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EC number: 414-310-2 | CAS number: 191358-81-3
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-01-07 to 2003-03-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline Study (OECD 473)
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 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adopted July 21, 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human
- Details on mammalian cell type (if applicable):
- Human venous blood from healthy, adult donors was drawn into sterile, heparinized “vacutainers”. Whole blood cultures were initiated in 15 mL centrifuge tubes by adding 0.6 mL of fresh heparinized blood into a sufficient volume of culture medium so that the final volume was 10 mL in the assay without metabolic activation after the addition of the test article in its chosen vehicle or was 10 mL in the assay with metabolic activation after the addition of the test article in its chosen vehicle and the S9 mix.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from rat liver
- Test concentrations with justification for top dose:
- 1st experiment:
test concentrations: 3.39 - 500 µg/mL with and without metabolic activation
evaluated concentrations: 20.2, 41.2, 58.8, 84.0 µg/mL without metabolic activation and 3.39, 6.92, 14.1, 20.2 pg/mL with metabolic activation
2nd experiment:
test concentrations: 1.25 - 75 µg/mL without metabolic activation and 5 - 75 µg/mL with metabolic activation
evaluated concentrations: 20.0, 25.0, 37.5, 75.0 µg/mL with and without metabolic activation - Vehicle / solvent:
- Ethanol
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 1st exp.: 3h (with and without S9 mix), 2nd exp.: 3 h (with S9 mix) and 22 h (without S9 mix)
- Expression time (cells in growth medium): 22 h
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF EXPERIMENTS AND REPLICATIONS: 2 independent experiments, duplicate cultures
NUMBER OF CELLS EVALUATED: One hundred cells, if possible, from each duplicate culture from four concentrations of the test article, the negative and vehicle controls, and one dose level from the positive control cultures were analyzed for the different types of chromosomal aberrations.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: Percent polyploidy and endoreduplication were also analyzed by evaluating at least 100 metaphases per culture, if available. - Evaluation criteria:
- Evaluation of a Positive Response.
A test article was considered positive for inducing chromosomal aberrations if a significant increase (the difference was considered significant when p <= 0.01) in the number of cells with chromosomal aberrations was observed at one or more concentrations. The linear trend test evaluated the dose responsiveness. If a significant increase was seen at one or more concentrations, a dose-response should be observed.
Evaluation of a Negative Response.
A test article was considered negative for inducing chromosomal aberrations if no significant increase was observed in the number of cells with chromosomal aberrations at any of the concentrations.
Equivocal Evaluation.
Although most assays give clearly positive or negative results, in rare cases the data set would preclude making a definitive judgment about the activity of the test article. Results might remain equivocal or questionable regardless of the number of times the assay is repeated. - Statistics:
- Statistical analysis employed a Cochran-Armitage test for linear trend and Fisher’s Exact Test (Thakur et al., 1985).
Results and discussion
Test results
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation and solubility:
1st exp.: In the assay with and without metabolic activation, a precipitate was observed after dosing at 58.8 µg/mL and higher; slight precipitate was observed after dosing at 14.1 up to 41.2 µg/mL.
2nd exp.: In the assay without metabolic activation, a slight precipitate was observed after dosing at 75.0 µg/mL. A precipitate was observed on the slides prepared from the cultures treated with 37.5, 50.0, and 75.0 µg/mL. In the assay with metabolic activation, a slight precipitate was observed after dosing at 75.0 µg/mL. A precipitate was observed on the slides prepared from the cultures treated with 50.0 and 75.0 µg/mL.
COMPARISON WITH HISTORICAL CONTROL DATA:
The chromosomal aberration rates ater treatment with the test item were within the historical contral data range.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Test 1: Due to excessive toxicity, only dead cells were present on the slides prepared from the cultures treated with 500 µg/mL. Reductions of 19%, 21%, 14%, 0%, 21%, 14%, 14%, and 51% were observed in the mitotic indices of the cultures treated with 6.92, 9.89, 14.1, 20.2, 28.8, 41.2, 58.8, and 84.0 µg/mL, respectively, as compared with the vehicle control cultures.
Test 2: Reductions of 8%, 33%, 28%, and 49% were observed in the mitotic indices of the cultures treated with 25.0, 37.5, 50.0, and 75.0 µg/mL, respectively, as compared with the vehicle control cultures.
OTHER:
The test article did not induce polyploidy or endoreduplication. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
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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