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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-10-01 to 1985-10-07
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 405 (Acute Eye 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 not reported

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male/female
- Weight at study initiation: 2.2 - 2.5 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
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

Vehicle:
unchanged (no vehicle)
Controls:
other: identical animals, left eyes remained untreated
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
not rinsed - no removal of test substance
Observation period (in vivo):
1, 24, 48, 72 hours, and 6  days after  treatment
Number of animals or in vitro replicates:
6
Details on study design:
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, and 6  days after  treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp /  visual inspections
- Scoring system: Draize (1959); 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:
4.29
Max. score:
110
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 1.33
- Conjunctivae (Chemosis): 0.11
- Overall irritation score: 4.29/110
REVERSIBILITY: complete within 6 days
Other effects:
no other effects

Any other information on results incl. tables

no other results

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize (1959); Appendix VI of 79/831/EEC
Conclusions:
According to the study, the test item 4-vinylcyclohex-1-ene showed no irritant effect on the eyes and mucosa of male and female rabbits.
Classification: not irritating
Executive summary:

To test the acute irritant effect on eyes and mucosa the test item 4-vinylcyclohex-1-ene was administered undiluted into eyes or eyelid sacs of male and female rabbits. According to the study, the test item 4-vinylcyclohexene showed no irritant effect on the eyes and mucosa of male and female rabbits.