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:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
other: cattle eye
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Eyes from adult cattle were obtained from a local abattoir as a by-product from freshly
slaughtered animals. The eyes were excised by an abattoir employee and placed in
Hanks’ Balanced Salt Solution (HBSS), supplemented with Penicillin/Streptomycin, and
transported to the laboratory on ice packs.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
240 min
Number of animals or in vitro replicates:
0

Results and discussion

In vivo

Results
Irritation parameter:
other: in vitro irritancy Score
Basis:
other:
Time point:
other: 240 minutes
Score:
5.2
Reversibility:
other: not relevant

Any other information on results incl. tables

Results

Treatment In Vitro Irritancy Score

Test Item 5.2

Negative Control 6.1

Positive Control 92.1

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was considered not to be an ocular corrosive or severe irritant.