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)
Rationale for reliability incl. deficiencies:
other: study performed according to standard in vitro methods; GLP-compliant (EPA, FDA)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Standard methods cited in literature.
Principles of method if other than guideline:
Protocol based on methodology described in ‘Bovine Corneal Opacity and Permeability Test: An In Vitro Assay of Ocular Irritancy (1982)’; Gautheron, P., Dukic, M., Alix, D., and Sina, J.F.; Fundamental and Applied Toxicology, 18, 442-449. In Vitro classification based on Southee, J.A., 1998. Evaluation of the Prevalidation Process, Part 2, final report, volume 2, The Bovine Corneal Opacity and Permeability (BCOP) Assay.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Powder (grey)
- Storage condition of test material: Room temperature and humidity

Test system

Controls:
other: Not applicable
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): 20% solution in MEM (Minimum Essential Medium)

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Details on study design:
As per quoted methods.
In brief, five bovine corneas were 'dosed' with 0.75 mL of a 20% solution (in MEM, Minimum Essential Medium) of the test item. Opacity measurements and sodium fluorescein permeability were determined.

Results and discussion

In vivo

Irritant / corrosive response data:
The corrected mean optical score was 118.2. The corrected mean optical density (permeability) score was 0.054. The in vitro score in this BCOP study was calculated as 119.0 and, accordingly, the test item was classified as a very severe irritant.

Any other information on results incl. tables

Results

Individual Control Scores for BCOP

Cornea #:

Pretest

4 Hours

O.D. Scores

C3

0

0

0.043

C4

0

0

0.019

Mean

0

0

0.031

Corrected Mean Control Opacity Score

0

 

 

Corrected Mean Control Opacity Score = 4 hour mean score minus pretest mean score

Individual Test Scores

Cornea

Pretest Scores

4 Hour Scores

O.D. Scores

6

C3

-1

C4

-2

C3

122

C4

122

0.053

7

C3

-1

C4

-1

C3

129

C4

128

0.056

8

C3

-2

C4

-2

C3

94

C4

92

0.103

9

C3

-2

C4

-1

C3

112

C4

112

0.124

10

C3

-4

C4

-4

C3

125

C4

125

0.087

Calculated Scores

Cornea #

Corrected Opacity Scores

Corrected O.D.

4 Hour Scores

6

C3

123

C4

124

0.022

7

C3

130

C4

129

0.025

8

C3

96

C4

94

0.072

9

C3

114

C4

114

0.093

10

C3

129

C4

129

0.056

Corrected Mean Optical Density =

0.054

Corrected Mean Optical Score =

118.2

Corrected Mean Opacity Score (CMOS) = mean treated opacity score minus corrected mean control opacity score Calculated In Vitro Score

CMOS =118.2 + 15 (0.054)

CMOS =118.2 + (0.810)

CMOS =119.0

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The in vitro score in this BCOP study was calculated as 119.0 and, accordingly, the test item was classified as a very severe irritant.
Executive summary:

This study protocol is based on methodology described in ‘Bovine Corneal Opacity and Permeability Test: An In Vitro Assay of Ocular Irritancy (1982)’. Five bovine corneas were 'dosed' with 0.75 mL of a 20% solution (in MEM, Minimum Essential Medium) of the test item. Opacity measurements and sodium fluorescein permiability were determined. The in vitro score in this BCOP study was calculated as 119.0 and, accordingly, the test item was classified as a very severe irritant.