Registration Dossier
Registration Dossier
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EC number: 202-848-9 | CAS number: 100-40-3
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- other: publication
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: secondary literature, no details
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Type of method:
- in vivo
Test material
- Reference substance name:
- 4-vinylcyclohexene
- EC Number:
- 202-848-9
- EC Name:
- 4-vinylcyclohexene
- Cas Number:
- 100-40-3
- Molecular formula:
- C8H12
- IUPAC Name:
- 4-ethenylcyclohex-1-ene
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- other: mouse and rat
- Strain:
- other: B6C3F1 mice and F344 rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 30 days
- Frequency of treatment:
- daily
- Duration of test:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10-800 mg/kg/day
Basis:
no data
- No. of animals per sex per dose:
- no data
- Details on study design:
- VCH and epoxide metabolites injected; some animals pretreated with chloramphenicol or phenobarbital
- Statistics:
- no data
Results and discussion
Observed effects
-rats: 30 daily i.p. injections (800 mg/kg) of VCH failed to cause detectable ovotoxicity
-mice pretreated with chloramphenicol:69% inhibition of VCH epoxidation and protected mice from ovotoxocity.
- VCH epoxidation increased in phenobarbital pre-treated mice
-increasing VCH dose led to increase of circulating VCH epoxide (mice)
Applicant's summary and conclusion
- Conclusions:
- -VCH diepoxide is the most potent ovotoxic substance
- lack of ovotoxicity in VCH treated rats compared to mice because of slower rates of VCH biotransformation to epoxides and because of 20 fold higher rate of epoxide detoxification
- female B6C3F1 mouse : expression of P450IIA and P450IIB; female F344 rat: lack of related P450IIA mouse isoform and very low amounts of P450IIB
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