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EC number: 203-624-3 | CAS number: 108-87-2
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. Refer to endpoint summary Genetic toxicity and IUCLID Section 13 for reporting and justification of the analogue approach.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Cyclohexane
- EC Number:
- 203-806-2
- EC Name:
- Cyclohexane
- Cas Number:
- 110-82-7
- IUPAC Name:
- cyclohexane
- Details on test material:
- - Name of test material (as cited in study report): Cyclohexane
- Molecular formula: C6H12
- Molecular weight: 84.16
- Smiles notation: C1CCCCC1
- InChl: 1S/C6H12/c1-2-4-6-5-3-1/h1-6H2
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: assumed 100%
- Solubility: 50 mg/mL in dimethylsulfoxide
Constituent 1
Method
- Target gene:
- TK locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Fischer’s medium F10p
- Properly maintained: yes
- Periodically "cleansed" against high spontaneous background: yes, by treatment with THMG prior to use in experiments
- Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- 8, 12, 17, 24, 34, 50, 70 and 100 µg/mL with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- 620 µg/mL without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Remarks:
- 1 µg/mL 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): 2 days
- Selection time: 12 ± 2 days
- Fixation time (start of exposure up to fixation or harvest of cells): 14 ± 2 days
SELECTION AGENT: 2 µg/mL trifluorothymidine (TFT)
NUMBER OF REPLICATIONS: triplicates
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency and relative total growth - Evaluation criteria:
- A test substance was considered positive if a dose-related response was obtained in which the mutation frequencies at two or more test concentrations (in the absence of severe toxicity) were at least two to three-fold higher than the mutation frequency of the solvent control.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 100 µg/mL with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Other confounding effects: At 8, 24 and 70 µg/mL, the test substance induced a 2.1-, 2.5 and 2.0-fold increase in mutant frequency, respectively. However, there was no evidence for a dose-related response. Therefore, the criteria for a positive result were not met.
ADDITIONAL INFORMATION ON CYTOTOXICITY: In a preliminary toxicity test, cells treated with 100 µg/mL of the test substance exhibited 65% growth inhibition in the presence of metabolic activation. Therefore, 100 µg/mL was the maximum concentration selected for the mutagenicity test. Cytotoxicity was confirmed in the mutagenicity test, in which 63.6% growth inhibition was observed in the presence of S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Results of the Mouse Lymphoma Forward Mutation Assay.
Test item |
Concentration (µg/mL) |
Total survival (%) |
Mutation frequency per 1E5 cells |
Fold increase |
Without S9 mix |
||||
Medium |
- |
70.0 |
2.7 |
0.7 |
DMSO |
1 µl/mL |
100.0 |
3.7 |
1.0 |
Test substance |
8 |
107.3 |
3.3 |
0.9 |
12 |
142.4 |
1.8 |
0.5 |
|
17 |
94.4 |
2.6 |
0.7 |
|
24 |
107.3 |
2 |
0.5 |
|
34 |
167.5 |
3.1 |
0.8 |
|
50 |
93.4 |
3.8 |
1.0 |
|
70 |
162.0 |
3.6 |
1.0 |
|
100 |
142.9 |
2.9 |
0.8 |
|
EMS |
620 |
43.8 |
56.7 |
15.3 |
With S9 mix |
||||
Medium |
- |
TE |
TE |
TE |
DMSO |
1 µl/mL |
100.0 |
2.8 |
1.0 |
Test substance |
8 |
57.6 |
5.8 |
2.1 |
12 |
119.9 |
4.5 |
1.6 |
|
17 |
31.3 |
3.6 |
1.3 |
|
24 |
105.6 |
6.9 |
2.5 |
|
34 |
108.0 |
2.8 |
1.0 |
|
50 |
75.2 |
4.7 |
1.7 |
|
70 |
87.5 |
5.6 |
2.0 |
|
100 |
36.4 |
3.8 |
1.4 |
|
MCA |
1 |
96.0 |
7.1 |
2.5 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Cyclohexane was tested for its ability to induce forward mutations in a Mouse Lymphoma Assay conducted following a protocol equivalent to OECD guideline 476. Mouse lymphoma L5178Y cells were incubated with the test material at 8, 12, 17, 24, 34, 50, 70 and 100 µg/mL for 4 h in the presence and absence of a metabolic activation system (S9 mix). The maximum concentration of 100 µg/mL was selected on a preliminary toxicity test (65% growth inhibition in the presence of metabolic activation). Untreated, solvent (DMSO) and positive controls (ethylmethanesulphonate, -S9 mix; 3-methylcolanthrene, +S9 mix) were included in the test.
No cytotoxicity and no increase in mutant frequency was observed at any concentration without metabolic activation. In the presence of S9 mix, cytotoxic effects were observed at the highest concentration and a 2- to 2.5-fold increase in mutant frequency was noted at 8, 24 and 70 µg/mL. However, the increases in forward mutations were not dose-related and therefore the criteria for a positive result were not met. Therefore, the test was considered negative in the limits of the range tested.
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