Registration Dossier
Registration Dossier
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EC number: 909-034-9 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1989-08-14 to 1989-09-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions: No positive control (not required by 1981 version of Test Guideline)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
- Principles of method if other than guideline:
- Method: other: OECD Guideline 406 (1981)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A skin sensitization test according to OECD 406 has already excisted since 1989 and is sufficient for evaluation of the skin sensitisation potential of the test substance.
Test material
- Reference substance name:
- Cyclododecanol
- EC Number:
- 217-031-2
- EC Name:
- Cyclododecanol
- Cas Number:
- 1724-39-6
- Molecular formula:
- C12H24O
- IUPAC Name:
- cyclododecanol
- Details on test material:
- TS: Cyclododecanol of Hüls AG, produced 04 May 1986.
Purity ca. 99.5 %.
Main impurity ca. 0.3 % cyclododecanone (CAS RN 830-13-7).
Constituent 1
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 397 g (Treated); 394 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:
- corn oil
- Concentration / amount:
- 1st application: Induction 1 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 1st application: Induction 1 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
- No. of animals per dose:
- 20 test
10 control - Details on study design:
- ADMINISTRATION/EXPOSURE
- Induction schedule:
day 0 injection,
day 6 induction of slight irritation (10 % sodium dodecyl sulfate in petrolatum)
days 7-9 patch treatment (48 hours)
- Injection details: 0.1 ml each at 6 positions on shoulders:
2 x Freund's Complete Adjuvant / deionized water (50:50)
2 x test substance 1 % in corn oil
2 x test substance 1 % in Freund's Complete Adjuvant / corn oil (50:50)
simultaneous and symmetrical application of each solution
controls: corn oil instead of test substance
- Challenge schedule: 2 weeks after end of induction, patch treatment for 24 hours
- Concentrations used for challenge:
25 % in corn oil with filter paper on left side; corn oil on opposite side 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
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 % in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 % in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 % in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 % in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
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 cyclododecanol showed no dermal sensitization in female guinea pigs.
- Executive summary:
In a guinea pig maximization test performed with the test item cyclododecanol, after intracutane and epidermal inductions and 24 hours as well as 48 hours after epidermal challenge none 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 cyclododecane showed no dermal sensitization in female guinea pigs.
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