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EC number: 216-835-0 | CAS number: 1678-91-7
- 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:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethylcyclohexane
- EC Number:
- 216-835-0
- EC Name:
- Ethylcyclohexane
- Cas Number:
- 1678-91-7
- Molecular formula:
- C8H16
- IUPAC Name:
- ethylcyclohexane
- Test material form:
- liquid: volatile
Constituent 1
- Specific details on test material used for the study:
- Name:Ethylcyclohexane
Additional name: Hexahydroethylbenzene
CAS registry number: 1678-91-7
Batch number:
Purity: 99.9%
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- With the direct method, the range of 0.156–5 µg per plate (common divisor: 2) was set for all strains. With the metabolic activation method, 3.13–100 µg per plate was set for TA100, TA1535, TA98, and TA1537, and 6.25–200 µg per plate for WP2uvrA (common divisor: 2).
- Vehicle / solvent:
- acetone
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)-acrylamide, 2-Aminoanthracene
- Evaluation criteria:
- A result that met the following three criteria was determined positive based on mean revertant colony count per plate at each dose.
(1) The revertant colony count at least two times higher than that in the negative control group was observed in a test substance group.
(2) The revertant colony count was raised as an increase in the dose of test substance (dose dependency).
(3) Reproducibility of the increase in revertant colony count was observed based on the results of the tests performed two times. However, a result was determined positive if no significant dose dependency but reproducibility in positive results was observed.
Results and discussion
Test resultsopen allclose all
- 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:
- 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
Applicant's summary and conclusion
- Conclusions:
- Ethylcyclohexane was determined not mutagenic for bacteria under the described test conditions.
- Executive summary:
A reverse mutation test was performed to investigate mutagenesis of ethylcyclohexane using Salmonella typhimurium TA100, TA1535, TA98, TA1537, and Escherichia coli WP2uvrA as indicator bacteria without the S9 mix (direct method) and with the S9 mix (metabolic activation method) by preincubation. Based on results of a dose finding study (preliminary test), dose inhibiting bacterial growth was considered the maximum dose. With the direct method, the range of 0.156–5 µg per plate (common divisor: 2) was set for all strains. With the metabolic activation method, 3.13–100 µg per plate was set for TA100, TA1535, TA98, and TA1537, and 6.25–200 µg per plate for WP2uvrA (common divisor: 2). The test was performed two times. The results showed no increase in the revertant colony count in all strains, irrespective of metabolic activation. With the direct method, bacterial growth inhibition was observed at 5 μg per plate in all strains and at 2.5 μg per plate in TA1537 during the second test. With the metabolic activation method, bacterial growth inhibition was observed at 100 μg per plate in TA100, TA1535, TA98, and TA1537, at 200 μg per plate in WP2uvrA, and at 50 μg per plate in TA1535 during the first test. From the findings above, ethylcyclohexane was determined not mutagenic for bacteria under the test conditions.
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