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Diss Factsheets
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EC number: 905-559-2 | 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 4-vinylcyclohexene
- EC Number:
- 202-848-9
- EC Name:
- 4-vinylcyclohexene
- Cas Number:
- 100-40-3
- Molecular formula:
- C8H12
- IUPAC Name:
- 4-vinylcyclohexene
- Details on test material:
- - Name of test material (as cited in study report): 4-vinylcyclohexene
- Batch No: #1
- Supplied by: Union Carbide Corporation, Institute, WV, USA
- Analytical purity: 99.8 (supplied), 99.6-99.7% (reanalysis)
- 4-tertbutylcatechol present as inhibitor
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding laboratories (B6C3F1/CrlBR)
- Age at study initiation: approximately 5 weeks
- Weight at study initiation: 16-25 g (males), 13-20 g (females) at approximately 24 days old
- Assigned to test groups randomly: using a computerised, stratified randomisation program
- Fasting period before study: no
- Housing: individually housed in in stainless steel wire-mesh cages (except during exposure)
- Diet: Purina Certified Rodent Chow (chunk) #5002 ad libitum (except during exposure)
- Water: tap water ad libitum (except during exposure)
- Quarantine period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature: target 23±2°C
- Humidity: target 55±15%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: 26 January 1993 to 28 May 1993
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- air
- Details on exposure:
- TYPE OF INHALATION EXPOSURE: whole body
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel and glass with a nominal volume of 150 or 300 L
- Method of holding animals in test chamber: within stainless steel cage modules inside the exposure chamber
- System of generation: The exposure chambers operated in a one-pass, flow-through mode. VCH was vaporised by metering VCH into a glass heated flask. The vapour produced was diluted with filtered air to give the desired concentrations for each of the 4 VCH chambers.
- Temperature, humidity, pressure in air chamber: target of 23±2°C, 40-60%, pressure not reported
- Air flow rate: approximately 40 L/min for the 150 l chambers and 60-70 L/min for the 300 L chambers
- Method of particle size determination: not applicable
- Treatment of exhaust air: Passed through a carbon bed prior to venting through a roof exhaust system
TEST ATMOSPHERE
- Brief description of analytical method used: GC-FID (at approximately 30 min intervals throughout exposure)
- Samples taken from breathing zone: yes - Duration of treatment / exposure:
- 13 week
- Frequency of treatment:
- 6hours/day, 5 days/week
- Post exposure period:
- approximately 24 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 50, 250, 1000 ppm
Basis:
other: target concentration
- Remarks:
- Doses / Concentrations:
0, 53 (9.7), 250 (27), 1000 (80) ppm
Basis:
analytical conc.
(SD)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, sham-exposed
- Positive control(s):
- 1,3-butadiene
- Route of administration: whole body inhalation
- Doses / concentrations: 1000 ppm
- Analytical purity: 99.9% (composition unchanged over course of study)
- 4-tertbutylcatechol present as inhibitor
Examinations
- Tissues and cell types examined:
- bone marrow erythrocytes
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES (in addition to information in specific fields): Mice killed by CO2 inhalation and bone marrow smears prepared from the femurs.
DETAILS OF SLIDE PREPARATION: at least 2 slides/animal, fixed in methanol, stained with acridine orange in phosphate buffer (pH7.4)
METHOD OF ANALYSIS: Cell preparations examined with incident light fluorescence microscopy. - Evaluation criteria:
- Proportion of PCEs out of 1000 erythrocytes (PCE frequency) and proportion of MN PCEs among 1000 PCEs (MN frequency) determined.
- Statistics:
- Data transformed using arcsin square root transformation. Normal distribution - parametric methods used, if not - non-parametric methods (Kruskal-Wallis and Mann-Whitney U tests used).
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Mortality, clinical signs and bodyweight: At 1000 ppm all males and three females died. Tremors and lethargy present in 1 male and 2 females at 50 ppm but no clinical signs at 250 ppm. Statistically significant decrease in bodyweight gain in females at 250 ppm over duration of study.
Micronucleus assessment: No statistically significant reductions in PCE frequency nor any increases in MN frequency in any 4-vinylcyclohexene groups compared to controls. There was a statistically significant increase in MN frequency in the positive control group.
Mean PCE frequency
Concentration(ppm) |
Mean PCE frequency % (SD) |
|
Males |
Females |
|
0 |
55.1 (49.8, 60.3) |
59.8 (48.5, 70.6) |
50 |
57.5 (47.8, 66.9) |
59.4 (50.4, 68.1) |
250 |
54.9 (49.6, 60.1) |
60.2 (53.2, 67.1) |
1000 |
no data |
63.2 (47.5, 77.5) |
Positive control (1000 ppm 1,3-butadiene) |
61.1 (48.1, 73.4) |
72.3 (64.8, 79.2) |
Mean MN PCE frequency
Concentration(ppm) |
Mean MN PCE frequency % (SD) |
|
Males |
Females |
|
0 |
0.14 (0.00, 0.50) |
0.10 (0.00, 0.35) |
50 |
0.24 (0.12, 0.41) |
0.14 (0.01, 0.43) |
250 |
0.33 (0.12, 0.66) |
0.23 (0.11, 0.39) |
1000 |
no data |
0.19 (0.00, 3.58) |
Positive control (1000 ppm 1,3-butadiene) |
1.56 (0.24, 3.98) |
1.67 (1.29, 2.10) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
4-vinylcyclohexene did not cause any apparent physiological or toxic effects on the bone marrow or induce chromosomal or spindle damage in the nucleated erythroblast cells. - Executive summary:
In a mouse micronucleus assay, 4-vinylcyclohexene did not cause any apparent physiological or toxic effects on the bone marrow or induce chromosomal or spindle damage in the nucleated erythroblast cells.
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