Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: BASF internal standard protocol
Principles of method if other than guideline:
50 mm3 of the test substance were introduced into the lower conjunctival sac of 2 rabbits' right eyes. The left eyes were used as control and treated with NaCl solution. The eyes were not washed after the application. The animals were observed for 8 days with readings after 1 hour, 24 hours and 8 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
about 50 mm3
Duration of treatment / exposure:
8 days
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
2
Details on study design:
The test substance was not washed out.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: corrosion
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other: corrosion
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: corrosion
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 8 days
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: incorporating vessels, sanies, scar formation at eyelid
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 8 days
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: incorporating vessels, sanies, scar formation at eyelid

Any other information on results incl. tables

The test item caused marked opacity as well as incorporating vessels, sanies, and scar formation at the eyelid which were not reversible within 8 days.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The test item caused marked opacity as well as incorporating vessels, sanies, and scar formation at the eyelid which were not reversible within 8 days.