Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other:
Score:
0
Max. score:
4
Remarks on result:
other:
Irritation parameter:
iris score
Basis:
mean
Time point:
other:
Score:
0
Max. score:
2
Remarks on result:
other:
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other:
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within:
Remarks on result:
other:
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other:
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other:
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other:
Score:
1
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other:
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other:
Score:
3
Max. score:
3
Reversibility:
fully reversible within:
Remarks on result:
other:
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other:
Score:
1
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other:
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other:
Score:
2
Max. score:
3
Reversibility:
fully reversible within:
Remarks on result:
other:

Applicant's summary and conclusion