Registration Dossier
Registration Dossier
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EC number: 203-907-1 | CAS number: 111-78-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- 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:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- 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 1990 and is sufficient for evaluation of the skin sensitisation potential of the test substance.
Test material
- Reference substance name:
- Cycloocta-1,5-diene
- EC Number:
- 203-907-1
- EC Name:
- Cycloocta-1,5-diene
- Cas Number:
- 111-78-4
- Molecular formula:
- C8H12
- IUPAC Name:
- (1Z,5Z)-cycloocta-1,5-diene
- Details on test material:
- cis,cis-1,5-cyclooctadiene of Hüls AG. Produced May / June 1989; purity > 99.5 %
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: 360 g (mean test); 351 g (mean control)
- 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)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: corn oil
- Concentration / amount:
- 1st application: Induction 5 % intracutaneous
2nd application: Induction 100 % occlusive epicutaneous
3rd application: Challenge 100 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: corn oil
- Concentration / amount:
- 1st application: Induction 5 % intracutaneous
2nd application: Induction 100 % occlusive epicutaneous
3rd application: Challenge 100 % occlusive epicutaneous
- No. of animals per dose:
- 20
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Induction schedule:
day 0 injection,
day 6 induction of slight to moderate 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 5 % in corn oil
2 x test substance 5 % 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:
100 % with filter paper on left 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
- Pilot study: skin irritation - Challenge controls:
- vehicle
- Positive control substance(s):
- not required
- Remarks:
- not required by 1981 version of Test Guideline
Study design: in vivo (LLNA)
- Statistics:
- no data
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- 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: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- 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: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
RESULTS OF PILOT STUDY: 100 % test substance caused no dermal irritation
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 (all): severe erythema, edema, and
necrosis
1st induction, test substance application sites: distinct erythema and edema
1st induction, vehicle application sites: slight erythema and edema
2nd induction, test and control groups:
1 hour after patch removal: erythema over the entire application area,
severe and partly bleeding inflammation with edema (wounds), partly eschar
formation, slight inflammation of the other injection sites, agitation of
the animals and scratching in the application area.
24 hours after patch removal: formation of eschar on inflamed injection
areas.
- Other: Mean body weight gain 128 g in test group, 116 g in control
group = expected range.
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 1,5 -Cyclooctadien showed no dermal sensitization in
male guinea pigs. - Executive summary:
In a guinea pig maximization test according to OECD 406 performed with the test item 1,5 -cyclooctadiene, after intracutane and epidermal inductions and 24 hours as well as 48 hours after epidermal challenge, no one 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 -cyclooctadien showed no dermal sensitization in male guinea pigs.
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