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Diss Factsheets
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EC number: 292-697-5 | CAS number: 90989-41-6
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, non-guideline animal experimental study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rats were exposed to cyclohexane by the dermal and intravenous routes, exposure was compared.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cyclohexane
- EC Number:
- 203-806-2
- EC Name:
- Cyclohexane
- Cas Number:
- 110-82-7
- Molecular formula:
- C6H12
- IUPAC Name:
- cyclohexane
- Details on test material:
- Non-radiolabelled
- Name of test material (as cited in study report): cyclohexane
- Analytical purity: Analysed but not reported
- Supplied by: DuPont, Newark, DE, USA.
- Lot/batch No.: H-21174, H-21,174
- Storage condition of test material: Room temperature
Radiolabelled
- Supplied by: Wizard Laboratories, Inc., West Sacramento, CA, USA.
- Chemical purity: 99.5%
- Physical state: liquid
- Lot/batch No.: 950712
- Radiochemical purity (if radiolabelling): >=98%
- Specific activity (if radiolabelling): 10.46 mCi/mmol
- Storage condition of test material: Approximately -20C
Constituent 1
- Radiolabelling:
- yes
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 Laboratories, Inc., Raleigh, NC and Kingston, NY, USA.
- Age at study initiation: Males 10-11 weeks, females 10-12 weeks
- Weight at study initiation: Males 211-247 g, females 146-168 g
- Housing during the metabolism experiments: Individually in all glass Roth-Type metabolism chambers which provided for separate collection of urine, faeces, and expired volatiles. Animals were acclimated for a minimum of 24 h prior to the initiation of the study.
- Diet: Purina Certified Rodent Chow (#5002) ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18-26°C
- Humidity: 40-70 %
- Air changes: 10-15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Intralipid for IV, no vehicle for dermal
- Duration of exposure:
- Dermal exposure for 6 h
- Doses:
- Nominal doses: Dermal exposure - 1 mg/cm2 (approximately 6 mg/rat) and 100 mg/cm2 (approximately 600 mg/rat); IV bolus - 10mg/kg
- No. of animals per group:
- IV bolus: 5/sex
Dermal: 6/sex - Control animals:
- no
- Details on study design:
- Intravenous administration:
Bolus injection into a lateral tail vein.
Dermal exposure:
The test site was clipped approximately 24 h prior to dosing and a non-absorptive containment appliance was bonded to the rat's skin using super glue. The dose was applied to the 6cm2 area of clipped skin within the containment appliance. At the end of the exposure period, the unabsorbed cyclohexane was recovered from the containment appliance.
Biological sampling:
Urine, faeces and exhaled organics were collected separately over timed intervals for up to 72 h after dosing and analysed for radioactivity. Blood samples were taken from a separate group of animals at intervals for determination of radioactivity. Following sacrifice, adipose samples were removed and the remaining carcass solubilised for determination of radioactivity. Additionally for the dermally exposed animals, the dose site skin was removed and solubilised and analysed for radioactivity.
Sample Analysis:
All samples were analysed for total radioactivity by liquid scintillation counting.
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- Dermal absorption
1mg/cm2: Male; 39%, Female; 60%
100mg/cm2: Male and female; 4% - Total recovery:
- 1mg/cm2: Male; 80±12%, Female; 82±16%
100mg/cm2: Male; 97±2, Female; 99±1%
Any other information on results incl. tables
Cyclohexane was rapidly excreted after either intravenous or dermal administration. Expired breath was the major route of excretion of radiolabel accounting for ca. 70% of the excreted radiolabel following intravenous administration of cyclohexane, ca. 78% of the excreted radiolabel following dermal exposure to cyclohexane at 1 mg/cm2, and ca. 57% of the excreted radiolabel following dermal exposure to cyclohexane at 100 mg/cm2. Urine was a lesser route of excretion of radiolabel, accounting for ca. 29% of the excreted radiolabel following intravenous administration of cyclohexane, ca. 20% of the excreted radiolabel following dermal exposure to cyclohexane at 1 mg/cm2, and ca. 40% of the excreted radiolabel following dermal exposure to cyclohexane at 100 mg/cm2. Essentially no radiolabel was excreted in faeces following either intravenous or dermal administration of [14C]cyclohexane.
Male rats and female rats absorbed approximately 39% and 60%, respectively, of the 1 mg/cm2dermal dose of cyclohexane. The average absorption rates of cyclohexane were 0.06 and 0.1 mg/cm2 of exposed skin/h for male rats and female rats, respectively. Exposure at this dose level was primarily to cyclohexane vapours. These values are averages of the absorption calculated by three different methods: total excretion and residual body burden of radiolabel following the dermal dose; relative urinary excretion of radiolabel following dermal and intravenous doses of [14C]cyclohexane; and relative AUCo for total radiolabel in blood following dermal and intravenous doses of [14C]cyclohexane.
Increase of the dermal dose by two orders of magnitude (from 1 to 100 mg/cm) produced only a ca. one order of magnitude increase in the rate of absorption of cyclohexane.
Both male rats and female rats absorbed approximately 4% of the 100 mg/cm2 dermal dose of cyclohexane. The average absorption rates of cyclohexane were 0.6 and 0.7 mg/cm2 of exposed skin/h for male rats and female rats, respectively. Exposure was primarily to cyclohexane liquid present as an "infinite dose". Values are averages calculated as described for the 1 mg/cm2 dermal dose.
The areas under the concentration of total radiolabel in blood vs. time curves AUC(0 - ∞) were similar for male and female rats following intravenous administration of [14C]cyclohexane. The AUC(0 - ∞) values following dermal exposure to cyclohexane were ca. 3 times greater for females than for males at the 1 mg/cm2 exposure level and ca. 2 times greater for females than for males at the 100 mg/cm2 exposure level. Thus there appear to be quantitative differences in the way dermally applied cyclohexane is handled by the two sexes.
Less than 0.1% of the dose remained in the carcass 72 h after dermal exposure to cyclohexane at 100 mg/cm2 and less than 0.4% of the dose remained in the carcass 72 h after dermal exposure to cyclohexane at 1 mg/cm2. Thus, neither cyclohexane nor its metabolites would be expected to accumulate after repeated exposure to cyclohexane.
Applicant's summary and conclusion
- Conclusions:
- Cyclohexane is rapidly excreted. Expired air is the major route of excretion, urinary excretion also occurs with essentially no radioactivity in faeces. Approximately 39 and 60% of a dermal dose of 1mg/cm2 cyclohexane (primarily vapour) were absorbed in male and female rats respectively; the corresponding value after a dermal dose of 100mg/cm2 (primarily liquid) was 4% for both sexes. AUC(0-∞) values for radioactivity in blood indicate a sex difference in systemic exposure following dermal exposure to cyclohexane.
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