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EC number: 266-831-8 | CAS number: 67634-26-8
- 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 July, 2006 - 10 August, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of [(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]methyl acetate and [(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]methyl acetate
- Molecular formula:
- C11H18O2
- IUPAC Name:
- Reaction mass of [(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]methyl acetate and [(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]methyl acetate
- Test material form:
- liquid
1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and 5, 6-benzoflavone.
- Test concentrations with justification for top dose:
- - Dose range finding test 1:
All 5 strains without and with S9-mix: 4.88, 19.5, 78.1, 313, 1250 and 5000 μg/plate
- Dose range finding test 2:
Strain TA98, TA100, TA1535 and TA1537 without and with S9-mix and WP2uvrA without S9-mix: 9.77, 19.5, 39.1, 78.1, 156 and 313 μg/plate
- Main test:
Strain TA98, TA100, TA1535 and TA1537 without and with S9-mix and WP2uvrA without S9-mix: 9.77, 19.5, 39.1, 78.1, 156 and 313 μg/plate
Strain WP2uvrA with S9-mix: 39.1, 78.1, 156, 313, 625 and 1250 μg/plate - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: the test substance was insoluble in distilled water at 50 mg/mL but it was soluble in DMSO at 50 mg/mL.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (100 µL/plate DMSO)
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other:
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: pre-incubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
NUMBER OF CELLS EVALUATED: 2.5 - 4.1x10^9 cells/mL
NUMBER OF REPLICATIONS:
- Doses of the test substance and positive control were tested in duplicate in each strain, the negative control was tested in triplicate in each strain.
DETERMINATION OF CYTOTOXICITY
- Method: bacterial growth inhibition under a stereomicroscope. - Evaluation criteria:
- The test substance was judged to be positive when the number of revertant colonies increased to twice or more that in the negative control in a concentration-dependent manner and also the reproducibility of the test results was obtained. In all other cases, it was judged negative.
- Statistics:
- Not performed.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 5000 µg/plate.
RANGE-FINDING/SCREENING STUDIES:
- Dose range finding test 1: The bacterial growth inhibition was observed at and above 313 µg/plate in all test strains without S9-mix and at and above 313 µg/plate in TA100, TA1535, TA98 and TA1537 with S9-mix and at and above 1250 µg/plate in WP2uvrA with S9-mix.
- Dose range finding test 2: The bacterial growth inhibition was observed at and above 156 µg/plate in all test strains without S9-mix and at 313 µg/plate in TA100, TA1535, TA98 and TA1537 with S9-mix.
HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Main test: The bacterial growth inhibition was observed at and above 156 µg/plate in all test strains without S9-mix and at 313 µg/plate in TA100, TA1535, TA98 and TA1537 with S9-mix and at and above 625 µg/plate in WP2uvrA with S9-mix.
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and Escherichia coli reverse mutation assay performed equivalent to OECD 471 guideline and GLP principles.
- Executive summary:
The mutagenic activity of the substance was evaluated equivalent to OECD 471 guideline and according to GLP principles. The test was performed in three independent pre-incubation experiments, both in the absence and presence of S9-mix up to and including 5000 μg/plate in the first dose range finding test. In the second dose range finding test and the main test, the test substance was tested up to and including the cytotoxic concentration of 313 μg/plate in the absence and presence of S9 –mix. Except WP2uvrA with S9-mix which was not tested in the second dose range finding test and was tested in the main test up to and including 1250 μg/plate. No precipitation was observed up to and including the top dose of 5000 µg/plate.
Adequate negative and positive controls were included in all three experiments. In the main test, the bacterial growth inhibition was observed at and above 156 µg/plate in all test strains without S9-mix and at 313 µg/plate in TA100, TA1535, TA98 and TA1537 with S9-mix and at and above 625 µg/plate in WP2uvrA with S9-mix. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in E. coli strain WP2uvrA, both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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