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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:
1984-08-01 to 1984-08-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Cyclododecane of Hüls AG, purity ca. 99.5 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ORGANISMS: 
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation: males 125 g, females 107 g (mean)
- Fasting period before study: 16 hours
- Diet: ad libitum, Sniff
- Water: ad libitum, tab water
- Acclimation period: 4 -8 days
- Temperature (°C): 20 °C +/- 1° C
- Humidity (%): 60 % +/- 5 %
- Air changes (per hr): 15 times
- Photoperiod (hrs dark / hrs ligh: 12 hours light/ 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: corn oil
Details on oral exposure:
ADMINISTRATION: 
- Doses: 10000 mg/kg b.w.
- Doses per time period: 2 applications separated by 2 hours;   temperature of applied substance 40-45 degree C
- Volume administered or concentration: 20 ml/kg
Doses:
10000 mg/kg b.w.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
EXAMINATIONS:
- Post dose observation period: 14 days
- Body weights: before and 1 , 7, and 14 days post dosing
- Clinical signs: observed 6 hours after treatment and thereafter daily
- Macroscopic examination at necropsy
Statistics:
- LD50 calculation: according to Litchfield and Wilcoxon, in connection  with the Gauß integral

Results and discussion

Preliminary study:
preliminary test was conducted with reduced number of animals but no data available
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
MORTALITY: 
- Time of death: within 7 hours
- Number of deaths at each dose: 2/5 females, no males 
Clinical signs:
CLINICAL SIGNS: 1/2 - 2 hours post application, animals revealed  pilo-erection and diuresis, later accompanied by tremor, convulsions,  diarrhoea, 
blood from eyes and noses, lying on back, side, or in prone  position, sounds in case of contact, Straub reaction and walking on toes.  Symptoms of 
toxicity were visible for up to 72 hours.
Body weight:
- Body weights: not affected
Gross pathology:
NECROPSY FINDINGS: Pale mucosa of stomach and gastro-intestinal tract,  bright discoloration of kidney and spleen, dark spots and small blood 
vessels on the liver were observed in animals that died during the study.  Necroscopy at the end of the study revealed hyperemia of the intestinal  
mucosa and in one animal of the forestomach. In some animals, liver and  kidneys were brighter or covered with bright petechiae.
Other findings:
no other findings

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulation EC No 1272/2008 (CLP)
Conclusions:
Under the conditions of this study the acute toxicity of Cyclododecane after oral application in rats is very low.
Executive summary:

The test item Cyclododecane was applied two times, separated by 2 hours, to 5 male and 5 female Wistar rats in dose of 10.000 mg/kg bw, volume of administration was 20 ml/kg. The observation period was 14 days. Two female rats died within 7 hours after oral application of the test item. Pale mucosa of stomach and gastro-intestinal tract, bright discoloration of kidney and spleen,dark spots and small blood vessels on the liver were observed in animals that  died during the study. 1/2 - 2 hours post application, animals revealed  pilo-erection and diuresis, later accompanied by tremor,  convulsions,  diarrhoea, blood from eyes and noses, lying on back, side, or in prone  position, sounds in case of contact,  Straub reaction and walking on toes.  Symptoms of toxicity were visible for up to 72 hours. Under the conditions of this study the acute toxicity of Cyclododecane after oral application in rats is very low.