Registration Dossier
Registration Dossier
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EC number: 216-835-0 | CAS number: 1678-91-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- The Metabolism of Ethylcyclohexane in Fischer 344 Rats.
- Author:
- M. P. Serve et al.
- Year:
- 1 990
- Bibliographic source:
- Chemosphere, Vol.20, No.1-2, p. 43-49 (1990)
Materials and methods
- Objective of study:
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Urinary metabolism was studied in rats by GC-MS.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethylcyclohexane
- EC Number:
- 216-835-0
- EC Name:
- Ethylcyclohexane
- Cas Number:
- 1678-91-7
- Molecular formula:
- C8H16
- IUPAC Name:
- ethylcyclohexane
- Test material form:
- liquid: volatile
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Weight: 307 ± 10 g
Feed: ad libitum
Drinking water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- once daily
Doses / concentrations
- Dose / conc.:
- 800 mg/kg bw/day (nominal)
- No. of animals per sex per dose / concentration:
- 8 treated, 6 control
- Control animals:
- other: yes, water
- Positive control reference chemical:
- not required
- Details on dosing and sampling:
- Following the 14-day exposure period the rats were sacrified and histopathological examination was performed.
During the first 48 hours the rats were placed in metabolism cages and the urine collected. The samples were hydrolyzed and analysed by GC-MS.
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- 2c-hydroxy-4-ethylcyclohexanol, 2c-hydroxy-4t-ethylcyclohexanol, 2-hydroxy-4-ethylcyclohexane, trans-4-ethylcyclohexane, 2t-hydroxy-4t-ethylcyclohexanol, 2t-hydroxy-4c-ethylcyclohexanol
Applicant's summary and conclusion
- Conclusions:
- The urinary metabolism of ECH administered by gavage was investigated in Fischer 344 rats.
The following urinary metabolites were identified: 2c-hydroxy-4-ethylcyclohexanol, 2c-hydroxy-4t-ethylcyclohexanol, 2-hydroxy-4-ethylcyclohexane, trans-4-ethylcyclohexane, 2t-hydroxy-4t-ethylcyclohexanol, 2t-hydroxy-4c-ethylcyclohexanol.
ECH did not undergo metabolism on the alkyl chain. Metabolism of the ring structure (dihydroxylation) was strongly favoured. Histopathological results revealed mild to moderate renal damage. - Executive summary:
The urinary metabolism of ECH administered by gavage was investigated in Fischer 344 rats.
The following urinary metabolites were identified: 2c-hydroxy-4-ethylcyclohexanol, 2c-hydroxy-4t-ethylcyclohexanol, 2-hydroxy-4-ethylcyclohexane, trans-4-ethylcyclohexane, 2t-hydroxy-4t-ethylcyclohexanol, 2t-hydroxy-4c-ethylcyclohexanol.
ECH did not undergo metabolism on the alkyl chain. Metabolism of the ring structure (dihydroxylation) was strongly favoured. Histopathological results revealed mild to moderate renal damage.
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