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EC number: 209-513-6 | CAS number: 583-60-8
- 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
Endpoint summary
Administrative data
Description of key information
In order to predict the repeated dose toxicity for 2-methylcyclohexanone, a read across study was performed using the source substance as Cyclohexanone.
It is concluded that a highly similarity exists between the target and the source compound since the identified structural difference, i.e. methyl group, is not expected to significantly impact the toxicity of the two chemicals. The mechanistic profile comparison leads to the conclusion that the target 2-methylcyclohexanone and the source cyclohexanone show very similar mechanistic profiles. The analysis highlights that the target 2-methylcyclohexanone and the source cyclohexanone show overall
similar physicochemical profiles. The analysis of the reactivity properties highlights that the target 2-methylcyclohexanone and the source cyclohexanone show very similar reactivity profiles.
The results for oral repeated-dose toxicity test of cyclohexanone exhibit qualitative and quantitative consistency. The combined oral NOEL in male and female rats of 508 mg/kg/day can be employed to estimate the repeated dose toxicity of the target compound - 2-methylcyclohexanone.
Therefore, the study can be used for predicting repeated dose toxicity of the target 2-methylcyclohexanone.
According to CLP Regulation (EU CLP, 2008), classification is not warranted since no significant toxic effects are expected at doses <100 mg/kg/day after repeated oral exposures.
The prediction is associated with an overall low uncertainty coming from a similarity justification and high-tier complex endpoint (repeated dose toxicity).
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-1986
- Reliability:
- 2 (reliable with restrictions)
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- The animals received a solution of cyclohexanone in tap water acidified with HCl to pH 2.5 ad libitum, (for bacterial growth suppression). The solutions were dispensed into bottles with sipper tubes and prepared every 2 weeks and stored at 5 degrees C. Bottles were changed three times a week. Control animals received only acidified water and were kept in the same room. All animals were 7-8 weeks old at the beginning of the treatment The weighing of animals occurred once a week and at the end of the study. The weight of the male rats was 162 g (139-180 g); female rats - 126 g (107-143); male mice - 23 g (20-26 g); and female mice - 20 g (17-23 g). For the subchronic study, rats were housed 5 to a cage and mice were housed 10 to a cage. In the chronic study, rats and mice were housed 4 to a cage. The study with both species was conducted in a single animal holding room at 22-24°C in which there was frequent change of air (15 times per h). The animals were raised and housed behind a barrier, in a facility with clean-unclean corridors, the air pressure within the room being arranged so that air from the room would flow to the unclean side. Mice were monitored for murine virus antibodies. The animals were fed Wayne Sterilizable Lab Meal ad libitum. Animals were sacrificed and dissected, organs and tissues were fixed in Formalin, slides were prepared for histopathological examination.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Route of administration:
- oral: drinking water
- Details on route of administration:
- The drinking water: solution of cyclohexanone in tap water acidified with HCl to pH 2.5 ad libitum, (for bacterial growth suppression). The solutions were dispensed into bottles with sipper tubes and prepared every 2 weeks and stored at 5 degrees C. Bottles were changed three times a week.
- Vehicle:
- water
- Duration of treatment / exposure:
- 25 weeks
- Frequency of treatment:
- Daily
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- equiv. 6500 ppm
- Dose / conc.:
- 723 mg/kg bw/day (nominal)
- Remarks:
- equiv. 4700 ppm
- Dose / conc.:
- 508 mg/kg bw/day (nominal)
- Remarks:
- equiv. 3300 ppm
- Dose / conc.:
- 246 mg/kg bw/day (nominal)
- Remarks:
- equiv. 1600 ppm
- Dose / conc.:
- 122 mg/kg bw/day (nominal)
- Remarks:
- equiv. 800 ppm
- Dose / conc.:
- 61 mg/kg bw/day (nominal)
- Remarks:
- equiv. 400 ppm
- Dose / conc.:
- 29 mg/kg bw/day (nominal)
- Remarks:
- equiv. 190 ppm
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Observations and examinations performed and frequency:
- The weighing of animals occurred once a week and at the end of the study. Animals were sacrificed and dissected, organs and tissues were fixed in Formalin, slides were prepared for histopathological examination.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- In both male and female rats receiving 6,500 ppm cyclohexanone, there was a depression of weight gain, which approximated 10% less than the weight gain of the controls during the 25-week treatment, however no significant histopathological findings were observed.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 723 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- body weight and weight gain
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 508 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- body weight and weight gain
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- System:
- other: depression in weight gain
- Conclusions:
- The oral 25-week repeated-dose assay in rats provided a NOEL value (508 mg/kg/day) and a NOAEL (No Observed Adverse Effect Level) value (723 mg/kg/day).
- Executive summary:
A 25-week repeated-dose study was conducted in F344 rats by administering a solution of cyclohexanone in drinking water. All trested animals survived by the end of the treatment. A NOEL value (508 mg/kg/day - equiv. 3300 ppm) and a NOAEL (No Observed Adverse Effect Level) value (723 mg/kg/day - equiv 4700 ppm) was established. A 10 % depression in weight gain was observed at 1000 mg/kg/day (equiv. 6500 ppm). The only pathological change observed was a mild degenerative change in the thyroid gland of 2 male rats given 4,700 ppm cyclohexanone, not seen in other animals.
Reference
Other than mentioned above, the only pathological change observed was a mild degenerative change in the thyroid gland of 2 male rats given 4,700 ppm cyclohexanone, not seen in other animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 508 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to CLP Regulation (EU CLP, 2008), classification is not warranted since no significant toxic effects are expected at doses <100 mg/kg/day after repeated oral exposures. As the prediction did not presented any possible significant toxic effects arising from repeated exposure, the 2-methylcyclohexanone does not meet the criteria for classification for STOT RE (specific target organ toxicity, repeat exposure) according to Regulation (EC) No 1272/2008, Annex I section 3.9.
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