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EC number: 922-049-5 | CAS number: 656247-17-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 - 19 August 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and according to an OECD guideline (see below).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- methyl (3Z)-3-[({4-[N-methyl-2-(4-methylpiperazin-1-yl)acetamido]phenyl}amino)(phenyl)methylidene]-2-oxo-2,3-dihydro-1H-indole-6-carboxylate
- EC Number:
- 922-049-5
- Cas Number:
- 656247-17-5
- Molecular formula:
- C31H33N5O4
- IUPAC Name:
- methyl (3Z)-3-[({4-[N-methyl-2-(4-methylpiperazin-1-yl)acetamido]phenyl}amino)(phenyl)methylidene]-2-oxo-2,3-dihydro-1H-indole-6-carboxylate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): BIBF 1120 BS
- Physical state:solid
- Analytical purity: 100%
- Purity test date: 18 July 2006
- Lot/batch No.: V12EUN00033
- Expiration date of the lot/batch: guaranteed until February 2007
- Storage condition of test material: at room temperature, protected from light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, D-97633 Sulzfeld
- Age at study initiation: approximately 4 months
- Weight at study initiation: 3.6 kg – 3.9 kg
- Housing: Rabbits were housed individually in solid wire cages. The bottoms of the cages were changed at least once a week and cleaned.
- Diet (e.g. ad libitum): Dry food (Kliba No. 3413.0.25, Provimi Kliba SA, CH-4303 Kaiseraugst, Switzerland) and
municipal drinking water were supplied ad libitum
- Acclimation period: 5 - 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 45 % – 75 %
- Air changes (per hr): approximately 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 h, with lights on from 6:00 h to 18:00 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: demineralized water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL / VEHICLE
On each day of application, the necessary amount of the test item was mixed with the
smallest amount of demineralized water as vehicle to achieve a paste. Approximately 0.5 g of
this test item mixture was applied per skin site. - Duration of treatment / exposure:
- 3 min (area 1)
1 h (area 2)
4 h (area 3) - Observation period:
- Treated skin sites were examined immediately after the end of exposure, as well as 1 h, 24 h,
48 h, and 72 h thereafter - Number of animals:
- 3 (female)
- Details on study design:
- On the day before application of the test item, the dorsal skin of the rabbit was shaved with an electric razor and the respective skin area was carefully washed with hand-warm water. The area to be treated (about 6 cm2) was marked with water-proof color. On the animal with multiple application sites, individual skin areas were clearly identified.
The shaved and marked skin areas were treated with the test item and occluded by muslin tissue and fixed by a non-skin-irritating plaster.
At the end of the indicated exposure times, the respective skin area was washed with demineralized water to remove the test item.
According to the test strategy described in OECD Guideline 404, only one animal was treated initially (Group 1, initial test). Sequentially, the test item was applied to three skin sites for 3 min (area 1), 1 h (area 2), and 4 h (area 3), respectively. Application to the next skin area was only performed in the absence of serious skin alterations in the previous one. When no serious skin alterations occurred subsequent to 4 h of exposure on the first rabbit, the test item was applied to two more animals (Group 2, confirmatory test) on the following day for 4 h at a single site only.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
BIBF 1120 BS had no irritating or corrosive effect on rabbit skin subsequent to dermal application.
No alterations of the rabbits' general appearance were observed subsequent to local application of the test item. In addition, no skin reaction beyond the area of exposure was observed and application of BIBF 1120 BS did not result in any effect on body weight development.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. CLP
- Conclusions:
- Under the conditions of the present study, BIBF 1120 BS was well tolerated subsequent to topical application on rabbit skin. There were no macroscopic signs of irritation or corrosion. In addition, there were no signs of systemic side effects or of skin alterations beyond the area of exposure.
Thus, according to the Globally Harmonized Hazard Classification and Labeling Scheme (GHS), the test item BIBF 1120 BS is not classified.
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.
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