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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