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:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
The test substance was instilled in the right eye of each rabbit
Observation period (in vivo):
1, 24, 48 and 72 hours
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: 1h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h
Score:
10
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48h
Score:
5
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72h
Score:
3.3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h
Score:
0
Reversibility:
other: no effects were observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h
Score:
0
Reversibility:
other: no effects were observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48h
Score:
0
Reversibility:
other: no effects were observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72h
Score:
0
Reversibility:
other: no effects were observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h
Score:
13.3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
10.7
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48h
Score:
6
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72h
Score:
2
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance did not require labelling with the risk phrase R36, "irritating to eyes" in accordance with Commission Directive 2001/59/EEC