Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
4-vinylcyclohexene of Hüls AG, purity > 99 %

Test animals

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals 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.