Cyclododeca-1,5,9-triene

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-11-15 to 1988-12-09

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

Test material information

Constituent 1

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, produced October 1988.
Purity = 99.8 % (incl. 1 % trans-trans-trans-1,5,9-cyclododecatriene); 25 ppm 4-tert-butylpyrocatechol [98-29-3]

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:   test group mean 330 g, control group mean 333.5 g
- Number of animals: 20
- Controls: 10 animals; treatment: vehicle
- 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)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

corn oil

Induction 2

Concentration / amount:

1st application: Induction 10 % intracutaneous
2nd application: Induction 20 % occlusive epicutaneous
3rd application: Challenge 10 % occlusive epicutaneous

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

corn oil

Challenge 2

Concentration / amount:

1st application: Induction 10 % intracutaneous
2nd application: Induction 20 % occlusive epicutaneous
3rd application: Challenge 10 % occlusive epicutaneous

No. of animals per dose:

test group: 20
control group: 10

Details on study design:

ADMINISTRATION/EXPOSURE 
- Induction schedule: single intracutaneous treatment, 1 week later dermal induction; patch removed after 48 h 
- Challenge schedule: after 2 further weeks, occlusive epicutaneous,  removal of patch after 24 hours, readings after further 24 and 48 hours.
EXAMINATIONS
- Grading system: possible scores 0 - 3       
0 % of animals scored > 0: no sensitization  
1 -  8 % of animals scored > 0: very slight sensitization
 9 - 28 % of animals scored > 0: slight sensitization
29 - 64 % of animals scored > 0: distinct sensitization
65 - 80 % of animals scored > 0: severe sensitization
81 -100 % of animals scored > 0: extreme sensitization

Challenge controls:

vehicle

Positive control substance(s):

not required

Remarks:

not required by 1981 version of Test Guideline

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

10 % preparation of test item in corn oil

No. with + reactions:

2

Total no. in group:

20

Clinical observations:

see overall remarks (below)

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % preparation of test item in corn oil. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: see overall remarks (below).

Results 2

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

10 % preparation of test item in corn oil

No. with + reactions:

1

Total no. in group:

29

Clinical observations:

see overall remarks (below)

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % preparation of test item in corn oil. No with. + reactions: 1.0. Total no. in groups: 29.0. Clinical observations: see overall remarks (below).

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

10 % preparation of test item in corn oil

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

see overall remarks (below)

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 % preparation of test item in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: see overall remarks (below).

Results 4

Reading:

1st reading

Hours after challenge:

48

Group:

negative control

Dose level:

10 % preparation of test item in corn oil

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

see overall remarks (below)

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 % preparation of test item in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: see overall remarks (below).

Any other information on results incl. tables

RESULTS OF TEST
- Sensitization reaction: 2/20 animals showed a sensitization 24 hours, 1/20 animals 48 hours after challenge   = slight sensitization (no  classification)
- Clinical signs: After intracutaneous application, the following signs  were observed in the places of application:

 FCA treatment: intense erythema and edema as well as necroses; Test substance treatment: slight erythema and edema;
  Vehicle treatment: slight redness
  After removal of the induction patch, severe inflammation with  discharge of matter and in some cases blood was observed in the    FCA  treatment positions.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: other: Regulation EC 1272/2008

Conclusions:

Under the conditions of the study, the test item 1,5,9 -cyclododecatriene showed no dermal sensitization in female guinea pigs. Hence according to the outcome of the study the test item 1,5,9 -cyclododecatriene is not classified regarding dermal sensitisation according to 67/548/EEC and according CLP regulation (1272/2008).

Executive summary:

In a guinea pig maximization test performed with the test 1,5,9 -cyclododecatriene, after intradermal and epidermal inductions and 24 hours as well as 48 hours after epidermal challenge, two (48h) and one (24h) of the 20 animals examined in this study, showed positive response regarding dermal sensitization.

Under the conditions of this guinea pig maximization test, the test item 1,5,9 -cyclododecatriene showed no dermal sensitization in female guinea pigs.