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:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Principles of method if other than guideline:
Chenge of technique application of the test substance - the open chamber method was used. The test substance suspension (20 % concentration) was applied in quantities enough to completely cover the cornea. This change is deviation from study plan and had no impact on the results of the study.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid - liquid: suspension
Details on test material:
- Name of test material (as cited in study report): 2-methpoxy-5-nitrophenyl acetate

- Physical state: solid powder
- Analytical purity: 95 % w/w


- Lot/batch No.: 102014
- Expiration date of the lot/batch: unlisted

- Stability under test conditions: unlisted
- Storage condition of test material: Store in dry place, in dark in closed container at the room temperature

Test animals / tissue source

Species:
other: bovine eyes

Results and discussion

In vivo

Results
Irritation parameter:
other: In Vitro Irritancy Score (IVIS)
Basis:
mean
Time point:
other: -
Score:
44.59
Reversibility:
not specified
Irritant / corrosive response data:
Limit value for IVIS is 55.1 - larger value means positive response.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: not specified