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
Study period:
1969
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:
1969
Report Date:
1970

Materials and methods

Principles of method if other than guideline:
Method: other: BASF test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca 2 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: 50 µl NaCl was applied into the left eye and served as control
Amount / concentration applied:
50 µl
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of two animals
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of two animals
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
other: iris and cornea
Basis:
mean
Remarks:
of two animals
Time point:
24/48/72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met