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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-03-14 to 1989-04-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test

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:
Test substance: cyclododecane of Hüls AG, purity 99.7 %; impurities: 0.01 % cyclododecene, 0.04 % butyl cyclododecane

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: Dunkin-Hartley (bor: DHPW)
- Sex: female
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation:    mean 296 g (Treated); 309 g (control)
- Controls: 10 animals; vehicle treatment
- Environmental conditions:
- feed: G4 diet for guinea pigs (Ssniff; Soest, Germany)
- water: tap water ad libitum
- room temperature: 20°C (+/- 1°C)
- humidity: 60% (+/- 5%)
- air change: 15 times/hour
- light-dark rhythm: 12 hours light/dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: corn oil
Concentration / amount:
1st application: Induction 10 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: corn oil
Concentration / amount:
1st application: Induction 10 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
No. of animals per dose:
19 test
10 control
Details on study design:
ADMINISTRATION/EXPOSURE 
- Preparation of test substance for induction: dissolved at 50-80 degree C
- Induction schedule: intracutaneous treamtent followed after one week by  48 hour patch test
- Challenge schedule: 2 weeks after end of induction patch treatment for  24 hours; readings 24 and 48 hours after removal of patch
- Rechallenge: no
- Positive control: no
Challenge controls:
Treatment: vehicle
Positive control substance(s):
not required
Remarks:
not required by 1981 version of Test Guideline

Results and discussion

Positive control results:
not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 % v/v
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % v/v. No with. + reactions: 0.0. Total no. in groups: 19.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 % v/v
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % v/v. No with. + reactions: 0.0. Total no. in groups: 19.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 % v/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 % v/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 % v/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 % v/v. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

- In general treatment with the test substance cyclododecane had no influence on body weights in this study - reddening and swelling as well as inflammation, necroses and encrustation on FCA treated injection sites in test and control animals

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this guinea pig maximization test, the test item cyclododecane showed no dermal sensitization in female guinea pigs.
Executive summary:

In a guinea pig maximization test performed with the test item cyclododecane, after intracutane and epidermal inductions and 24 hours as well as 48 hours after epidermal challenge none of the 19 animals examined in this study, showed positive response regarding dermal sensitization. Under the conditions of this guinea pig maximization test, the test item cyclododecane showed no dermal sensitization in female guinea pigs.