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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:
1983-04-19 to 1983-04-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1,5-Cyclooctadiene of Hüls AG; Purity 99.5 %

Test animals / tissue source

Species:
rabbit
Strain:
other:
Details on test animals or tissues 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: 2.1 - 2.9 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
- 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

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, not removed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Comment: not rinsed
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet
- Tool used to assess score: sodium fluorescein / ophthalmic lamp /  visual inspections

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
3.71
Max. score:
110
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.04
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.06
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.61
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.28
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.04
- Iris: 0.06
- Conjunctivae: 0.61
- chemosis: 0.28
- Overall irritation score: 3.71/110
Other effects:
REVERSIBILITY: almost complete within 72 hours (1 score for redness in 1  animal left)

Any other information on results incl. tables

no further results

Applicant's summary and conclusion

Conclusions:
According to the study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.
Executive summary:

The test item was investigated for irritant effects on the eye and associated mucous membranes of 3 female and 3 male rabbits according to OECD TG 405 (1981). The test substance was applied in a single dose of 0.1 ml into the conjuntival sac of each animal. According to the study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.