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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Directive 84/449/EC, B.5
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

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:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Score:
2.3
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 1
Irritation parameter:
chemosis score
Basis:
mean
Score:
1.3
Max. score:
2
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h;Max. value at end of observation period: 2
Irritation parameter:
iris score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU