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EC number: 942-532-4 | CAS number: -
- 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 18,201 3 to July 25,2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to internationally accepted testing guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Notification No. 7 of Japanese Ministry of Health, Labour and Welfare, No. 5 of Japanese Ministry of Economy, Trade and Industry, No. 110331009 of Japanese Ministry of the Environment on March 3 1,2011
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: The standard that the Minister of Labor establishes based on the Industrial Safety and Health Law Article 57-3 Paragraph 1
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- NACET00502
- IUPAC Name:
- NACET00502
- Reference substance name:
- 3-Methyl-5-(2,2,3-trimethylcyclopentyl)pentan-2-one
- Cas Number:
- 119464-63-0
- Molecular formula:
- C14H26O
- IUPAC Name:
- 3-Methyl-5-(2,2,3-trimethylcyclopentyl)pentan-2-one
- Test material form:
- other: light yellow oil
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 0.610 , 1.22, 2.44, 4.88, 9.77, 19.5, 39.1, 78.1, 156, 313, 625, 1250, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: test substance was hardly-soluble in water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: Name: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9
- Details on test system and experimental conditions:
- RANGE-FINDING STUDY: In the dose-finding study, 226.96 mg (250 µL) of the test substance was weighed and 4.289 ml of dimethylsulfoxide was added and the test substance was dissolved to prepare a 50 mg/ml test solution. In the main study, 352.18 mg (400 µl) of the test substance was weighed and 6.644 ml of dimethylsulfoxide was added and the test substance was dissolved to prepare a 50 mg/mL test solution. In the confirmatory study, 134.45 mg (150 µl) of the test substance was weighed and 2.539 ml of dimethylsulfoxide was added and the test substance was dissolved to prepare a 50 mg/mL test solution. Dimethylsulfoxide was previously dehydrated with molecular sieve (3A). In the dose-finding study, total five lower concentrations were prepared by dilution of the 50 mg/mL solution (highest concentration) with dimethylsulfoxide. In the main and confirmatory studies, total thirteen lower concentrations were prepared.
METHOD OF APPLICATION: in agar.
Soft agar consisting of sodium chloride at 0.5 % (w/v) and Bacto agar at 0.6 % (w/v) was dissolved by heating. A mixture solution of 0.5 mmol/L biotin , 0.5 mmol/L histidine and 0.5 mmol/L tryptophan was added to the soft agar solution in the ratio of 1 : 10.
NUMBER OF CELLS EVALUATED: 1 x 10^9 cells/mL or more
OTHER: Sterility Test
The sterility test was conducted to examine for contamination in the test substance or S9 mix. Mixture of 0.1 mL of the test solution of highest concentration or 0.5 mL of S9 mix and 2 mL of top agar was overlaid on a minimum glucose agar plate. After the top agar solidified, each minimum glucose agar plate was inverted and cultivated for 48 hours at 37°C (FMU-404 1, Fukushima Industries Corporation). - Evaluation criteria:
- The test results were judged positive when biologically meaningful increase in the number of revertant colonies, such as dose-related increases with reproducibility were observed.
- Statistics:
- The number of revertant colonies per plate, the mean values and standard deviation per dose of the test substance, and the negative control were tabulated for each bacterial strain. The number of revertant colonies per plate and the mean values were tabulated for each strain as for the positive control. Dose-response curves of each strain were drawn for the test substance group. Two statistical analyses of Dunnett's multiple comparison method (one-side test) and linear regression method were used in this test. The number of revertant colonies of each bacterial strain at each dose in the main study and confirmatory study was compared with that of the negative control in both the presence and absence of metabolic activation, and statistically significant difference in the number of revertant colonies between those two groups was analyzed first by the multiple comparison method (p<0.05). The dose-reactivity was analyzed by linear regression method (p<0.05) when the statistically significant difference was detected by the multiple comparison method.
Application usage:
Mean and standard deviation; Microsoft EXCEL 2003 for Windows (Version 11 )
Statistical analysis; SAS system for Window (Release 9.1.3)
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test substance was not observed at any dose levels in both the presence and absence of metabolic activation.
- Other confounding effects: No contaminants were found in the sterility test
RANGE-FINDING/SCREENING STUDIES: Six doses including 5000 µg/plate as the highest dose obtained using a common ratio of 4 were tested - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Statistically significant difference in the number of revertant colonies between the test substance group and the negative control was not observed in any bacterial strains at any dose levels regardless of the presence or absence of metabolic activation. Reproducibility
was observed between the results from the main study and confirmatory study. These results revealed that no biologically meaningful increase in the number of revertant colonies due to mutagenicity of the test substance was observed. The number of revertant colonies in the positive control was twice or more than that of the negative control in all bacterial strains regardless of the presence or absence of metabolic activation. The mean values of colony counts in the negative and positive controls were within the range of background data in both the main study and confirmatory study.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the above results, the test substance was considered to have no potency of mutagenicity under the conditions of this study. - Executive summary:
The inducibility of gene mutation in 3-methyl-5-((1 R)-2,2,3-trimethylcyclopentyl) pentan-2-one was evaluated by the reverse mutation test with a pre-incubation method at 37°C for 20 minutes using five bacterial strains, Salmonella typhimurium TA98, TA100, TA1535, TA1537, and Escherichia coli WP2 uvrA. The test was composed of the dose-finding, main and confirmatory studies, and the reproducibility between the results from the main study and confirmatory study was confirmed. All studies were performed in the presence and absence of metabolic activation. As a result, biologically meaningful increase in the number of revertant colonies due to mutagenicity of the test substance was not observed in any bacterial strains at any dose levels regardless of the presence or absence of metabolic activation. The number of revertant colonies in the positive control was twice or more than that of the negative control in all bacterial strains regardless of the presence or absence of metabolic activation. The mean values of revertant colonies in both the negative and positive controls were within the range of calculated reference value from background data in the main and confirmatory studies. No contaminants were found in the sterility test. These results demonstrated that the test was properly performed. No suspected factor that affected the reliability of the studies was confirmed. Based on the above results, the inducibility of gene mutation in the test substance was determined as negative under the test conditions employed.
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