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EC number: 692-722-3 | CAS number: 835621-07-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to soil microorganisms
Administrative data
- Endpoint:
- toxicity to soil microorganisms
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan - Feb 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted with the base (BAY 73-4605) according to OECD guideline under GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 216 (Soil Microorganisms: Nitrogen Transformation Test)
- Deviations:
- no
- Principles of method if other than guideline:
- not relevant
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}-3-fluorophenoxy)-N-methylpyridine-2- carboxamide
- IUPAC Name:
- 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}-3-fluorophenoxy)-N-methylpyridine-2- carboxamide
- Details on test material:
- - Name of test material (as cited in study report): Regorafenib (BAY 73-4605)
- Analytical purity: 100.2%
- Lot/batch No.: BXR3JPV
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
Test substrate
- Vehicle:
- no
Test organisms
- Test organisms (inoculum):
- soil
Study design
- Total exposure duration:
- 28 d
Test conditions
- Moisture:
- The moisture content of the soil used for the definitive test was 26.1% based on dry weight, corresponding to 43.5% of the maximum water holding
capacity (WHC) of 60 g /100 g dry soil.
On test day 7 the moisture content of the samples was increased to approximately 28.4% which is equal to 47.3% of the maximum WHC.
Results and discussion
Effect concentrations
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- nitrate formation rate
Any other information on results incl. tables
Table 1: Mean nitrate transformation in the test concentrations determined on day 28 of the soil microflora study with BAY 73-4506
Treatment group | Mean Nitrate (mg N03-/kg dry soil) | ||||
With Lucerne Meal | Without Lucerne Meal | Contribution of the Test Item | N03- Transformation corrected for Test Item | Inhibition(%) | |
Day 28 ¿ Day 0 | Day 28 ¿ Day 0 | ||||
Control | 206 | 51,1 | NA | NA | NA |
1000 mg a.i./kg dry soil | 196 | 59,4 | 8,2 | 188 | 8,9 |
NA Not Applicable.
Note: all results are based on unrounded numbers
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- BAY 73-4506 shows no effects on the nitrification of soil microflora. Owing to the outcome of the test, no calculation of the ECx values is possible.
The NOEC is 1000 mg a.i./kg. - Executive summary:
This study was conducted to assess the effects of BAY 73-4506 on major microbiological processes of a sandy loam soil. Based on preliminary testing, a limit test with a concentration of 1000 mg a.i./kg dry soil was performed.
The study was conducted according to the OECD Guideline # 216, Soil Microorganisms: Nitrogen Transformation Test (OECD, 2000).
Each test concentration was performed in triplicates, resulting in a total of 12 systems. An amount of approximately 189 g of soil (150 g dry weight) was weighed into each of the 12 flasks. After addition of the soil, the replicates of the Control and the 1000 mg a.i./kg were amended with 0.75 g of lucerne meal. To the nitrification controls no lucerne meal was added. The samples were incubated at a temperature of 20 ± 2°C in an environmental climate chamber. The temperature was recorded continuously. The moisture content of the soil samples was checked and adjusted on days 7, 14, 21 and 28. On test day 7 the moisture content of the samples was increased to approximately 28.4% which is equal to 47.3% of the maximum WHC.
On day 0, all replicates (with and without lucerne meal) showed similar nitrate concentrations, ranging from 53.5 to 70.7 mg NO3-/kg dry soil. In the NC control samples (no test item, without lucerne meal) the nitrate formation showed an increase of 51.1 mg NO3-/kg dry soil after 28 days of incubation. For the NC 1000 mg a.i. samples (1000 mg a.i./kg dry soil, without lucerne meal) the formed amount was 59.4 mg/kg dry soil. The contribution of the test item was therefore 8.2 mg NO3-/kg dry soil.
In the control samples (no test item, with lucerne meal) the nitrate formation showed an increase of 206 mg NO3-/kg dry soil after 28 days of incubation. For the 1000 mg a.i. samples (1000 mg a.i./kg dry soil, with lucerne meal) the formed amount was 196 mg/kg dry soil. With respect to the contribution of the test item, the formed amount in the samples with 1000 mg a.i./kg dry soil was 188 mg NO3-/kg dry soil, which is 91.1% of the amount formed in the control (based on unrounded numbers). The % inhibition is therefore 8.9%.
Based on the results of the preliminary study and the definitive study, the test item has no significant effect on the soil microflora responsible for nitrification.
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