Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 2004/73/EG, B.5
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
other: rbt, NZW Crl:KBL(NZW)

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean value including 24, 48, 72 h observation
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean value including 24, 48, 72 h observation
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean value including 24, 48, 72 h observation
Score:
> 1 - < 2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean value including 24,48,72 h observation
Score:
> 0 - < 1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days

Applicant's summary and conclusion

Interpretation of results:
other: not classified