Even though formally not triggered under Commission Regulation (EU) No 283/2013 in accordance with Regulation (EC) No 1107/2009, field soil dissipation studies have been conducted for mesosulfuron-methyl at six European sites. The studies tested a by factor 7 exaggerated application rate of 105 g as/ha, and included spring and autumn treatments. The studies were EU evaluated and accepted during the Annex I inclusion of mesosulfuron-methyl (Review Report SANCO/10298/2003-Final, 25 June 2004).
The following studies are included in the baseline dossier:
Report: BNロ ,q,5,$,゜n く$:;z§.ゕ//(I み,;2000;M-198875-01
Title: The degradation of AE F130060 in soil following a single application of AE F130060 01 1K12 A1 at 6 locations in Europe
Report No: C009594
Document No: M-198875-01-1 Guidelines: Deviation not specified
GLP/GEP: yes
Reference Followed guidance Guidance currently in force Differences Critical assessment of the study / Deviations / conclusion about its Reliability
& European Eco-Regions Part I Guidance for Conducting obtain DegT50 values of active substances of plant protection
Surface processes are not expected to have
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
any other commercial purpose is prohibited and constitutes
a violation of the underlying license agreement.
Report: XGゕ _,7・,k,,b jvo;Lh(ä.fe?゛zI ゕ,;2000;M-198499-01
Title: Evaluation of field dissipation data from different sites in Europe Code: AE F130060
Report No: C010143
Document No: M-198499-01-1
Guidelines: not applicable (computer modelling report) GLP/GEP: not applicable (computer modelling report)
Study KCA 7.1.2.2.1 /02, kinetic modelling evaluation of study KCA 7.1.2.2.1 /01, has been updated to comply with current FOCUS kinetic guidance (2006). Report KCA 7.1.2.2.1 /02 is therefore replaced by a new evaluation KCA 7.1.2.2.1 /03 as summarised below:
Report: AゕU v,o,§,23, 5l_;>üぢ:l.ai W,; み/hz8.utäJ ,C;2009;M-359355-01 Title: Kinetic evaluation of field dissipation studies with
mesosulfuron-methyl under European conditions
Report No: MEF-09/697 Document No: M-359355-01-1
Guidelines: not applicable;not applicable
GLP/GEP: no
Executive Summary
A kinetic analysis of soil residue data from the field dissipation study KCA 7.1.2.2.1 /01 (M-198875-01-1) was performed with the software MatLab and PEARL according to FOCUS kinetics (2006) to derive normalised (20 °C and field capacity) half-lives for mesosulfuron-methyl.
Single first order was the most appropriate kinetic model for simulating the degradation of mesosulfuron-methyl at the sites Dürrn (autumn and spring application, Germany), Warpe (autumn application, Germany), Schleithal (autumn and spring application, France), Launton (autumn application, UK), Dugliolo (spring application, Italy) and Rotgla (spring application, Spain), as well as first order multi compartment at sites Warpe (spring application, Germany) and Launton (spring application, UK) under field conditions with an application rate of 105 g/ha and normalised to 20 °C and field capacity.
The normalised DT50 values of mesosulfuron-methyl ranged from 16.1 days to 54.0 days, the geometric mean DT50 value over all studies was 34.6 days. These data are consistent with the laboratory half-life information, considering biological variation, and the exaggerated dose rate tested.
I. METHODS
Soil residue data from the field dissipation study KCA 7.1.2.2.1 /01 (M-198875-01-1) were used. In this study, the degradation of mesosulfuron-methyl was studied at sites Dürrn (Germany), Warpe (Germany), Schleithal (France), Launton (UK), Dugliolo (Italy) and Rotgla (Spain) under field conditions for up to 12 months with an application rate of 105 g/ha. At four sites (Dürrn, Warpe, Schleithal and Launton) separate field plots were treated either in autumn or in spring. At Dugliolo and Rotgla, mesosulfuron-methyl was only applied in spring.
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
any other commercial purpose is prohibited and constitutes
a violation of the underlying license agreement.
For the simulation of water and heat flow in soil, the PEARL model (version 1.5.8-F2) was used. The kinetic evaluations and the statistical calculations for the quality checks were implemented in the numerical software package MatLab 7.0.4.365 (MatLab, 2005) using two different kinetic models:
single first order (SFO) and first-order multiple compartment (FOMC). The differential equations were integrated by a Runge-Kutta method, and the Levenberg-Marquardt algorithm was used for the non-linear parameter optimisation. All other calculations were done with Microsoft Excel XP spreadsheets. Model input datasets were the residual amounts found in each test system at each sampling interval. The most appropriate kinetic model was selected on the basis of a detailed statistical analysis including visual assessment of the goodness of the fits, chi2 scaled-error criterion and t-test significance. The DT50 value was calculated from the resulting kinetic parameters.
II. RESULTS
Single first order was the most appropriate kinetic model for modelling purpose for the degradation of mesosulfuron-methyl at the sites Dürrn (autumn and spring application, Germany), Warpe (autumn application, Germany), Schleithal (autumn and spring application, France), Launton (autumn application, UK), Dugliolo (spring application, Italy) and Rotgla (spring application, Spain), as well as first order multi compartment at sites Warpe (spring application, Germany) and Launton (spring application, UK). Results of the kinetic analysis are summarised in Table CA 7.1.2.2.1-1.
Table CA 7.1.2.2.1- 1: Kinetic parameters for the degradation of mesosulfuron-methyl in soil under field conditions for modelling purpose according to FOCUS (normalised to 20 °C and field capacity)
Site (season) Kinetic DT502 Chi2 Error t-test Visual
Model 1 [days] [%] Assessment 3
Dürrn (autumn) SFO 38.9 18.6 0.0079 o
Dürrn (spring) SFO 17.9 13.8 0.0013 +
Warpe (autumn) SFO 41.6 15.1 0.0027 +
Warpe (spring) FOMC 44.4 2.6 α 0.0001
β 0.0026 +
Schleithal (autumn) SFO 35.3 12.7 0.0014 +
Schleithal (spring) SFO 38.5 15.5 0.0088 +
Launton (autumn) SFO 37.4 17.7 0.0041 o
Launton (spring) FOMC 16.1 10.4 α 0.0125 β 0.0911
o
Dugliolo (spring) SFO 43.0 19.1 0.01123 o
Rotgla (spring) SFO 54.0 10.4 0.0005 +
geomean 34.6
1 SFO: single first order, FOMC: first order multi compartment
2 for FOMC: DT50 was calculated as DT90/3.32
3 visual assessment: + = good, o = acceptable III. CONCLUSIONS
The normalised DT50 values of mesosulfuron-methyl ranged from 16.1 days to 54.0 days. The geometric mean DT50 value over all studies is 34.6 days. These data are consistent with the laboratory half-life information, considering biological variation, and the exaggerated dose rate tested.