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EC number: 218-491-7 | CAS number: 2163-00-0
- 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 / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-05-24 to 2012-08.17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 487 (In Vitro Mammalian Cell Micronucleus Test /MNvit)) 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- 1,6-dichlorohexane
- EC Number:
- 218-491-7
- EC Name:
- 1,6-dichlorohexane
- Cas Number:
- 2163-00-0
- Molecular formula:
- C6H12Cl2
- IUPAC Name:
- 1,6-dichlorohexane
- Test material form:
- other: liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: in Ham’s F-12K medium
- Periodically checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver post-mitochondrial fraction (S9 mix) from Aroclor 1254 induced animals
- Test concentrations with justification for top dose:
- 15.63, 31.3, 62.5, 125, 250 µg test item/mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without metabolic activation (clastogen)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation (clastogen)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Colchicine
- Remarks:
- without metabolic activation (aneugen)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 and 20 hours (without S9 mix), 4 hours (with S9 mix, twice)
- Fixation time (start of exposure up to fixation or harvest of cells): 20 hours after the end of exposure
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 5 * 10000 cells
DETERMINATION OF CYTOTOXICITY
- Method: cytokinesis proliferation block index (CPBI)
OTHER EXAMINATIONS:
- Determination of relative frequencies of mononucleate, binucleate, and multi-nucleate cells: treatment of cultures with cytoB (Cytochalasin B) - Evaluation criteria:
- The assay demonstrates its ability to reliably and accurately detect substances of known aneugenic and clastogenic activity, with and without metabolic activation.
Solvent/vehicle control and untreated cultures give reproducibly low and consistent micronuclei frequencies, typically 5 – 25 micronuclei per 1000 cells according to OECD 487. Data from negative and positive controls are used to establish historical control ranges. These values are used in deciding the adequacy of the concurrent negative/positive controls for an experiment i.e. the negative/positive control data must be within the historical ranges. - Statistics:
- The assessment was carried out by a comparison of the samples with the positive and the vehicle control using a chi-square test corrected for continuity according to YATES (COLQUHOUN, 1971) as recommended by the UKEMS guidelines (The United Kingdom Branch of the European Environmental Mutagen Society: Report of the UKEMS subcommittee on guidelines for mutagenicity testing, part III, 1989: Statistical evaluation of mutagenicity data). However, the results of statistical testing were assessed with respect to dose-response relationship. Reproducibility and historical data were also be taken into consideration.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at the top concentration of 250 µg 1,6-Dichlorohexane/mL
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: In the preliminary experiment without and with metabolic activation was tested the concentrations of 0, 10, 25, 100, 250, 1000, 2500, 5000 µg test item/mL. In the experiment pronounced to complete cytotoxicity was noted starting at concentrations of 250 µg test item/mL.
COMPARISON WITH HISTORICAL CONTROL DATA: The historical control range of micronucleus frequency of the untreated controls was 1.0 to 9.0 micronuclei per 1000 binucleated cells.
ADDITIONAL INFORMATION ON CYTOTOXICITY: In the main stuy cytotoxicity was noted at the top concentration of 250 µg test item/mL in the experiment without and with metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the present test conditions, 1,6- dichlorohexane tested up to a cytotoxic concentration of 250 µg/mL in the absence and in the presence of metabolic activation employing two exposure times (without S9) and one exposure time (with S9) revealed no indications of mutagenic properties in the vitro micronucleus test.
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