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:
4 (not assignable)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V, B5
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
White powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: Overall at 24, 48 and 72h
Score:
0.67
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: Overall at 24, 48 and 72h
Score:
2
Remarks on result:
other: Max duration: 6h; Max value at end of observatio period: 2 (related to all animals)
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: Overall at 24, 48 and 72h
Score:
2
Remarks on result:
other: Max duration: 6h; Max value at end of observatio period: 2 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0.67
Remarks on result:
other: Max duration: 6h; Max value at end of observatio period: 1 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall 24, 48 and 72 h
Score:
1.67
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24,48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24,48 and 72 h
Score:
1
Max. score:
2
Remarks on result:
other: Max duration: 6h; Max duration at end of observation period: 2 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 24,48 and 72 h
Score:
0.67
Max. score:
2
Remarks on result:
other: Max duration: 6h; Max duration at end of observation period: 2 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Remarks on result:
other: Max duration: 6h; Max duration at end of observation period: 1 (related to all animals)
Other effects:
Additional signs of irritation included Harderian discharge and erythema and oedema of the eyelids in one animal, and additionally in another animal, included irregular corneal surface, haemorrhage of the nictitating membrane, raised corneal opacity, bulging and ulceration of the cornea and neovascularistaion. The latter animal was killed due to irritation 6 days after dosing.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information