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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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: subchronic toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Equivalent to guidellne with limited documentation
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
- GLP compliance:
- not specified
- Limit test:
- no
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:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): cyclohexanone oxime
- Analytical purity: 99,5%
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: Charles
River Breeding Laboratories (Kingston, NY, USA)
- Housing: individually
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 5
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- not performed
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days (main study)
- Frequency of treatment:
- 5 days/week
- Details on study schedule:
- subchronic toxicity study
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.25, 2.5 or 25 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 20 (main study)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- subchronic toxicity study
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- The complete range of observations and examinations is reported in chapter 7.5.1
- Oestrous cyclicity (parental animals):
- not examined
- Sperm parameters (parental animals):
- not examined
- Litter observations:
- not examined
- Postmortem examinations (parental animals):
- HISTOPATHOLOGY / ORGAN WEIGTHS
Testes and ovaries were weighed. Testes with epididymis, prostate, ovaries and uterus were examined microscopically
The complete range of observations and examinations is reported in chapter 7.5.1 - Postmortem examinations (offspring):
- not examined
- Statistics:
- Continuous variables: Bartlett's homogeneity of variance, analysis of variance, and Duncan's multiple range test.
If Bartlett's test indicated heterogeneous variance or where data were ranked or suspected to be nonparametric, Kruskall-Wallis nonparametric analysis of variance and Wilcoxan rank sum tests were used. - Reproductive indices:
- not calculated
- Offspring viability indices:
- not calculated
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- on reproductive organs
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Details on results (P0)
Through the first 9 weeks of the study: Highest dose males: persistent red nasal discharge, chromodacryorrhea and swollen conjuntiva (also mid dose), the effects gradually subsided and had disappeared by the end of the study
Females after 2 weeks of exposure: chromodacryorrhea (high dose) and corneal opacity (high and mid dose), which both gradually subsided but persisted at study termination
Three females of the high dose died (additionally on female of low dose group due to dosing accident)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects observable in reproductive organs (testes with epididymis, prostate, ovaries, uterus)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
No effects were evident in reproductive organs of animals of both sexes
Applicant's summary and conclusion
- Conclusions:
- The reproductive organs were unaffected in this subchronic toxicity study
- Executive summary:
Groups of F-344 rats (20 per sex per dose) were treated by oral gavage with the test substance for 5 days/w for 90 days at doses of 0, 0.25, 2.5 or 25 mg/kg body weight. No histopathological alterations were observed in testes, uteri and ovaries. The main effect in this study was haematotoxicity (for a full description of study results see chapter 7.5.1).
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