Bis(2-ethylhexyl) succinate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 November 2012 to 21 December 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

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)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) succinate

EC Number:

220-836-1

EC Name:

Bis(2-ethylhexyl) succinate

Cas Number:

2915-57-3

Molecular formula:

C20H38O4

IUPAC Name:

1,4-bis(2-ethylhexyl) butanedioate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Bis(2-ethylhexyl) Succinate
- Storage condition of test material: In a sealed container, at room temperature, in the dark

Test animals / tissue source

Species:

cattle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Details on study design:

Measurement of pH
As a preliminary test, the pH of the test material was checked. A 50 % w/v dispersion in purified waster had a pH of 4. Since this was within the acceptable range of pH 2.0 - 11.5, the study continued.

BCOP Assay
Fresh corneas, mounted onto specifically designed holders were treated topically with the test material. Eye corrosion / severe irritation potential was based on the combined effect of the test material on the opacity of the cornea following the treatment and the cornea’s ability to resist penetration of a fluorescent dye through the tissue. The assay was conducted in accordance with OECD Guidelines for Testing of Chemicals Method 437 (adopted 7 September 2009).

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Run / experiment:

Mean corrected opacity

Value:

1.7

Negative controls validity:

valid

Remarks:

Mean corrected capacity = 0

Positive controls validity:

valid

Remarks:

Mean corrected capacity = 50

Results 2

Irritation parameter:

other: Corneal Permeability

Run / experiment:

Mean group Corrected OD490

Value:

-0.024

Negative controls validity:

valid

Remarks:

Mean group Corrected OD490 = 0

Positive controls validity:

valid

Remarks:

Mean group Corrected OD490 = 0.217

Results 3

Irritation parameter:

in vitro irritation score

Run / experiment:

IVIS (mean opacity + (15 x mean permeability))

Value:

1.31

Negative controls validity:

valid

Remarks:

IVIS = 0

Positive controls validity:

valid

Remarks:

IVIS = 53.26

Other effects / acceptance of results:

The test material produced an IVIS score of 1.31 and was considered not to be corrosive or severely irritating to the eye.

The results for the negative and positive control articles met the acceptance criteria specified in the protocol.

Any other information on results incl. tables

Table 1: Corneal Opacity

Test substance	Cornea number	Initial opacity	Post incubation opacity	Change in opacity	Mean change in opacity	Corrected opacity	Mean corrected opacity
Test material	35	5	8	3	N/A	1.3	1.7
	37	3	6	3		1.3
	39	2	6	4		2.3
Negative control	13	3	3	0	1.67	-1.7	0
	15	3	6	3		1.3
	36	4	6	2		0.3
Positive control	8	2	60	58	N/A	56.3	50
	16	3	61	58		56.3
	17	3	42	39		37.3

Table 2: Corneal Permeability

Test substance	Cornea number	Mean blank OD490	OD490	Corrected OD490	Mean Corrected OD490	Final Corrected OD490	Mean group Corrected OD490
Test material	35	-	0.035	0.035	N/A	-0.018	-0.024
	37		0.011	0.011		-0.043
	39		0.043	0.043		-0.01
Negative control	13	0	0.062	0.062	0.053	0.009	0
	15		0.041	0.041		-0.012
	36		0.056	0.056		0.003
Positive control	8	-	0.304	0.304	N/A	0.251	0.217
	16		0.298	0.298		0.245
	17		0.21	0.21		0.157

Table 3: Calculated IVIS

Test substance	Mean opacity	Mean permeability	IVIS (mean opacity + (15 x mean permeability))
Negative control	0	0	0
Positive control	50	0.217	53.26
Test article	1.7	-0.024	1.31

The test material produced an IVIS score of 1.31 and was considered not to be corrosive or severely irritating to the eye.

The results for the negative and positive control articles met the acceptance criteria specified in the protocol.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study, the test material was considered not to be corrosive or severely irritating to the eye.

Executive summary:

The purpose of the study was to determine the eye corrosion potential of the test material following the standardised guideline OECD 437. The study was conducted under GLP conditions. Bovine corneas were used and the effect of the test substance on opacicity and permeability was examined.

Under the conditions of the study the test material was considered not to be corrosive or severely irritating to the eye. The in vivo test was therefore conducted.