovine somatotropin on milk properties.
Study date
29 January 1987
Data no
95975
Author
Anon
Title
CVM ADE Comprehensive Clinical Detail Report Listing: Cumulative Date Range: 01/01/1987 -thru- 12/31/2012. Drug Listing: N;O;P;Q;R;S. pages 388-398
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
95933
Author
Birmingham BK, White TC, Lanza GM, Miller MA, Hale MD, Duque JA, Ganguli S, Hintz RL, Mitchell JW.
Title
Report MSL 6578: Characterisation of the pharmacokinetic parameters of CP104301 in lactating cows.
Study date
31 March 1987
Data no
95934
Author
Birmingham BK, White TC, Lanza GM, Miller MA, Ganguli S, Chmielewski MA, Hintz RL, Duque JA.
Title
Report MSL 6603: Characterisation of the pharmacological parameters of MBS AlaVal and AlaValHis in lactating cows.
Study date
31 March 1987
Data no
95935
Author
Birmingham BK, White TC, Lanza GM, Chmielewski MA, Duque JA, Franson SE, Ganguli S, Hintz RL, Hoffman SE, Miller MA, Mitchell JW.
Title
Report MSL 6610: Determination of somatotropin release kinetics in dairy cows administered several doses of CP115099 prolonged release formulation.
Study date
31 March 1987
Data no
95936
Author
Mehta JM, Goodwin GL, Rogan GJ, Torkelson AR, Ryan RL.
Title
Report MSL 6611: Evaluation of BST metabolic pathways in dairy cows after intramuscular administration of BST-formulation.
Study date
25 March 1987
Data no
95937
Author
Janson CA, Birmingham BK, Torkelson AR, Violand BN, Schlittler M.
Title
Report MSL 6749: Comparison of bovine pituitary and recombinant somatotropins by in vitro degradation with proteases: thrombin, trypsin and leukocyte elastase.
Study date
21 May 1987
Data no
95938
Author
Bennett HP, McMartin C
Title
Peptide hormones and their analogues: Distribution, clearance from the circulation and inactivation in vivo.
Study date
1979
Authorising party
Public
Auth party contact address
-
Data no
95939
Author
Trenkle A
Title
Estimates of the kinetic parameters of growth hormone metabolism in fed and fasted calves and sheep.
Study date
1976
Authorising party
Public
Auth party contact address
-
Data no
95940
Author
Trenkle A
Title
Changes in growth hormone status related to body weights of growing cattle.
Study date
1977
Authorising party
Public
Auth party contact address
-
Data no
95941
Author
Kostyo JL
Title
The search for the active core of pituitary growth hormone.
Study date
1974
Authorising party
Public
Auth party contact address
-
Data no
95942
Author
Graf L, Barat E, Borvendeg J, Hermann I, Patthy A
Title
Action of thrombin on ovine, bovine and human pituitary growth hormones.
Study date
1976
Authorising party
Public
Auth party contact address
-
Data no
95943
Author
Postel-Vinay MM, Kayser C, Desbuqois B
Title
Fate of injected human growth hormone in the female rat liver in vivo.
Study date
1982
Authorising party
Public
Auth party contact address
-
Data no
95944
Author
Donner DB, Nakayama K, Tani S, Lutz U, Sonenberg M
Title
The uptake and degradation of growth hormone fragments by isolated rat hepatocytes.
Study date
1978
Authorising party
Public
Auth party contact address
-
Data no
95945
Author
Paladini AC, Pena, C, Retegui LA
Title
The intriguing nature of the multiple actions of growth hormone.
Study date
1979
Authorising party
Public
Auth party contact address
-
Data no
95946
Author
Collipp PJ, Patrick JR, Goodhart C, Kaplan SA
Title
Distribution of tritium labelled human growth hormone in rats and guinea pigs.
Study date
1966
Authorising party
Public
Auth party contact address
-
Data no
95947
Author
Mayberry HE, Van Den Brande JL, Van Wyk JJ, Waddell WJ
Title
Early localisation of 125I-labelled human growth hormone in adrenals and other organs of immature hypophysectomised rats.
Study date
1971
Authorising party
Public
Auth party contact address
-
Data no
95948
Author
Salmon S, Utiger R, Paker M, Reichlin S
Title
The fate of 131I-labelled human growth hormone in the rabbit.
Study date
1962
Authorising party
Public
Auth party contact address
-
Data no
95949
Author
Sonenberg M, Money WI, Dorans JF, Lucan V, Bourque L
Title
The distribution of radioactivity in the administration of radioactive growth hormone preparations.
Study date
1954
Authorising party
Public
Auth party contact address
-
Data no
95950
Author
Rabkin R, Pimstone BL, Eales L, Christie A
Title
Autoradiographic demonstration of glomerular filtration and proximal tubular absorption of 125I-labelled growth hormone in the mouse.
Study date
1973
Authorising party
Public
Auth party contact address
-
Data no
95951
Author
Stacy BD, Wallace ALC, Gremmell GT, Wilson BW
Title
Adsorption of 125I-labelled sheep growth hormone in single proximal tubules of the rat kidney.
Study date
1976
Authorising party
Public
Auth party contact address
-
Data no
95952
Author
Parker ML, Utiger RD, Daughaday WH
Title
Studies on human growth hormone. II. Physiological disposition and metabolic fate of human growth hormone in man.
Study date
1962
Authorising party
Public
Auth party contact address
-
Data no
95953
Author
Etherton TD, Bauman DE
Title
Biology of somatotropin in growth and lactation of domestic animals.
Study date
1998
Authorising party
Public
Auth party contact address
-
Data no
95954
Author
Miller MA.
Title
Report MSL 9672: Effect of sometribove on blood clinical chemistries and hormones in dairy cattle.
Study date
9 January 1990
Data no
95955
Author
Politis I, Block E, Turner JD
Title
Effect of somatotropin on the plasminogen and plasmin system in the mammary gland: Proposed mechanism of action for somatotropin on the mammary gland.
Study date
1990
Authorising party
Public
Auth party contact address
-
Data no
95891
Author
Collier RJ, McGrath MF, Ribelin WE, White TC
Title
Report MSL 11545: A histological evaluation of injection sites with visual scores of 2 and 3 following chronic subcutaneous administration of sometribove prolonged release formulation
Study date
25 November 1991
Data no
95892
Author
Eppard PJ, Carter JL, Ribelin WE, Meserole VK, White TC, Collier RJ
Title
Report MSL 11509: A histopathological evaluation of persistent local inflammatory lesions following tailhead (ischiorectal fossa) injection of rbST in dairy cows (study 100-DDC-COW-PJE-91-068)
Study date
21 November 1991
Data no
95893
Author
Meserole VK, Franson SE, Swenson GH
Title
Supplement to Report 6757: Long Term Evaluation of Zinc Methionyl Bovine Somatotropin Treatment in a Prolonged Release System for Lactation Cows producing high fat and high protein milk Summary report: injection site swellings
Study date
August 1988
Data no
95894
Author
Bussen SC, Collier RJ, Hartnell GF, White TC
Title
Report MSL 9012: Injection site and carcass evaluation following subcutaneous administration of sometribove prolonged release formulation
Study date
24 May 1989
Data no
95909
Author
Starbuck et al
Title
Effect of a single growth hormone (rbST) treatment at breeding on conception rates and pregnancy retention in dairy and beef cattle
Study date
2006
Authorising party
Public
Auth party contact address
-
Data no
95910
Author
Hasler et al
Title
Effect of recombinant bovine somatotropin on superovulatory response and recipient pregnancy rates in a commercial embryo transfer program
Study date
2003
Authorising party
Public
Auth party contact address
-
Data no
95899
Author
Kuehner et al
Title
The effect of a depot injection of recombinant bovine somatotropin on follicular development and embryo yield in superovulated Holstein heifers
Study date
1993
Authorising party
Public
Auth party contact address
-
Data no
95900
Author
Kirby CJ, Smith MF, Keisler DH, Lucy MC
Title
Follicular function in lactating dairy cows treated with sustained-release bovine somatotropin
Study date
1997
Authorising party
Public
Auth party contact address
-
Data no
95901
Author
Bussen SC, Collier RJ, Hartnell GF, White TC, Curran TL
Title
Supplement to Report MSL 9012: Evaluation of injection sites and carcass quality following subcutaneous administration of sometribove in a prolonged release formulation in jersey cows
Study date
8 December 1989
Data no
95902
Author
McGrath MF, Ribelin WE, Collier RJ
Title
Report MSL 11476: Injection site evaluation following subcutaneous administration of somatotropin prolonged release formulation
Study date
21 October 1991
Data no
95911
Author
Bartolome J, Hernandez J, Sheerin P, Luznar S, Kelbert D, Thatcher WW, Archbald LF
Title
Effect of pretreatment with bovine somatotropin (bST) and/or gonadotropin-releasing homone (GnRH) on conception rate of dairy cows with ovarian cysts subjected to synchronisation of ovulation and timed insemination.
Study date
2003
Authorising party
Public
Auth party contact address
-
Data no
95912
Author
Moreira F, Orlandi C, Risco CA, Mattos R, Lopes F, Thatcher WW
Title
Effects of presynchronisation and bovine somatotropin on pregnancy rates to a timed artificial insemination protocol in lactating dairy cows.
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
95913
Author
Santos JEP, Juchem SO, Cerri RLA, Galvao KN, Chebel RC, Thatcher WW, Dei CS, Bilby CR
Title
Effect of bST and Reproductive Management on Reproductive Performance of Holstein Dairy Cows.
Study date
2004
Authorising party
Public
Auth party contact address
-
Data no
95914
Author
Rivera F, Narciso C, Oliveira R, Cerri RLA, Correa-Caldero
Title
Effect of bovine somatotropin (500mg) administered at ten-day intervals on ovulatory responses, expression of estrus, and fertility in dairy cows.
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
95915
Author
Morales-Roura JS, Zarco L, Hernandez-Ceron, Rodriguez G
Title
Effect of short-term treatment with bovine somatotropin at estrus on conception rate and luteal function of repeat-breeding dairy cows.
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
95916
Author
Moreira F, Badinga L, Burnley C, Thatcher WW.
Title
l (2002) Bovine somatotropin increases embryonic development in superovulated cows and improves post-transfer pregnancy rates when given to lactating recipient cows.
Study date
2002
Authorising party
Public
Auth party contact address
-
Data no
95917
Author
Jousan FD, de Castro e Paula LA, Block J, Hansen PJ
Title
Fertility of lactating dairy cows administered recombinant bovine somatotropin during heat stress.
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
95918
Author
Cole WJ, Collier RJ, Eppard PJ, Hartnell GF, Hintz RL, Hoffman RG, Loesch TL, McLaughlin CL, McCrate MM, Selby BD, Sorbet RH, Veenhuizen JJ, Vicini JL
Title
Report MSL 12026: Effect of sometribove treatment of dairy cows on the incidence of clinical signs and birth abnormalities in the resultant offspring.
Study date
16 September 1992
Data no
95919
Author
Whitaker DA, Smith EJ, Kelly JM, Hodgson-Jones LS
Title
Health, welfare and fertility implications of the use of bovine somatotropin in dairy cattle.
Study date
1988
Authorising party
Public
Auth party contact address
-
Data no
95920
Author
Annexstad RJ, Otterby DE, Linn JG, Hansen WP, Soderholm CG, Wheaton JE, Eggert RG
Title
Somatotropin treatment for a second consecutive lactation.
Study date
1990
Authorising party
Public
Auth party contact address
-
Data no
95921
Author
Burton JH, MacLeod GK, McBride BW, Burton JL, Bateman K, McMillan I, Eggert RG
Title
Overall efficacy of chronically administered recombinant bovine somatotropin to lactating dairy cows.
Study date
1990
Authorising party
Public
Auth party contact address
-
Data no
95922
Author
McBride BW, Burton JL, Gibson JP, Burton JH, Eggert RG
Title
Use of recombinant bovine somatotropin for up to two consecutive lactations on dairy production traits.
Study date
1990
Authorising party
Public
Auth party contact address
-
Data no
95923
Author
McGuffey RK, Basson RP, Spike TE
Title
Lactation response and body composition of cows receiving somatotropin and three ratios of forage to concentrate.
Study date
1991
Authorising party
Public
Auth party contact address
-
Data no
95924
Author
Gibson JP, McBride BW, Burton JH, Politis I, Zhao X
Title
Effect on production of the use of recombinant bovine somatotropin for up to three consecutive lactations.
Study date
1992
Authorising party
Public
Auth party contact address
-
Data no
95925
Author
Lotan E, Sturman H, Weller JI, Ezra E
Title
Effects of recombinant bovine somatotropin under conditions of high production and heat stress.
Study date
1993
Authorising party
Public
Auth party contact address
-
Data no
95926
Author
Remond B, Cisse M, Ollier A, Chilliard Y
Title
Slow release somatotropin in dairy heifers and cows fed two levels of energy concentrate. 1. Performance and body condition.
Study date
1991
Authorising party
Public
Auth party contact address
-
Data no
95927
Author
Soderholm CG, Otterby DE, Linn JG, Ehle FR, Wheaton JE, Hansen WP, Annexstad RJ
Title
Effects of recombinant bovine somatotropin on milk production, body composition and physiological parameters.
Study date
1988
Authorising party
Public
Auth party contact address
-
Data no
95928
Author
Tessman NJ, Dhiman TR, Kleinmans J, Radloff HD, Satter LD
Title
Recombinant bovine somatotropin with lactating cows fed diets differing in energy density.
Study date
1991
Authorising party
Public
Auth party contact address
-
Data no
95929
Author
Ruegg PL, Fabellar A, Hintz RL
Title
Effect of the use of bovine somatotropin on culling practices in thirty-two dairy herds in Indiana, Michigan and Ohio.
Study date
1998
Authorising party
Public
Auth party contact address
-
Data no
95930
Author
Cole WJ, Collier RJ, Eppard PJ, Hartnell GF, Hintz RL, Hoffman RG, McCrate MM, Sorbet RH, Veenhuizen JJ, Vicini JL, White TC.
Title
Report MSL 11838: Effect of sometribove on incidence of clinical signs in dairy cows.
Study date
1 May 1992
Data no
95931
Author
White TC, Madsen KS, Hintz RL, Sorbet RH, Collier RJ, Hard DL, Hartnell GF, Samuels WA
Title
Clinical mastitis in cows treated with sometribove (recombinant bovine somatotropin) and its relationship to milk yield.
Study date
1994
Authorising party
Public
Auth party contact address
-
Data no
95932
Author
Wells SJ, Trent AM, Collier RJ, Cole WJ
Title
Effect of long-term administration of a prolonged release formulation of bovine somatotropin (sometribove) on clinical lameness in dairy cows.
Study date
1995
Authorising party
Public
Auth party contact address
-
Data no
95898
Author
Luna-Dominguez JE, Enns RM, Armstrong DV, Ax RL
Title
Reproductive performance of Holstein cows receiving somatotropin
Study date
2000
Authorising party
Public
Auth party contact address
-
Data no
95890
Author
Bilby TR, Thatcher WW, Hansen PJ
Title
Effects of recombinant growth hormone on fertility: Dependence upon seasonal variations, dosage differences and lactational status
Study date
2009
Data no
95887
Author
Eppard PJ, Lanza GM, Hammond BG, Boysen BG, Calabotta MG, Cole WJ, Duque JA, Franson SE, Ganguli S, Hudson S, Miller MA, Ribelin WE, White TC
Title
Report MSL 7119: Effect of CP115099-F treatment of the dam on the subsequent health and reproductive performance of first generation heifers; interim report from birth through 4 months of life
Study date
18 September 1987
Data no
95888
Author
Cole WJ, Hintz RL, McCrate MM, Sorbet RH
Title
Report MSL 9639: Effect of sometribove on health of dairy cattle
Study date
18 January 1991
Data no
95881
Author
Eppard PJ, Lanza GM, Hammond BG, White TC, Cole WJ, Hudson S, Hintz RL, Franson SE, Madsen KS, Metzger LE, Vicini JL, de Leon JM, Miller MA, Torkelson
Title
Report MSL 8133: Toxicity of CP115099 in a prolonged release system in lactating cows through two lactations of treatment: final report
Study date
2 September 1988
Data no
95882
Author
Eppard PJ, Hudson S, De Leon JM, Cole WJ, Hammond BG, Hintz RL, Madsen KS, McCrate MM, Miller MA, Showers ME, Sorbet RH, White TC, Collier RJ
Title
Report MSL 9671: Toxicity of CP115099 in a prolonged release system in lactating cows through two lactations of treatment: additional analyses
Study date
10 January 1990
Data no
95883
Author
Eppard PJ, Hintz RL, Collier RJ
Title
Report MSL 9671 - Amendment: Toxicity of CP115099 in a prolonged release system in lactating cows through two lactations of treatment: additional analyses
Study date
21 April 1993
Data no
95815
Author
Anon
Title
Discussion of Overseas Registration Submissions for POSILAC
Study date
March 2013
Data no
95816
Author
Brinckman, D
Title
The regulation of rBST: The European case.
Study date
2000
Authorising party
Public
Auth party contact address
-
Data no
95817
Author
Baker DE
Title
Final response to citizens petition.
Study date
2000
Authorising party
Public
Auth party contact address
-
Data no
95818
Author
Forge F
Title
Recombinant bovine somatotropin (rbST).
Study date
1998, revised 1999
Authorising party
Public
Auth party contact address
-
Data no
95819
Author
FDA, Centre for Veterinary Medicine
Title
CVM Update: FDA Analysis of DGXXIV Report on Public Health Aspects of BST.
Study date
April 13, 1999
Authorising party
Public
Auth party contact address
-
Data no
95820
Author
Standing Senate Committee on Agriculture and Forestry
Title
rbST and the Drug Approval Process, Interim Report. March 1999.
Study date
March 1999
Authorising party
Public
Auth party contact address
-
Data no
95821
Author
Melnyk M
Title
Recombinant Bovine Somatotropin: Challenging Canadas Science-based Regulatory System and the Emergence of Post-Normal Science.
Study date
2005
Authorising party
Public
Auth party contact address
-
Data no
95822
Author
Hammond BG
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6578-86, Monsanto reference No. BD-86-132
Study date
1986
Data no
95823
Author
JECFA
Title
JECFA (2000) WHO Food Additives Series 43: Porcine Somatotropins
Study date
2000
Authorising party
Public
Auth party contact address
-
Data no
95824
Author
Hammond BG
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6582-86, Monsanto reference No. BD-86-131
Study date
1986
Data no
95825
Author
Fisher LF, Negilski DS, Brown GE
Title
The acute oral and dermal toxicity and primary ocular and dermal irritation of EL-349 parental injection. Unpublished report on studies R-0-155-86. R-0-154-86. 8-D-120-86 and 8-E-100-86.
Study date
1987
Data no
95826
Author
Hammond BG
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6579-86, Monsanto reference No. BD-86-132
Study date
1986
Data no
95827
Author
Sherman J
Title
Skin and eye irritation and dermal sensitization attributed to sometribove zinc formulation.
Study date
2010
Data no
95828
Author
Hammond BG
Title
Primary dermal irritation study in rabbits, Bio/dynamics project No. 6583-86, Monsanto reference No. BD-86-131
Study date
1986
Data no
95829
Author
Sherman JG
Title
Potential for Posilac (recombinant bovine somatotropin, rbST) to stimulate hormonal activity in Humans
Study date
2011
Data no
95830
Author
Bauman DE, Collier RJ
Title
Use of Bovine Somatotropin in Dairy Production
Study date
2010
Data no
95831
Author
Cline MJ
Title
Cline, 2007. Assessing the Mammary Gland of Nonhuman Primates: Effects of Endogenous Hormones and Exogenous Hormonal Agents and Growth Factors.
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
95832
Author
Collier et al.
Title
Factors effecting insulin-like growth factor -1 concentration in bovine milk.
Study date
1991
Authorising party
Public
Auth party contact address
-
Data no
95833
Author
Groewegen et al.
Title
Bioactivity of milk from bst-treated cows.
Study date
1990
Authorising party
Public
Auth party contact address
-
Data no
95834
Author
Liu et al.
Title
Episodic evolution of growth hormone in primates and emergence of the species specificity of human growth hormone receptor.
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
95835
Author
Parodi PW
Title
Parodi, 2005. Dairy Product consumption and the risk of breast cancer.
Study date
2005
Authorising party
Public
Auth party contact address
-
Data no
95836
Author
Raymond et al
Title
Recombinat Bovine Somatotropin (rbST): A safety Assessment
Study date
2010
Data no
95837
Author
M.A. Miller
Title
WHO Food Additive Series 31: Bovine somatotropins
Study date
1993
Authorising party
Public
Auth party contact address
-
Data no
95838
Author
Vicini et al.
Title
Survey of retail milk composition as affected by label claims regarding farm-management practices
Study date
2008
Authorising party
Public
Auth party contact address
-
Date Application No

Application Number

147467
Product/Active constituent Name

Application Product Name

hypochlorous acid (super-oxidised solution)

Application details

Product name:

hypochlorous acid (super-oxidised solution)

Product number:

95889

Applicant Name:

MEDIMARK SYNERGY PTY LTD

Application purpose and description of use:

Registration of a hypochlorous acid in liquid formulated for use in livestock farms.
Date Application No

Application Number

150391
Product/Active constituent Name

Application Product Name

Thursday Plantation Walkabout Insect Repellent

Application details

Product name:

Thursday Plantation Walkabout Insect Repellent

Product number:

96682

Applicant Name:

HOMART WELLNESS AUST PTY LTD

Application purpose and description of use:

Registration of a (concentration/active) household insecticide product containing Tea Tree Oil (Melaleuca Oil), Lemon scented Tea Tree Oil (Leptospermum Petersonii Leaf Oil) and Citronellal for personal protection against biting insects and flies.

Reference details:

46146 - THURSDAY PLANTATION AUSTRALIA'S ORIGINAL WALKABOUT INSECT REPELLENT

Description of data provided:

Data no
294553
Author
Tismor Health & Wellness Pty Ltd
Title
Batch 409334 Certificate of Analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294556
Author
Tismor Health & Wellness Pty Ltd
Title
Packaging Work Order
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294552
Author
Tismor Health & Wellness Pty Ltd
Title
Finished Product Specification
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294557
Author
APVMA
Title
Holder Transfer Notice
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294554
Author
Homart Wellness AUST Pty Ltd
Title
Product Label
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294555
Author
Homart Wellness AUST Pty Ltd
Title
Safety Data Sheet
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Date Application No

Application Number

149719
Product/Active constituent Name

Application Product Name

Planterra GoldPrime Vegetable Oil Concentrate

Application details

Product name:

Planterra GoldPrime Vegetable Oil Concentrate

Product number:

96540

Applicant Name:

PLANTERRA PTY LTD

Application purpose and description of use:

Registration of an 835 g/L emulsifiable Vegetable Oil Concentrate product for increasing droplet spread, chemical uptake and rainfastness, improves drift control, reduces foam generation, assists with odour reduction and evaporation of various agricultural and horticultural sprays.

Reference details:

55994 - CHEMAG EXTEND VEGETABLE OIL CONCENTRATE

Description of data provided:

Data no
291369
Author
Anon
Title
Registration Dossier
Study date
2025
Authorising party
Applicant
Auth party contact address
82 Holzwart Road Emerald Australia
Data no
294310
Author
Anon
Title
Part 2 Chemistry and Manufacturer
Study date
2025
Authorising party
Applicant
Auth party contact address
82 Holzwart Road Emerald Australia
Data no
291370
Author
Planterra
Title
eLabel - Planterra GoldPrime Vegetable Oil Concentrate - Draft DFU Label
Study date
2025
Authorising party
Applicant
Auth party contact address
82 Holzwart Road Emerald Australia