Page 1 of 515 Bayer CropScience Document Title Summary of the ecotoxicological studies Deltamethrin EW 15 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 This document is retrieved from the Bayer TransparencyDate website. 2017-05-15 Please note that its content could be subject to copy-right and other IP-rights. Any use for commercial purposes is prohibited. M -480040-05 -3 Page 2 of 515 Bayer CropScience 2017-05-15 VRy Document MCP: Section 10 Ecotoxicological studies DLT EW 15 Author(s) ä§JれIg i:ゝ6zq_, X3-?5` gLIJj, /jXcetz 5tH・8, Foiä z?K_に$k, ?bz0öロtzI 9äjJAl5tv, ä:Fa( F8N/p, FJev3c・ Ez_?6j(RIo?t, zIgヸ れt:cJ, z?SJ?/ Czyöj Bayer CropScience This document is retrieved from the Bayer Transparency website. Please note that its content could be subject to copy-right and other IP-rights. Any use for commercial purposes is prohibited. Page 3 of 515 bayer] Bayer CropScience 2017-05-15 Document MCP: Section 10 Ecotoxicological studies DLT EW 15 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 The summaries and evaluations contained in this document are based on unpublished proprietary data submitted for the purpose of the assessment undertaken by the regulatory authority.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authorities should not grant, amend, or renew a registration on the basis of the summaries and evaluation of unpublished proprietary data contained in this document unless they have received the data on which the summaries and evaluation are based, either: • From Bayer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 retrieved from the Bayer Transparency website. Please note that its content could be subject to copy-right and other IP-rights. Any use for commercial purposes is prohibited. Page 4 of 515 Bayer CropScience 2017-05-15 VRy Document MCP: Section 10 Ecotoxicological studies DLT EW 15 Version history Date Data points containing amendments or additions1 and Document identifier and brief description version number 2015-11-04 Update of Point CP 10.3.1.5 and author list M-480040-02-1 2016-05-20 Update of Point CP 10.3.2.4 inclusion of study M-408272- M-480040-03-1 01-1 and the summary 2017-05-15 Update of Point CP 10.3.2 with docuemnts M-557588- M-480040-04-1 01-1 and M-588250-01-1 2017-05-15 Update fo Point CP 10.2 inclusion of document M- M-480040-05-1 583896-01-1 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 Additions to the document after the Completeness Check are highlighted in yellow. Content not necessary anymore is crossed out. This document is retrieved from the Bayer Transparency website. 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Page 5 of 515 Bayer CropScience 2017-05-15 VRy Document MCP: Section 10 Ecotoxicological studies DLT EW 15 Table of Contents Page CP 10 ECOTOXICOLOGICAL STUDIES ON THE PLANT PROTECTION PRODUCT .......................................................................................................... 7 CP 10.1 Effects on birds and other terrestrial vertebrates .............................................. 10 CP 10.1.1 Effects on birds ................................................................................................. 10 CP 10.1.1.1 Acute oral toxicity ............................................................................................ 16 CP 10.1.1.2 Higher tier data on birds ................................................................................... 16 CP 10.1.2 Effects on terrestrial vertebrates other than birds ............................................. 16 CP 10.1.2.1 Acute oral toxicity to mammals ........................................................................ 21 CP 10.1.2.2 Higher tier data on mammals ............................................................................ 21 CP 10.1.3 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) ........ 21 CP 10.2 Effects on aquatic organisms ............................................................................ 21 CP 10.2.1 Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes ...................................................................................................... 54 CP 10.2.2 Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms ..................................................................... 61 CP 10.2.3 Further testing on aquatic organisms ................................................................ 61 CP 10.3 Effects on arthropods ........................................................................................ 92 CP 10.3.1 Effects on bees .................................................................................................. 92 CP 10.3.1.1 Acute toxicity to bees ..................................................................................... 111 CP 10.3.1.1.1 Acute oral toxicity to bees .............................................................................. 111 CP 10.3.1.1.2 Acute contact toxicity to bees ......................................................................... 133 CP 10.3.1.2 Chronic toxicity to bees .................................................................................. 142 CP 10.3.1.3 Effects on honey bee development and other honey bee life stages............... 142 CP 10.3.1.4 Sub-lethal effects ............................................................................................ 143 CP 10.3.1.5 Cage and tunnel tests ...................................................................................... 147 CP 10.3.1.6 Field tests with honeybees .............................................................................. 365 CP 10.3.2 Effects on non-target arthropods other than bees ........................................... 415 CP 10.3.2.1 Standard This laboratorydocument testing is retrieved for non-target from arthropods .................................... 421 CP 10.3.2.2 Extended the laboratory Bayer testing,Transparency aged residue website. studies with non-target arthropods ........................................................................................................................ 445 CP 10.3.2.3 Semi-field studies with non-target arthropods ................................................ 481 CP 10.3.2.4 Field studies Please with nonnote-target that arthropods its content ................................ could be ........................ 481 CP 10.3.2.5 Other routes of exposure for non-target arthropods ....................................... 508 CP 10.4 Effects on non-target soil meso- and macrofauna .......................................... 508 CP 10.4.1 Earthworms subject ................................ to copy-right................................ and other ................................IP-rights. ..... 508 CP 10.4.1.1 Earthworms - sub-lethal effects ...................................................................... 510 CP 10.4.1.2 Earthworms - field studies .............................................................................. 510 CP 10.4.2 Effects on non Any-target use soil for meso commercial- and macrofauna purposes (other isthan prohibited. earthworms) ... 510 CP 10.4.2.1 Species level testing ........................................................................................ 512 CP 10.4.2.2 Higher tier testing ........................................................................................... 512 CP 10.5 Effects on soil nitrogen transformation .......................................................... 512 CP 10.6 Effects on terrestrial non-target higher plants ................................................ 514 CP 10.6.1 Summary of screening data ............................................................................ 514 CP 10.6.2 Testing on non-target plants ........................................................................... 514 CP 10.6.3 Extended laboratory studies on non-target plants ........................................... 514 Page 6 of 515 Bayer CropScience 2017-05-15 VRy Document MCP: Section 10 Ecotoxicological studies DLT EW 15 CP 10.6.4 Semi-field and field tests on non-target plants ............................................... 514 CP 10.7 Effects on other terrestrial organisms (flora and fauna) ................................. 515 CP 10.8 Monitoring data .............................................................................................. 515 This document is retrieved from the Bayer Transparency website. Please note that its content could be subject to copy-right and other IP-rights. Any use for commercial purposes is prohibited. Page 7 of 515 Bayer CropScience 2017-05-15 Document MCP: Section 10 Ecotoxicological studies DLT EW 15 CP 10 ECOTOXICOLOGICAL STUDIES ON THE PLANT PROTECTION PRODUCT Use pattern considered in this risk assessment Table10- 1: Intended application pattern Crop Timing of Number of Application