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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- No guideline available
- GLP compliance:
- not specified
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: unlabelled material from supplier recrystallised
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- [1-C14]-cyclohexanone oxime, specific activity 6.85 mCi per mmol
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
Administration / exposure
- Route of administration:
- other: exposure routes: oral, dermal and i.v
- Vehicle:
- other: oral exposure: water, dermal exposure: acetone
- Details on exposure:
- Dermal exposure: The interscapular region was clipped 24 h before exposure. The animals were anesthesised with ketamine and 30 mg/kg bw were applied at 0.2 mL/kg bw in a circular area of 1 cm2. The application site was covered with a perforated metal tissue capsule, glued directly to the skin. The aminals were kept individually in metabolism cages and sacrificed 24 h after exposure.
- Duration and frequency of treatment / exposure:
- single exposures: oral (gavage), dermal and i.v.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
#1) oral (gavage): 1, 10 or 30 mg/kg bw
#2) dermal (semiocclusive): 30 mg/kg bw
#3) i.v.: 1 mg/kg bw
- No. of animals per sex per dose / concentration:
- 3
- Control animals:
- no
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Oral exposure: nearly complete; Dermal exposure: about 5%
- Type:
- distribution
- Results:
- Throughout the whole body
- Type:
- metabolism
- Results:
- Cyclohexanone, cyclohexanol, cyclohexane-1,2-diol; alcohols glucuronidated
- Type:
- excretion
- Results:
- After orale exposure: nearly complete excretion after 24 h
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- #1: Based on the distribution and excretion data (see below), a nearly complete absorption can be assumed after oral exposure.
#2: Based on the distribution and excretion data (see below), a low absorption can be assumed after dermal exposure (4-5%). - Details on distribution in tissues:
- #1: Oral exposure (6 h after exposure): large mass compartiments such as muscle (12.6% of administered dose), skin (4.0%) and fat (2.9%) accounted for about 50% of the retained total radioactivity. The gastrointestinal tract (incl. contents), liver, kidney and blood also contained high concentrations. Brain, spleen, testes and lungs contained few radioactivity.
Oral exposure, 24 h after exposure: very low levels of radioactivity (2-3%) were retained in the tissues 24 hours after exposure.
#2: 24 h after dermal exposure, skin and muscle revealed the highest amounts of retained radioactivity (0.1% of admininstered dose each)
- Details on excretion:
- Oral exposure, within 6 h after dosing (only 30 mg/kg bw tested): 40% of the radioactivity was excreted in urine, 1% in feces.
Oral exposure, within 24 h after dosing (1-30 mg/kg bw): The majority of the radioactivity (68-87% of the dose) was excreted in the urine. Elimination in the feces accounted for 5-9% of the dose, 2% were expired as CO2 and very low levels of radioactivity (2-3%) were retained in the tissues 24 hours after exposure.
Dermal exposure (within 24 h after exposure start): 3.9% was excreted in urine, < 0.1% in feces, 4.5% remained at the application site and 0.4% in tissues.
23% volatilised within 3-5 min after application
Toxicokinetic parametersopen allclose all
- Test no.:
- #3
- Toxicokinetic parameters:
- other: volume of distribution: 0.65 L/kg
- Test no.:
- #3
- Toxicokinetic parameters:
- half-life 1st: in plasma: 1.6 min
- Test no.:
- #3
- Toxicokinetic parameters:
- half-life 2nd: in plasma: 18.2 min
- Test no.:
- #3
- Toxicokinetic parameters:
- AUC: 32,100,000 min x µg/L
- Test no.:
- #3
- Toxicokinetic parameters:
- other: clearance: 0.036 L/Kg/min
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Three main metabolites were identified in urine of treated animals: the monoglucuronides of cis- and trans-cyclohexane-1,2-diol, and the glucuronide of cyclohexanol.
In vitro incubations of the test substance with rat liver S9 fraction contained cyclohexanone and cylohexanol, cis- and trans-cyclohexane-1,2-diol
Any other information on results incl. tables
Distribution and elimination after dermal application were not different from those observed after oral administration.
Based on the identidied metabolites, the authors proposed the following metabolism scheme:
Cyclohexanone oxime is cleaved in the initial step to cyclohexanone and hydroxylamine. Cyclohexanone is further metabolised to cyclohexanol and cyclohexane-1,2-diols, which were glucuronidated and excreted in urine.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Under the conditions of this study no bioaccumulation has to be expected - Executive summary:
Rats were exposed orally to cyclohexanone oxime in doses of 1 to 30 mg/kg bw. The substance was distributed throughout the whole body. Within 24 h 68 -87% of the administered dose was excreted in the urine, elimination in the feces accounted for 5-9% of the dose, 2% were expired as CO2 and very low levels of radioactivity (2-3%) were retained in the tissues 24 hours after exposure. The main metabolites in urine were monoglucuronides of cis- and trans-cyclohexane-1,2-diol, and the glucuronide of cyclohexanol. It can be assumed that absorption after oral exposure is nearly complete.
Dermal exposure: within 24 h after exposure start, 3.9% was excreted in urine and 0.1% in feces, 4.5% remained at the application site and 23% had volatilised within 3-5 min after application. Therefore the systemic uptake after dermal exposure is in the range of 5% of the administered dose.
The plasma half-life after i.v. exposure was 1.6 min (first phase) and 18.2 min (second phase).
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