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Diss Factsheets

Administrative data

Endpoint:
toxicity to soil microorganisms
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: SETAC Guideline - Procedures for Assessing the Environmental Fate and Ecotoxicity of Pesticides, Soil Micro-organisms
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 216 (Soil Microorganisms: Nitrogen Transformation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 217 (Soil Microorganisms: Carbon Transformation Test)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
Cas Number:
167173-85-5
Molecular formula:
C26H30N2O9
IUPAC Name:
(3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
Specific details on test material used for the study:
Substance name: X642188 (metabolite of XDE-777)
Lot#: YC2-106153-15
Purity: 99%

Sampling and analysis

Analytical monitoring:
no

Test substrate

Vehicle:
yes

Test organisms

Test organisms (inoculum):
soil

Study design

Total exposure duration:
28 d

Test conditions

Test temperature:
18-22°C
Moisture:
46% - 49%
Organic carbon content (% dry weight):
0.78
Nominal and measured concentrations:
0.088 and 0.438 mg/kg soil dw
Reference substance (positive control):
yes
Remarks:
Sodium chloride was applied at a rate of 16 g/kg dry soil in a separate study within one year of the start of the experimental phase of this study

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
28 d
Basis for effect:
nitrate formation rate
Remarks on result:
other: The difference in the soil nitrate formation rates between the control and both treatments was clearly below the OECD guideline 216 trigger value of 25 % at the 14 to 28 day interval. These deviations were not statistically significant different
Key result
Duration:
28 d
Dose descriptor:
other:
Basis for effect:
respiration rate
Remarks on result:
other: The soil respiration rates were within the trigger value of ±25% set by OECD guideline 217 throughout the experiment. On day 28 the values differed by 2.43% and 1.10% from the control for the low and high dose rate, respectively.
Remarks:
There were statistically no significant differences on day 28 between control and both test item treated groups.

Applicant's summary and conclusion

Conclusions:
Based on the results of this study, it is concluded that the test substance had no significant impact on soil microorganisms (carbon mineralisation and nitrogen transformation) when applied at concentrations up to 0.438 mg/kg soil dry weight. It can be concluded that the test substance will not have any long term influence on soil microorganisms.
Executive summary:

The objective of the study was to evaluate the effects of the test substance on the activity of soil microflora in the laboratory. The study was conducted according to OECD Guidelines 217 and 216.


Biologically active agricultural soil (mid loamy sand) was used. Control, 0.088 and 0.438 mg/kg soil dry weight are the test rates used in this study. Endpoints observed were O2-consumption and NO3-nitrogen production after 28 days of exposure


Soil respiration was determined in soil after addition of glucose. Three replicates were used per treatment and concentration. A BSB-Sensomat System® was used to determine the CO2-production over a period of up to 24 hours at different sampling intervals.


Nitrogen-transformation (nitrate-nitrogen levels) was determined in soil enriched with lucerne mean (concentration in soil 0.5%). Three replicates were used per treatment and concentration. NO3-nitrogen formed from the nitrification process was determined by means of a Dionex ion chromatography system.


Sampling was done 0, 7, 14 and 28 days after treatment (soil respiration and soil nitrogen transformation test). Sub-samples were withdrawn from the soil bulk batches and subjected to analysis.


Soil moisture was 46% to 49% of its maximum water holding capacity (carbon and nitrogen transformation). Soil samples were incubated at 20 °C ± 2 °C while stored in plastic boxes covered by perforated lids. The soil pH was in the range of 7.0 to 7.2.


Calculation of mean values per treatment, standard deviation and coefficient of variation. Normality and homogeneity of variances were tested using the R/S-Test Test (α = 0.05) and Levene´s test (α = 0.05), respectively, and pair-wise comparisons of treated and control values according to Student t-test (α = 0.05) were performed.


The soil respiration rates were within the trigger value of ±25% set by OECD guideline 217 throughout the experiment. On day 28 the values differed by 2.43% and 1.10% from the control for the low and high dose rate, respectively. There were statistically no significant differences on day 28 between control and both test item treated groups (Welch t-test, α = 0.05).


No adverse effects of test substance on nitrogen transformation in soil could be observed in both test substance concentrations (0.088 mg/kg dry soil and 0.438 mg/kg dry soil) after 28 days. Deviations from the control of 4.21% (application rate 0.088 mg/kg dry soil) and 8.39% (application rate 0.438 mg/kg dry soil) were measured at the end of the 28-day incubation period. There was a statistically significant difference on day 28 between control and the high treatment group (Student t-test, α = 0.05).


The soil nitrate formation rates were calculated on an incremental basis (i.e. between successive sampling dates). In the last interval between days 14 and 28, the deviations from control were -3.92% and 2.61% for the low and high test concentration of test substance. Thus, the difference in the soil nitrate formation rates between the control and both test item treatments was clearly below the OECD guideline 216 trigger value of 25 % at the 14 to 28 day interval. These deviations were not statistically significant different (Student t-test, α = 0 .05).


Based on the results of this study, it is concluded that the test substance had no significant impact on soil microorganisms (carbon mineralisation and nitrogen transformation) when applied at concentrations up to 0.438 mg/kg soil dry weight.


It can be concluded that the test substance will not have any long term influence on soil microorganisms.