Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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 arthropods
Administrative data
- Endpoint:
- toxicity to terrestrial arthropods: long-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb - Mar 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted with the base (BAY 73-4605) accordind 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:
- other: OECD No. 232 Collembolan Reproduction Test in Soil
- Deviations:
- no
- Principles of method if other than guideline:
- not relevant
- GLP compliance:
- yes (incl. QA statement)
- Application method:
- soil
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):
- Folsomia candida
- Animal group:
- Collembola (soil-dwelling springtail)
Study design
- Study type:
- laboratory study
- Limit test:
- yes
- Total exposure duration:
- 28 d
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
Any other information on results incl. tables
Table 1: Number of alive adults, percent mortality and number of juveniles per replicate in the reproduction toxicity test exposing Folsomia candida to Regorafenib (BAY 73-4506 monohydrat).
Treatments (mg a.i./kg dry soil) | Replicate | # Alive Adults | % Mortality Adults | # Juveniles |
Control | 1 | 6 | 40 | 404 |
2 | 10 | 0 | 812 | |
3 | 10 | 0 | 529 | |
4 | 9 | 10 | 470 | |
5 | 10 | 0 | 527 | |
6 | 10 | 0 | 864 | |
7 | 10 | 0 | 536 | |
8 | 10 | 0 | 559 | |
1 | 1 | 9 | 10 | 388 |
10 | 1 | 9 | 10 | 525 |
100 | 1 | 8 | 20 | 466 |
2 | 10 | 0 | 473 | |
3 | 9 | 10 | 435 | |
4 | 9 | 10 | 562 | |
5 | 9 | 10 | 528 | |
6 | 10 | 0 | 820 | |
7 | 10 | 0 | 573 | |
8 | 10 | 0 | 604 | |
Toxic Standard | 1 | 7 | 30 | 221 |
2 | 8 | 20 | 226 | |
3 | 8 | 20 | 364 | |
4 | 8 | 20 | 253 | |
5 | 9 | 10 | 346 | |
6 | 7 | 30 | 315 | |
7 | 10 | 0 | 282 | |
8 | 8 | 20 | 285 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The NOEC and LOEC values for mortality and reproduction were determined to be ¿ 100 and > 100 mg a.i./kg dry soil, respectively. Therefore, the test item was not considered to be harmful to Folsomia candida.
- Executive summary:
The objective of this study was to determine the potential effects of Regorafenib (BAY 73-4506 monohydrat) on the reproduction of the springtail Folsomia candida (Collembola). In order to estimate a NOEC and LOEC, the mortality and number of offspring was assessed 28 days after experimental start.
This study was performed according to the OECD guideline # 232 Collembolan reproduction test in soil (2009).
Folsomia candida were obtained from cultures maintained at Smithers Viscient AG originally initiated with organisms obtained from Cecotox, EPFL, Lausanne, Switzerland. During culturing, the organisms were fed ad libitum with granulated yeast. Springtails used in this study were 11 to 12 days old.
Artificial soil was used as test substrate (OECD # 207, 1984). The test substrate consisted of 70% industrial sand with more than 50% of particles between 80 and 200 ¿m, 20% kaolin clay with more than 30% kaolinite content and 10% sphagnum peat moss finely ground. The pH was adjusted with CaCO3. Prior to the test start, the soil moisture content (based on dry weight) was 20.4% and the pH 6.26. The total water holding capacity of the artificial soil was determined to be 60.3%.
A limit test with a definitive test concentration of 100 mg a.i./kg dry soil was selected. Two additional range-finding concentrations (i.e., 10 and 1.0 mg a.i./kg dry soil) were included to determine the range of test item concentrations, if a following definitive test needed to be conducted. Additionally, a control with quartz sand was prepared. The toxic standard with boric acid was applied at a concentration of 100 mg product/kg dry soil.
Four weeks after the experimental start, the number of adult and juvenile springtails per test vessel was counted as follows: water was added to each test vessel and the adult organisms, floating on the water surface, were counted.
The differences between the control and the 100 mg a.i./kg dry soil test item treatment were not statistically significant different (Fisher¿s Exact test p > 0.05). Therefore, the NOEC and LOEC values for mortality were determined to be ¿ 100 and > 100 mg a.i./kg dry soil, respectively. No statistical significant differences between the control and the 100 mg a.i./kg dry soil test item treatment were found (Dunnett t test p > 0.05). Therefore, the NOEC and LOEC values for mortality were determined to be ¿ 100 and > 100 mg a.i./kg dry soil, respectively.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.