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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
study conducted on the analogue substance; The Reliability of the Source Study is 2.
Justification for type of information:
The read across justification is detailed in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US Department of Health, Education and Welfare : Fed Reg 37 (83), 8535, 1972
Principles of method if other than guideline:
In order to evaluate the eye irritation of the test substance, a single dose was applied into the eyes of six rabbits. The exposoure was of 5 minutes and 24 hours. The degree of eye irritation/corrosion was evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals of 24, 48, 72 hours and 7, 14 and 21 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: singly
- Diet ad libitum
- Water ad libitum
standard conditions

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
no details
Duration of treatment / exposure:
5 min or 24 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
4 per exposure period
Details on study design:
According to the US Department of Health, Education and Welfare (Fed Reg 37 (83), 8535, 1972).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0.33
Reversibility:
not fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
no irrtation is observed

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC) No. 1272/2008
Conclusions:
The test substance was found to be not irritant when applied to intact rabbit eye.
Executive summary:

The test item was investigated for eye irritating property in rabbits using a guideline given by the US Department of Health, Education and Welfare (Fed Reg 37 (83), 8535, 1972). A single dose was applied into the eyes of six rabbits. The exposure was 5 minutes and 24 hours. The degree of eye irritation/corrosion was evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals of 24, 48, 72 hours and 7, 14 and 21 days.

The test item was found not to be irritating to the eyes of rabbits.


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