Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Study period:
09/1964
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964

Materials and methods

Test guideline
Qualifier:
no guideline followed
Deviations:
not applicable
Principles of method if other than guideline:
Method: other: Farbenfabriken Bayer AG; details described in sections "Test animals" and "Administration/Exposure"
GLP compliance:
no
Test type:
other: description of inhalative tests see under "Administration/Exposure"
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclododecane
EC Number:
206-033-9
EC Name:
Cyclododecane
Cas Number:
294-62-2
Molecular formula:
C12H24
IUPAC Name:
cyclododecane
Details on test material:
IUCLID4 Test substance: "pure" cyclododecane, no further information

Test animals

Species:
other: 20 mice, 10 rats, 2 guinea pigs, 1 rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: Test 1: methylene chlorid : alcohol (1:1); Test 2: no vehicle; Test 3: no vehicle
Details on inhalation exposure:
TEST 1: 
In a 2 m3 exposure chamber, 20 ml of a 10 % solution of  cyclododecane in methylene chloride/alcohol (1:1) was sprayed at intervals of 1/2 hour in  the presence of the test animals. The mean concentration was 1.49 mg/l  (indirect determination with "oil  Red"). Duration of the test was 4 hours.

TEST 2: 
In a 400 l exposure chamber, 10 g of pure cyclododecane were  heated constantly at 100 degree C in the presence of the test animals,  which caused sublimation of all 10 g of the test substance in the course  of the exposure period (4 hours).

TEST 3: 
In a 400 l exposure chamber, on each of 5 consecutive days 4 g of  pure cyclododecane were sublimed by heating at 100 degree C in the  presence of the test animals. The post exposure observation period was 14  days.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
only done for Test 2: mean concentration: 1.49 mg/l (indirect determination with "oil red")
Duration of exposure:
4 h
Remarks on duration:
4 hours in Test 1+2; 4 hours/day on 5 consecutive days in Test 3
Concentrations:
see in section "Details on inhalation exposure"
No. of animals per sex per dose:
1 rabbit, 2 guinea pigs, 10 rats, 20 mice per test
Control animals:
no
Details on study design:
see in section "Details on inhalation exposure"
Statistics:
no data

Results and discussion

Preliminary study:
no data
Mortality:
No mortalities described in tests 1, 2 and 3.
Clinical signs:
other: TEST 1: The animals showed some restlessness and irritation of the mucosa  during exposure but recovered soon afterwards. TEST 2: The animals showed minor impairment of general condition but  recovered soon after the end of exposure. TEST 3: No symptoms
Body weight:
not reported
Gross pathology:
no data
Other findings:
no other findings

Any other information on results incl. tables

RS-Freetext:
TEST 1: The animals showed some restlessness and irritation of the mucosa  during exposure but recovered soon afterwards.
TEST 2: The animals showed minor impairment of general condition but  recovered soon after the end of exposure.
TEST 3: No symptoms of intoxication could be observed.

Applicant's summary and conclusion

Conclusions:
After inhalation of cyclododecane for 4 hours (Test 1 and Test2) the examined animals (1 rabbit, 2 guinea pigs, 10 rats, 20 mice) showed only transient mild clinical signs (e.g. restlessness, irritation of mucosa) which recovered soon after end of exposure. No symptoms of intoxication could be observed in Test 3, where the animals were exposed to cyclododecane via inhalation for 5 consecutive days (4 hours/day). No mortalities were described for tests 1, 2 and 3.
Executive summary:

TEST 1: 

In a 2 m3 exposure chamber, 20 ml of a 10 % solution of  cyclododecane in methylene chloride/alcohol (1:1) was sprayed at intervals of 1/2 hour in  the presence of the test animals (1 rabbit, 2 guinea pigs, 10 rats, 20 mice).

 The mean concentration was 1.49 mg/l  (indirect determination with "oil  Red"). Duration of the test was 4 hours. The animals showed some restlessness and irritation of the mucosa  during exposure but recovered soon afterwards.

 

TEST 2: 

In a 400 l exposure chamber, 10 g of pure cyclododecane were  heated constantly at 100 degree C in the presence of the test animals (animals: see test 1),  which caused sublimation of all 10 g of the test substance in the course  of the exposure period (4hours). The animals showed minor impairment of general condition but  recovered soon after the end of exposure.

 

TEST 3: 

In a 400 l exposure chamber, on each of 5 consecutive days 4 g of  pure cyclododecane were sublimed by heating at 100 degree C in the  presence of the test animals (animals: see test 1). The post exposure observation period was 14  days.

No symptoms of intoxication could be observed.