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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: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was very old and performed before the GLP standard was established. However, the inhalation protocol and the results were well described.
Data source
Reference
- Reference Type:
- publication
- Title:
- The physiological response of animals to cyclohexane, mehtylcyclohexane, and certain derivatives of these compounds. II. Inhalation.
- Author:
- Treon JF, Crutchfield WE, Kitzmiller KV
- Year:
- 1 943
- Bibliographic source:
- Journal of Industrial Hygiene and Toxicology, 25, 323-347
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Subchronic inhalation study
- GLP compliance:
- no
- 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:
- no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Acclimation period: 2 to 6 weeks
- Source, age at study initiation, weight at study initiation, fasting period before study, housing, diet, water: data not available
ENVIRONMENTAL CONDITIONS
- Temperature: 24 °C
- Humidity: controlled not to exceed 45%
- Air changes: 30-60 per hour
- Photoperiod (hrs dark / hrs light): data not available
IN-LIFE DATES: data not available
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: no data
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The prolonged inhalation of lower concentration was effected by the use of a battery of nine insulated plywood cages, each having a capacity of 600 litres and equipped with a front glass door. The rate of flow into the cage ranged from 350 to 800 L per minute. The equipment for conditioning the air in these cages has been described by Moore (1941). A special apparatus was used for constant vaporization of liquid with low vapour pressures and slow rates of evaporation such as cyclohexanone.
TEST ATMOSPHERE
The concentrations of cyclohexanone in air were determined colorimetrically by measuring in the air alcoholic extract compound the intensity of the pink colour produced by a reaction of the Zimmerman type, with m-dinitrobenzene. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Period of 10 weeks
- Frequency of treatment:
- 5 days a week, 6 hours daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
190 ppm (0.75 mg/L), 309 ppm (1.21 mg/L), 773 ppm (3.04 mg/L), 1414 ppm (5.56 mg/L)
Basis:
no data
- No. of animals per sex per dose:
- 4 per dose group
- Control animals:
- yes
- Details on study design:
- Post-exposure period: Observation for 2 months after the end of exposure
Examinations
- Observations and examinations performed and frequency:
- * CAGE SIDE OBSERVATIONS: No data
* DETAILED CLINICAL OBSERVATIONS: No data
* BODY WEIGHT: Yes
- Time schedule for examinations: daily
* FOOD CONSUMPTION: No data
* WATER CONSUMPTION: No data
* OPHTHALMOSCOPIC EXAMINATION: No data
* HAEMATOLOGY: Yes
- Time schedule for collection of blood: weekly
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: data not available
- Parameters: blood cell analysis (erythrocytes and leucocytes) and
hemoglobin concentration
* CLINICAL CHEMISTRY: No data
* URINALYSIS: Yes
- Time schedule for collection of urine: weekly
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: Yes / No / No data
- Parameters: urine of rabbits exposed to 190 ppm, 309 ppm and 1414 ppm cyclohexanone were analysed for the excretion of organic and inorganic sulfates using a turbidimetric method. Urine of rabbits exposed to the lowest concentration ( 190 ppm = 0.75 mg/L) were analysed for their glucuronic-acid content using a naphthoresorcinol method.
* NEUROBEHAVIOURAL EXAMINATION: No data
* OTHER: rectal temperature was determined daily - Sacrifice and pathology:
- * GROSS PATHOLOGY: Yes
* HISTOPATHOLOGY: Yes
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
- Haematological findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Details on results:
- - CLINICAL SIGNS AND MORTALITY:
At the lowest concentration (190 ppm = 0.75 mg/L) no abnormality in the behaviour of the animals was noted but degenerative changes in the liver and kidney were barely
demonstrated. These changes, not significative, were observed only at the lowest concentration and can not be considered as an effect of the test substance.
At the highest concentration (1414 ppm), slight lethargy, distention of the ear veins, salivation and conjunctival irritation manifested by congestion, lacrimation, and secretion of mucus were noted throughout the daily periods of exposure.
A lesser degree of ocular irritation resulted from exposure to the concentrations at 309 ppm and 773 ppm while slight salivation was observed under the latter conditions (773 ppm).
No mortality was observed.
- BODY WEIGHT AND WEIGHT GAIN: The rabbits gained in weight during exposure at the different concentrations.
- HAEMATOLOGY: No specific or general toxic effects upon the cellular elements of the peripheral blood were observed.
- URINALYSIS: The weekly variations in the percentage of inorganic sulfates (in relation to the total urinary sulfates) were normal before and immediately after the termination of exposures. However, some conjugation occurred during exposure to all but the lowest concentration (190 ppm = 0.75 mg/L), the mean value for this period being within normal limits (84.5%).
At this lowest concentration, there was an average daily out-put of 61 mg of glucuronic acid per rabbit during the period before exposure, with an increase to 222 mg per rabbit during exposure, and a decrease to 39 mg per rabbit after exposure had been terminated.
The changes in body temperature of the exposed animals were comparable to those observed in control animals.
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 190 ppm
- Sex:
- not specified
- Basis for effect level:
- other: Local effects (ocular irritation) / 190 ppm correspond to 750 mg/m3.
- Dose descriptor:
- LOAEC
- Effect level:
- 309 ppm
- Sex:
- not specified
- Basis for effect level:
- other: Local effects (ocular irritation) / 309 ppm correspond to 3040 mg/m3.
- Dose descriptor:
- NOAEC
- Effect level:
- 773 ppm
- Sex:
- not specified
- Basis for effect level:
- other: Systemic effects / 773 ppm correspond to 3040 mg/m3
- Dose descriptor:
- LOAEC
- Effect level:
- 1 414 ppm
- Sex:
- not specified
- Basis for effect level:
- other: Systemic effects / 1414 ppm correspond to 5560 mg/m3.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The LOAEL was 309 ppm since only ocular irritation was observed at this concentration.
- Executive summary:
In a subchronic inhalation toxicity study (Treon, 1943) cyclohexanone (purity unknown) was administered to rabbits (4/group), by exposure at concentrations of 0.75, 1.21, 3.04, 5.56 mg/L (190, 309, 773 and 1414 ppm) for 6 hours per day, 5 days/week for a total of 10 weeks.
At the lowest concentration (190 ppm), no depression in body weight gain, no changes in body temperature, no abnormality in the behavior of the animals and no specific or general toxic effects upon cellular elements of the peripheral blood were noted. However, barely demonstrated degenerative changes in the liver and kidney were observed in the rabbits exposed to 190 ppm. However, these changes were not significant and were not observed at higher doses. At the highest concentration (1414 ppm), slight lethargy, distention of the ear veins, salivation and conjunctival irritation manifested by congestion, lacrimation, and secretion of mucus were noted throughout the daily periods of exposure. A lesser degree of ocular irritation resulted from exposure to the concentrations at 309 ppm and 773 ppm while slight salivation was observed under the latter conditions (773 ppm). Based on this study, a NOAEC of 773 ppm (3.04 mg/L) can be identified for systemic effects (lethargy, distention of the ear veins) and a NOAEC of 190 ppm (0.75 mg/L) for local effect (eye irritation).
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