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EC number: 248-742-6 | CAS number: 27939-60-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23-05-2007 to 27-06-2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Ministry of Labor, Official Notification, February 8, 1999
- Qualifier:
- according to guideline
- Guideline:
- other: "III Mutagenicity test" of "Reverse-Mutation Assay in Bacteria" prescribed in "Testing Methods Relating to the New Chemical Substances"
- Version / remarks:
- Notification No. 1121002 of the Pharmaceutical and Food Safety Bureau, MHLW, No.2 (2003.11.13) of the Manufacturing Industrie Bureau, MeTI & No. 031121002 of Environmental Health Department, MOE (November 21, 2003)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dimethylcyclohex-3-ene-1-carbaldehyde
- EC Number:
- 248-742-6
- EC Name:
- Dimethylcyclohex-3-ene-1-carbaldehyde
- Cas Number:
- 27939-60-2
- Molecular formula:
- C9H14O
- IUPAC Name:
- (1R,6R)-3,6-dimethylcyclohex-3-ene-1-carbaldehyde; (1R,6R)-4,6-dimethylcyclohex-3-ene-1-carbaldehyde
- Test material form:
- liquid
Constituent 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
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- - Dose range finding test 1: TA 100, TA 1535, WP2uvrA, TA 98 and TA 1537 (without and with S9-mix): 4.88, 19.5, 78.1, 313, 1250 and 5000 µg/plate. The number of relevant colonies in the test substance treatment groups was less than twice compared to the solvent control. The bacterial growth inhibition was observed at 313 µg/plate or more in all test strains with and without S9-mix.
- Dose range finding test 2: TA 100, TA 1535, WP2uvrA, TA 98 and TA 1537 (without and with S9-mix): 9.77, 19.5, 39.1, 78.1, 156, 313 µg/plate.
The number of relevant colonies in the test substance treatment groups was less than twice compared to the solvent control. Bacterial growth inhibition was observed for all strains at test substance concentrations of 156 µg/plate or above with S9 mix and 313 µg/plate or above without S9-mix
- Main experiment: Based on the results of dose finding test-1 and 2, a total of 6 doses was employed in all test strains with and without S9-mix. TA 100, TA 1535, WP2uvrA, TA 98 and TA 1537: 9.77, 19.5, 39.1, 78.1, 156, 313 µg/plate - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: the test substance was insoluble in distilled water at 50 mg/mL and dissolved in DMSO at 50 mg/mL. The test substance solution of 50 mg/mL prepared with DMSO was considered to be stable from the facts that there was no change in color nor heat generation at room temperature within 2 hours after preparation.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 100 µL DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see section "Any other information on materials and methods incl. tables"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Preincubation method
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS:
Triplicate plates were used for the negative control group and duplicate plates per dose for the test substance treatment groups and the positive control groups.
DETERMINATION OF CYTOTOXICITY
The bacterial growth inhibition was observed by using a stereomicroscope. For the plates in which the bacterial growth inhibition was observed, the number of colonies was counted with a manual counter, and the other plates were counted by using a colony analyzer. Square correction and miss counting correction were performed in colony analyzer. - Evaluation criteria:
- The test substance was judged to be positive when the number of revertant colonies increased to twice or more compared to 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 to be negative.
Results and discussion
Test resultsopen allclose all
- 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
- Untreated negative controls validity:
- not applicable
- 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
- Untreated negative controls validity:
- not applicable
- 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
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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
- Untreated negative controls validity:
- not applicable
- 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
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The precipitation of the test substance was not observed at any doses in the groups of with and without S9-mix.
- Other confounding effects: It was confirmed that the test system was free from bacterial contamination, which indicates the test results to be valid.
RANGE-FINDING/SCREENING STUDIES:
- Bacterial growth inhibition was observed for all strains at test substance concentrations of 156 µg/plate or above without S9-mix and 313 µg/plate or above with S9-mix in the dose-range finding studies.
HISTORICAL CONTROL DATA:
- Positive historical control data: The numbers of the revertant colonies in the positive controls were above two times that in the negative controls. The test results showed that the numbers of revertant colonies in the positive controls were within the range of the historical data at the testing facility.
- Negative (solvent/vehicle) historical control data: The test results showed that the numbers of revertant colonies in the negative control was within the range of the historical data at the testing facility.
Applicant's summary and conclusion
- Conclusions:
- The test substance, under the present test conditions, was negative in the bacterial reverse mutation assay (Ames) according to OECD TG 471.
- Executive summary:
The mutagenic activity of the test substance was evaluated in a study equivalent to OECD TG 471 and according to GLP principles. The test was performed according to the pre-incubation method, in the absence and presence of S9-mix. The dose levels were selected based on observed growth inhibition in all strains (156 µg/plate or above without S9 mix and 313 µg/plate or above with S9-mix). Adequate vehicle and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant colonies in any of the five tester strains (S. typhimurium TA100, TA1535, TA98, TA1537 and E. coli WP2uvrA), both in the absence and presence of metabolic activation. Based on the results of this study it is concluded that the test substance is not mutagenic in the bacterial reverse mutation assay.
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