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EC number: 204-435-9 | CAS number: 120-92-3
- 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: The study was well conducted. The protocol and the results were detailed. The cyclohexanone purity was known and confirmed by analysis. The GLP were not mentioned.
Data source
Reference
- Reference Type:
- publication
- Title:
- Chronic toxicity study of cyclohexanone in rats and mice.
- Author:
- Lijinsky W, Kovatch RM
- Year:
- 1 986
- Bibliographic source:
- J Nat Cancer Inst, 77, 941-949
Materials and methods
- Principles of method if other than guideline:
- Sub-chronic toxicity study in drinking water
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Cyclohexanone
- EC Number:
- 203-631-1
- EC Name:
- Cyclohexanone
- Cas Number:
- 108-94-1
- Molecular formula:
- C6H10O
- IUPAC Name:
- cyclohexanone
- Details on test material:
- Cyclohexanone (CAS 108-94-1)
- Details on test material:
* Molecular formula: C6-H10-O
* Molecular weight: 98.14 g
* Smiles notation: O=C(CCCC1)C1
* Substance type: pure active substance
* Physical state: liquid
* Analytical purity: 96 %
* Impurities: 3 % water, 1% unidentified compounds
* Purity test date: data not available
* Lot/batch No: data not available
* Expiration date of the lot/batch: data not available
* Stability under test conditions: stable
* Storage condition of test material: stored at 5 °C
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: Animal Production Facility of the NCI-Frederick Cancer Reasearch Facility
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: the weight of the male rats averaged 162 g (139-180 g), that of the female rats 126 g (107-143 g)
- Fasting period before study: data not available
- Housing: 5 to a cage
- Diet: Wayne Sterilizable Lab Meal, ad libitum
- Water: data not available
Acclimation period: data not available
* ENVIRONMENTAL CONDITIONS:
- Temperature: 22 to 24 °C
- Air changes: 15 times per hour
- Humidity, photoperiod: data not available
IN-LIFE DATES: data not available
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- other: acidified water
- Details on oral exposure:
- * PREPARATION OF DOSING SOLUTIONS: cyclohexanone was dissolved in acidified water (pH 2.5) and stored at 5 °C. The solution was prepared every 2 weeks, stored at 5 °C.
* VEHICLE:
Justification for use and choice of vehicle: water was acidified to suppress bacterial growth - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analysis of the solution at intervals and after 28 days showed that there was no detectable decomposition during this time. Cyclohexanone was also
completely stable at room temperature for at least 4 days. - Duration of treatment / exposure:
- For 25 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
190 ppm (29 mg/kg bw), 400 ppm (61 mg/kg bw), 800 ppm (122 mg/kg bw), 1600 ppm (246 mg/kg bw), 3300 ppm (508 mg/kg bw), 4700 ppm (723 mg/kg bw), 6500 ppm (1000 mg/kg bw). The ppm doses would provide approximately mg/kg bw/day doses.
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- * Dose selection rationale: based on a LD50 at 1.6 g/kg bw
* Rationale for animal assignment: data not available - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- * CAGE SIDE OBSERVATIONS: No data
* DETAILED CLINICAL OBSERVATIONS: No data
* BODY WEIGHT: Yes
Time schedule for examinations: once a week and at the end of the study
* WATER CONSUMPTION AND COMPOUND INTAKE: No data
* OPHTHALMOSCOPIC EXAMINATION: No data
* HAEMATOLOGY: No data
* CLINICAL CHEMISTRY: No data
* URINALYSIS: No data
* NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- - Clinical signs and mortality: no effects
Up to the termination study at 25 weeks, cyclohexanone did not affect survival, even in the rats exposed to 6500 ppm concentration.
There was moderate chronic respiratory disease in all animals, cyclohexanone-treated and control rats.
- Body weight and weight gain: yes: a depression of body weight gain (10% less than controls) was noted in both male and female rats exposed to
cyclohexanone at 6500 ppm for the 25 weeks exposure.
- Histopathology: non-neoplastic: yes: the only histopathological change observed was a mild degenerative change in the thyroid gland of 2/5 male
rats exposed to 4700 ppm but not seen in other animals.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 4 700 ppm
- Sex:
- male/female
- Basis for effect level:
- other: Depression of body weight gain / 4700 ppm correspond to 723 mg/kg b.w./day.
- Dose descriptor:
- LOAEL
- Effect level:
- 6 500 ppm
- Sex:
- male/female
- Basis for effect level:
- other: Depression of body weight gain / 6500 ppm correspond to 1000 mg/kg b.w./day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
In a sub-chronic toxicity study (Lijinsky W, 1986) Cyclohexanone (96% purity) was administered to 5 F344 rat/sex/dose in water at dose levels of 0, 190, 400, 800, 1600, 3300, 4700, 6500 ppm (equiv. to ca. 29, 61, 122, 246, 508, 723, 1000 mg/kg bw/day).
Up to the end of the study at 25 weeks, cyclohexanone did not affect survival, even in the rats exposed to 6500 ppm concentration. However, the body weight gain was 10% lower than controls in both male and female rats at the highest dose. It was concluded that in absence of significant histopathologic findings, the MTD was 6500 ppm, dose also considered as the LOAEL in Fisher 344 rats. The NOAEL was 4700 ppm (723 mg/kg bw).
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