Registration Dossier
Registration Dossier
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EC number: 212-595-6 | CAS number: 830-13-7
Skin sensitisation
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:
- 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
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Cyclododecanone
- EC Number:
- 212-595-6
- EC Name:
- Cyclododecanone
- Cas Number:
- 830-13-7
- Molecular formula:
- C12H22O
- IUPAC Name:
- cyclododecanone
- Details on test material:
- cyclododecanone of Hüls AG, produced 09 Nov 1988. Purity ca. 99.7 %
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: 313 g (mean test); 309 g (mean control)
- Controls: 10 animals; treatment: vehicle
Environmental conditions:
- Room temperature: 20°C (+/- 1°C)
- Humidity: 60% (+/- 5%)
- Air change: 15 times/hour
- Light: 12 hour light/dark rhythm
- Diet: G4 complete feed for guinea pigs (Ssniff, Soest, Germany) ad libitum
- Water: tap water ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- 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:
- 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:
- 20 test
10 control - Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance for induction: melting at ca. 50 °C, solution in vehicle
- Induction schedule:
day 0 injection,
day 6 induction of slight inflammation (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 10 % in corn oil
2 x test substance 10 % 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
EXAMINATIONS
- Grading system:
possible scores 0 / 1 / 2 / 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:
- 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 % in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- see below
- 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: see below.
- 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:
- see below
- 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: see below.
- 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:
- see below
- 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: see below.
- 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:
- see below
- 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: see below.
Any other information on results incl. tables
RESULTS OF TEST
- Sensitization reaction:
0/20 animals positive at 24 hours and at 48 hours = no sensitization
no animals positive in control group
no skin reaction upon corn oil treatment on opposite side (both groups)
- Clinical signs:
1st induction, FCA application sites: distinct erythema and edema, slight necroses
1st induction, vehicle application sites: slight erythema
1st induction, vehicle + test substance application sites: slight erythema and edema
2nd induction, test and control groups: severe inflammation of all FCA injection sites with bleeding; soon after patch removal
bleeding wounds from scratching in the application area; crust formation within 24 hours
- Other: Mean body weight gain 64 g in test group, 76 g in control group = below expected range. Weight loss was observed
in 8/20 test animals and 4/10 control animals during weeks 2 and 3. No reason for this could be identified.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- According to the outcome of the study cyclododecanone showed no skin sensitizing effects under the conditions of the test.
- Executive summary:
In a guinea pig maximisation test the test substance cyclododecanone showed no skin sensitizing properties.
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