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Summary of the Ecotoxicological Studies for Flurtamone

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Summary of the Ecotoxicological Studies for Flurtamone Page 1 of 144 Document Title Summary of the ecotoxicological studies for Flurtamone Data Requirements EU Regulation 1107/2009 & EU Regulation 283/2013 Document KCA Section 8: Ecotoxicological studies According to the guidance document, SANCO 10181/2013, for preparing dossiers for the approval of a chemical active substance This document is copyright protected. Date 15th March 2014 Any distribution, reproduction or publication requires the consent of Bayer AG (or its respective affiliate). Any use of the document or its content for regulatory or a violation of the underlying license agreement. any other commercialAuthor(s) purpose is prohibited and constitutes JäoB$Jq?. じ,. Zjä! ・ Ph4ujl:・J oYO&, for Bayer CropScience AG ä§7 ??9.Eä R., Bayer CropScience AG M-482307-01-5 Page 2 of 144 2014-03-15 Document KCA: Section 8 Ecotoxicological studies flurtamone 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 The summaries and evaluations contained in this document are based on unpublished proprietary data submitted for the purpose of the assessment undertaken by the regulatory authority.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authorities should not grant, amend, or renew a registration on the basis of the summaries and evaluation of unpublished proprietary data contained in this document unless they have received the data on which the summaries and evaluation are based, either: • From Bayer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 the document or its content for regulatory or a violation of the underlying license agreement. any other commercial purpose is prohibited and constitutes Page 3 of 144 2014-03-15 Document KCA: Section 8 Ecotoxicological studies flurtamone Version history Date Data points containing amendments or additions1 Document identifier or version number 1 Note how the amendments or additions are represented (italics/colour etc) This document is copyright protected. Any distribution, reproduction or publication requires the consent of Bayer AG (or its respective affiliate). Any use of the document or its content for regulatory or a violation of the underlying license agreement. any other commercial purpose is prohibited and constitutes Page 4 of 144 2014-03-15 Document KCA: Section 8 Ecotoxicological studies flurtamone Table of Contents Page Section 8 - ECOTOXICOLOGICAL STUDIES ON THE ACTIVE SUBSTANCE ................ 6 Introduction ................................................................................................................................ 6 CA 8.1.1 - Effects on Birds ...................................................................................................... 10 CA 8.1.1.1 - Acute oral toxicity to birds .................................................................................. 10 CA 8.1.1.2 - Short-term dietary toxicity to birds ..................................................................... 10 CA 8.1.1.3 - Sub-chronic and reproductive toxicity to birds ................................................... 10 CA 8.1.2 - Effects on terrestrial vertebrates other than birds ................................................... 10 CA 8.1.2.1 - Acute oral toxicity to mammals .......................................................................... 11 CA 8.1.2.2 - Long-term and reproduction toxicity to mammals .............................................. 11 CA 8.1.3 - Effects of active substance bioconcentration in prey of birds and mammals ........ 12 CA 8.1.4 - Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians) .................................................................................................................................................. 12 CA 8.1.5 - Endocrine disrupting properties ............................................................................. 12 CA 8.2 - Effects on aquatic organisms ..................................................................................... 13 CA 8.2.1 - Acute toxicity to fish .............................................................................................. 17 CA 8.2.2 - Long-term and chronic toxicity to fish ................................................................... 20 CA 8.2.2.1 - Fish early life stage toxicity test .......................................................................... 20 CA 8.2.2.2 - Fish full life cycle test ......................................................................................... 26 CA 8.2.2.3 - Bioconcentration in fish ...................................................................................... 26 CA 8.2.3 - Endocrine disrupting properties ............................................................................. 26 CA 8.2.4 - Acute toxicity to aquatic invertebrates ................................................................... 27 CA 8.2.4.1 - Acute toxicity to Daphnia magna ........................................................................ 27 CA 8.2.4.2 - Acute toxicity to Mysid species .......................................................................... 31 CA 8.2.5 - Long-term and chronic toxicity to aquatic invertebrates ........................................ 31 CA 8.2.5.1 - Reproductive This document and development is copyright toxicity protected. to Daphnia magna ............................... 31 CA 8.2.5.2 - Reproductive and development toxicity to an additional aquatic invertebrate species ...................................................................................................................................... 31 CA 8.2.5.3 - Development and emergence in Chironomus species ......................................... 31 CA 8.2.5.4 - Sediment dwelling organisms ............................................................................. 31 CA 8.2.6 - Effects Anyon algal distribution, growth ................................ reproduction or publication................................ requires ........................... 32 the consent of Bayer AG (or its respective affiliate). CA 8.2.6.1 - Effects on growth of green algae ......................................................................... 32 CA 8.2.6.2 - Effects on growth of an additional algal species ................................................. 41 Any use of the document or its content for regulatory or CA 8.2.7 - Effects on aquatic macrophytes a violation ................................ of the underlying................................ license agreement............... 41 CA 8.2.8 - Further testing on aquatic organisms ...................................................................... 76 any other commercial purpose is prohibited and constitutes CA 8.3.1 - Effects on bees ........................................................................................................ 79 CA 8.3.1.1 - Acute toxicity to bees .......................................................................................... 80 CA 8.3.1.1.1 - Acute oral toxicity ............................................................................................ 80 CA 8.3.1.1.2 - Acute contact toxicity ....................................................................................... 82 CA 8.3.1.2 - Chronic toxicity to bees ....................................................................................... 83 CA 8.3.1.3 - Effects on honeybee development and other honeybee life stages ..................... 85 CA 8.3.1.4 - Sub-lethal effects ................................................................................................. 87 CA 8.3.2 - Effects on non-target arthropods other than bees ................................................... 88 CA 8.3.2.1 - Effects on Aphidius rhopalosiphi ........................................................................ 89 CA 8.3.2.2 - Effects on Typhlodromus pyri ............................................................................. 90 CA 8.4.1 - Earthworm, sub-lethal effects ................................................................................. 93 Page 5 of 144 2014-03-15 Document KCA: Section 8 Ecotoxicological studies flurtamone CA 8.4.2 - Effects on non-target soil meso- and macrofauna (other than earthworms) ........ 100 CA 8.4.2.1 - Species level testing .......................................................................................... 110 CA 8.5 - Effects on soil nitrogen transformation ................................................................... 110 CA 8.6 – Effects on terrestrial non-target higher plants ........................................................ 116 CA 8.6.1 - Summary of screening data .................................................................................. 116 CA 8.6.2 - Testing on non-target plants ................................................................................. 116 CA 8.7 - Effects on other terrestrial organisms (flora and fauna) .......................................... 121 CA 8.8 - Effects on biological methods for sewage treatment ............................................... 143 CA 8.9 - Monitoring data ......................................................................................................
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