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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 january 2003 - 21 february 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 471) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
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: 2 april 2002
- Lot/batch No.: 8260050
- Expiration date of the lot/batch: 31 january 2003
- Storage condition of test material: at room temperature in the dark (ambient humidity)
Constituent 1
Method
- Target gene:
- S. typhimurium
TA 1537 hisC3076 rfa uvrB - Frameshift
TA 98 hisD3052 rfa uvrB pKM101 Frameshift
TA 100 hisG46 rfa uvrB pKM101 Base substitution
TA 1535 hisG46 rfa uvrB - Base substitution
TA 102 hisG428 rfa + pKM101, pAQ1 Base substitution
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 100, 1000, 2500, 5000, 7500 µg/plate of the test substance
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation
DURATION
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: 3 each per concentration level and positive control and 6 per negative control
- Evaluation criteria:
- A reproducible, concentration-dependent increase in the number of revertants of at least one tester strain over the vehicle control value and/or outside the historical control range is indicative of genotoxic activity. Since the results were unequivocal, no detailed statistical evaluation was performed.
- Statistics:
- The assay was considered valid since the following criteria were met:
All tester strains exhibited a characteristic number of spontaneous revertants per plate. The ranges experienced in our laboratory covering about 70 experiments were as follows:
TA 1535: 2-20
TA 1537: 0-15
TA 98: 8-49
TA 100: 28-114
TA 102: 64-239
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Neither precipitation, nor bacteriotoxicity, as been by a reduced background lawn and/or a decrease of absolute revertants, was observed up to the highest concentration.
BIBF 1120/CDBB213BS did not increase the number of revertants after exposure up to the maximum concentration of 7500 µg/plate using the plate incorporation method. Addition of S9 liver fraction from rats pretreated with Aroclor 1254 had no influence on the mutation frequency. The negative were quantitatively confirmed in the repeat experiment using the preincubation method.
Detailed test results are attached as pdf.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The test substance caused neither base-pair substitutions nor frameshift mutations up to concentrations of 7500 µg/plate when tested in different strains of S. typhimurium in the presence and absence of metabolic activation. Therefore, the test substance can be classified as 'Ames negative'.
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