Registration Dossier
Registration Dossier
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EC number: 225-533-8 | CAS number: 4904-61-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- 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
- Reference substance name:
- 1,5,9-cyclododecatriene
- IUPAC Name:
- 1,5,9-cyclododecatriene
- Details on test material:
- 1,5,9-cyclododecatriene of Hüls AG, purity > 99.5%
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.2 - 2.7 kg
- Number of animals: 3 males, 3 females
- Feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
- Water: tap water ad libitum
Environmental conditions:
- Room temperature: 20°C (+/- 1°C);
- Humidity: 60% (+/- 5%);
- Air change: 15 times/hour;
- Light: 12 hour light/dark rhythm;
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: no vehicle
- Controls:
- no
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 1, 24, 48, 72 hours; 6, 8, 11, 14 days after exposure
- Number of animals:
- 6
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Area of exposure: ca. 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Postexposure period: 14 days
- Removal of test substance: dist. water
EXAMINATIONS
- Scoring system: OECD; evaluation: VCI notes on safety data sheet
- Examination time points: 1, 24, 48, 72 hours; 6, 8, 11, 14 days; evaluation based on readings 1-4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 1.2
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.61
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 1.00
- Edema: 0.61 - Other effects:
- no other effects
Any other information on results incl. tables
no further remarks
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information but not classified 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 a slightly irritant effect on the skin of male and female rabbits which leads to no classification according to 67/548/EEC and according CLP regulation (1272/2008).
- Executive summary:
To test the acute skin irritant effect the test item 1,5,9 -cyclododecatrien was applied to the shaven dorsal skin of 3 male and 3 female rabbits (OECD 404 guideline study). The product was administered undiluted and the time of exposure in the patch test was 4 hours. Observations were made at various unspecified time points. Test item produced minimal erythema in all rabbits and minial edema of the abraded skin in two rabbits. Subsequent observations revealed a gradual return to normal (complete after one week).
According to the study, the test item 1,5,9 -cyclododecatrien showed a slightly irritant effect on the skin of male and female rabbits.
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