Download Advice Summary - Product No. 63651, Application No. 49642

ADVICE SUMMARY
APPLICATION FOR REGISTRATION OF A CHEMICAL PRODUCT
Product name:
ZAMPRO FUNGICIDE
Applicant:
BASF AUSTRALIA LTD.
Product number:
63651
Application number:
49642
Purpose of Application and Description of Use:
Registration of a 300 g/L Ametoctradin, 225 g/L Dimethomorph suspension concentrate product for downy mildew
control in grapevines.
Active Constituent(s): AMETOCTRADIN
Regulatory Decision:
To grant the application subject to the following conditions:
Standard Conditions of Registration/Approval
1. Containers must meet AgVet Code Regulation 18
2. Agricultural products must meet Active Constituents Quality Assurance Requirements
3. Label must contain a Date of Manufacture and Batch Number
For full conditions, refer to Standard Conditions for Applications on the APVMA website.
49642
Page 1 of 23
KP25S_F39 Version: 2 Issued: 14/08/2007
ADVICE
Australian Government Department Of Health And Ageing, Office Of Chemical Safety
The submitted studies on the active constituent ametoctradin in rats showed that, following ingestion, ametoctradin was rapidly absorbed with a moderate
bioavailability, widely distributed into organs and tissues, and extensively metabolised and completely eliminated with no evidence of accumulation in the
body. In contrast, dermal absorption of ametoctradin was poor (≤6.5% in rats and humans).
In animal studies, both ametoctradin and Zampro Fungicide were of low acute oral, dermal and inhalation toxicity in rats, and neither was an irritant to the skin
and eyes of rabbits, or skin sensitisers in guinea pigs and mice.
Ametoctradin was of low toxicity in repeat oral dose studies in rats, mice and dogs, with no adverse treatment-related effects seen at doses close to or
exceeding the limit dose of 1000 mg/kg bw/d. Ametoctradin was not carcinogenic n the rat or mouse and was not mutagenic or genotoxic with and without
metabolic activation in vitro, and was not genotoxic in vivo. Additionally, ametoctradin was not a reproductive toxicant in rats, a developmental toxicant in rats
and rabbits, neurotoxic or immunotoxic in rats.
Toxicological studies on three major metabolites (M650F02, M650F03 and M650F04) indicated they were not mutagenic or genotoxic with and without
metabolic activation in vitro, genotoxic in vivo and/or no adverse treatment-related effects were seen at doses close to or exceeding the limit dose of 1000
mg/kg bw/d n repeat dose oral studies in rats.
Farmers and their employees will be the main users of Zampro Fungicide. Workers may be exposed to the product when opening containers, mixing/loading,
application and cleaning up spills and equipment. The main route of exposure to the product will be dermal with inhalation, although ocular exposure is also
possible.
In the absence of exposure data for the proposed mode of application, the Pesticide Handler Exposure Database (PHED) Surrogate Exposure Guide (1998)
was used to estimate exposure. Exposure to the product during mixing, loading and ground-airblast application were at an acceptable level without the use of
personal protective equipment (PPE). Thus, PPE is not required during use (i.e. mixing, loading and application) of the product.
Based on the risk assessment, a First Aid Instruction and Safety Directions have been recommended for the product label.
Based on the assessment of the toxicology, it was considered that there should be no adverse effects on human health from the use of Zampro Fungicide
when used in accordance with the label directions.
49642
Page 2 of 23
KP25S_F39 Version: 2 Issued: 14/08/2007
Data relied on to provide the advice
Data
No
Data
Source*
40076
S
Gamer A.O.,
Landsiedel R.
BAS 650 00 F - Acute oral toxicity study in rats
2006-11-09
Toxicology
Acute Oral Studies,
Product
Applicant
40091
S
Gamer A.O. et al.
14C-BAS 650 F in BAS 651 00 F - Study of
penetration through rat and human skin in vitro
2007-05-11
Toxicology
Other Information
Applicant
40095
S
Landsiedel R.,
Remmele M.
BAS 651 00 F - Acute dermal irritation / corrosion
in rabbits
2007-01-05
Toxicology
Acute Skin Irritation
Studies, Product
Applicant
40096
S
Landsiedel R.,
Ma-Hock L.
BAS 651 00 F - Acute inhalation toxicity study in
Wistar rats 4-hour liquid aerosol exposure
2007-01-25
Toxicology
Acute Inhalation Studies,
Product
Applicant
40101
S
Gamer A.O.,
Landsiedel R.
BAS 651 00 F - Modified BUEHLER test (9
inductions) in guinea pigs
2007-09-19
Toxicology
Acute Skin Sensitisation
Studies, Product
Applicant
40104
S
Gamer A.O.,
Landsiedel R.
BAS 651 00 F: Acute dermal toxicity study in rats
2007-01-05
Toxicology
Acute Dermal Studies,
Product
Applicant
40105
S
Landsiedel R.,
Remmele M.
BAS 651 00 F: Acute eye irritation in rabbits
2007-01-05
Toxicology
Acute Eye Irritation
Studies, Product
Applicant
40106
S
Gamer A.O.,
Landsiedel R.
BAS 651 00 F: Acute oral toxicity study in rats
2007-01-05
Toxicology
Acute Oral Studies,
Product
Applicant
40109
S
Gamer A.O.,
Landsiedel R.
BAS 651 00 F: Murine local lymph node assay
(LLNA)
2007-01-05
Toxicology
Acute Skin Sensitisation
Studies, Product
Applicant
40118
S
Canez V.
Handler exposure and margin of safety
assessments during the application of BAS 651 00
F (Zampro fungicide), a suspension concentration
co-formulation containing 27.0% BAS 650 F
(Ametoctradin) and 20.3% Dimethomorph to
grapes in Australia
2010-02-05
OH and S
Worker Exposure
Applicant
40122
S
Canez V.
Reentry exposure and margin of safety
assessments following the application of BAS 651
00 F (Zampro fungicide) a suspension
concentration co-formulation containing 27.0%
BAS 650 F (Ametoctradin) and 20.3%
Dimethomorph to grapes in Australia
2010-02-05
OH and S
Worker Exposure
Applicant
46350
I
Schneider S., Hellwig J.,
Fabian E., van
Ravenzwaay B.
BAS 650 F: Prenatal Developmental Toxicity
Study in Wistar Rats - Oral Administration
(Gavage) - Addendum to Part III of III
(Supplement)
2006-08-03
Toxicology
Developmental
(Teratology) Studies
BASF AUSTRALIA
LTD.
49642
Author(s)
Title
Date
Page 3 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
50049
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
46351
I
Schneider S., Hellwig J.,
Fabian E., van
Ravenzwaay B.
BAS 650 F: Prenatal Developmental Toxicity
Study in Himalayan Rabbits - Oral Administration
(Gavage) - Addendum to Part III of III
(Supplement)
2008-06-26
Toxicology
Developmental
(Teratology) Studies
BASF AUSTRALIA
LTD.
53917
S
Bounds, S., V., J.
CL 336,379 Absorption study in the male rat after
topical application.
1995
Toxicology
Acute Dermal Studies,
Active
Applicant
53918
S
Gamer, A., O. and
Landsiedel, R.
14C-BAS 550 F (dimethomorp) in BAS 651 00 F
study of penetration through human skin in vitro.
2008
Toxicology
Acute Dermal Studies,
Product
Applicant
67608
I
Hempel K. et al.
BAS 650 F: Repeated dose 90-day oral toxicity
study in Beagle dogs - Administration in the diet
2007-08-21
Toxicology
Sub-chronic Studies
BASF AUSTRALIA
LTD.
50049
67609
I
Hempel K. et al.
BAS 650 F - Chronic toxicity study in Beagle dogs
- Administration in the diet for 12 months
2008-08-26
Toxicology
Sub-chronic Studies
BASF AUSTRALIA
LTD.
50049
67610
I
Kaspers U. et al.
BAS 650 F - Repeated dose 90-day oral toxicity in
Wistar rats; Administration in the diet
2007-06-20
Toxicology
Sub-chronic Studies
BASF AUSTRALIA
LTD.
50049
67611
I
Kaspers U. et al.
BAS 650 F: Repeated dose 90-day oral toxicity
study in C57BL/6NCrl mice; Administration in the
diet
2007-06-25
Toxicology
Sub-chronic Studies
BASF AUSTRALIA
LTD.
50049
67612
I
Kaspers U. et al.
BAS 650 F - Repeated dose 90-day oral
neurotoxicity study in Wistar rats; Administration in
the diet
2009-09-29
Toxicology
Sub-chronic Studies
BASF AUSTRALIA
LTD.
50049
67613
I
Kaspers U. et al.
BAS 650 F - Immunotoxicity study in female
C57BL/6 J Rj mice - Administration in the diet for
4 weeks
2009-11-23
Toxicology
Studies of Other Special
Effects
BASF AUSTRALIA
LTD.
50049
67614
I
Kaspers U. et al.
BAS 650 F - Repeated dose 28-day dermal
toxicity study in Wistar rats (Including amendment
no. 1)
2009-03-30
Toxicology
Short-term Studies
BASF AUSTRALIA
LTD.
50049
67615
I
Schneider S. et al.
BAS 650 F - Two-generation reproduction toxicity
study in Wistar rats - Administration via the diet
2008-06-26
Toxicology
Reproduction Studies
BASF AUSTRALIA
LTD.
50049
67616
I
Fabian E., Landsiedel R.
14C-BAS 650 F study on the biokinetics in rats
2008-08-07
Toxicology
Other Information
BASF AUSTRALIA
LTD.
50049
67617
I
Fabian E., Landsiedel R.
Study on the dermal penetration of 14C-BAS 650
F in BAS 650 00 F in rats
2008-12-23
Toxicology
Other Information
BASF AUSTRALIA
LTD.
50049
67618
I
Hafemann C.,
Kloeppner U.
The metabolism of 14C-BAS 650 F (Reg.No.
4993353) in rats
2008-07-23
Toxicology
Other Information
BASF AUSTRALIA
LTD.
50049
49642
Author(s)
Title
Date
Page 4 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
50049
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
67620
I
Engelhardt G., Hellwig J.
Cytogenetic study in vivo with Reg.No. 5178870
(metabolite of Reg.No. 4993353) in the mouse
micronucleus test - Single oral administration
(Including amendment no. 1)
2006-02-09
Toxicology
Metabolites and Impurities
Studies
BASF AUSTRALIA
LTD.
50049
67621
I
Engelhardt G., Hellwig J.
Salmonella typhimurium/Escherichia coli reverse
mutation assay (standard plate test and
preincubation test) with Reg.No. 5178870
(metabolite of Reg.No. 4993353) (Including
amendment no. 1)
2006-02-23
Toxicology
Metabolites and Impurities
Studies
BASF AUSTRALIA
LTD.
50049
67622
I
Engelhardt G., Hellwig J.
Salmonella typhimurium/Escherichia coli reverse
mutation assay (standard plate test and
preincubation test) with Reg.No. 5178871
(metabolite of Reg.No. 4993353) (Including
amendment no. 1)
2006-02-23
Toxicology
Metabolites and Impurities
Studies
BASF AUSTRALIA
LTD.
50049
67623
I
Engelhardt G.,
Landsiedel R.
In vitro gene mutation test with Reg.No. 5178870
(metabolite of BAS 650 F) in CHO cells (HPRT
locus assay)
2006-06-12
Toxicology
Metabolites and Impurities
Studies
BASF AUSTRALIA
LTD.
50049
67624
I
Engelhardt G., Mellert
W.
Cytogenetic study in vivo with Reg.No. 5178871
(metabolite of BAS 650 F) in the mouse
micronucleus test - Single oral administration
2006-03-31
Toxicology
Metabolites and Impurities
Studies
BASF AUSTRALIA
LTD.
50049
67625
I
Hellwig J., Schulz M.
In vitro gene mutation test in CHO cells (HPRT
locus assay) with Reg.No. 5211623 (metabolite of
BAS 650 F)
2006-12-14
Toxicology
Metabolites and Impurities
Studies
BASF AUSTRALIA
LTD.
50049
67626
I
Kaspers U. et al.
Reg.No. 5211623 (metabolite of BAS 650 F) Repeated dose 90-day oral toxicity study in Wistar
rats; administration in the diet
2008-08-15
Toxicology
Metabolites and Impurities
Studies
BASF AUSTRALIA
LTD.
50049
67627
I
Kaspers U. et al.
Reg.No. 5178870 (metabolite of BAS 650 F) Repeated dose 90-day oral toxicity study in Wistar
rats; Administration in the diet
2008-08-22
Toxicology
Metabolites and Impurities
Studies
BASF AUSTRALIA
LTD.
50049
67628
I
Landsiedel R.,
Schulz M.
Salmonella typhimurium/Escherichia coli reverse
mutation assay (standard plate test and
preincubation test) with Reg.No. 5211623
(metabolite of BAS 650 F)
2007-01-22
Toxicology
Metabolites and Impurities
Studies
BASF AUSTRALIA
LTD.
50049
67629
I
Landsiedel R.,
Schulz M.
In vitro chromosome aberration assay with
Reg.No. 5178870 (metabolite of BAS 650 F) in
V79 cells
2007-05-09
Toxicology
Metabolites and Impurities
Studies
BASF AUSTRALIA
LTD.
50049
67630
I
Landsiedel R.,
Schulz M.
In vitro chromosome aberration assay in V79 cells
with Reg.No. 5211623 (Metabolite of BAS 650 F)
2007-05-31
Toxicology
Metabolites and Impurities
Studies
BASF AUSTRALIA
LTD.
50049
49642
Author(s)
Title
Date
Page 5 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
67631
I
Engelhardt G.,
Leibold E.
Cytogenetic study in vivo with Reg.No. 4993353 in
the mouse micronucleus test single oral
administration
2005-09-29
Toxicology
Genotoxicity
(Mutagenicity) Studies
BASF AUSTRALIA
LTD.
50049
67632
I
Engelhardt G.,
Leibold E.
Bone marrow chromosome analysis in vivo with
Reg.No. 4993353 in Wistar rats - Single oral
administration (Including amendment no. 1)
2008-08-21
Toxicology
Genotoxicity
(Mutagenicity) Studies
BASF AUSTRALIA
LTD.
50049
67633
I
Honarvar N.
In vivo unscheduled DNA synthesis in rat
hepatocytes with Reg.No. 4993353
2005-08-03
Toxicology
Genotoxicity
(Mutagenicity) Studies
BASF AUSTRALIA
LTD.
50049
67634
I
Landsiedel R.,
Schulz M.
Salmonella typhimurium/Escherichia coli reverse
mutation assay (standard plate test and
preincubation test) with BAS 650 F
2006-09-27
Toxicology
Genotoxicity
(Mutagenicity) Studies
BASF AUSTRALIA
LTD.
50049
67635
I
Landsiedel R.,
Schulz M.
In vitro gene mutation test in CHO cells (HPRT
locus assay) with BAS 650 F
2007-03-20
Toxicology
Genotoxicity
(Mutagenicity) Studies
BASF AUSTRALIA
LTD.
50049
67636
I
Schulz M.
In vitro chromosome aberration test in Chinese
hamster V79 cells with Reg.No. 4993353
2005-07-28
Toxicology
Genotoxicity
(Mutagenicity) Studies
BASF AUSTRALIA
LTD.
50049
67637
I
Schneider S. et al.
BAS 650 F: Prenatal developmental toxicity study
in Wistar rats - Oral administration (gavage)
2006-08-03
Toxicology
Developmental
(Teratology) Studies
BASF AUSTRALIA
LTD.
50049
67638
I
Schneider S. et al.
BAS 650 F: Prenatal developmental toxicity study
in Himalayan rabbits - Oral administration
(gavage)
2008-06-26
Toxicology
Developmental
(Teratology) Studies
BASF AUSTRALIA
LTD.
50049
67639
I
Kamp H. et al.
BAS 650 F - Carcinogenicity study in C57BL/6 J
Rj mice; administration via the diet over 18 months
2008-08-21
Toxicology
Chronic/Carcinogenicity
Studies
BASF AUSTRALIA
LTD.
50049
67640
I
Kaspers U. et al.
BAS 650 F - Combined chronic
toxicity/carcinogenicity study in Wistar rats;
administration via the diet up to 24 months
2008-08-22
Toxicology
Chronic Studies
BASF AUSTRALIA
LTD.
50049
67641
I
Gamer A.O.,
Landsiedel R.
BAS 650 F: Murine local lymph node assay
(LLNA)
2007-01-26
Toxicology
Acute Skin Sensitisation
Studies, Active
BASF AUSTRALIA
LTD.
50049
67642
I
Gamer A.O.,
Landsiedel R.
BAS 650 F - Maximization test in guinea pigs
(Including amendment no. 1)
2009-04-02
Toxicology
Acute Skin Sensitisation
Studies, Active
BASF AUSTRALIA
LTD.
50049
67643
I
Landsiedel R.,
Remmele M.
BAS 650 F: Acute dermal irritation / corrosion in
rabbits
2007-01-25
Toxicology
Acute Skin Irritation
Studies, Active
BASF AUSTRALIA
LTD.
50049
67644
I
Gamer A.O.,
Landsiedel R.
BAS 650 F: Acute oral toxicity study in rats
2007-01-26
Toxicology
Acute Oral Studies, Active
BASF AUSTRALIA
LTD.
50049
67645
I
Kaspers U. et al.
BAS 650 F - Acute oral neurotoxicity study in
Wistar rats; Administration via gavage
2009-04-28
Toxicology
Acute Oral Studies, Active
BASF AUSTRALIA
LTD.
50049
49642
Author(s)
Title
Date
Page 6 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
67646
I
Landsiedel R.,
Ma-Hock L.
BAS 650 F - Acute inhalation toxicity study in
Wistar rats - 4-hour dust exposure
2006-10-30
Toxicology
Acute Inhalation Studies,
Active
BASF AUSTRALIA
LTD.
50049
67647
I
Landsiedel R.,
Remmele M.
BAS 650 F: Acute eye irritation in rabbits
2007-01-25
Toxicology
Acute Eye Irritation
Studies, Active
BASF AUSTRALIA
LTD.
50049
67648
I
Landsiedel R.,
Remmele M.
BAS 650 F - Acute eye irritation in rabbits
2007-05-09
Toxicology
Acute Eye Irritation
Studies, Active
BASF AUSTRALIA
LTD.
50049
67649
I
Gamer A.O.,
Landsiedel R.
BAS 650 F: Acute dermal toxicity study in rats
2007-01-26
Toxicology
Acute Dermal Studies,
Active
BASF AUSTRALIA
LTD.
50049
Australian Government Department Of Environment And Heritage
Ametoctradin is hydrolytically stable, only slightly degradable by aqueous photolysis and not ready biodegradable. It does not persist in microbially-active
aerobic and anaerobic water/sediment systems where it rapidly dissipates by partitioning. Ametoctradin is also not persistent in aerobic soils and is rapidly
biotransformed to a series of polar carboxylic acid metabolites. The active constituent is ultimately mineralised in aerobic soil or converted to non-extractable
bound residues. The active constituent is predicted to undergo rapid photochemical oxidation in the troposphere and is not expected to persist in the
atmosphere. Ametoctradin is persistent in anaerobic soils, but is otherwise not persistent in any environmental compartment. The mobility of ametoctradin in
soil is low to immobile and it has a low potential to leach through the soil horizon as confirmed by multiple field dissipation studies. The active constituent does
not accumulate in soil and has a low potential to be transported as dissolved substance in run-off water from a vineyard.
Ametoctradin has relatively low ecotoxicity to most non-target organisms that have been tested. It is practically non-toxic to birds and wild mammals, and very
slightly toxic to bees and earthworms. The active constituent has no adverse effects on soil microorganisms responsible for carbon and nitrogen
mineralisation in soil, no-phytotoxic effects and no significant effects on arthropods under field exposure conditions. Ametoctradin is only slightly soluble in
water and the majority of the aquatic species tested show no signs of toxic effects up to the functional solubility limit of the active constituent in water or
media. However, ametoctradin is very highly toxic to the freshwater diatom, Navicula pelliculosa. It is also moderately toxic to freshwater invertebrates and
fish in long term exposures. Ametoctradin does not bioconcentrate in fish.
The environmental risk assessment has shown that there are no unacceptable risks to any non-target terrestrial organisms. A standard spray drift
assessment for application of Zampro Fungicide to grapevines by airblast sprayer demonstrated that the environmental risks to aquatic organisms are
acceptable with a 10-metre downwind no-spray zone. There are no unacceptable risks to aquatic organisms from run-off of ametoctradin bound to eroded soil
and dimethomorph dissolved in water.
49642
Page 7 of 23
KP25S_F39 Version: 2 Issued: 14/08/2007
Data relied on to provide the advice
Data
No
Data
Source*
Data Type
Data Sub-type
40065
S
Hernadi D.
Effect of BAS 650 00 F on the predatory mite
(Typhlodromus pyri) in a laboratory trial
2006-12-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Other
Applicant
40066
S
Hernadi D.
Effect of BAS 650 00 F on the parasitic wasp
(Aphidius rhopalosiphi) in a laboratory trial
2007-03-12
Environment Toxicology
Non-target Invertebrates
(terrestrial) Other
Applicant
40067
S
Hernadi D.
Effect of BAS 650 00 F on the parasitic wasp
(Aphidius rhopalosiphi) in an extended laboratory
trial
2007-09-19
Environment Toxicology
Non-target Invertebrates
(terrestrial) Other
Applicant
40068
S
Friedrich S.
Effects of BAS 650 00 F on the reproduction of the
collembolans Folsomia candida in artificial soil
with 5 percent peat
2007-12-14
Environment Toxicology
Non-target Invertebrates
(terrestrial) Other
Applicant
40069
S
Roehlig U.
Effects of BAS 650 00 F on the green lacewing
Chrysoperla carnea STEPH. under laboratory
conditions - Rate-response test
2008-03-26
Environment Toxicology
Non-target Invertebrates
(terrestrial) Other
Applicant
40070
S
Vertesi A.
Acute toxicity of BAS 650 00 F on earthworms
(Eisenia fetida) in artificial soil with 5 percent peat
2006-11-28
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40071
S
Friedrich S.
Sublethal toxicity of BAS 650 00 F to the
earthworm Eisenia fetida in artificial soil with 5
percent peat
2007-12-04
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40072
S
Schmitzer S.
Effects of BAS 650 00 F (acute contact and oral)
on honey bees (Apis mellifera L.) in the laboratory
2006-11-20
Environment Toxicology
Non-target Invertebrates
(terrestrial) Bees
Applicant
40076
S
Gamer A.O.,
Landsiedel R.
BAS 650 00 F - Acute oral toxicity study in rats
2006-11-09
Toxicology
Acute Oral Studies,
Product
Applicant
40092
S
Vertesi A.
Acute toxicity of BAS 651 00 F on earthworms
(Eisenia fetida) in artificial soil with 5% peat
(Including amendment no. 1)
2008-09-19
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40093
S
Muether-Paul J.
Assessment of side effects of BAS 651 00 F to the
honey bee, Apis mellifera L. in the laboratory
2006-08-08
Environment Toxicology
Non-target Invertebrates
(terrestrial) Bees
Applicant
40097
S
Zok S.
BAS 651 00 F - Acute toxicity in the bobwhite quail
(Colinus virginianus) after single oral
administration (LD50)
2008-02-27
Environment Toxicology
Vertebrates Acute
Applicant
40098
S
Zok S.
BAS 651 00 F - Acute toxicity study on the
rainbow trout (Oncorhynchus mykiss) in a static
system over 96 hours
2007-05-18
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40099
S
Zok S.
BAS 651 00 F - Determination of the acute effect
on the swimming ability of the water flea Daphnia
magna STRAUS
2007-12-10
Environment Toxicology
Aquatic Organisms
Acute
Applicant
49642
Author(s)
Title
Date
Page 8 of 23
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
40100
S
Zok S.
BAS 651 00 F - Determination of the inhibitory
effect on the cell multiplication of the unicellular
green algae Pseudokirchneriella subcapitata
KORSHIKOV
2008-02-25
Environment Toxicology
Aquatic Organisms
Other
Applicant
40102
S
Porch J.R. et al.
BAS 651 00 F: A toxicity test to determine the
effects of the test substance on seedling
emergence of ten species of plants
2009-09-11
Environment Toxicology
Non-target Vegetation Laboratory
Applicant
40103
S
Porch J.R. et al.
BAS 651 00 F: A toxicity test to determine the
effects of the test substance on vegetative vigor of
ten species of plants
2009-09-10
Environment Toxicology
Non-target Vegetation Laboratory
Applicant
40106
S
Gamer A.O.,
Landsiedel R.
BAS 651 00 F: Acute oral toxicity study in rats
2007-01-05
Toxicology
Acute Oral Studies,
Product
Applicant
40110
S
Sipos K.
Effect of BAS 651 00 F on the parasitic wasp
(Aphidius rhopalosiphi) in a laboratory trial
2007-11-13
Environment Toxicology
Non-target Invertebrates
(terrestrial) Other
Applicant
40111
S
Sipos K.
Effect of BAS 651 00 F on the parasitic wasp
(Aphidius rhopalosiphi) in an extended laboratory
trial (Including amendment no. 1)
2008-08-22
Environment Toxicology
Non-target Invertebrates
(terrestrial) Other
Applicant
40112
S
Sipos K.
Effect of BAS 651 00 F on the predatory mite
(Typhlodromus pyri) in a laboratory trial (Including
amendment no. 1)
2009-09-04
Environment Toxicology
Non-target Invertebrates
(terrestrial) Other
Applicant
40113
S
Schulz L.
Effects of BAS 651 00 F on the activity of soil
microflora (Carbon transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
40114
S
Schulz L.
Effects of BAS 651 00 F on the activity of soil
microflora (Nitrogen transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
40115
S
Roehlig U.
Effects of BAS 651 00 F on the green lacewing
Chrysoperla carnea STEPH. under laboratory
conditions - Rate-response-test
2008-06-06
Environment Toxicology
Non-target Invertebrates
(terrestrial) Other
Applicant
40116
S
Friedrich S.
Effects of BAS 651 00 F on the reproduction of the
collembolans Folsomia candida in artificial soil
with 5% peat
2007-12-14
Environment Toxicology
Non-target Invertebrates
(terrestrial) Other
Applicant
40125
S
Friedrich S.
Sublethal toxicity of BAS 651 00 F to the
earthworm Eisenia fetida in artificial soil with 5%
peat
2007-12-04
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40126
S
Junker, M.
Effect of BAS 550 01 F on the growth of Lemma
gibba.
2001
Environment Toxicology
Aquatic Organisms
Short-term
Applicant
40147
S
Bayer H., Kuhnke G.
The anaerobic soil metabolism of BAS 650 F
2008-07-14
Environment Fate
Biodegradation Soils
Applicant
49642
Author(s)
Title
Date
Page 9 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
40148
S
Bayer H., Janz U.
The aerobic soil metabolism of BAS 650 F
2008-08-04
Environment Fate
Biodegradation Soils
Applicant
40149
S
Jordan J., Warren R.
Terrestrial field dissipation of BAS 650 F following
applications of BAS 650 00 F in vegetable use
patterns
2010-01-28
Environment Fate
Field Dissipation Soils
Applicant
40150
S
Jordan J., Warren R.
Terrestrial field dissipation of BAS 650 F following
applications of BAS 650 00 F in orchard/vineyard
and root vegetable use patterns
2010-01-29
Environment Fate
Field Dissipation Soils
Applicant
40159
S
Hassink J.
Soil photolysis of BAS 650 F
2008-03-18
Environment Fate
Physicochemical
Degradation
Photodegradation
Applicant
40167
S
Zok S.
Reg.No. 4993353 - Avian dietary LC50 test in
ducklings of the mallard duck (Anas
platyrhynchos)
2005-09-29
Environment Toxicology
Vertebrates Short-term
Applicant
40168
S
Zok S.
Reg.No. 4993353 - Avian dietary LC50 test in
chicks of the bobwhite quail (Colinus virginianus)
2005-09-29
Environment Toxicology
Vertebrates Short-term
Applicant
40169
S
Bayer H., Janz U.
Rate of degradation of BAS 650 F in aerobic soil
2008-06-27
Environment Fate
Biodegradation Soils
Applicant
40170
S
Staudenmaier H.
Rate of degradation in soil of M650F04, metabolite
of BAS 650 F
2008-07-01
Environment Fate
Biodegradation Soils
Applicant
40171
S
Hassink J.
Rate of degradation in soil of M650F03 (metabolite
of BAS 650 F)
2008-07-10
Environment Fate
Biodegradation Soils
Applicant
40186
S
Rzodeczko H.
M650F03 - Daphnia magna reproduction test
2008-09-29
Environment Toxicology
Aquatic Organisms
Other
Applicant
40189
S
Zmijowski G.
M650F02 (Metabolite of BAS 650 F): Daphnia
magna, acute immobilisation test
2009-07-08
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40194
S
Leite R.
Investigation of the storage stability of BAS 650 F
and its metabolites M650F01, M650F02, M650F03
and M650F04 in soil samples under usual storage
conditions
2008-07-23
Environment Fate
Field Dissipation Soils
Applicant
40195
S
Leite R., Santiago L.
Investigation of the storage stability of BAS 650 F
and its metabolites M650F01, M650F02, M650F03
and M650F04 in soil sample under usual storage
conditions
2009-12-04
Environment Fate
Field Dissipation Soils
Applicant
40209
S
Gooding R.F.
Freezer storage stability of BAS 650 F and its
relevant metabolites in soil samples
2010-02-05
Environment Fate
Field Dissipation Soils
Applicant
40210
S
Grote C., Tilting N.
Field soil dissipation study of M650F04 in the
formulation EXP 5211623 F on bare soil at five
different locations in Europe, 2007-2008
2008-08-26
Environment Fate
Field Dissipation Soils
Applicant
49642
Author(s)
Title
Date
Page 10 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
40211
S
Grote C., Tilting N.
Field soil dissipation study of M650F03 in the
formulation EXP 5178870 F on bare soil at five
different locations in Europe, 2007-2008
2008-08-28
Environment Fate
Field Dissipation Soils
Applicant
40216
S
Schulz L.
Effects of Reg.No. 5211623 (metabolite of BAS
650 F, M650F04) on the activity of soil microflora
(nitrogen transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
40217
S
Schulz L.
Effects of Reg.No. 5211623 (metabolite of BAS
650 F, M650F04) on the activity of soil microflora
(carbon transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
40218
S
Schulz L.
Effects of Reg.No. 5211623 (metabolite of BAS
650 F, M650F04) on the activity of soil microflora
(carbon transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
40219
S
Luehrs U.
Effects of Reg.No. 5211623 (metabolite of BAS
650 F, M650F04) on reproduction of the
collembola Folsomia candida in artificial soil
2008-07-15
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40220
S
Royer S.
Effects of Reg.No. 5211623 (metabolite of BAS
650 F, M650F04) on reproduction of soil mites
Hypoaspis aculeifer in artificial soil
2008-07-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40221
S
Luehrs U.
Effects of Reg.No. 5211623 (metabolite of BAS
650 F, M650F04) on reproduction and growth of
earthworms Eisenia fetida in artificial soil
2008-07-08
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40222
S
Schulz L.
Effects of Reg.No. 5178870 (metabolite of BAS
650 F, M650F03) on the activity of soil microflora
(nitrogen transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
40223
S
Schulz L.
Effects of Reg.No. 5178870 (metabolite of BAS
650 F, M650F03) on the activity of soil microflora
(nitrogen transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
40224
S
Schulz L.
Effects of Reg.No. 5178870 (metabolite of BAS
650 F, M650F03) on the activity of soil microflora
(carbon transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
40225
S
Schulz L.
Effects of Reg.No. 5178870 (metabolite of BAS
650 F, M650F03) on the activity of soil microflora
(carbon transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
49642
Author(s)
Title
Date
Page 11 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
Data Type
Data Sub-type
40226
S
Luehrs U.
Effects of Reg.No. 5178870 (metabolite of BAS
650 F, M650F03) on reproduction of the
collembola Folsomia candida in artificial soil
2008-07-15
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40227
S
Royer S.
Effects of Reg.No. 5178870 (metabolite of BAS
650 F, M650F03) on reproduction of soil mites
Hypoaspis aculeifer in artificial soil
2008-07-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40228
S
Luehrs U.
Effects of Reg.No. 5178870 (metabolite of BAS
650 F, M650F03) on reproduction and growth of
earthworms Eisenia fetida in artificial soil
2008-07-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40229
S
Schulz L.
Effects of Reg. No. 5211623 (metabolite of BAS
650 F, M650F04) on the activity of soil microflora
(nitrogen transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
40230
S
Schmitzer S.
Effects of BAS 650 F (acute contact and oral) on
honey bees (Apis mellifera L.) in the laboratory
2006-12-07
Environment Toxicology
Non-target Invertebrates
(terrestrial) Bees
Applicant
40231
S
Schulz L.
Effects of BAS 650 00 F on the activity of soil
microflora (nitrogen transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
40232
S
Schulz L.
Effects of BAS 650 00 F on the activity of soil
microflora (carbon transformation test) (Including
amendment no. 1)
2009-06-18
Environment Toxicology
Non-target Invertebrates
(terrestrial) Soil Micros
Applicant
40233
S
Rosenkranz B.
Effects of BAS 650 00 F on predatory mites
(Acari, Phytoseiidae) under field conditions in vine
(late application)
2008-05-14
Environment Toxicology
Non-target Invertebrates
(terrestrial) Predators
Applicant
40234
S
Rosenkranz B.
Effects of BAS 650 00 F on predatory mites
(Acari, Phytoseiidae) under field conditions in vine
(early application)
2008-04-02
Environment Toxicology
Non-target Invertebrates
(terrestrial) Predators
Applicant
40235
S
Hanewald N.
Effects of BAS 650 00 F on populations of
predatory mites (Acari, Phytoseiidae e.g.
Typhlodromus pyri) under field conditions in a
vineyard - 4 late applications
2008-06-27
Environment Toxicology
Non-target Invertebrates
(terrestrial) Predators
Applicant
40236
S
Hanewald N.
Effects of BAS 650 00 F on populations of
predatory mites (Acari, Phytoseiidae e.g.
Typhlodromus pyri) under field conditions in a
vineyard - 4 early applications
2008-06-27
Environment Toxicology
Non-target Invertebrates
(terrestrial) Predators
Applicant
40237
S
Chandrasehar G.
Effect of Reg.No. 5211623 on the growth of green
alga, Pseudokirchneriella subcapitata
2008-01-05
Environment Toxicology
Aquatic Organisms
Other
Applicant
49642
Author(s)
Title
Date
Page 12 of 23
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
40238
S
Ayyappan S.
Effect of Reg.No. 5178870 (metabolite of BAS 650
F) on the growth of green alga,
Pseudokirchneriella subcapitata
2008-02-26
Environment Toxicology
Aquatic Organisms
Other
Applicant
40239
S
Hoffmann F.
Effect of BAS 650 F (Reg.No. 4993353) on the
growth of the marine diatom Skeletonema
costatum
2009-10-27
Environment Toxicology
Aquatic Organisms
Other
Applicant
40240
S
Hoffmann F.
Effect of BAS 650 F (Reg.No. 4993353) on the
growth of the green alga Pseudokirchneriella
subcapitata (Including amendment no. 1)
2009-01-16
Environment Toxicology
Aquatic Organisms
Other
Applicant
40241
S
Hoffmann F.
Effect of BAS 650 F (Reg.No. 4993353) on the
growth of the fresh water diatom Navicula
pelliculosa
2009-10-27
Environment Toxicology
Aquatic Organisms
Other
Applicant
40242
S
Hoffmann F.
Effect of BAS 650 F (Reg.No. 4993353) on the
growth of the blue-green alga Anabaena flosaquae
2009-10-14
Environment Toxicology
Aquatic Organisms
Other
Applicant
40243
S
Hoffmann F.
Effect of BAS 650 F (Reg.No. 4993353) on the
growth of Lemna gibba in a semi-static test
2009-11-23
Environment Toxicology
Aquatic Organisms
Other
Applicant
40244
S
Stroemel C. et al.
Effect of BAS 650 00 F on vegetative vigour of ten
species of terrestrial plants
2007-11-26
Environment Toxicology
Non-target Vegetation Laboratory
Applicant
40245
S
Stroemel C. et al.
Effect of BAS 650 00 F on seedling emergence of
ten species of terrestrial plants
2007-11-26
Environment Toxicology
Non-target Vegetation Laboratory
Applicant
40252
S
Beck I.-C., Class T.
Determination of the adsorption / desorption
behavior of M650F02 (metabolite of BAS 650 F)
on soils (OECD Guideline 106)
2008-12-05
Environment Fate
Mobility
Adsorption/Desorption
Applicant
40258
S
Ebert D.
Degradation of BAS 650 F in water/sediment
systems under aerobic conditions
2008-08-04
Environment Fate
Biodegradation Water
Applicant
40263
S
Weltje L. et al.
Chronic toxicity of the pyrimidylamine (BAS 650 F)
formulation BAS 650 00 F to the non-biting midge
Chironomus riparius - A spiked sediment study
2008-06-11
Environment Toxicology
Aquatic Organisms
Other
Applicant
40264
S
Bergtold M., Janson G.
Chronic toxicity of BAS 650 F (Reg.No. 4993353)
to Daphnia magna Straus in a 21 day semi-static
test
2008-06-19
Environment Toxicology
Aquatic Organisms
Other
Applicant
40266
S
Rabe U. et al.
Bioaccumulation and metabolism of 14C BAS 650
F in bluegill sunfish (Lepomis macrochirus)
2010-02-02
Environment Toxicology
Aquatic Organisms
Other
Applicant
40274
S
Schwarz H.
BAS 650 F: Determination of the inhibition of
oxygen consumption by activated sludge in the
activated sludge respiration inhibition test
2006-12-22
Environment Toxicology
Other Information
Applicant
49642
Author(s)
Title
Date
Page 13 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
40275
S
Hartman M., Singh M.
BAS 650 F: Anaerobic aquatic metabolism
2009-12-23
Environment Fate
Biodegradation Water
Applicant
40276
S
Zok S.
BAS 650 F: Acute toxicity study on the rainbow
trout (Oncorhynchus mykiss) in a flow through
system over 96 hours
2007-03-08
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40277
S
Zok S.
BAS 650 F: Acute toxicity in the mallard duck
(Anas platyrhynchos) after single oral
administration (LD50)
2007-02-01
Environment Toxicology
Vertebrates Acute
Applicant
40282
S
Salinas E.
BAS 650 F Acute toxicity study with the fathead
minnow (Pimephales promelas)
2009-11-30
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40290
S
Zok S.
BAS 650 F - Early life-stage test on the fathead
minnow (Pimephales promelas) in a flow through
system
2006-08-31
Environment Toxicology
Aquatic Organisms
Short-term
Applicant
40291
S
Schwarz H.
BAS 650 F - Determination of the biodegradability
in the CO2-evolution test
2006-09-29
Environment Fate
Biodegradation Soils
Applicant
40295
S
Sayers L.E., Staab F.
BAS 650 F - Acute toxicity to sheepshead minnow
(Cyprinodon variegatus) under flow-through
conditions, following OPPTS draft guideline
850.1075
2009-08-27
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40296
S
Sayers L.E., Staab F.
BAS 650 F - Acute toxicity to mysids
(Americamysis bahia), under flow-through
conditions following OPPTS guideline 850.1035
2009-08-28
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40297
S
Staab F., York D.O.
BAS 650 F - Acute toxicity to eastern oyster
(Crassostrea virginica) under flow-through
conditions, following OPPTS Guideline (draft)
850.1025
2009-08-28
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40298
S
Zok S.
BAS 650 F - Acute toxicity study on the bluegill
sunfish (Lepomis macrochirus) in a flow-throughsystem over 96 hours
2007-03-09
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40299
S
Zok S.
BAS 650 F - Acute toxicity on the common carp
(Cyprinus carpio) in a flow-through system over 96
hours
2007-08-29
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40300
S
Zok S.
BAS 650 F - Acute toxicity in the Zebra finch
(Taeniopygia guttata) after single oral
administration (LD50)
2009-06-25
Environment Toxicology
Vertebrates Acute
Applicant
40301
S
Zok S.
BAS 650 F - Acute toxicity in the bobwhite quail
(Colinus virginianus) after single oral
administration (LD50)
2007-01-30
Environment Toxicology
Vertebrates Acute
Applicant
49642
Author(s)
Title
Date
Page 14 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
40305
S
Zok S.
BAS 650 F - 1-generation reproduction study on
the mallard duck (Anas platyrhynchus) by
administration in the diet (Including amendment
no. 1)
2009-07-17
Environment Toxicology
Vertebrates Other
Applicant
40306
S
Zok S.
BAS 650 F - 1-generation reproduction study on
the bobwhite quail (Colinus virginianus) by
administration in the diet (Including amendment
nos. 1 and 2)
2009-07-17
Environment Toxicology
Vertebrates Other
Applicant
40312
S
Thomas S. et al.
BAS 650 00 F: A 10-day whole sediment toxicity
test with Leptocheirus plumulosus using spiked
sediment
2010-01-07
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40313
S
Zok S.
BAS 650 00 F - Determination of the inhibitory
effect on the cell multiplication of unicellular green
algae Pseudokirchneriella subcapitata
2007-03-30
Environment Toxicology
Aquatic Organisms
Other
Applicant
40314
S
Zok S.
BAS 650 00 F - Determination of the acute effect
on the swimming ability of the water flea Daphnia
magna STRAUS
2007-05-04
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40315
S
Zok S.
BAS 650 00 F - Acute toxicity study on the
rainbow trout (Oncorhynchus mykiss) in a static
system over 96 hours
2007-12-21
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40316
S
Ebert D.
Aqueous photolysis of M650F03 (metabolite of
BAS 650 F)
2008-07-08
Environment Fate
Physicochemical
Degradation
Photodegradation
Applicant
40320
S
Singh M. et al.
Aerobic soil metabolism of BAS 650 F
2010-01-26
Environment Fate
Biodegradation Soils
Applicant
40321
S
Harder U., Reinhard K.
Adsorption/desorption - Study of BAS 650 F
metabolite M650F04 (Reg.No. 5211623) on five
soils differing in pH
2008-08-01
Environment Fate
Mobility
Adsorption/Desorption
Applicant
40322
S
Zirnstein M.
Adsorption/desorption - Study of BAS 650 F
metabolite M650F04 (Reg.No. 5211623) on five
European and two North American soils and one
Japanese soil (Including amendment no. 1)
2009-08-03
Environment Fate
Mobility
Adsorption/Desorption
Applicant
40323
S
Harder U., Reinhard K.
Adsorption/desorption - Study of BAS 650 F
metabolite M650F03 (Reg.No. 5178870) on five
soils differing in pH (Including amendment no. 1)
2008-08-04
Environment Fate
Mobility
Adsorption/Desorption
Applicant
40324
S
Zirnstein M.
Adsorption/desorption - Study of BAS 650 F
metabolite M650F03 (Reg.No. 5178870) on five
European and two North American soils and one
Japanese soil
2007-03-29
Environment Fate
Mobility
Adsorption/Desorption
Applicant
49642
Author(s)
Title
Date
Page 15 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
40325
S
Zirnstein M.
Adsorption / desorption study of BAS 650 F
metabolite M650F01 (Reg.No. 5178872) on five
European and two North American soils and one
Japanese soil
2008-08-04
Environment Fate
Mobility
Adsorption/Desorption
Applicant
40326
S
Zirnstein M.
Adsorption / desorption - Study of BAS 650 F
(Reg.No. 4993353) on five European and two
North American soils and one Japanese soil
(Including amendment no. 1)
2008-07-29
Environment Fate
Mobility
Adsorption/Desorption
Applicant
40327
S
Chittibabu R.A.
Acute toxicity study of Reg.No. 5211623 to
freshwater fish, Oncorhynchus mykiss
2008-01-08
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40328
S
Gopi R.A.
Acute toxicity study of Reg.No. 5178870
(metabolite of BAS 650 F) to freshwater fish,
Oncorhynchus mykiss
2008-02-11
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40329
S
Vertesi A.
Acute toxicity of Reg.No. 5211623 (metabolite of
BAS 650 F, M650F04) on earthworms (Eisenia
fetida)
2006-12-19
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40330
S
Vertesi A.
Acute toxicity of Reg.No. 5178872 (metabolite of
BAS 650 F, M650F01) on earthworms (Eisenia
fetida) - Amended report
2008-08-12
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40331
S
Janson G.-M.
Acute toxicity of Reg.No. 5178872 (metabolite of
BAS 650 F) to Daphnia magna Straus in a 48 hour
static test
2008-06-26
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40332
S
Vertesi A.
Acute toxicity of Reg.No. 5178870 (Metabolite of
BAS 650 F, M650F03) on earthworms (Eisenia
fetida)
2007-08-31
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40333
S
Vertesi A.
Acute toxicity of BAS 650 F on earthworms
(Eisenia fetida) in artificial soil with 5% peat
2007-07-17
Environment Toxicology
Non-target Invertebrates
(terrestrial) Earthworms
Applicant
40334
S
Janson G.-M.
Acute toxicity of BAS 650 F (Reg.No. 4993353) to
Daphnia magna STRAUS in a 48 hour static test
(Including amendment no. 1)
2010-01-13
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40335
S
Chittibabu R.A.
Acute immobilisation test with Reg.No. 5211623 in
Daphnia magna
2008-01-08
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40336
S
Gopi R.A.
Acute immobilisation test with Reg.No. 5178870
(metabolite of BAS 650 F) in Daphnia magna
2008-02-11
Environment Toxicology
Aquatic Organisms
Acute
Applicant
40337
S
Lehmhus J.
A field study to evaluate the effects of BAS 650 00
F on predatory mites (Acari: Phytoseiidae) in a
vineyard in Southern France - 4 late applications
2008-01-28
Environment Toxicology
Non-target Invertebrates
(terrestrial) Predators
Applicant
49642
Author(s)
Title
Date
Page 16 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
Data Type
Data Sub-type
40338
S
Lehmhus J.
A field study to evaluate the effects of BAS 650 00
F on predatory mites (Acari: Phytoseiidae) in a
vineyard in Southern France - 4 early applications
2008-01-28
Environment Toxicology
Non-target Invertebrates
(terrestrial) Predators
Applicant
67610
I
Kaspers U. et al.
BAS 650 F - Repeated dose 90-day oral toxicity in
Wistar rats; Administration in the diet
2007-06-20
Toxicology
Sub-chronic Studies
BASF
AUSTRALIA
LTD.
50049
67615
I
Schneider S. et al.
BAS 650 F - Two-generation reproduction toxicity
study in Wistar rats - Administration via the diet
2008-06-26
Toxicology
Reproduction Studies
BASF
AUSTRALIA
LTD.
50049
67626
I
Kaspers U. et al.
Reg.No. 5211623 (metabolite of BAS 650 F) Repeated dose 90-day oral toxicity study in Wistar
rats; administration in the diet
2008-08-15
Toxicology
Metabolites and
Impurities Studies
BASF
AUSTRALIA
LTD.
50049
67627
I
Kaspers U. et al.
Reg.No. 5178870 (metabolite of BAS 650 F) Repeated dose 90-day oral toxicity study in Wistar
rats; Administration in the diet
2008-08-22
Toxicology
Metabolites and
Impurities Studies
BASF
AUSTRALIA
LTD.
50049
67637
I
Schneider S. et al.
BAS 650 F: Prenatal developmental toxicity study
in Wistar rats - Oral administration (gavage)
2006-08-03
Toxicology
Developmental
(Teratology) Studies
BASF
AUSTRALIA
LTD.
50049
67644
I
Gamer A.O., Landsiedel
R.
BAS 650 F: Acute oral toxicity study in rats
2007-01-26
Toxicology
Acute Oral Studies,
Active
BASF
AUSTRALIA
LTD.
50049
67656
I
Adam D.
BAS 650 F: Hydrolysis at four different pH values
2006-09-06
Chemistry and
Manufacture
Active Constituent,
Other Information
BASF
AUSTRALIA
LTD.
50049
67659
I
Daum A.
Determination of the water solubility of Reg.No.
4993353 PAI in deionized water and at pH4, pH7,
pH9 at 20°C
2005-07-27
Chemistry and
Manufacture
Active Constituent,
Other Information
BASF
AUSTRALIA
LTD.
50049
67660
I
Daum A.
Determination of the solubility in organic solvents
at 20°C of Reg.No. 4993353 PAI
2005-08-09
Chemistry and
Manufacture
Active Constituent,
Other Information
BASF
AUSTRALIA
LTD.
50049
67661
I
Daum A.
Determination of the melting point / boiling point
and the appearance of Reg.No. 4993353 PAI
2005-08-19
Chemistry and
Manufacture
Active Constituent,
Other Information
BASF
AUSTRALIA
LTD.
50049
67662
I
Daum A.
Determination of the octanol/water partition
coefficient of Reg.No. 4993353 PAI at 20°C
2005-08-29
Chemistry and
Manufacture
Active Constituent,
Other Information
BASF
AUSTRALIA
LTD.
50049
49642
Author(s)
Title
Date
Page 17 of 23
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
67663
I
Daum A.
Spectra (UV-VIS, NMR, IR, MS) of Reg.No.
4993353 PAI
2005-11-24
Chemistry and
Manufacture
Active Constituent,
Other Information
BASF
AUSTRALIA
LTD.
50049
67664
I
Fischer A.
Determination of the dissociation constant of
Reg.No. 4993353 (BAS 650 F) in accordance with
OECD-Guideline 112
2006-07-24
Chemistry and
Manufacture
Active Constituent,
Other Information
BASF
AUSTRALIA
LTD.
50049
67666
I
Hassink J.
Aqueous photolysis of BAS 650 F
2008-07-10
Chemistry and
Manufacture
Active Constituent,
Other Information
BASF
AUSTRALIA
LTD.
50049
67667
I
Kroehl T.
BAS 650 F - Reg.No. 4993353: Physical
properties of the pure active ingredient
2006-12-06
Chemistry and
Manufacture
Active Constituent,
Other Information
BASF
AUSTRALIA
LTD.
50049
67669
I
Kroehl T.
Henry s law constant for BAS 650 F (Reg.No.
4993353)
2007-04-03
Chemistry and
Manufacture
Active Constituent,
Other Information
BASF
AUSTRALIA
LTD.
50049
APVMA Chemistry And Residues Program, Residues Team
As part of the residues assessment for ametoctradin, plant and animal metabolism studies, analytical methods and storage stability, supervised residue trials,
crop rotation studies, processing studies and trade aspects were considered.
Based on the available plant and animal metabolism data, it was concluded that parent ametoctradin was the only residue found in treated leaves and fruits.
No metabolic pathway was proposed for plants since parent ametoctradin was the only residue found in treated leaves and fruits; low levels of the metabolites
M650F03 and M650M04 were found in tubers (not in directly treated leaves and fruits). A residue definition of parent compound is proposed for ametoctradin
in commodities of plant origin, for both MRL enforcement and dietary risk assessment.
The hen metabolism study showed that ametoctradin was the only identified compound in eggs. The goat metabolism study showed that the metabolites
M650F01 and M650F06 were the major identified compounds in goat milk, liver, kidney and fat. Higher amounts of M650F06 than M650F01 were observed.
A dairy cow feeding study showed that when finite residues of M650F01 were observed (in liver and kidney), higher residues of M650F06 were also
observed. In addition finite residues of M650F06 were observed in liver at a lower feeding level. A metabolism scheme for animals was proposed in which
degradation proceeds via oxidation of the aliphatic side chain to the respective terminal carboxylic acid and subsequent stepwise shortening of the aliphatic
side chain. A residue definition of the sum of residues of ametoctradin and the metabolite M650F06 was proposed for ametoctradin in commodities of animal
origin, for both MRL enforcement and dietary risk assessment.
In support of the proposed grape use, the applicant has provided details of six Australia residues trials (including two processing studies), 13 United States
residues trials and four German processing studies. Observations from the Australian and United States trials gave a supervised trial median residue
(STMR) of 0.62 mg/kg and a highest residue (HR) of 1.74 mg/kg. On the basis of these data, a maximum residue limit (MRL) of 3 mg/kg is recommended for
49642
Page 18 of 23
KP25S_F39 Version: 2 Issued: 14/08/2007
ametoctradin in grapes. Crop rotation studies from the United States and Europe show that the proposed use of Zampro Fungicide should not result in
rotational crop concerns.
The processing studies showed that ametoctradin residues do not concentrate in wine during processing, but do concentrate in wet pomace, dry pomace
and raisins (highest processing factors being 5.2, 35 and 6.3×, respectively). An MRL for grape pomace (dry) at 70 mg/kg is recommended. Use on grapes
for dried fruit production is not permitted due to the dimethomorph component of the Zampro formulation; therefore, an MRL for ametoctradin in raisins was
not proposed.
On the basis of the results of a lactating cow feeding study and the laying hen metabolism study, an MRL of 0.02 mg/kg set at the combined LOQ for
ametoctradin and the metabolite M650F06 was proposed for eggs, mammalian & poultry meat, milks, and edible mammalian & poultry offal.
The chronic dietary exposure to ametoctradin, as estimated by the national estimated daily intake (NEDI) calculation, showed that potential exposure was
equivalent to 0.01% of the ADI. The DIAMOND model estimated the chronic dietary exposure of ametoctradin as 0.01% of the ADI for the general
population. The dietary exposure is therefore acceptable.
Grapes and wine are considered to be major exposure export commodities. Therefore, there is a theoretical risk to Australian trade relations if grapes
treated with Zampro Fungicide and wine made from treated grapes are exported to market which do not have MRLs in place, or have established MRLs
which are lower than Australian MRLs. The proposed Australian MRL for grapes (3 mg/kg) is lower than proposed Canadian MRL (4 mg/kg) and the
established European Union MRL (5 mg/kg). A separate wine MRL is not required, as residues in wine will not exceed the grape MRL. Levels of
ametoctradin above the LOQ (0.02 mg/kg) are not expected in any animal commodity as a result of the proposed use. Detectable resides are expected to
occur in grapes and may be above the standards of key export markets. To address this concern, the label cautions growers to check with BASF Australia
Ltd or the Australia Wine Research Institute for the latest information on MRLs before using the product. The following withholding period was recommended
in conjuction with the above MRLs:
WITHHOLDING PERIOD
Do not harvest for 4 weeks after application.
Data relied on to provide the advice
Data
No
Data
Source*
40129
S
Mackenroth C.,
Schweda Z.
Validation of BASF method L0117/01: Method for
the determination of BAS 650 F in plant matrices
2008-06-25
Residues
Analytical Methods
Applicant
40130
S
Mackenroth C.,
Schweda Z.
Validation of BASF method L0104/01: Method for
the determination of BAS 650 F and its metabolites
M650F01 and M650F06 in animal matrices
2008-07-17
Residues
Analytical Methods
Applicant
49642
Author(s)
Title
Date
Page 19 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
40131
S
Mackenroth C.,
Schweda Z.
Validation of BASF method L0078/01: Method for
the determination of BAS 650 F and its metabolites
M650F03 and M650F04 in plant matrices
2008-06-03
Residues
Analytical Methods
Applicant
40141
S
Glaessgen W.E.,
Kemper P.
The metabolism of 14C-BAS 650 F in laying hens
2008-08-21
Residues
Crop Residues Livestock Feed
Applicant
40144
S
Norris F.A., Saha M.
The magnitude of BAS 650 F and Dimethomorph
residues in wheat, lettuce and radish planted as
rotational crops following applications of BAS 651 00
F (plant back intervals of 30, 60, 90 and 120 Days)
2009-12-07
Residues
Crop Residues Human
Consumption
Applicant
40151
S
Klimmek S.
Study on the residue behaviour of BAS 650 F on the
rotational crops: Wheat, carrots, cauliflower and
lettuce after one application to the bare soil of BAS
650 00 F under field conditions in Germany, Italy,
The Netherlands and Southern France, 2007
2009-10-23
Residues
Crop Residues Human
Consumption
Applicant
40157
S
Mackenroth C., Rabe U.
Storage stability of BAS 650 F in samples from
metabolism studies
2008-08-15
Residues
Fate - Storage, Processing
and Cooking
Applicant
40176
S
Labib S., Rabe U.
Metabolism of BAS 650 F in tomatoes
2008-07-17
Residues
Crop Residues Human
Consumption
Applicant
40177
S
Labib S., Rabe U.
Metabolism of BAS 650 F in potatoes (Including
amendment no. 1)
2009-12-16
Residues
Crop Residues Human
Consumption
Applicant
40178
S
Labib S., Rabe U.
Metabolism of BAS 650 F in lettuce
2008-05-29
Residues
Crop Residues Human
Consumption
Applicant
40179
S
Bross M., Glaessgen
W.E.
Metabolism of 14C-BAS 650 F (14C-Reg. No.
4993353) in lactating goat
2008-08-01
Residues
Crop Residues Livestock Feed
Applicant
40180
S
Jordan J.M.
Magnitude of BAS 650 F and Dimethomorph
residues in grapes following applications of BAS 650
00 F and Forum fungicide
2009-09-17
Residues
Crop Residues Human
Consumption
Applicant
40193
S
Lehmann A.,
Mackenroth C.
Investigation of the storage stability of BAS 650 F,
M650F03 and M650F04 in plant matrices
2009-07-27
Residues
Fate - Storage, Processing
and Cooking
Applicant
40196
S
Klimmek S., Weber H.
Independent laboratory validation of BASF Method
L0078 for the determination of residues of BAS 650
F and its metabolites M650F03 and M650F04 in
wheat grain, potatoes, lettuce, sunflower seeds and
oranges (Including amendment no. 1)
2008-06-20
Residues
Analytical Methods
Applicant
40199
S
Schwarz T.
Independent laboratory validation (ILV) of BASF
method number L0117 for the determination of BAS
650 F in plant materials by LC-MS/MS
2008-06-19
Residues
Analytical Methods
Applicant
49642
Author(s)
Title
Date
Page 20 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
40207
S
Hassink J.
Hydrolysis of BAS 650 F at 90 degrees celcius, 100
degrees celcius and 120 degrees celcius
2008-02-01
Residues
Crop Residues Human
Consumption
Applicant
40212
S
Mackenroth C., Rabe U.
Extractability of representative samples generated
during plant metabolism studies
2008-08-01
Residues
Analytical Methods
Applicant
40256
S
Farrell P.
Determination of residues of BAS 650 F and its
metabolites in wine grapes, grape juice, wine and
pomace following three (3) foliar applications of BAS
650 00 F
2010-02-11
Residues
Crop Residues Human
Consumption
Applicant
40262
S
Labib S., Rabe U.
Confined rotational crop study with 14C-BAS 650 F
2008-08-15
Metabolism and
Kinetics
Plants
Applicant
40340
S
Fabian E., Landsiedel R.
14C-BAS 650 F - Absorption, distribution and
excretion after repeated oral administration in laying
hens
2007-11-21
Residues
Crop Residues Livestock Feed
Applicant
40341
S
Fabian E., Landsiedel R.
14C-BAS 650 F - Absorption, distribution and
excretion after repeated oral administration in
lactating goats
2007-11-21
Residues
Crop Residues Livestock Feed
Applicant
49362
S
MacDougall, J.
Magnitude of residues in milk and tissues of dairy
cows following multiple oral administrations of BAS
650 F.
2011
Residues
Crop Residues Livestock Feed
Applicant
Inherited
Application No.
State/External Efficacy Reviewer
Ametoctradin is a fungicide which belongs to the triazolopyrimidylamines chemical group and represents the first commercial development from this group.
The Fungicidal Mode of Action has not been fully characterised however ametoctradin is a strong inhibitor of mitochondrial respiration in complex III
(cytochrome bc1) of fungi belonging to the Class of Oomycetes. The exact binding site at complex III is not yet known. Ametoctradin is in the new Group 45
for fungicides resistance management. Ametoctradin is not intended for curative use; therefore, the reviewer advised that the label should contain a warning
that growers should use alternative products if disease is already established.
The existing active constituent dimethomorph is known to inhibit phospholipid biosynthesis and interfere with normal cell wall deposition, resulting in cell wall
lysis and subsequent death of the fungal cell. Dimethomorph is in Group 40 (carboxylic acid amides) for fungicides resistance management.
The new combination of ametoctradin and dimethomorph in Zampro Fungicide will offer an additional resistance management option to growers currently
using dimethomorph in grapevines.
A total of nine trials on grapevines were conducted in commercial vineyards over five years in three Australian States. Three grape cultivars were tested. In
the trials, efficacy of either ametoctradin alone or Zampro Fungicide in reducing the incidence and severity of leaf infection by downy mildew was compared
49642
Page 21 of 23
KP25S_F39 Version: 2 Issued: 14/08/2007
with a total of three currently registered appropriate industry standards (Acrobat containing dimethomorph; Cabrio containing pyraclostrobin; Ridomil
containing metalaxyl-M). Treatments with ametoctradin alone gave control equivalent or superior to the industry standards. Zampro Fungicide gave greater
control than dimethomorph alone and gave control equivalent or superior to the other industry standards. It is concluded that the efficacy of the new active
constituent ametoctradin, and the new product, Zampro Fungicide, are adequately demonstrated under appropriate commercial conditions. The trial data
support a maximum of two consecutive and no more than four applications per season. The reviewer also advised that the shorter application interval of 7
days is appropriate when conditions favouring infection are creating a high risk.
Data relied on to provide the advice
Data
No
Data
Source*
40080
S
Dr Trevor Wicks, Lee
Bartlett, & Barabara
Hall
Evaluation of BAS 651 and BAS 653 for the
control of Downy mildew (Plasmopara viticola)
on grapevines. cv. Chardonnay Lenswood South
Australia - 2008/2009
2009
Efficacy and Safety
Efficacy
Nufarm Australia
40081
S
Stephen Tancred
Comparison of BAS 651 00 F 300+225 SC and
BAS 653 GB F 80+480 WG with Cabrio 250 EC
& Acrobat 500 WP for the control of downy
mildew (Plasmopara viticola) in Shiraz grapes.
Stanthorpe, Qld, 2008-09
2010
Efficacy and Safety
Efficacy
Nufarm Australia
40082
S
R & D Solutions
Evaluation of the Efficacy of BAS651 and
BAS653 against Downy Mildew in Winegrapes
(Cultivar: Cabernet sauvignon)
2009
Efficacy and Safety
Efficacy
Nufarm Australia
40083
S
Stephen Tancred
Comparison of BAS 651 00 F 300+225 SC with
Product A, Cabrio 250 EC & Acrobat 500 WP for
the control of downy mildew (Plasmopara
viticola) in Shiraz grapes
2010
Efficacy and Safety
Efficacy
Nufarm Australia
40084
S
Dr Trevor Wicks, Lee
Bartlett, & Barabara
Hall
Evaluation of BAS 651 for the control of Downy
mildew (Plasmopara viticola) on grapevines. cv.
Chardonnay Lenswood South Australia 2009/10
2010
Efficacy and Safety
Efficacy
Nufarm Australia
40085
S
R & D Solutions
To Evaluate the Efficacy of BAS651 against
Downy Mildew in Winegrapes (Cultivar:
Chardonnay)
2010
Efficacy and Safety
Efficacy
Nufarm Australia
40086
S
R & D Solutions
To Evaluate the Efficacy of BAS651 against
Downy Mildew in Winegrapes (Cultivar:
Cabernet sauvignon)
2010
Efficacy and Safety
Efficacy
Nufarm Australia
49642
Author(s)
Title
Date
Page 22 of 23
Data Type
Data Sub-type
Authorising
Party
Inherited
Application No.
KP25S_F39 Version: 2 Issued: 14/08/2007
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
40087
S
Stephen Tancred
Comparison of BAS 650 200 SC, BAS 651
300+225 SC and BAS 653 80+480 SC with
Ridomil Gold MZ 680 WG and Acrobat 500 WG
for the control of downy mildew (Plasmopara
viticola) in winegrapes cv. Shiraz
2008
Efficacy and Safety
Efficacy
Applicant
40090
S
Stephen Tancred
Comparison of LAB 4993 353 F200 SC, LAB
4993 + Polyram 700 DF, LAB 4993 + Delan 700
WG, LAB 4993 + Acrobat 500 WP and Cabrio
250 EC for the control of downy mildew
(Plasmopara viticola) in wine grapes cv. Shiraz
2010
Efficacy and Safety
Efficacy
Applicant
Inherited
Application No.
* S = Data submitted with the application
I = Data inherited (that is, referenced) from another application
49642
Page 23 of 23
KP25S_F39 Version: 2 Issued: 14/08/2007