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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V - method B.5
GLP compliance:
yes

Test material

Constituent 1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
CA 100 MG
Observation period (in vivo):
9 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 9d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 4d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4d
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 9 days
Other effects:
Additional signs of irritation included convoluted eyelids, mucoid and harderian discharge and dried secretions on the upper and lower eyelids. Fluorescein staining revealed superficial erosion of approximately one quarter of the cornes in one animal. None of these effects persisted beyond seven days.

Any other information on results incl. tables

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The test substance was a mild irritant (class 4 on a 1-8 scale) to the rabbit eye and caused no, or practically no initial pain (class 0 to 1 on a 0-5 scale)
Executive summary:

A group of three female rabbits each received a single application of test substance into the left eye according to test method B.5. The animals were assessed daily for any signs of eye irritation for seven or nine days after application.

The test substance was a mild irritant (class 4 on a 1-8 scale) to the rabbit eye and caused no, or practically no initial pain (class 0 to 1 on a 0-5 scale)