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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 terrestrial plants
Administrative data
- Endpoint:
- toxicity to terrestrial plants: short-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Mar - Apr 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 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth 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
- Analytical purity: 100.2%
- Lot/batch No.: BXR3JPV
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
Test substrate
- Vehicle:
- no
Test organisms
open allclose all
- Species:
- Pisum sativum
- Plant group:
- Dicotyledonae (dicots)
- Details on test organisms:
- Pisum sativum, pea, Douce de Provence, Sativa Rheinau AG, Switzerland
- Species:
- Raphanus sativus
- Plant group:
- Dicotyledonae (dicots)
- Details on test organisms:
- Rhaphanus sativus, radish, Sora, Sativa Rheinau AG, Switzerland
- Species:
- Zea mays
- Plant group:
- Monocotyledonae (monocots)
- Details on test organisms:
- Zea mays, corn, sh2 mittelspät, Sativa Rheinau AG, Switzerland
Study design
- Test type:
- seedling emergence toxicity test
- Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- yes
- Total exposure duration:
- 21 d
Results and discussion
Effect concentrationsopen allclose all
- Species:
- Zea mays
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- seedling emergence
- Species:
- Raphanus sativus
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- seedling emergence
- Species:
- Pisum sativum
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- seedling emergence
Any other information on results incl. tables
Table 1 | Concentrations of Regorafenib measured in the soil samples. | (BAY | 73-4506 monohydrat) | ||
Nominal Concentration (mg a.i./kg dry soil) | Measured Concentration (mg a.i./kg dry soil) | % Recovery | Mean Measured Concentration (mg a.i./kg dry soil) | Mean % Recovery | |
Control | <LOQ | NA | NA | NA | |
1 | 1,13 | 113 | 1,22 | 122 | |
1,32 | 132 | ||||
10 | 9,21 | 92,1 | 9,65 | 96,5 | |
10,1 | 101 | ||||
100 | 91,2 | 91,2 | 92,7 | 92,7 | |
94,2 | 94,2 | ||||
QC#1 (0,873) | 0,902 | 103 | NA | NA | |
QC#2 (147) | 131 | 89,5 | NA | NA | |
LOQ NA QC |
Limit of quantification. (Determined as 0,780 mg a.i./kg dry soil). Not Applicable. Quality Control sample. |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- For all species, effects on emergence and shoot fresh weight data were not statistically significant at the 100 mg a.i. /kg dry soil treatment level, i.e.,
the NOEC and LOEC were >- 100 and >100 mg/kg dry soil for all species respectively. - Executive summary:
The purpose of this study was to estimate the potential effects of Regorafenib (BAY 73-4506 monohydrat) on the emergence and seedling growth of three non-target plants species according to OECD test guideline No. 208. Toxic endpoints were the emergence of seedlings and visual assessments 14 and 21 days after 50% control emergence. Additionally, shoot fresh weights were taken 21 days after 50% control emergence.
Seeds of corn, radish and pea were used during this study. Only untreated seeds were used. A standard soil, type 5M from Lufa, Speyer, Germany, was used as plant growth medium. The soil was a sandy loam (according to USDA) with 10.9 % clay, 27.7 % silt and 61.5 % sand. The pH (CaCl2) was 7.2 and the organic carbon content was with 0.98% within the required < 1.5%.
No pesticides or organic fertilizer were applied to the collecting site over the last three years, which was used as a meadow.
Based on the results of the preliminary test and at the request of the Study Sponsor, this test was conducted as a single concentration limit test (i.e., 100 mg a.i./kg dry soil), but included two additional concentrations (i.e., 10 and 1 mg a.i./kg dry soil). Additionally, an untreated control was performed.
On day 21 after 50% of control emergence, the fresh weight of each plant shoot was recorded. All soil and quality control (QC) samples were extracted and analyzed for Regorafenib (BAY 73-4506 monohydrat) by HPLC based on a validated method.
Emergence rates in the controls and test item concentrations were higher than 70%. All emerged plants of all three tested species survived at concentrations up to 100 mg a.i./kg dry soil. For all species, effects on emergence and shoot fresh weight data were not statistically significant at the 100 mg a.i./kg dry soil treatment level, i.e. the NOEC and LOEC were ¿100 and >100 mg a.i./kg dry soil for all species, respectively.
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