Registration Dossier

Administrative data

Endpoint:
toxicity to soil microorganisms
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Dec 2009- Jan 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted with Sorafenib Tosylate according to OECD guideline under GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 216 (Soil Microorganisms: Nitrogen Transformation Test)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sorafenib Tosylate BAY 54-9085
- Analytical purity: 99.5%
- Lot/batch No.: BXA4DZ4

Sampling and analysis

Analytical monitoring:
yes

Test substrate

Vehicle:
no

Test organisms

Test organisms (inoculum):
soil

Study design

Total exposure duration:
28 d

Test conditions

Moisture:
22.6%
Organic carbon content (% dry weight):
2.21%
Nitrogen content (% dry weight):
139.4 - 152.0 %

Results and discussion

Any other information on results incl. tables

Since the inhibition value is negative, no inhibitory effect of the test item on soil microflora concerning nitrate production on day 28 was found when compared to the control soil.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test substance shows no inhibitory effect on the nitrification of soil microflora. Owing the outcome of the test, no calculation of ECx values is
possible. The NOEC is 250 mg a.i./kg.
Executive summary:

The purpose of the study is the determination of effects on soil microflora activity of BAY 54 -9085. On day 0, all test samples (with and without lucerne meal) showed almost equal nitrate concentrations, ranging from 139.4 to 152.0 mg NO3-/kg dry soil for the samples with lucerne meal, and ranging from 162.3 to 188.1 mg NO3-/kg dry soil for the nitrification control (NC) samples (without lucerne meal). In the NC control samples (no test item, without lucerne meal), the nitrate concentration increased from an average of 172.7 mg NO3-/kg dry soil on day 0 to an average of 236.6 mg NO3-/kg dry soil on day 28. For the NC 250 samples (250 mg a.i./kg dry soil, without lucerne meal), the mean nitrate concentration increased from 167.0 mg/kg dry soil on day 0 to 294.6 mg/kg dry soil on day 28. After 28 days, the mean nitrate transformation rates in the NC samples were 2.3 and 4.6 mg NO3-/kg dry soil per day for the NC control and the NC 250 treatment, respectively. The % inhibition of the nitrification in the NC 250 treatment compared to the NC control was -99.9%. An apparent contribution (63.8 mg NO3-/kg dry soil) of the nitrogen from the test item in the nitrate formation was calculated in the NC samples without lucerne meal. The nitrate concentration in the control samples with lucerne meal increased from an average of 150.3 mg NO3-/kg dry soil on day 0 to an average of 360.7 mg NO3-/kg dry soil on day 28. For the 250 mg a.i./kg dry soil treatment with lucerne meal, the mean nitrate concentration increased from 140.6 mg/kg dry soil on day 0 to 424.4 mg/kg dry soil on day 28. After 28 days, the mean nitrate transformation rate in the control samples was 7.5 mg NO3-/kg dry soil per day. The mean nitrification rate for the 250 mg a.i./kg dry soil treatment, adjusted for the contribution of the test item, was 7.9 mg NO3-/kg dry soil per day, equivalent to an inhibition of the nitrification compared to the control of -4.6%. Since the inhibition value is negative, no inhibitory effect of the test item on soil microflora concerning nitrate production on day 28 was found when compared to the control soil.