Registration Dossier
Registration Dossier
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EC number: 213-243-4 | CAS number: 931-87-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-04-11 to 1983-04-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- (Z)-cyclooctene
- EC Number:
- 213-243-4
- EC Name:
- (Z)-cyclooctene
- Cas Number:
- 931-87-3
- Molecular formula:
- C8H14
- IUPAC Name:
- (Z)-cyclooctene
- Details on test material:
- Cyclooctene of Hüls AG; Purity: 92.7 %
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: males mean 269 g, females mean 146 g
- Fasting period before study: 16 hours
- Diet: Sniff R 10 complete feed for rats, ad libitum
- Water: ad libitum
- Acclimation period: 4 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 1 °C
- Humidity (%): 60 % +/- 5%
- Air changes (per hr): 15 times/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark rythm
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- paraffin oil
- Details on oral exposure:
- ADMINISTRATION:
- Doses per time period: single dose (gavage)
- Volume administered or concentration: 10 ml/kg bw
- Post dose observation period: 14 days
- Controls: no - Doses:
- 3160; 3980; 5010; 6310 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Body weights: before, and 1, 7, 14 days post dosing
- Clinical signs and mortality: within 6 hours after dosing, thereafter daily
- Necropsy: 2 males and 2 females per dose (macroscopic), no further details - Statistics:
- LD50 is determined according to Litchfield and Wilcoxon with 95% confidence limits
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 550 mg/kg bw
- Mortality:
- - Number of deaths at each dose:
3160 mg/kg bw: no deaths
3980 mg/kg bw: 3 males, 2 females dead within 96 hours
5010 mg/kg bw: 4 males, 3 females dead within 77 hours
6310 mg/kg bw: 5 males, 4 females dead within 96 hours
LD50 = 4550 (4099-5051) mg/kg bw - Clinical signs:
- other: CLINICAL SIGNS: The signs of toxicity observed about 90 minutes after application were ruffled fur, ataxia, prone position, crouched posture, staggering gait, agitation, spasms, tremor and sedation. With the animals surviving the treatment, the findin
- Gross pathology:
- NECROPSY FINDINGS: Dissection post mortem revealed redness of the gastro-intestinal mucosa and a deep-red or grey discoloration of the lungs.
Among the animals surviving the treatment, at the end of the period of observation 2 animals from the 3980 mg/kg bw dose group showed
erythema of the small intestinal mucosa and fusion of organs in the abdominal cavity, and one animal of the highest dose group showed fluid
accumulation in the fallopian tube. In all other cases, dissection revealed no organ findings.
Any other information on results incl. tables
no further information
Applicant's summary and conclusion
- Conclusions:
- In an acute oral toxicity study, groups of fasted rats, (5/sex/dose) were given a single oral dose (gavage) of Cyclooctene (10.0 mL/kg bw dilution in paraffine) and were observed for 14 days. Oral LD50 was 4550 mg/kg bw.
- Executive summary:
In an acute oral toxicity study, groups of fasted rats, (5/sex/dose) were given a single oral dose (gavage) of Cyclooctene (10.0 mL/kg bw dilution in paraffine) and were observed for 14 days. Oral LD50 was 4550 mg/kg bw. The signs of toxicity observed about 90 minutes after application were ruffled fur, ataxia, prone position, crouched posture, staggering gait, agitation, spasms, tremor and sedation. With the animals surviving the treatment, the findings had disappeared after nine days at the latest. Dissection post mortem revealed redness of the gastro-intestinal mucosa and a deep-red or grey discoloration of the lungs.
Among the animals surviving the treatment, at the end of the period of observation 2 animals from the 3980 mg/kg bw dose group showed erythema of the small intestinal mucosa and fusion of organs in the abdominal cavity, and one animal of the highest dose group showed fluid accumulation in the fallopian tube. In all other cases, dissection revealed no organ findings
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