Annex to Regulation 283/2013 Diflufenican M-CA, Section

Sapec Agro S.A. / Globachem NV 1

Diflufenican

Herbicide

Application for Renewal of Approval according to

Commission Regulation 844/2012

DOCUMENT M-CA, Section 8

ECOTOXICOLOGICAL STUDIES ON THE

ACTIVE SUBSTANCE

Globachem NV
Brustem Industriepark
Lichtenberglaan 2019
3800 Sint-Truiden
Belgium

SAPEC AGRO SA
Avenido do Rio Tejo
Herdade das Praias
2910-440 Setúbal
Portugal

Author: SAPEC AGRO – 31.11.2016 Document ID: DFF-2016-11-CA-section 8-1.1

Annex to Regulation 283/2013 Diflufenican M-CA, Section
Sapec Agro S.A. / Globachem NV 2

Version history
Date Data points containing amendments or additions Document identifier and
and brief description version number

30.06.2016 Original version from applicant SAPEC Agro S.A. & DFF-2016-06-CA-section 8-
Globachem N.V. for submission to z-RMS United 1.0
Kingdom in the frame of AIR 3 re-submission

31.11.2016 Original version from applicant SAPEC Agro S.A. & DFF-2016-11-CA-section 8-
Globachem N.V. for submission to z-RMS United 1.1
Kingdom in the frame of AIR 3 re-submission

Author: SAPEC AGRO – 31.11.2016 Document ID: DFF-2016-11-CA-section 8-1.1

Annex to Regulation 283/2013 Diflufenican M-CA, Section
Sapec Agro S.A. / Globachem NV 3

Table of Contents

CA 8 ECOTOXICOLOGICAL STUDIES ON THE ACTIVE

SUBSTANCE ...........................................................................5
CA 8.1 Effects on Birds and Other Terrestrial Vertebrates ............................... 7
CA 8.1.1 Effect on birds .......................................................................................... 7
CA 8.1.1.1 Acute oral toxicity to birds ............................................................................... 7
CA 8.1.1.2 Short-term dietary toxicity to birds .................................................................. 8
CA 8.1.1.3 Sub-chronic and reproductive toxicity to birds .............................................. 8
CA 8.1.2 Effects on terrestrial vertebrates other than birds .............................. 10
CA 8.1.2.1 Acute oral toxicity to mammals...................................................................... 10
CA 8.1.2.2 Long-term and reproductive toxicity to mammals ........................................ 11
CA 8.1.3 Effects of active substance bioconcentration in prey of birds
and mammals ......................................................................................... 11
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 .............................................................. 14
CA 8.2.1 Acute toxicity to fish .............................................................................. 17
CA 8.2.2 Long-term and chronic toxicity to fish ................................................. 19
CA 8.2.2.1 Fish early life stage toxicity test .................................................................... 20
CA 8.2.2.2 Fish full life cycle test ..................................................................................... 20
CA 8.2.2.3 Bioconcentration in fish ................................................................................. 21
CA 8.2.3 Endocrine disrupting properties........................................................... 22
CA 8.2.4 Acute toxicity to aquatic invertebrates ................................................ 22
CA 8.2.4.1 Acute toxicity to Daphnia magna ................................................................... 22
CA 8.2.4.2 Acute toxicity to an additional aquatic invertebrate species ....................... 30
CA 8.2.5 Long-term and chronic toxicity to aquatic invertebrates ................... 30
CA 8.2.5.1 Reproductive and development toxicity to Daphnia magna ........................ 30
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 riparius ................................. 31
CA 8.2.5.4 Sediment dwelling organisms ........................................................................ 31
CA 8.2.6 Effects on algal growth .......................................................................... 35
CA 8.2.6.1 Effects on growth of green algae ................................................................... 35

Author: SAPEC AGRO – 31.11.2016 Document ID: DFF-2016-11-CA-section 8-1.1

Annex to Regulation 283/2013 Diflufenican M-CA, Section
Sapec Agro S.A. / Globachem NV 4

CA 8.2.6.2 Effects on growth of an additional algal species .......................................... 43

CA 8.2.7 Effects on aquatic macrophytes ........................................................... 45
CA 8.2.8 Further testing on aquatic organisms .................................................. 51
CA 8.3 Effects on Arthropods ........................................................................... 52
CA 8.3.1 Effects on bees....................................................................................... 52
CA 8.3.1.1 Acute toxicity to bees ..................................................................................... 52
CA 8.3.1.1.1 Acute oral toxicity .............................................................................................. 52
CA 8.3.1.1.2 Acute contact toxicity......................................................................................... 52
CA 8.3.1.2 Chronic toxicity to bees .................................................................................. 53
CA 8.3.1.3 Effects on honeybee development and other honeybee life stages ............ 56
CA 8.3.1.4 Sub-lethal effects ............................................................................................ 60
CA 8.3.2 Effects on non-target arthropods other than bees .............................. 60
CA 8.3.2.1 Effects on Aphidius rhopalosiphi .................................................................. 61
CA 8.3.2.2 Effects on Typhlodromus pyri ........................................................................ 61
CA 8.4 Effects on Non-Target Soil Meso- and Macrofauna ............................ 61
CA 8.4.1 Earthworms – sub-lethal effects ........................................................... 63
CA 8.4.2 Effects on non-target soil meso- and macrofauna (other than
earthworms)............................................................................................ 79
CA 8.4.2.1 Species level testing ....................................................................................... 79
CA 8.5 Effects on Nitrogen Transformation ..................................................... 96
CA 8.6 Effects on Terrestrial Non-Target Higher Plants ............................... 105
CA 8.6.1 Summary of screening data ................................................................ 106
CA 8.6.2 Testing on non-target plants ............................................................... 106
CA 8.7 Effects on Other Terrestrial Organisms (Flora and Fauna) .............. 109
CA 8.8 Effects on Biological Methods for Sewage Treatment ...................... 109
CA 8.9 Monitoring Data .................................................................................... 111

Author: SAPEC AGRO – 31.11.2016 Document ID: DFF-2016-11-CA-section 8-1.1

Annex to Regulation 283/2013 Diflufenican M-CA, Section
Sapec Agro S.A. / Globachem NV 19

Report date: 1996

Guidelines: OECD 203 (1992)
EEC 92/69 Method C1 (1992)
GLP: Yes
Previous evaluation: KIIA 8.2.1 in diflufenican DAR 2006
Material and methods: Results were relied upon for the first inclusion in Annex I to Directive
91/414/EEC.
Metabolite of diflufenican AE B107137 technical: purity 99%
A total of 70 fish (10 fish per concentration) were exposed to five
concentrations of diflufenican, a solvent control and a dilution water
control for a period of 96 hours. The definitive test was conducted at:
1.3, 2.5, 5.0, 10.0 and 20 mg/L. The nominal concentrations were
verified by chemical analysis at test initiation, after 72 hours of
exposure and test termination

Results
The 96-hour LC50 to rainbow trout after application of AE B107137 was calculated to be >17.3 mg/l based
on the mean measured concentrations. The NOEC was found to be 4.9 mg/l.

CA 8.2.2 Long-term and chronic toxicity to fish

In compliance with Reg 544/2011, it is not necessary to perform a chronic toxicity test on juvenile fish
when a fish early life stage toxicity test or a fish life cycle test has been performed while. In addition, no
fish juvenile growth test is recommended under Reg 283/2013. However, a study was reviewed during the
EU Review for diflufenican (SANCO/3782/08 – rev.1, 14 March 2008) and is provided as supportive
information and briefly summarized subsequently.
Ref. Point: KCA 8.2.2
Authors: Odin-Feurtet M., Lafay G., Soun A.
Title: Diflufenican: Fish, juvenile growth test (28 days) under flow-through
conditions
Company/Source: Bayer CropScience
Report No. R005623
Report date: 1997
Guidelines: OECD 215 (1994)
GLP: Yes
Previous evaluation: KIIA 8.2.2 in diflufenican DAR 2006
Material and methods: Results were relied upon for the first inclusion in Annex I to Directive
91/414/EEC.
Diflufenican technical
Nominal concentrations were exposed to a range of five concentrations
3, 8, 20, 40 and 80 μg/l under flow through conditions.

Author: SAPEC AGRO – 31.11.2016 Document ID: DFF-2016-11-CA-section 8-1.1