Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
according to guideline

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 g per animal

Duration of treatment / exposure:
The treated eyes were not rinsed after instillation
Observation period (in vivo):
1, 24, 48, 72 h, as well as 7 and 10 days after administration
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: Varta Cliptrix diagnostic-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24h, 48h, 72h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 24h, 48h, 72h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 10 d
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 24h, 48h, 72h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24h, 48h, 72h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h

Applicant's summary and conclusion

Interpretation of results:
other: no significant or irriversible demage to the rabbit eye
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
the substance is not subject of classification and labeling