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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 macroorganisms except arthropods
Administrative data
- Endpoint:
- toxicity to soil macroorganisms except arthropods: short-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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 207 (Earthworm, Acute Toxicity Tests)
- 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 (species):
- Eisenia fetida
- Animal group:
- annelids
Study design
- Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- yes
- Total exposure duration:
- 14 d
Results and discussion
Effect concentrations
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
Any other information on results incl. tables
Table 1: LC50, NOEC and LOEC values for mortality on days 7 and 14 in the acute toxicity test with Regorafenib (BAY 73-4506
monohydrat).
Based on nominal concentration | |||
(mg a.i./kg dry soil) | |||
LC50 a (95% C.I.) | NOEC a LOEC a | ||
Day 7 | > 100 (NA) | ¿ 100 | > 100 |
Day 14 | > 100 (NA) | ¿ 100 | > 100 |
C.I. | Confidence Interval. | ||
NA | Not Applicable. | ||
a | Empirical estimation. | ||
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 7- and 14- day LC50 values were empirically estimated to be > 100 mg a.i./kg dry soil. Accordingly, Regorafenib is not harmful to the earthworm
Eisenia fetida. - Executive summary:
The objective of this study was to determine the acute toxicity of Regorafenib (BAY 73-4506 monohydrat) to the earthworm Eisenia fetida (Oligochaeta: Lumbricidae). In order to estimate an LC50 value, the NOEC and LOEC, the mortality was assessed 7 and 14 days after experimental start.
The toxicity test was performed according to the OECD Guideline # 207, Earthworm, Acute Toxicity Tests (OECD, 1984).
8 replicates for the control and 100 mg a.i./kg dry soil treatment and 1 replicate for the 1 and 10 mg a.i./kg dry soil
treatments (each replicate with 10 earthworms) was used. As test soil was used Artificial soil according to OECD Guideline # 207
On day 0: mean pH 6.14 and 41.0% mean moisture content.
After 7 and 14 days, earthworm mortality and health assessments were performed by testing their reaction to a mechanical stimulus. Mortality was defined as a lack of a visible movement after gentle mechanical stimulation. The general health of the earthworms was recorded by observing color changes, lethargy, lesions and the absence of burrowing. On days 0 and 14, individual earthworm weights were recorded.
On day 7 and 14, all worms were healthy and no mortality was observed in the control and the 1.0, 10 and 100 mg a.i./kg dry soil treatments, respectively. Therefore, the 7- and 14-day NOEC and LOEC values for mortality were empirically estimated to be ¿ 100 and > 100 mg a.i./kg dry soil, respectively. The 7- and 14- day LC50 values were empirically estimated to be > 100 mg a.i./kg dry soil.
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