Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to EG B.5 Teil B / OECD 405

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EG B.5 Teil B / OECD 405
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Nature of substance:liquid

Test animals / tissue source

Species:
other: rabbit,Weiße Neuseeländer

Test system

Amount / concentration applied:
0.1mg
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
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
2
Remarks on result:
other: Max. duration: 14 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
chemosis score
Max. score:
2
Remarks on result:
other: Max. duration: 7 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
2.3
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.6
Irritation parameter:
cornea opacity score
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 2 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Max. duration: 7 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 21 days
Other effects:
The test was also conducted as follows:
4 seconds after instillation of the test article in the eyes of 3 rabbits the eyes were washed for 5 min with water. the results correspond to the results achieved with out washing:
Cornea: in all animals turbation of cornea. In 2 animals vascularization.
Iris: in 2 animals inflamation of iris.
conjunctiva: in 2 animals diffuse highly red discolouration
of the conj., also swelling.
The eyes were after 14 days free of symptoms.
Another test was conducted as follows:
30 seconds after instillation of the test article in the
eyes of 3 rabbits the eyes were washed for 5 min with water.
the results correspond to the results achieved with out
washing:
Cornea: in all animals turbation of cornea.
Iris: in 2 animals inflamation of iris.
conjunctiva: in all animals diffuse highly red
discolouration of the conj., also swelling.
The eyes were after 7 days free of symptoms.

Applicant's summary and conclusion

Interpretation of results:
other: not classified