Formaldehyde, reaction products with ethylenediamine

Eye irritation

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

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. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

84066-92-2

Cas Number:

84066-92-2

IUPAC Name:

84066-92-2

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.