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EC number: 202-848-9 | CAS number: 100-40-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-09-27 to 1985-10-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
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:
- 4-vinylcyclohexene of Hüls AG, purity > 99 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Strain: Bor: WISW (SPF TNO)
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation: 5 males mean 242 g, 5 females mean 149 g
- Controls: no
Environmental conditions: - Feed: R 10 complete feed for rats (Ssniff, Soest; Germany);
- Water: tap water ad libitum
- Room temperature: 20°C (+/- 1°C)
- Humidity: 60% (+/- 5%)
- Air change: 15 times per hour; illumination: 12 hour light/dark rhythm
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: no vehicle
- Details on oral exposure:
- ADMINISTRATION:
- Doses per time period: single dose (gavage) of undiluted substance after 16 h of fasting
- Volume administered or concentration: 6.03 - 9.55 ml/kg bw - Doses:
- 5010; 6310; 7940 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- ADMINISTRATION:
- Post dose observation period: 14 days
EXAMINATIONS:
- Body weights: before, and 1, 7, 14 days post dosing
- Clinical signs and mortality: within 6 hours after dosing, thereafter daily
- Necropsy: all animals (macroscopic), no further details - Statistics:
- means of body weight and LD 50 according to Litchfield and Wilcoxon (1949), J. Pharmacol. Exp. Ther. 96, 99
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 6 300 mg/kg bw
- 95% CL:
- 5 040 - 7 875
- Mortality:
- MORTALITY:
- Number of deaths at each dose:
5010 mg/kg bw: 3 males, 1 female dead within 14 days
6310 mg/kg bw: 4 males, 0 females dead within 5 days
7940 mg/kg bw: 4 males, 3 females dead within 7 days
LD50 = 6300 (5040-7875) mg/kg bw - Clinical signs:
- other: CLINICAL SIGNS: - 1 hour after treatment: piloerection, increased motility when touched - later: sedation, ataxia, staggering, squatting or abdominal position, tremor, hypothermia, loss of weight, halting motion, sanguineous orbital margins, blood
- Gross pathology:
- NECROPSY FINDINGS:
- animals that died during the study: hyperemia and (sometimes) swelling in the mucosa of stomach and small intestine (several animals); swelling
and discoloration of kidneys, hyperemia of peritoneum and mucosa of the bladder (sporadic)
- terminal necropsy: partial hyperemia of the small intestine mucosa (2 animals), swelling of the forestomach mucosa (5 animals), fusion of stomach and liver with peritoneum and diaphragm (1 animal) - Other findings:
- no other findings
Any other information on results incl. tables
no other results
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU Directive 67/548/EEC
- Conclusions:
- In a determination of the acute oral toxicity on male and female rats it was found that the LD50 of the test item 4-vinylcyclohexene is 6300 mg/kg of
body weight. Under the conditions of this study the acute toxicity of 4-vinylcyclohexene afer oral application in rats is very low. - Executive summary:
In a determination of the acute oral toxicity on male and female rats it was found that the LD50 of the test item 4-vinylcyclohexene is 6300 mg/kg of body weight. The treated animals showed signs of toxicity during the 14 day observation period. Body weight gain was transiently inhibited significantly. Animals that died during the study showed hyperemia and (sometimes) swelling in the mucosa of stomach and small intestine (several animals); swelling and discoloration of kidneys, hyperemia of peritoneum and mucosa of the bladder (sporadic). Dissection at the end of the experiment revealed partial hyperemia of the small intestine mucosa (2 animals), swelling of the forestomach mucosa (5 animals), fusion of stomach and liver with peritoneum and diaphragm (1 animal). Under the conditions of this study the acute toxicity of 4-vinylcyclohexene afer oral application in rats is very low.
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