Registration Dossier

Administrative data

Endpoint:
eye irritation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP/Guideline Study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
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)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): XU-18838.00
- Physical state: powder
- Lot/batch No.: 20120135-18
- Storage condition of test material: room temperature, protected from light

Test animals / tissue source

Species:
other: cow
Details on test animals or tissues and environmental conditions:
Bovine eyes were obtained from a local abattoir as a by-product from freshly slaughtered
animals (J.W. TREUTH & SONS, Inc., Baltimore, MD). The eyes were excised and then placed
in Hanks' Balanced Salt Solution, containing Penicillin/Streptomycin (HBSS), and transported to
the laboratory on ice packs. Immediately upon receipt of the eyes into the laboratory, preparation
of the corneas was initiated.

Test system

Vehicle:
other: PEG-400
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μL
- Concentration (if solution): The test substance was tested as 20% (w/v) dilution in PEG-400

VEHICLE
- Amount(s) applied (volume or weight with unit): 750 μL
- Lot/batch no. (if required): Sigma-Aldrich, Lot # MKBF9334V
Duration of treatment / exposure:
4 hours
Observation period (in vivo):
Opacity measurement was performed after 4-hour exposure.
The optical density at 490 nm (OD490) was determined after 90-minute incubation.
Number of animals or in vitro replicates:
Not applicable.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):After the 4-hour exposure period, the control or test substance treatments
were removed. The epithelial side of each cornea was washed at least three times with Complete
MEM (containing phenol red) to ensure total removal of the control or test substances. The
corneas were then given a final rinse with Complete MEM (without phenol red). For the corneas
directly exposed to the test substance (without anterior chamber window), the test substance was
removed from the treated corneas by rinsing the exposed epithelium of the corneas (special care
was taken not to spray the corneas directly) with Complete MEM (containing phenol red).
- Time after start of exposure: 4 hrs

SCORING SYSTEM:
The optical density at 490 nm (OD490) was determined using a Molecular Devices Vmax
kinetic microplate reader.

Results and discussion

Results of in vivo study
Irritation parameter:
other: in vitro score
Basis:
other: opacity
Score:
ca. 5.4
Remarks on result:
other: In vitro score = Mean Opacity Value + (15 x Mean OD490 Value)
Irritant / corrosive response data:
The in vitro score obtained for the test substance, XU-18838.00, was 5.4.

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: other: UN GHS
Conclusions:
The in vitro score obtained for the test substance was 5.4. Based upon the results of the study, the
test substance, XU-18838.00, is not classified as eye corrosive (Globally
Harmonized System - GHS Category 1) according to the current OECD test guideline (OECD TG 437).
Executive summary:

The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy/toxicity of the test substance, XU-18838.00, Lot Number 20120135-18. Bovine corneas, obtained as a by-product from freshly slaughtered animals, were mounted in special holders and exposed to the test substance for four hours. Because the test substance was not soluble or miscible in aqueous solutions, the test substance was tested as 20% (w/v) suspension in polyethylene glycol 400. An in vitro score was determined for the test substance based on the induction of opacity and permeability (to fluorescein) in the isolated bovine corneas. The in vitro score obtained for the test substance was 5.4. Based upon the results of the study, the test substance, XU-18838.00, is not classified as eye corrosive (Globally Harmonized System - GHS Category 1) according to the current OECD test guideline (OECD TG 437).