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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 30, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline 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)
Principles of method if other than guideline:
The Bovine Corneal Opacity and Permeability (BCOP) test method is an ex vivo test method that can be used to classify substances as “ocular corrosives and severe irritants”. The BCOP is recommended for use as part of a tiered-testing strategy for regulatory classification and labelling within a specific applicability domain. Test substances can be classified as ocular corrosives or severe irritants without further testing in rabbits.
To ensure test method integrity the data of the BCOP assay (Bovine Corneal Opacity and Permeability Assay), reference substances are tested in parallel to the test item.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name: Formaldehyde, reaction product with ethylenediamine
CAS No.: 84066-92-2
Batch No.: PK280-61
Physical State: liquid
Colour: colourless to yellow
Purity: 100%

Test animals / tissue source

Species:
cattle

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
ca. 29
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

The eye irritancy potential of Formaldehyde, reaction product with ethylenediamine was investigated in the bovine corneal opacity and permeability assay.

The following mean in vitro irritation score was calculated: 29.32

Therefore the test item was classified as moderate irritant.

The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.

OPACITY

Cornea No.

Test Item

Initial Opacity

Final Opacity

Change of Opacity Value

Corrected Opacity Value

1

Negative Control

3

7

4

 

2

3

3

0

 

3

3

4

1

 

MV

3.0

4.67

1.67

 

4

Positive

Control

4

101

97

95.33

5

4

59

55

53.33

6

4

69

65

63.33

MV

4.0

76.33

72.33

70.67

7

Test Item

2

35

33

31.33

8

2

32

30

28.33

9

2

32

30

28.33

MV

2.0

33.00

31.00

29.33

PERMEABILITY

Cornea No.

Test Item

OD490

Corrected OD490 Value

1

Negative Control

0.038

 

2

0.024

 

3

0.031

 

MV

0.031

 

4

Positive

Control

0.370

0.039

5

0.183

0.152

6

0.328

0.297

MV

0.294

0.263

7

Test Item

0.037

0.006

8

0.004

-0.027

9

0.049

0.018

MV

0.030

-0.001

IN VITRO IRRITATION SCORE

Cornea No.

Test Item

Corrected Opacity Value

Corrected OD490 Value

IVIS

1

Negative Control

4.00

0.038

 

2

0.00

0.024

 

3

1.00

0.031

 

MV

1.67

0.031

2.13

4

Positive

Control

95.33

0.039

 

5

53.33

0.152

 

6

63.33

0.297

 

MV

70.67

0.263

74.61

7

Test Item

31.33

0.006

 

8

28.33

-0.027

 

9

28.33

0.018

 

MV

29.33

-0.001

29.32

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Formaldehyde, reaction product with ethylenediamine is classified as Eye Irrit 2
Executive summary:

The test was considered valid to confirm classification as Eye Irrit 2 being needed. No further animal testing is justified.