Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental Start Date: 21 February 2019 Experimental Completion Date: 21 February 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Annex VIII Data Requirement

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

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:
09 October 2017
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
0.75 mL
Duration of treatment / exposure:
10 minutes
Duration of post- treatment incubation (in vitro):
120 minutes
Number of animals or in vitro replicates:
3 eyes per exposure (i.e. negative control, positive control and test item)

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Value:
>= 6
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Value:
>= 12.7
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Treatment

Cornea Number

Opacity

Permeability (OD492)

In VitroIrritancy Score

Pre-Treatment

Post Treatment

Post Incubation

Post Incubation – Pre Treatment

Corrected Value

 

Corrected Value

Negative Control

1

4

3

4

0

 

0.003

 

 

2

2

2

2

0

 

0.001

 

 

3

3

2

2

0

 

0.000

 

 

 

 

 

 

0.0*

 

0.001$

 

0.0

Positive Control

6

3

30

31

28

28.0

0.849

0.848

 

9

3

29

34

31

31.0

1.250

1.249

 

10

3

26

27

24

24.0

0.998

0.997

 

 

 

 

 

 

27.7^

 

1.031^

43.1

Test Item

11

3

7

11

8

8.0

0.656

0.655

 

12

3

7

8

5

5.0

0.359

0.358

 

14

2

7

7

5

5.0

0.319

0.318

 

 

 

 

 

 

6.0^

 

0.443^

12.7

OD = Optical Density

*= Mean of the post-incubation – pre-treatment values

^= Mean corrected value

$=Mean permeability

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
No prediction of eye irritation can be made.
Executive summary:

Introduction

 

The purpose of this test was to identify test items that can induce serious eye damage and to identify test items not requiring classification for eye irritation or serious eye damage. The Bovine Corneal Opacity and Permeability (BCOP) test method is an organotypic model that provides short-term maintenance of normal physiological and biochemical function of the bovine cornea in vitro. In this test method, damage by the test item is assessed by quantitative measurements of changes in corneal opacity and permeability.

 

The test method can correctly identify test items (both chemicals and mixtures) inducing serious eye damage as well as those not requiring classification for eye irritation or serious eye damage, as defined by the United Nations (UN) Globally Harmonized System of Classification and Labelling of Items (GHS) and EU Classification, Labelling and Packaging (CLP) of chemicals (Regulation (EC) No 1272/2008), and it was therefore endorsed as scientifically valid for both purposes. Test items inducing serious eye damage are classified as UN GHS and EU CLP Category 1. Items not classified for eye irritation or serious eye damage are defined as those that do not meet the requirements for classification as UN GHS/EU CLP Category 1 or 2 (2A or 2B), i.e. they are referred to as UN GHS/EU CLP No Category.

 

Methods

 

The undiluted test item was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate anIn VitroIrritancy Score (IVIS).

 

Data Interpretation

 

The test item is classified according to the prediction model as follows:

 

IVIS

UN GHS

≤ 3

No category

> 3; ≤ 55

No prediction can be mae

> 55

Category 1

 

Results

 

TheIn Vitroirritancy scores are summarized as follows:

 

Treatment

In Vitro Irritancy Score

Test Item

12.7

Negative Control

0.0

Positive Control

43.1

 

Conclusion

 

No prediction of eye irritation can be made.