Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
4-vinylcyclohexene of Hüls AG, purity > 99 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
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 in urine, diarrhea, and defense reaction when touched
- end of study: piloerection (6 animals), timid behavior (5 animals),  slight 
staggering and halting motion (1 high dose animal)
Body weight:
Body weight gain was transiently inhibited significantly.
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.