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Fluoxastrobin + Prothioconazole EC 200 (100+100 G/L) Page 1 of 110 Document Title Summary of the ecotoxicological studies fluoxastrobin + prothioconazole EC 200 (100+100 g/L) Data Requirements EU Regulation 1107/2009 & EU Regulation 284/2013 Document MCP Section 10: Ecotoxicological studies According to the guidance document, SANCO 10181/2013, for preparing dossiers for the approval of a chemical active substance Date 2016-01-12 This document is copyright protected. Author(s) れäfkJ゛ ョ?Ljt9k H(_3 ゜?Wc`J säo:5c u!/ypGä Any distribution, reproductionれttagcä ü てorcJEd publication öれ?- requires the consent of Bayer AGz4Fj (or äy つitse*Gy respective affiliate). ノä3ä 龼--Jca :Q?tüaf Any use of thea violation documentYä27y ofor ・ jaRqtheits underlyingcontent for license regulatory agreement. or ce-ュ(1c G1e6 any otherQ$uc commercialョgj えü!に purposel8 )lfyjz hjt9h is -Jk:Jprohibited and constitutes M-544108-01-4 Page 2 of 110 2016-01-12 Document MCP: Section 10 Ecotoxicological studies FXA+PTZ EC 200 (100+100) G Bayer CropScience This document is copyright protected. Any distribution, reproduction or publication requires the consent of Bayer AG (or its respective affiliate). Any use of thea violation document ofor theits underlyingcontent for license regulatory agreement. or any other commercial purpose is prohibited and constitutes Page 3 of 110 2016-01-12 Document MCP: Section 10 Ecotoxicological studies FXA+PTZ EC 200 (100+100) G OWNERSHIP STATEMENT This document, the data contained in it and copyright therein are owned by Bayer CropScience. No part of the document or any information contained therein may be disclosed to any third party without the prior written authorisation of Bayer CropScience. The summaries and evaluations contained in this document are based on unpublished proprietary data submitted for the purpose of the assessment undertaken by the regulatory authority. Other registration authorities should not grant, amend, or renew a registration on the basis of the summaries and evaluation of unpublished proprietary data contained in this document unless they have received the data on which the summaries and evaluation are based, either: • From Bayer CropScience; or • From other applicants once the period of data protection has expired. This document is copyright protected. Any distribution, reproduction or publication requires the consent of Bayer AG (or its respective affiliate). Any use of thea violation document ofor theits underlyingcontent for license regulatory agreement. or any other commercial purpose is prohibited and constitutes Page 4 of 110 2016-01-12 Document MCP: Section 10 Ecotoxicological studies FXA+PTZ EC 200 (100+100) G Version history Date Data points containing amendments or additions1 and Document identifier and brief description version number 1 It is suggested that applicants adopt a similar approach to showing revisions and version history as outlined in SANCO/10180/2013 Chapter 4 How to revise an Assessment Report This document is copyright protected. Any distribution, reproduction or publication requires the consent of Bayer AG (or its respective affiliate). Any use of thea violation document ofor theits underlyingcontent for license regulatory agreement. or any other commercial purpose is prohibited and constitutes Page 5 of 110 2016-01-12 Document MCP: Section 10 Ecotoxicological studies FXA+PTZ EC 200 (100+100) G Table of Contents Page CP 10 ECOTOXICOLOGICAL STUDIES ON THE PLANT PROTECTION PRODUCT ................................................................................................................... 7 CP 10.1 Effects on birds and other terrestrial vertebrates .................................................... 9 CP 10.1.1 Effects on birds ............................................................................................................ 9 CP 10.1.1.1 Acute oral toxicity..................................................................................................... 11 CP 10.1.1.2 Higher tier data on birds ........................................................................................... 11 CP 10.1.2 Effects on terrestrial vertebrates other than birds ................................................. 11 CP 10.1.2.1 Acute oral toxicity to mammals .............................................................................. 14 CP 10.1.2.2 Higher tier data on mammals .................................................................................. 14 CP 10.1.3 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) ......... 14 CP 10.2 Effects on aquatic organisms ................................................................................... 14 CP 10.2.1 Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes ............................................................................................................... 60 CP 10.2.2 Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms ........................................................................... 64 CP 10.2.3 Further testing on aquatic organisms ...................................................................... 65 CP 10.3 Effects on arthropods ................................................................................................ 66 CP 10.3.1 Effects on bees ........................................................................................................... 66 CP 10.3.1.1 Acute toxicity to bees ............................................................................................... 71 CP 10.3.1.1.1 Acute oral toxicity to bees ....................................................................................... 71 CP 10.3.1.1.2 Acute contact toxicity to bees ................................................................................. 73 CP 10.3.1.2 Chronic toxicity to bees ........................................................................................... 74 CP 10.3.1.3 Effects on honey bee development and other honey bee life stages .................. 74 CP 10.3.1.4 Sub-lethal effects ....................................................................................................... 74 CP 10.3.1.5 Cage and tunnel tests ................................................................................................ 75 CP 10.3.1.6 Field tests with honeybees ....................................................................................... 75 CP 10.3.2 Effects on non-target arthropods other than bees ................................................. 75 CP 10.3.2.1 Standard laboratory testing for non-target arthropods ......................................... 78 CP 10.3.2.2 Extended laboratory testing, aged residue studies with non-target arthropods 78 CP 10.3.2.3 ThisSemi document-field studies is withcopyright non-target protected. arthropods ................................ ...................... 88 CP 10.3.2.4 Field studies with non-target arthropods ................................................................ 88 CP 10.3.2.5 Other routes of exposure for non-target arthropods ............................................. 88 CP 10.4 Effects on non-target soil meso- and macrofauna ................................................ 89 CP 10.4.1 Earthworms ................................................................................................................ 90 CP 10.4.1.1 Earthworms sub-lethal effects ................................................................................. 91 CP 10.4.1.2 Earthworms field studies .......................................................................................... 94 CP 10.4.2 Any distribution,Effects on non -reproductiontarget soil meso -or and publication macrofauna (other requires than earthworms) ..... 94 CP 10.4.2.1 the Species consent level of testing Bayer ................................ AG (or its respective................................ affiliate)................................. .. 96 CP 10.4.2.2 Higher tier testing ................................................................................................... 100 CP 10.5 EffectsAny use on ofsoil the nitrogena violation document transformation ofor theits ................................ underlyingcontent for license regulatory................................ agreement. or 101 CP 10.6 Effects on terrestrial non-target higher plants ..................................................... 105 CP 10.6.1 Summary any other of screening commercial data ................................ purpose is prohibited................................ and constitutes................... 106 CP 10.6.2 Testing on non-target plants .................................................................................. 106 CP 10.6.3 Extended laboratory studies on non-target plants ............................................... 109 CP 10.6.4 Semi-field and field tests on non-target plants .................................................... 109 CP 10.7 Effects on other terrestrial organisms (flora and fauna) .................................... 110 Page 6 of 110 2016-01-12 Document MCP: Section 10 Ecotoxicological studies FXA+PTZ EC 200 (100+100) G CP 10.8 Monitoring data ....................................................................................................... 110 This document is copyright protected. Any distribution, reproduction or publication requires the consent of Bayer AG (or its respective affiliate). Any use of thea violation document ofor theits underlyingcontent
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