Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Nature of substance: Fine powder

Test animals / tissue source

Species:
other: Rabbit (New Zealand White)

Test system

Amount / concentration applied:
70 MG
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Irritation parameter:
conjunctivae score
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Irritation parameter:
chemosis score
Max. score:
2
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
2
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 14 days
Other effects:
There were no signs of toxicity or ill health in any animal
during the observation period.
Two animals developed corneal opacities with iridial
inflammation, while all three animals showed a diffuse
crimson or beefy red colouration of the conjunctivae, in one
animal only one hour after instillation. These reactions
were accompanied by swelling with partial eversion of the
eyelids.

Applicant's summary and conclusion

Interpretation of results:
other: not classified