Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Equivalent to guideline with limited documentation
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- In compliance with U.S. Food and Drug Administration Good Laboratory Practices regulations (21 CFR, Part 58)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Cyclohexanone oxime
- EC Number:
- 202-874-0
- EC Name:
- Cyclohexanone oxime
- Cas Number:
- 100-64-1
- Molecular formula:
- C6H11NO
- IUPAC Name:
- cyclohexanone oxime
- Test material form:
- solid: crystalline
- Details on test material:
- Name of test material (as cited in study report): cyclohexanone oxime
- Substance type: white crystalline solid
- Analytical purity: > 99% for both lots used
- Impurities (identity and concentrations):
- Lot/batch No.: Lots 02616LT and 08812MX
- Stability under test conditions: no degradation of cyclohexanone oxime throughout the study
- Storage condition of test material: stable in aqueous solution at a concentration of 106 ppm for 4 weeks at 5 °C when stored in a sealed container, protected from light. Solutions exposed to light in drinking water bottles were stable for 5 days. Substance stored in a sealed container at 5 °C or less, protected from light.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS (data from repeated dose studies)
- Source: Taconic Farms (Germantown, NY, USA)
- Age at study initiation: 6 weeks
- Assigned to test groups randomly
- Housing: individually
- Diet (ad libitum): NIH-07 Open Formula Diet (Zeigler Brothers, Inc.,Gardners, PA) in pellet form
- Water (e.g. ad libitum): tap water
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 15
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Concentration of test material in vehicle: 400-1000 mg/kg bw dissolved in 0.4 mL - Details on exposure:
- No data
- Duration of treatment / exposure:
- 3 injections within 3 days
- Frequency of treatment:
- daily
- Post exposure period:
- Sacrifice 24 h after last exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 400, 600, 800, 1000 mg/kg bw/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Route of administration: i.p.
- Doses / concentrations: 25 mg/kg
Examinations
- Tissues and cell types examined:
- Polychromatic erythrocytes from femur bone marrow
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION: Air-dried smears were fixed and stained (no further details)
METHOD OF ANALYSIS: 2000 polychromatic erythrocytes were scored from in each animal - Evaluation criteria:
- A trial was considered positive when p-value of trend test was <= 0.025 or a single result had a p-value <= 0.025, divided by number of exposure groups
The final call of a positive result was determined considering the results of statistical analysis, reproducibility and magnitude of effects - Statistics:
- The one-tailed Cochran-Armitage test was used to analyse trends over exposure groups. Excess binominal variation was tested with a binominal dispersion test and if positive, the Cochran-Armitage test was adjusted upwards in proportion to the excess variation
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
The mean numbers of micronucleated polychromatic erythrocytes per 1000 were:
corn oil, 400, 600, 800 and 1000 mg/kg bw groups: 1.1 +/- 0.29, 1.2 +/-0.41, 1.2 +/-0.56, 0.5 +/-0.22 and 1.5 +/-0.41
positive control: 8.4 +/-0.24
All results are based on the mean of 5 animals, except 1000 mg/kg: 4 animals
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of this study the test substance did not induce micronucleus formation in vivo. - Executive summary:
An in vivo micronucleus test in male mice (5 per dose) was performed with intraperitoneal application (3 exposures on 3 consecutive days) with the test substance in corn oil at doses of 0, 400, 600, 800 and 1000 mg/kg bw/day. Cyclophosphamide served as positive control. 24 hours after the third injection, the mice were sacrificed and smears of femur bone marrow cells were prepared, fixed and stained. 2000 polychromatic erythrocytes were scored for frequency of micronucleated cells in each of 5 mice at each of 4 doses. No increase in micronucleated polychromatic erythrocytes could be observed in the treated groups. The positive control showed a mutagenic response, thus confirming the validity of this study.
Under the conditions of this study the test substance did not induce micronucleus formation in vivo.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.