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EC number: 206-007-7 | CAS number: 286-20-4
- 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

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with generally accepted scientific principles, with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- publication
- Title:
- Absorption, Disposition Kinetics, and Metabolic Pathways of Cyclohexene oxide in the Male Fischer 344 Rat and Female B6C3F1 Mouse
- Author:
- Sauer J M, Bao J, Smith R L, McClure T D, Mayersohn M, Pillai U, Cunningham M L & Spies I G
- Year:
- 1 997
- Bibliographic source:
- Drug Metabolism and Disposition, 25: 3 371-378
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of rats and mice received doses of test material, orally by gavage, five days per week for a period of 28 days. Animals were treated with 100, 50, 25, 12.5, 6.25 and 0 (vehicle control) mg/kg test material. Animals were weighed weekly and following sacrifice organ weights were determined. Histopathological evaluation was performed on the heart, ovary and forestomach since they demonstrated possible lesions of interest at gross pathology.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1,2-epoxycyclohexane
- EC Number:
- 206-007-7
- EC Name:
- 1,2-epoxycyclohexane
- Cas Number:
- 286-20-4
- Molecular formula:
- C6H10O
- IUPAC Name:
- 7-oxabicyclo[4.1.0]heptane
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): cyclohexene oxide
Constituent 1
Test animals
- Species:
- other: rats & mice
- Strain:
- other: F-344 rats and B6C3F1 mice
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- FEMALE RATS F-344
- Housed in groups of 5 per cage.
- Source: Hilltop Lab Animals, Inc. Scottsdale, PA, USA
MALE AND FEMALE MICE B6C3F1
-Males housed individually and females in groups of 5 per cage.
- Source: Harlan Sprague-Dawley, Inc. Indianapolis, IN, USA.
TEST ANIMALS
- Diet (e.g. ad libitum): Teklad 4% Mouse-rat diet, Teklad, Madison, WI, USA. ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 14 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled.
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hr dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% methyl cellulose.
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: dosing solutions were prepared every 2 weeks
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Performed by capillary GC and found to be within 10% of the target concentration.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Treatment performed performed 5 days a week. Treatment was not performed on weekends or holidays, however animals were dosed at least 2 consecutive days before the terminal sacrifice.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 50, 25, 12.5 and 6.25 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 animals per sex per species per dose.
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- - Animals were weighted on the first day of administration, once a week and again at sacrifice.
- Sacrifice and pathology:
- - Post mortem the following organs were weighed for all animals; liver, thymus, right kidney, right testicle, heart and lungs.
- Histopathological evaluation was performed on the following organs; heart, ovary and forestomach.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- see the field " details on results".
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- Organ weight: A non-significant gain in lung weight was observed.
Lesions: some lesions were noted, however they were not thought to be related to treatment with test material.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects were observed at this dose level.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1. Weight gain and relative organ weights for rats and mice after oral exposure to 100 mg/kg of Test Material
Test Animal | Body weight | Organ Weights % of control | |||
% of control | Liver | Heart | Kidney | Lung | |
Rats F-344 | |||||
Male | 102 | 106 ± 3 | 105 ± 3 | 100 ± 1 | 97 ± 23 |
Female | 101 | 100 ± 6 | 102 ± 5 | 99 ± 6 | 128 ± 30 |
Mice B6C3F1 | |||||
Male | 98 | 108 ± 5 | 100 ± 4 | 106 ± 4 | 99 ± 7 |
Female | 99 | 96 ± 6 | 105 ± 6 | 103 ± 3 | 99 ± 6 |
Applicant's summary and conclusion
- Conclusions:
- The 28-day repeat dose oral toxicity study revealed no evidence of systemic toxicity up to 100 mg/kg. No potential target organs were identified and no sexual differences were seen. The test concludes that the test material is not readily absorbed without first being hydrolysed and conjugated, thus only a small amount of the test material will enter the blood, with less entering the tissue.
- Executive summary:
Rats and mice were exposed daily via oral gavage to the test material in varying concentrations. The study was continued for 28 days before termination.The 28-day repeat dose oral toxicity study revealed no evidence of systemic toxicity up to 100 mg/kg. No potential target organs were identified and no sexual differences were seen. The test concludes that the test material is not readily absorbed without first being hydrolysed and conjugated, thus only a small amount of the test material will enter the blood, with less entering the tissue.
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