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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: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- publication
- Title:
- ABSORPTION, DISPOSITION KINETICS, AND METABOLIC PATHWAYS OFCYCLOHEXENE OXIDE IN THE MALE FISCHER 344 RAT AND FEMALE B6C3F1 MOUSE
- Author:
- Sauer JM et al.
- Year:
- 1 996
- 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:
- Peer-reviewed publication assessing the absorption, distribution, metabolism, and excretion of the test item.
- GLP compliance:
- not specified
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
Constituent 1
Test animals
- Species:
- other: Rat and mouse
- Details on species / strain selection:
- 6C3F1 Mice
Fischer 344 Rats - Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Male JVC F-344 rats were obtained from Hilltop Lab Animals, Inc. (Scottsdale, PA). Female
B6C3F1 mice were obtained from Harlan Sprague-Dawley, Inc. (Indianapolis, IN).
- Weight at study initiation: Rats (175-250 g), Mice (21-27 g)
- Housing: Nalgene metabolism cages
- Diet (e.g. ad libitum): Teklad 4% Mouse-Rat Diet, Teklad, Madison, WI) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Animals were acclimated for 5–7 days in a temperature-controlled 12-hr light/
dark cycle facility before any treatment.
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12-hr light/dark
Administration / exposure
- Vehicle:
- acetone
- Details on exposure:
- TEST MATERIAL
- Concentration (if solution): 60, 30, 15, 7.5, and 3.75 mg/kg)
- Constant volume or concentration used: yes
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Capillary GC, within 10% of the target concentration.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Each dose concentration remained constant, and the volume (2 ml/kg for rats, 0.5 ml/kg for mice) was adjusted weekly to maintain the appropriate mg/kg mean body weight exposure.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 3.75 mg/kg bw/day (nominal)
- Dose / conc.:
- 7.5 mg/kg bw/day (nominal)
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- Dose / conc.:
- 60 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- five animals per sex per species
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Animals were weighed on the first day of test item administration, once each week and at euthanasia. After euthanasia, organ weights (liver, thymus, right kidney, right testicle, heart, and lungs) were determined for all animals. Histopathological evaluation was performed on heart, ovary, forestomach
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, organ weights (liver, thymus, right kidney, right testicle, heart, and lungs) were determined for all animals
HISTOPATHOLOGY: Yes, heart, ovary, forestomach
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- 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:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Very few gross lesions were found at necropsy, and none were considered compound -related.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 60 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical signs
- dermal irritation
- gross pathology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- urinalysis
- Remarks on result:
- other:
- Remarks:
- The publication does not provide a NOEL, but no effects were observed in any of the parameters evaluated
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
Table 1. Weight gain and relative organ weights for rats and mice after dermal exposure to 60 mg/kg of Test Material
Test Animal |
Body weight |
Organ Weights % of control |
||||
% of control |
Liver |
Heart |
Kidney |
Lung |
||
Rats F-344 |
Male |
100 |
99 ± 5 |
104 ± 4 |
101 ± 3 |
99 ± 8 |
Female |
97 |
102 ± 4 |
99 ± 5 |
102 ± 3 |
95 ± 6 |
|
Mice B6C3F1 |
Male |
99 |
99 ± 4 |
105 ± 4 |
101 ± 6 |
85 ± 15 |
Female |
101 |
100 ± 4 |
97 ± 5 |
100 ± 5 |
100 ± 13 |
Applicant's summary and conclusion
- Conclusions:
- The test item showed no signs of toxicity at concentrations up to 60 mg/kg on the test organisms after 28 days of dermal exposure.
- Executive summary:
B6C3F1 Mice and Fischer 344 Rats were exposed topically to five concentrations of the test item and a vehicle control. The study was carried during 28 days. Regular wieghing of the organisms plus systemic and histological effects after the organisms were euthanised were recorded. No relevant effects were seen in any of the paramenters recorded, therefore, we can establish a NOEL of 60 mg/kg, the greatest concentration of test item used. These data are consistent with the demonstration that the test item is rapidly hydrolyzed and conjugated after both oral and dermal administrations.
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