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Toxicological information

Acute Toxicity: oral

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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:
1983
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

Constituent 1
Chemical structure
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
Constituent 2
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%

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:
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 the test appeared normal after 5  
days at the latest.
Body weight:
Increase of body weight was practically unaffected by the treatment.
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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