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EC number: 203-620-1 | CAS number: 108-83-8
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.2009 - 04.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2,6-dimethylheptan-4-one
- EC Number:
- 203-620-1
- EC Name:
- 2,6-dimethylheptan-4-one
- Cas Number:
- 108-83-8
- Molecular formula:
- C9H18O
- IUPAC Name:
- 2,6-dimethylheptan-4-one
Constituent 1
- Specific details on test material used for the study:
- Test Material Name: Diisobutyl Ketone
Chemical Name; 2,6-Dimethyl-4-heptanone
Synonyms: DIBK
Supplier, City, State (Lot, Reference Number): The Dow Chemical Company, Freeport, Texas (Lot# XA2355T643)
Method
- Target gene:
- Hypoxanthine-guanine-phosphoribosyltransferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- CHO-K1-BH4
The cells are routinely maintained in Ham's F-12 nutrient mix supplemented with 5% (V/V) heat-inactivated (56°C, 30 minute), dialyzed fetal bovine serum, antibiotics, and antimycotics (penicillin G, 100 units/ml; streptomycin sulfate, 0.1 mg/ml; fungizone, 0.25 µg/ml), and an additional 2 mM L-glutamine. The selection medium used for the detection of HGPRT- mutants will be Ham's F-12 nutrient mix without hypoxanthine, supplemented with 10 µM 6-thioguanine and 5% serum and the above-mentioned antibiotics.
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- preliminary toxicity assay: 0 (solvent control), 5.7, 11.3, 22.7, 45.3, 90.6, 181.3, 362.5, 725, and 1450 μg/ml
mutagenicity assay: 0 (solvent control), 200, 400, 600, 800, 1000, 1200, and 1450 μg/ml in the absence of S9 and 0 (solvent control), 100, 200, 400, 500, 600, 700, 800, and 1000 μg/ml in the presence of S9 - Vehicle / solvent:
- The test material was first dissolved in DMSO and further diluted (1:100) with the treatment medium to obtain the desired concentrations.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 20-methylcholanthrene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 h
- Expression time (cells in growth medium): 8 days
- Selection time (if incubation with a selection agent): 7 to 9 days
SELECTION AGENT (mutation assays): 6-thioguanine
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency / colony formation - Evaluation criteria:
- For an assay to be acceptable, the mutant frequency in positive controls should have been significantly higher than the solvent controls. An additional criteria was that the mutant frequency in the solvent controls should have been within reasonable limits of the laboratory historical control values and literature values. The test chemical was considered positive if it induced a statistically significant, dose related, reproducible increase in mutant frequency. The final interpretation of the data took into consideration such factors as the mutant frequency and cloning efficiencies in the solvent controls.
- Statistics:
- The frequency of mutants per 106 clonable cells was statistically evaluated using a weighted analysis of variance; weights were derived from the inverse of the mutant frequency variance. The actual plate counts are assumed to follow a Poisson distribution therefore the mean plate count was used as an estimate of variance. If the analysis of variance was significant at alpha = 0.05, a Dunnett's t-test was conducted, comparing each treated group and the positive control to the solvent control (alpha = 0.05, one-sided). Linear dose-related trend tests were performed
if any of the pairwise comparisons of test material with the solvent control yielded significant differences.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The pH and osmolality of treatment medium containing approximately 2589 μg/ml of the test material and medium containing 1% DMSO were determined using a Denver Basic pH meter (Denver Instrument Co., Arvada, Colorado) and an OSMETTE A freezing point osmometer (Precision Systems, Inc., Natick, Massachusetts). Alterations in the pH and osmolality of the culture medium have been shown to induce false positive responses in in vitro genotoxicity assays. There was no appreciable change in the pH at this concentration as compared to the culture medium with solvent alone and the slight drop in the osmolality was interpreted to be inconsequential to the conduct of the assay (culture medium with the test material, pH = 7.38, osmolality = 435 mOsm/kgH2O; culture medium with 1% DMSO, pH = 7.39, osmolality = 463 mOsm/kgH2O).
- 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
The results of the CHO/HGPRT forward gene mutation assay with diisobutyl ketone indicated that under the conditions of this study, the test article was non-mutagenic when evaluated in the absence or presence of an externally supplied metabolic activation (S9) system. - Executive summary:
Diisobutyl ketone (2,6 dimethyl-4-heptanone) was evaluated in the in vitro Chinese hamster ovary cell/hypoxanthine-guanine-phosphoribosyl transferase (CHO/HGPRT) forward gene mutation assay. The genotoxic potential of the test material was assessed in two independent assays in the absence and presence of an externally supplied metabolic activation (S9) system. The concentrations ranged from 200 to 1450 μg/ml in the absence of S9 and from 100 to 1000 μg/ml in the presence of S9. The highest concentration for each activation system was based on the initial toxicity assay, where these concentrations resulted or exceeded relative cell survivals of 10-20%. The adequacy of the experimental conditions for detection of induced mutations was confirmed by employing positive control chemicals, ethyl methanesulfonate for assays in the absence of S9 and 20-methylcholanthrene for assays in the presence of S9. Solvent control cultures were treated with the solvent used to dissolve the test material (i.e. dimethyl sulfoxide). The results of the CHO/HGPRT forward gene mutation assay with diisobutyl ketone indicated that under the conditions of this study, the test article was non-mutagenic when evaluated in the absence or presence of an externally supplied metabolic activation (S9) system.
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