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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 microorganisms
Administrative data
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct 2010
- 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 209 (Activated Sludge, Respiration Inhibition 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): Bay 73-4605
- Analytical purity: 100.2%
- Lot/batch No.: BXR3JPV
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
Test solutions
- Vehicle:
- no
Test organisms
- Test organisms (species):
- activated sludge of a predominantly domestic sewage
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 3 h
Results and discussion
Effect concentrations
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 40 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
Any other information on results incl. tables
Table 1: Inhibition of the respiration rate (%) of the activated sludge after 3 hours incubation with exposure to Regorafenib
Concentration of BAY 73-4506 in test vessel (mg/L) | Inhibition in percent |
control | 0 |
8 | 5,8 |
16 | -36 |
24 | 13,1 |
32 | 7,4 |
40 | -3,1 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Regorafenib (BAY 73-4506) had no concentration-depended inhibitory effect on the respiration rate of activated sludge.
- Executive summary:
The purpose of this study was to determine the effects of the test compound Regorafenib (BAY 73-4506) on the activity of activated sludge micro-organisms. Regorafenib is a multikinase inhibitor for cancer therapy. The study was conducted in agreement with the test guideline OECD no. 209.
The test substance Regorafenib was incubated in a test system consisting of aerated activated sludge with microorganisms from a municipal sewage treatment plant including synthetic sewage feed for approximately 3 hours followed by the measurement of the respiration rate by an oxygen probe. The synthetic sewage feed solution was made up of mainly peptone, meat extract and urea. Regorafenib is only slightly soluble, therefore the substance was introduced directly into the test vessel. 2, 4, 6, 8 and 10 mg substance were suspended in 42 mL demineralized water, ultrasonified and constantly stirred each for approximately 30 min. To each vessel the synthetic feed and inoculum was added. The resulting nominal concentrations were 8, 16, 24, 32 and 40 mg/L. Additionally, a reference substance (3.5-Dichlorophenole) in three concentrations (5, 15 and 30 mg/L in test vessel) was prepared. For the control two vessels with tap water were used. The activated sludge and the positive control were exposed to each concentration in single vessels. Two vessels were prepared for the control. The activated sludge was incubated under standardized conditions (constant stirring, aerated and at room temperature). As a parameter for the activity of the sludge, the respiration rate was measured with an oxygen probe. The decrease of the respiration rate was calculated on the basis of the oxygen consumption per hour. The inhibitory effect of the test and the reference substance at a particular concentration was expressed as a percentage of the mean respiration rate of the controls.
The respiration rate in the test vessels was not relevantly inhibited.
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