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: GLP - Guideline study.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 404/EWG
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
other: rbt weiβer wiener

Test system

Amount / concentration applied:
24 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
Remarks:
(mean score 1)
Time point:
other: overall at 24,48 and 72h
Score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24,48 and 72h
Score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: overall at 24,48 and 72h
Score:
1.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
2
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72h
Score:
0.7
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72h
Score:
1.7
Irritation parameter:
chemosis score
Max. score:
2
Remarks on result:
other: Max. duration: 72h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72h
Score:
0.3
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72h
Score:
1
Irritation parameter:
cornea opacity score
Max. score:
1
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72h
Score:
1
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72h
Score:
1
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72h
Score:
1
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Max. duration: 72h; Max. value at end of observation period: (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 15 days
Other effects:
Constricted pupil marginal vascularization of the cornea, bloody secretion, loss of substance of the cornea, suppuration.

Pupille verengt, marginale Vaskularisation der Hornhaut, blutige Sekretion, Substanzverluste der Hornhaut, Eiterung

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information