Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 April 2016 to 28 April 2016
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016

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)
Deviations:
yes
Remarks:
One of the negative control eyes was excluded from the analysis since a spot was present after the incubation which resulted in an IVIS >3. This result does not affect the study outcome.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
other: Bovine
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Isolated bovine cornea

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
750 μl
Duration of treatment / exposure:
10 ± 1 minutes at 32 ± 1°C
Duration of post- treatment incubation (in vitro):
120 ± 10 minutes at 32 ± 1°C

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
2.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not induce ocular irritation under the conditions of this study.
Executive summary:

In an in vitro eye corrosion/irritation study, isolated bovine cornea was exposed to undiluted substance for 10-minutes. The in vitro irritation score was 2.3% and so the substance is considered to be a non-irritant to the eye.