Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
single administration of 0.1g of the test item
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after the test article application. After the 24 and 48-hour reading, the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution.
Number of animals or in vitro replicates:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0

Any other information on results incl. tables

No general clinical signs were noted in any rabbit.

Locally, at the application site, transiet mild conjuctival redness was mainly observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article administered to rabbits as a single ocular application, is to be considered "non irritant" for the eye.