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: basic information given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
Single instillation into the conjunctival sac of the right eyelid; 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:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: corroded mucosa
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
1.5
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: corroded mucosa
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: corroded mucosa
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Other effects:
Effects were not fully reversible after 8 days and the animals had developed iritis.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)