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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP status unknown, near guideline study, animal experimental study, published in peer reviewed literature. No restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: standard NTP methodology
- Principles of method if other than guideline:
- Standard NTP methodology for dose selection on the 2 year study
- GLP compliance:
- not specified
- Limit test:
- no
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
- Substance type: a dimer of 1,3-butadiene
- Physical state: colourless liquid
- Lot/batch No.: C592777 (supplied by Chemical Samples Company, Columbus, Ohio, USA) for initial 44 weeks, A061181 (supplied by Aldrich Chemical Company, Milwaukee, WI, USA) for remainder of study.
- Analytical purity: Lot C592777 >99%, Lot A061181 >98%
- Impurities (identity and concentrations): Lot C592777 100 ppm (0.01%) butylated hydroxytoluene (BHT). Lot A061181 50 ppm (0.005%) tert-butylcatechol. (Inhibitors of peroxide formation).
- Stability under test conditions: yes
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: 7 weeks
- Housing: 5/cage in polycarbonate cages
- Diet: NIH 07 Rat and Mouse Ration pellets ad libitum
- Water: acidified water (pH 2.5) ad libitum
- acclimatisation: 17 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22-24°C
- Humidity: 30-70 %
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 21 January 1980 To: 22 April 1980
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: 4-vinylcyclohexene and corn oil were mixed to give the desired dosing concentrations.
Dose volume = 3.33 mL/kg. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- GC analysis of the dosing solutions demonstrated that the achieved concentration was 95 - 100% of target.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 100, 200, 400 or 800 mg/kg bw/d
Basis:
other: nominal in corn oil
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice per day
BODY WEIGHT: Yes
- Time schedule for examinations: Once per week
FOOD CONSUMPTION: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. Necropsies were performed on all animals (survivors and decedents).
HISTOPATHOLOGY: Yes. Kidneys and stomachs of all males and stomachs of all females. The following tissues from all animals in control and 800 mg/kg/day groups and any animal dying before scheduled termination: gross lesions and masses, adrenal glands, blood smear, brain, colon, oesophagus, eyes, heart, kidneys, liver, lung and mainstem bronchi, mammary gland, mandibular lymph nodes, salivary glands, sternebrae (including marrow), thyroid gland, parathyroids, small intestine, colon, liver, prostate/testes or ovaries/uterus, lungs and mainstem bronchi, skin, heart, oesophagus, stomach, brain, thymus, pancreas, spleen, kidneys, adrenal glands, urinary bladder, pituitary gland, trachea, eyes, mammary gland, blood smear, and spinal cord (if neurologic signs present). - Statistics:
- It is not stated if any statistical analysis was applied to the data.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS AND MORTALITY: There were premature deaths in single animals from the 400 mg/kg bw/d (male) and 800 mg/kg bw/d (female) groups. (No further details.)
BODY WEIGHT AND WEIGHT GAIN: Body weight gain was decreased in the higher dose males, with a less marked effect in females. Final bw by dose level relative to controls: males: 100%, 101%, 96%, 97%, 93%, 87%, females: 100%, 101%, 96%, 97%, 99%, 94%
GROSS PATHOLOGY: No gross macroscopic lesions are described in the report.
HISTOPATHOLOGY: Microscopic examination revealed hyaline droplet degeneration of the proximal convoluted tubule of the kidney in males (not females). Severity was diagnosed as minimal for all groups with the exception of 800 mg/kg males (where it was described to be of a degree that might reduce longevity in a 2 year study). Inflammation of the submucosa of the nonglandular stomach (severity not defined) was present in 1 male and 3 females given 800 mg/kg bw/d. No other treatment-related histological abnormalities present.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- subchronic (13 week)
- Effect level:
- 200 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: single mortality at 400 mg/kg. Inflammation of the stomach and decreased terminal body weight at higher doses
- Dose descriptor:
- NOAEL
- Remarks:
- subchronic (13 week)
- Effect level:
- 400 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: inflammation of the stomach and decreased terminal body weight at higher doses
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The sub-chronic NOAEL for 4-vinylcyclohexene in the rat was 200 mg/kg bw/d in males and 400 mg/kg bw/d in females (based on increased severity of hyaline droplet degeneration of the renal proximal convoluted tubule, inflammation of the stomach and decreased terminal body weight at higher doses in both sexes).
- Executive summary:
In a 13 week gavage study, male and female F344 rats were administered 4-VCH in corn oil, 5 days/week for 13 weeks at 0, 50, 100, 200, 400 or 800 mg/kg bw/d. There was a single mortality at 400 mg/kg and decreased body weight gain in males at >400 mg/kg body weight/day and females at 800 mg/kg/day. There was a minimal increased severity of hyaline droplet degeneration of the renal proximal convoluted tubule in males at 800 mg/kg/d and some inflammatory changes in non-glandular stomach of high dose males and females. Overall the findings indicate a sub-chronic oral NOAEL of 200-400 mg/kg body weight/day for male and female rats, respectively.
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