Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 February 2018 - 15 February 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

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)
Version / remarks:
adopted October 09, 2017
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: 171116
- Expiration date of the lot/batch: 16 November 2019

STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light

Test animals / tissue source

Species:
cattle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
Substance: 329.10 to 362.21 mg.
750 µl of the negative control.
750 µl 20% (w/v) Imidazole solution (positive control).
Duration of treatment / exposure:
240 ± 10 minutes
Duration of post- treatment incubation (in vitro):
None.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
-1.7
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 144 and within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, the substance induced an IVIS ≤ 3, therefore no classification is required for eye irritation or serious eye damage.
Executive summary:

The eye hazard potential of the substance as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea was assessed using the Bovine Corneal Opacity and Permeability test (BCOP test). The eye damage of the substance was tested through topical application for approximately 240 minutes.  The substance did not induce ocular irritation for both endpoints (opacity and permeability), resulting in a mean in vitro irritancy score (IVIS) of -1.7 after 4 hours of treatment. In conclusion, since the substance induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage and the substance is considered to be a non-irritant to the eye.