Registration Dossier
Registration Dossier
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EC number: 202-848-9 | CAS number: 100-40-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-10-01 to 1985-10-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-vinylcyclohexene
- EC Number:
- 202-848-9
- EC Name:
- 4-vinylcyclohexene
- Cas Number:
- 100-40-3
- Molecular formula:
- C8H12
- IUPAC Name:
- 4-ethenylcyclohex-1-ene
- Details on test material:
- 4-vinylcyclohexene of Hüls AG, purity > 99 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male and female
- Weight at study initiation: 2.2 - 2.5 kg
- Number of animals: 3 males, 3 females
Environmental conditions:
- Room temperature: 20°C (+/- 1°C)
- Humidity: 60% (+/- 5%)
- Air change: 15 times/hour
- Light: 12 hour light/dark rhythm
- Feed: K4 complete feed for rabbits (Ssniff, Soest, Germany)
- Water: tap water ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: no vehicle
- Controls:
- not required
- Amount / concentration applied:
- - Total volume applied: 0.5 ml, undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Post exposure period: 14 days
- Number of animals:
- 6 animals, 3 males and 3 females
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Area of exposure: 6 cm2
- Total volume applied: 0.5 ml
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance : washing with warm water
- Post exposure period: 14 days
EXAMINATIONS
- Examination time points: 1, 24, 48, 72 hours, 6, 8, 10 and 14 days after patch removal; evaluation based on readings 1-4 - Scoring system:
OECD; evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 3.79
- Max. score:
- 8
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.56
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.17
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 2.56
- Edema: 1.17
REVERSIBILITY: not reversible - Other effects:
- Induration and dryness (day 6) of treated skin, cracked skin (days 8-10), and formation (days 8-10) and subsequent detachment of eschar
Any other information on results incl. tables
no further results
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize Scores and according to EU Directive 67/548/EEC
- Conclusions:
- The test item 4-vinylcyclohexene showed a irritant effect on the skin of male and female rabbits under the conditions of the study. .Classification: irritating
- Executive summary:
To test the acute skin irritant effect the test item 4 -vinylcyclohex-1-ene was applied to the shaven dorsal skin of rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours. The treated rabbits showed induration and dryness (day 6) of treated skin, cracked skin (days 8-10), and formation (days 8-10) and subsequent detachment of eschar. According to the study, the test item 4-vinylcyclohexene showed a irritant effect on the skin of male and female rabbits.
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