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Summary of the Ecotoxicological Studies Page 1 of 187 Document Title Summary of the ecotoxicological studies Thiacloprid OD 240 (240 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 2014-09-29 This document is copyright protected. Author(s) B1)Jjetjk H-Jläcu Any distribution, reproduction or publication requires the consent of BayerBayer AG (orCropScience 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 M-497688-01-3 Page 2 of 187 2014-09-29 Document MCP: Section 10 Ecotoxicological studies Thiacloprid OD 240 (240 g/L) 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 The summaries and evaluations contained in this document are based on unpublished proprietary data submitted for the purpose of the assessment undertaken by the regulatory authority.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authorities should not grant, amend, or renew a registration on the basis of the summaries and evaluation of unpublished proprietary data contained in this document unless they have received the data on which the summaries and evaluation are based, either: • From Bayer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 3 of 187 2014-09-29 Document MCP: Section 10 Ecotoxicological studies Thiacloprid OD 240 (240 g/L) 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 4 of 187 2014-09-29 Document MCP: Section 10 Ecotoxicological studies Thiacloprid OD 240 (240 g/L) Table of Contents Page CP 10 ECOTOXICOLOGICAL STUDIES ON THE PLANT PROTECTION PRODUCT .......................................................................................................... 6 CP 10.1 Effects on birds and other terrestrial vertebrates ................................................ 7 CP 10.1.1 Effects on birds ................................................................................................... 7 CP 10.1.1.1 Acute oral toxicity .............................................................................................. 9 CP 10.1.1.2 Higher tier data on birds ..................................................................................... 9 CP 10.1.2 Effects on terrestrial vertebrates other than birds ............................................. 26 CP 10.1.2.1 Acute oral toxicity to mammals ........................................................................ 28 CP 10.1.2.2 Higher tier data on mammals ............................................................................ 28 CP 10.1.3 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) ........ 28 CP 10.2 Effects on aquatic organisms ............................................................................ 28 CP 10.2.1 Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes ...................................................................................................... 39 CP 10.2.2 Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms ..................................................................... 39 CP 10.2.3 Further testing on aquatic organisms ................................................................ 41 CP 10.3 Effects on arthropods ........................................................................................ 41 CP 10.3.1 Effects on bees .................................................................................................. 41 CP 10.3.1.1 Acute toxicity to bees ....................................................................................... 46 CP 10.3.1.1.1 Acute oral toxicity to bees ................................................................................ 46 CP 10.3.1.1.2 Acute contact toxicity to bees ........................................................................... 49 CP 10.3.1.2 Chronic toxicity to bees .................................................................................... 50 CP 10.3.1.3 Effects on honey bee development and other honey bee life stages................. 50 CP 10.3.1.4 Sub-lethal effects .............................................................................................. 50 CP 10.3.1.5 Cage and tunnel tests ........................................................................................ 51 CP 10.3.1.6 Field tests with honeybees ................................................................................ 63 CP 10.3.2 Effects on non-target arthropods other than bees ............................................. 72 CP 10.3.2.1 Standard laboratory testing for non-target arthropods ...................................... 87 CP 10.3.2.2 ThisExtended document laboratory is copyright testing, aged protected. residue studies with non-target arthropods ........................................................................................................................ 111 CP 10.3.2.3 Semi-field studies with non-target arthropods ................................................ 137 CP 10.3.2.4 Field studies with non-target arthropods ........................................................ 141 CP 10.3.2.5 Other routes of exposure for non-target arthropods ....................................... 172 CP 10.4 Effects on non-target soil meso- and macrofauna .......................................... 172 CP 10.4.1 Earthworms ..................................................................................................... 173 CP 10.4.1.1 Any distribution, Earthworms sub reproduction-lethal effects ................................ or publication ................................requires ........ 174 CP 10.4.1.2 the Earthworms consent of field Bayer studies AG ................................ (or its respective................................ affiliate)................. 175 CP 10.4.2 Effects on non-target soil meso- and macrofauna (other than earthworms) ... 176 CP 10.4.2.1 SpeciesAny use level of testing thea violation document ................................ ofor theits underlyingcontent................................ for license regulatory........................ agreement. or 177 CP 10.4.2.2 Higher tier testing ........................................................................................... 180 CP 10.5 Effects any onother soil nitrogen commercial transformation purpose ................................ is prohibited ..........................and constitutes 180 CP 10.6 Effects on terrestrial non-target higher plants ................................................ 182 CP 10.6.1 Summary of screening data ............................................................................ 184 CP 10.6.2 Testing on non-target plants ........................................................................... 185 CP 10.6.3 Extended laboratory studies on non-target plants ........................................... 187 Page 5 of 187 2014-09-29 Document MCP: Section 10 Ecotoxicological studies Thiacloprid OD 240 (240 g/L) CP 10.6.4 Semi-field and field tests on non-target plants ............................................... 187 CP 10.7 Effects on other terrestrial organisms (flora and fauna) ................................. 187 CP 10.8 Monitoring data .............................................................................................. 187 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 6 of 187 2014-09-29 Document MCP: Section 10 Ecotoxicological studies Thiacloprid OD 240 (240 g/L) CP 10 ECOTOXICOLOGICAL STUDIES ON THE PLANT PROTECTION PRODUCT Introduction The representative formulation submitted in the first Annex I listing process is no longer considered as a representative formulation for the renewal of thiacloprid. One of the representative formulations used for the submission of the renewal of the approval of thiacloprid is the spray formulation Thiacloprid OD 240. The summaries of formulation studies and the risk assessment will be presented in this Dossier. Ecotoxicological
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