Registration Dossier
Registration Dossier
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EC number: 225-533-8 | CAS number: 4904-61-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-11-29 to 1982-12-21
- 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:
- Cyclododeca-1,5,9-triene
- EC Number:
- 225-533-8
- EC Name:
- Cyclododeca-1,5,9-triene
- Cas Number:
- 4904-61-4
- Molecular formula:
- C12H18
- IUPAC Name:
- cyclododeca-1,5,9-triene
- Reference substance name:
- 1,5,9-cyclododecatriene
- IUPAC Name:
- 1,5,9-cyclododecatriene
- Details on test material:
- 1,5,9-cyclododecatriene of Hüls AG, purity > 99.5%
Constituent 1
Constituent 2
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: females mean 117 g, males mean 121 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:
- petrolatum
- Details on oral exposure:
- ADMINISTRATION:
- Doses: 1250, 2510, 3980, 4495, 5010 mg/kg
- Doses per time period: single dose
- Volume administered or concentration: 10 ml/kg
- Post dose observation period: 14 days - Doses:
- 1250; 3980; 4495; 5010 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Post dose observation period: 14 days
- Clinical signs and mortality: Up to 6 hours after treatment and daily thereafter
- Body weights: before treatment and on days 1, 7, 14
- Necropsy: Macroscopic in 4 animals per dose group (2 females, 2 males) - Statistics:
- Litchfield and Wilcoxon (1949), J. Pharmacol. Exp. Ther. 96, 99
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 400 mg/kg bw
- 95% CL:
- >= 4 150 - <= 4 664
- Mortality:
- MORTALITY:
- Number of deaths at each dose:
1250 mg/kg, 2510 mg/kg: 0/10
3980 mg/kg: 1 male, 3 females; within 6-48 hours
4495 mg/kg: 4 males, 4 females; within 24-36 hours
5010 mg/kg: all animals within 24 hours - Clinical signs:
- other: CLINICAL SIGNS: 30 minutes after application animals showed abnormal symptoms (restlessness, rough skin, decrease of responsiveness, hunched posture, diarrhoea, moderate to severe tremors, convulsions, sedation, prone position. Those animals surviving
- Gross pathology:
- NECROPSY FINDINGS: When submitted to autopsy, those animals which died during the test showed redness of the mucosa of the gut and stomach
and an accumulation of liquor. Animals which survived the study showed no pathological changes. - Other findings:
- no other findings
Any other information on results incl. tables
LD50 = 4400 (4150-4664) mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Regulation EC 1272/2008 (CLP)
- Conclusions:
- In a determination of the acute oral toxicity on male and female rats it was found that the LD50 of the test item 1,5,9-cyclododecatriene is
4400 mg/kg of body weight. Under the conditions of this study the acute toxicity of 1,5,9-cyclododecatriene 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 1,5,9-cyclododecatriene is 4400 mg/kg bw. 30minutes after application animals showed restlessness, rough skin, decrease of responsiveness, hunched posture, diarrhoea, moderate to severe tremors, convulsions, sedation, prone position. Those animals surviving the test appeared normal after 5 days at the latest. There was practically no influence on the increase in body weight. Dissection at the end of the experiment revealed redness of the mucosa of the gut and stomach and an accumulation of liquor. Animals which survived the study showed no pathological changes. Under the conditions of this study the acute toxicity of 1,5,9-cyclododecatriene afer oral application in rats is very low.
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