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EC number: 200-824-2 | CAS number: 74-95-3
- 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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and appropriate guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- US OPPTS 870.5375 and CFR 799.9537
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Dibromomethane
- EC Number:
- 200-824-2
- EC Name:
- Dibromomethane
- Cas Number:
- 74-95-3
- Molecular formula:
- CH2Br2
- IUPAC Name:
- dibromomethane
- Details on test material:
- Clear colourless liquid, 99.4% purity, DBM
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: human lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- with and without S-9 from liver homogenate from rates induced with phenobarbitone and B-naphthofavone
- Test concentrations with justification for top dose:
- Experiment 1: 27.19, 54.38, 108.75, 217.5, 435, 870 ug/ml (with and without S9)
Experiment 2: without S9: 54.38, 108.75, 217.5, 652.5, 870 ug/ml
with S9: 13.60, 27.19, 54.38, 108.75, 217.5, 435 ug/ml - Vehicle / solvent:
- Dimethyl sulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: In the absence of S9, mitomycin C (MMC) at 0.4 ug/ml for culture in Experiment 1. It was dissolved in Minimal Essential Medium. In th presence of S9, cyclophosphamide (CP) at 5ug/ml. It was dissolved in dimethyl sulphoxide.
- Details on test system and experimental conditions:
- Two treatment conditions were used for the study.
Four hours exposure in the presence of an induced rat liver homogenate metabolising system (S9), at a 2% final concentration followed by cell harvest after a 20-hour expression period; and a 4 hours exposure in the absence of metabolic activation (S9) with a 20-hour expression period.
The test material (99.4% purity, dibromomethane) was dissolved in dimethyl sulphoxide and dilutions prepared. Duplicate cultures of human lymphocytes, treated with the test material, were evaluated for chromosome aberrations at three dose levels, together with vehicle and positive controls.
Positive control materials were Mitomycin C at 0.4 µg/ml in the absence of S-9, and dissolved in the media whereas, in the presence of S-9, cyclophosphamide at 5 µg/ml was used.
The dose levels were selected following a preliminary toxicity test using doses levels ranged from 27.19 to 870 µg/ml. The dose levels selected for metaphase analysis were 54.38, 108.75 and 217.5 µg/ml in both the absence and presence of S9.
Following mitosis arrest, cells were harvested, placed on slide and stained with 5% Gurrs Giemsa. Slides were checked microscopically to determine quality of the metaphase and also toxicity and presence of precipitation. - Evaluation criteria:
- The slides were checked microscopically to determine the quality of the metaphases and also the toxicity and extent of precipitation, if any, of the test material. These observations were used to select the dose levels for mitotic index evaluation. A total of 2000 lymphocyte cell nuclei were counted and the number of cells in metaphase recorded and expressed as the mitotic index and as a percentage of the vehicle control value. Where possible the first 100 consecutive well-spread metaphases from each culture were counted except where there were approximately 50% cells with aberrations then slide evaluation was terminated at approximately 50 cells. If the cell had 44-48 chromosomes, any gaps, breaks or rearrangements were noted according to the simplified system of Savage (1976) recommended in the 1983 UKEMS guidelines for mutagenicity testing (Appendix I). Cells with chromosome aberrations were reviewed as necessary by a senior cytogeneticist prior to decoding the slides.
- Statistics:
- The frequency of cells with aberrations excluding gaps and the frequency of polyploid cells were compared, where necessary, with the concurrent vehicle control value using Fisher's Exact test.
Results and discussion
Test results
- Species / strain:
- other:
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Evidence of toxicity and dose related mitotic inhibition in all three exposure groups (see mitotic index attached). Based on the toxicity, the maximum dose level tested was 870 ug/l for both 4(20) hour exposure groups.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: human lymphcytes taken from whole blood was drawn from vloenteers
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- The test material was considered to be clastogenic to human lymphocytes in vitro because of a statistically significant dose-related
increase in the frequency of cells with chromosome aberrations both in the presence and absence of a liver enzyme metabolizing
system. - Executive summary:
In vitro mammalian chromosome aberration test in human lymphocytes was conducted.
Two treatment conditions were used for the study. Four hours exposure in the presence of an induced rat liver homogenate metabolising system (S9), at a 2% final concentration followed by cell harvest after a 20-hour expression period; and a 4 hours exposure in the absence of metabolic activation (S9) with a 20-hour expression period.
The test material (99.4% purity, dibromomethane) was dissolved in dimethyl sulphoxide and dilutions prepared. Duplicate cultures of human lymphocytes, treated with the test material, were evaluated for chromosome aberrations at three dose levels, together with vehicle and positive controls. Positive control materials were Mitomycin C at 0.4 µg/ml in the absence of S-9, and dissolved in the media whereas, in the presence of S-9, cyclophosphamide at 5 µg/ml was used.
The dose levels were selected following a preliminary toxicity test using doses levels ranged from 27.19 to 870 µg/ml. The dose levels selected for metaphase analysis were 54.38, 108.75 and 217.5 µg/ml in both the absence and presence of S9.
Following mitosis arrest, cells were harvested, placed on slide and stained with 5% Gurrs Giemsa. Slides were checked microscopically to determine quality of the metaphase and also toxicity and presence of precipitation.
Results: The test material induced a statistically significant increase in the frequency of cells with aberrations at all dose levels analysed, in both exposure groups, using a dose range that included a dose level that induced greater than 50% mitotic inhibition. No increase in the incidence of polyploid cells was observed in either the absence or presence of S9.
All vehicle (solvent) controls gave frequencies of cells with aberrations within the range expected for normal human lymphocytes. All the positive control materials induced statistically significant increases in the frequency of cells with aberrations indicating the satisfactory performance of the test and of the activity of the metabolising system.
Therefore, the test material was considered clastogenic to human lymphocytes in vitro.
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