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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:
February to April 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A single dose was administered followed by a 1 day observation period. Due to severe ocular irritation and tissue damage, the animals were sacrificed on day 1 for humane reasons.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Description: Clear light yellow liquid
- Date of receipt : april 7, 1988
- Storage : room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: at least 8 weeks
- Housing: Animals individually housed in suspended stainless steel cages
- Diet: ad libitum
- Water: municipal water ad libitum
- Acclimation period: 56 days
- No known contaminants that were reasonably expected in food or water that would interfere with the study.
- Animals considered unsuitable were excluded from selection for the study

ENVIRONMENTAL CONDITIONS
- Temperature: 60-70 °F
- Relative humidity of 30-70 %
- Photoperiod: 12-h light/dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Dose : 0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1 day
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to the Draize scale

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 1h
Score:
0.5
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: 1 rabbit with a score of 1, and one rabbit with a score of 2
Irritation parameter:
conjunctivae score
Remarks:
(chemosis)
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 1h
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 rabbits with a score of 2 and 2 rabbits with a score of 1
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 1h
Score:
2.17
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: 5 rabbits with a score of 2, one rabbit with a score of 3
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 1h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: All rabbits have a score of 4
Irritation parameter:
cornea opacity score
Remarks:
(area)
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 1h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: All rabbits have a score of 4
Irritant / corrosive response data:
The test material was corrosive to the eye. All six animals exhibited severe conjunctival and corneal tissue destruction. Due to the severe ocular response, all animals were sacrificed after the 1-hour observation for humane reasons.
Score of iritis cannot be calculated because of necrosis.

Applicant's summary and conclusion

Interpretation of results:
other: EU Category 1
Conclusions:
Under the conditions of this study, the test material was corrosive to eyes.
Executive summary:

The potential of the test material to cause irritation to the eye was investigated.

A single dose of the test material was administered into the eye of a rabbit, followed by a one day observation period.

The test material was corrosive to the eye. All six animals exhibited severe conjunctival and corneal tissue destruction. Due to the severe ocular response, all animals were sacrificed after the 1-hour observation for humane reasons.

Under the conditions of this study, the test material was corrosive to eyes.