Registration Dossier
Registration Dossier
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EC number: 202-848-9 | CAS number: 100-40-3
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- 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
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
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:
- stock solution of the substance containing 0.01% butylated hydroxytoluene
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- oral intubation
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 100, 200, 400, 800 mg/kg/day
Basis:
no data
- No. of animals per sex per dose:
- 10 male and 10 female rats per dose
- Control animals:
- other: yes; 0 mg/kg/day of test substance
- Details on study design:
- Range finder study was conducted before:
- duration: 14 days
- doses: 0, 300, 600, 1250, 2500, 5000 mg/kg/day
- 5 males and 5 females per dose
Examinations
- Observations and examinations performed and frequency:
- no data
- Sacrifice and pathology:
- no data
- Other examinations:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- mortality: observed in the 14 day range finder (all animals killed at doses of 1250, 2500 and 5000 mg/kg/day; not described for main study; clinical signs: central nervous system depression, tremors and gastrointestinal distress in the range finder study
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- mortality: observed in the 14 day range finder (all animals killed at doses of 1250, 2500 and 5000 mg/kg/day; not described for main study; clinical signs: central nervous system depression, tremors and gastrointestinal distress in the range finder study
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- body weight gain depression in main study
- Gross pathological findings:
- not specified
- Description (incidence and severity):
- in range finder study no compound related gross changes were observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- hyaline droplet degeneration of kidney proximal convoluted tubules in males inmain study; in range finder study no compound related histologic changes were observed
- Details on results:
- body weight reduction : male: doses 400 and 800 mg/kg; female dose 800 mg/kg
histopathology: males dose related hyaline droplets in renal tubules; females: no compound related changes
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
