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EC number: 939-634-6 | CAS number: 262368-30-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 February - 17 March 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: CPMP/SWP/1042/99
- GLP compliance:
- yes
Test material
- Reference substance name:
- BIBF 1120/CDBB 213 BS
- IUPAC Name:
- BIBF 1120/CDBB 213 BS
- Details on test material:
- - Name of test material (as cited in study report): BIBF 1120/CDBB 213 BS
- Physical state: weak yellow-white solid substance
- Analytical purity: 99.2 % (HPLC)
- Purity test date: 23 january 2003
- Lot/batch No.: 8260050
- Expiration date of the lot/batch: 31 december 2003
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CrlGlxBrlHan:WI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous hydroxyethylcellulose
- Duration of treatment / exposure:
- BIBF 1120/CDBB 213 BS was given orally by gavage in the morning on 7 days per week,
using a Tuberculin syringe and stomach tube, for 2 weeks. The test substance was
administered as a solution in 0.5% Natrosol 250 HX® (Hydroxyethylcellulose) on a quantity
of 10 mL/kg. The individual dose volume was based on the most recent body weight record.
The test substance was administered to all animals for at least 14 days and until the day
before sacrifice, except for those scheduled for the recovery period.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 mg/kg bw/day (nominal)
- Dose / conc.:
- 3 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 1 mg/ml: 14 males/ 14 females
3 mg/ml: 14 males/ 14 females
10 mg/ml: 24 males/ 24 females - Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- None of the animals of the Control and all dose group did show any dose- or test item-related
changes of behavior or clinical findings.
Only in a single animal (No. 453) a clinical finding was observed and recorded (a scabby
hairless area behind the left ear was observed first on Day -5, ameliorated thereafter and
disappeared on Day 8). - Mortality:
- no mortality observed
- Description (incidence):
- No test item-related deaths occurred.
Two accidental deaths were observed. On Day 1 the female No. 261 of the toxicokinetic
satellite group died during narcosis between blood collection times 4 h and 8 h after
administration. This animal was immediately replaced by a spare animal (No. 265), which
completed this satellite group on Day 11. The recovery female No. 469 died during narcosis
for blood collection (clinical pathology) on Day 16. - Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: highest dose tested
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the present study, daily oral (gavage)administration of
BIBF 1120/CDBB 213 BS to rats over a period of 2 weeks at dose levels up to 10 mg/kg was
associated with no adverse effects.
Hence the highest dose of 10 mg/kg/day was set as NOAEL (No Observed Adverse Effect
Level). At this dose the maximum plasma concentration Cmax of BIBF 1120/CDBB 213 BS
was 1620 and 1690 ng/mL and the systemic exposure (AUC0-24h) was 5440 and
5160 ng·h/mL in males and females, respectively (Day 11; group mean).
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