Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex 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
Year:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed

Test system

Vehicle:
other: corn oil
Controls:
yes, concurrent vehicle
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
750 μL, 20% in corm oil
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
4.93
Vehicle controls validity:
valid
Remarks:
0.69
Negative controls validity:
valid
Remarks:
0.55
Positive controls validity:
valid
Remarks:
113.07

Applicant's summary and conclusion

Interpretation of results:
other: no prediction can be made