Registration Dossier

Administrative data

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

Data source

Reference
Title:
No information
Author:
Anonymous
Year:
2011
Bibliographic source:
NICNAS (Australia)

Materials and methods

Test guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
80 mg
Duration of treatment / exposure:
21 days
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Results
Irritation parameter:
other: clinical observations
Basis:
animal #1
Time point:
other: 21 days
Score:
> 75
Max. score:
110
Reversibility:
not fully reversible within: 21 days

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU