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Diss Factsheets
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EC number: 202-874-0 | CAS number: 100-64-1
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to guideline with acceptable deviations and limited documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- fewer animals per group, longer exposure period, positive control group
- 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
- IUPAC Name:
- cyclohexanone
- Test material form:
- other: vapour
- Details on test material:
- - Name of test material (as cited in study report): cyclohexanone
- Molecular formula (if other than submission substance): C6H10O
- Analytical purity: 99.8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonsen Laboratories, Gilfroy, CA, USA
- Housing: individually
- Diet (ad libitum): standard rat chow (except daily exposure period)
- Water (ad libitum): tap water (except daily exposure period)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: solvent vapour generating system
- Method of holding animals in test chamber: individually in cages
- Source and rate of air: purified
- Method of conditioning air: desired concentrations by mixing with purified air
- Temperature, humidity, pressure in air chamber: 22-25 °C, not stated, 1 inch of water below atmospheric pressure
TEST ATMOSPHERE
- Brief description of analytical method used: Continuous monitoring by infrared gas analyser
- Samples taken from breathing zone: not stated - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Continuous monitoring by infrared gas analyser
- Details on mating procedure:
- not stated
- Duration of treatment / exposure:
- 16 days (gestation days 5 -20)
- Frequency of treatment:
- 7 h/day
- Duration of test:
- 17 days sacrifice on day 21)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 100, 250 or 500 ppm (408, 1020 or 2040 mg/m3)
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
0, 300 or 400 µL/kg
Basis:
actual ingested
via gavage, positive control 2-ethoxyethanol
- No. of animals per sex per dose:
- 10 pregant rats per exposure groups, 15 in control groups (5 each in concurrent controls to 3 test substance concentration groups) and 15 in positive control groups (5 each in concurrent groups to 3 test substance concentration groups)
- Control animals:
- yes, concurrent vehicle
- other: positive control: 2-ethoxyethanol (by gavage)
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: start and end of exposure
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: gross pathology, see also ovaries and uterus content - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: half per litter
- Fetal body weight, sex: Yes - Statistics:
- A t-test statistic for multiple comparisons was used.
- Indices:
- not calculated
- Historical control data:
- not stated
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Slight, not significant reduction in maternal body weight gain (actual and corrected by gravid uterus weight) in all treated groups, significant actual reduction in all positive control groups
grey mottling of lungs in several dams at >= 250 ppm
No effects on implantation or number of corpora lutea (also in positve control groups)
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEC
- Effect level:
- 1 020 mg/m³ air
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- 408 mg/m³ air
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- >= 2 040 mg/m³ air
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No significant increase in the mean percent of rudimentary ribs/ litter was observed in the treated groups.
No significant increase in numbers of external, skeletal or visceral malformations were noted, and no significant differences were evident between the treated and control groups in fetal weight, resorption sites, fetal death or sex ratio.
The positve controls revealed a markedly higher, significant percentage of resorptions and reduced fetal weight. The malformation rate was significantly higher than in controls.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study cyclohexanone was toxic to the dams, but not a developmental toxicant.
- Executive summary:
Pregnant Sprague-Dawley rats (10 per exposure groups, 15 (combined) in 3 separate concurrent control groups and 15 (combined) in 3 separate concurrent positive control groups) were exposed to 0, 100, 250 and 500 ppm cyclohexanone (408, 1020 and 2040 mg/m3) on gestation days 5-20 for 7 h/d. Positive controls (3 concurrent groups) were exposed via gavage to 300 or 400 µL/kg 2 -ethoxyethanol. Animals were sacrificied at gestation day 21. The maternal weight gain of the animals of the exposure groups was only slightly lower than in control groups (not significant). Grey mottling of the lung was seen in several of the exposed dams at 250 and 500 ppm. No significant differences between treated and control groups were observed with respect to fetal weight, resorption sites, fetal death or sex ratio, as well as external visceral or skeletal malformations or variations.
The positive controls showed a significantly increased percentage of resorptions and reduced fetal weight. The malformation rate was significantly higher than in controls.
Under the conditions of this study the maternal LOAEC and NOAEC was 250 and 100 ppm (1020 and 408 mg/m3), respectively. The developmental NOAEL was >= 500 ppm in this study (2040 mg/m3).
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