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EC number: 434-850-2 | CAS number: 1680-31-5
- 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
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:
- 1999-10-06 to 2000-01-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- February 1998, adopted July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- EEC Directive 92/69, L 383 A, dated December 29, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver microsome preparations (S9 mix); ß-naphthoflavone/phenobarbital induced
- Test concentrations with justification for top dose:
- 2860 µg/mL ( = 10 mM) were applied as top concentration for treatment of the cultures in the pre-test.
Test item concentrations between 22.3 and 2860 µg/mL (with and without S9-mix) were chosen for the evaluation of cytotoxicity. - Vehicle / solvent:
- - Solvent used:
Ethanol (E. MERCK, D-64293 Darmstadt, Germany; purity 99.8 %). On the day of the experiment (immediately before treatment ), the test item was dissolved in ethanol. The final concentration of ethanol in the culture medium was 0.5% (v/v).
- Justification for choice of solvent:
The solvent was chosen to its solubility properties and its relative nontoxicity to the cell cultures.
Controls
- Untreated negative controls:
- yes
- Remarks:
- culture medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Ethylmethane sulfonate (without metabolic activation), Cyclophosphamide (with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation
Preparation of the Cultures:
16 h and 26 h, respectively after the start ofthe treatment colcemid was added (0.2 µg/mL culture medium) to the cultures. 2 h later, the cells on the slides were treated in the chambers with hypotonic solution (0.4 % KCl) for 20 min at 37° C. After incubation in the hypotonic solution the cells were fixed with 3 + 1 methanol + glacial acetic acid. Per experiment both slides per group were prepared. After preparation the cells were stained with Giemsa (E. Merck, D-64293 Darmstadt). Additionally, two cultures per test item and solvent control treatment group, not treated with Colcemid, were set up in parallel. These cultures were stained in order to determine microscopically the cell number within 1 0 defined fields per slide. The toxicity of the test item is given as reduction of % cells as compared to the solvent control.
DETERMINATION OF CYTOTOXICITY
The chromosomes were prepared 18 h and 28 h after start of treatment with the test item. In experiment I, the exposure period was 4 h with and without metabolic activation. In experiment li the exposure period was 4 h with S9 mix and 18 h and 28 h without S9 mix. The chromosomes were prepared 18 h (exp. I and II) and 28 h (exp. lI) after start of treatment with the test item.
In each experimental group two parallel cultures were set up. Per culture 100 metaphase plates were scored for structural chromosome aberrations.
OTHER EXAMINATIONS:
- Analysis of Metaphase Cells: Evaluation of the cultures was performed using NIKON microscopes with 100x oil immersion objectives.
Breaks, fragments, deletions, exchanges and chromosome disintegrations were recorded as structural chromosome aberrations. Gaps were recorded as
well but not included in the calculation of the aberration rates. 100 weil spread metaphase plates per culture were scored for cytogenetic darnage on coded slides. Only metaphases with characteristic chromosome numbers of 22 ± 1 were included in the analysis. To describe a cytotoxic effect the mitotic index (% cells in mitosis) was determined. In addition, the number of polyploid cells was determined (% polyploid metaphases; in the case of this aneuploid cellline polyploid means a near tetraploid karyotype).
NUMBER OF REPLICATIONS: triplicate
OTHER: Two independent tests were performed with and without metabolic activation. - Evaluation criteria:
- Evaluation of the cultures was performed using NIKON microscopes with 100 x oil immersion objectives. Breaks, fragments, deletions, exchanges and chromosome disintegrations were recorded as structural chromosome aberrations. Gaps were recorded as well but not included in the calculation of the aberration rates. 100 well spread metaphase plates per culture were scored for cytogenetic darnage on coded slides. Only metaphases with characteristic chromosome numbers of 22 ± 1 were included in the analysis. To describe a cytotoxic effect the mitotic index (% cells in mitosis) was determined. In addition, the number of
polyploid cells was determined (% polyploid metaphases; in the case of this aneuploid cellline polyploid means a near tetraploid karyotype).
The chromosome aberration assay was considered acceptable if it meets the following criteria:
a) The number of structural aberrations found in the negative and/or solvent controls falls within the range of our historicallaboratory control data: 0.00 %- 4.00 %.
b) The positive control substances should produce significant increases in the number of cells with structural chromosome aberrations, which are within the range of the laboratories historical control data.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- 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:
- Toxic effects indicated by reduced cell numbers were observed after 4 h treatment with 44.7 µg/mL and above in the absence of S9 mix and with 2860 µg/mL in the presence of S9 mix. In addition, 24 h continuous treatment with 22.3 µg/ml and above in the absence of S9 mix induced a toxic effect.
Turbidity of the test item in culture medium was observed after treatment with 89.4 µg/mL and above in the absence of S9 mix and at 178.8 µg/mL and above in the presence of S9 mix in the pre-test.
No relevant influence of the test item on the pH value or osmolarity was observed (solvent contro: 404 mOsm, pH 7.2 versus 346 mOsm and pH 7.3 at 2860 µg/mL).
In experiment I, in the absence of S9 mix clearly reduced mitotic indices were observed at the 18 h interval after 4 h treatment with 400 µg/mL (33.0 % of control). In experiment II, in the absence of S9 mix the mitotic indices were reduced after treatment with 25 µg/mL (39.7 % of control) at the 18 h interval and 200 µg/mL (9.9 % of control) at the 28 h interval. In the presence of S9 mix only slightly reduced mitotic indices were observed after 4 h treatment with 2860 µg/mL (64.7 % of control).
In both experiments, EMS (600 and 1000 µg/mL, respectively) and CPA (0.71 µg/mL) were used as positive controls and showed distinct increases in cells with structural chromosome aberrations.
It can be stated that in the study described and under the experimental conditions reported, the test item did not induce structural chromosome aberrations in V79 cells (Chinese hamster cellline ). - 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.
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.
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