bis[2-(2-butoxyethoxy)ethyl] succinate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study complies to OECD Test Guidance 437 and GLP, and is considered to be relevant, adequate and reliable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

bis[2-(2-butoxyethoxy)ethyl] succinate

EC Number:

807-645-4

Cas Number:

701920-77-6

Molecular formula:

C20H38O8

IUPAC Name:

bis[2-(2-butoxyethoxy)ethyl] succinate

Constituent 2

Reference substance name:

bis[2-(2-butoxyethoxy)ethyl]butanedioate

IUPAC Name:

bis[2-(2-butoxyethoxy)ethyl]butanedioate

Constituent 3

Reference substance name:

bis[2-(2-butoxyethoxy)ethyl]succinate

IUPAC Name:

bis[2-(2-butoxyethoxy)ethyl]succinate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): bis[2-(2-butoxyethoxy)ethyl]butanedioate; Di-butoxy-ethoxy-ethyl succinate ; bis[2-(2-butoxyethoxy)ethyl]succinate
- Substance type: Organic mono constituent substance
- Physical state: Colourless liquid
- Analytical purity: 97.1%
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 91.7%
- Purity test date: 08/07/2014
- Lot/batch No.: 20142205JC
- Expiration date of the lot/batch: Not applicable
- Stability under test conditions: stable
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:

other: ex vivo

Strain:

other: Bovine cornea

Details on test animals or tissues and environmental conditions:

The assay uses isolated corneas obtained as a by-product from animals freshy slaughtered at the abattoir A. Moksel AG, Buchloe, Germany. On the test day, fresh eyes were collected from the slaughterhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories. Immediately after arrival of the eyes, cornea preparation was initiated.

Test system

Amount / concentration applied:

The test item was used as provided by the sponsor.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: IVIS

Basis:

mean

Score:

-1.05

Max. score:

3

Remarks on result:

other: Test group

Results 2

Irritation parameter:

other: IVIS

Basis:

mean

Score:

2.28

Max. score:

3

Remarks on result:

other: Negative control group

Results 3

Irritation parameter:

other: IVIS

Basis:

mean

Score:

72.12

Max. score:

55

Remarks on result:

other: Positive control group

Any other information on results incl. tables

The eye irritancy potential of bis[2-(2-butoxyethoxy)ethyl]butanedioate was investigated in the bovine corneal opacity and permeability assay.
The test item was tested as provided by the sponsor.

The following mean in vitro irritation score was calculated: -1.05.

Therefore the test item was classified into UN GHS No Category.
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.

 

Table 1. Opacity

Cornea No.	Test item	Initial Opacity	Final Opacity	Change of Opacity Value	Corrected Opacity Value
1	Negative Control	4	7	3
2		4	4	0
3		4	5	1
MV		4.00	5.33	1.33
4	Positive Control	5	58	53	51.67
5		5	61	56	54.67
6		5	55	50	48.67
MV		5.00	58.00	53.00	51.67
7	Test item	3	4	1	-0.33
8		5	5	0	-1.33
9		5	5	0	-1.33
MV		4.33	4.67	0.33	-1.00

MV = mean value

 

Table 2. Permeability

Cornea No.	Test item	OD490	Corrected OD490 Value
1	Negative Control	0.043
2		0.082
3		0.065
MV		0.063
4	Positive Control	1.778	1.715
5		2.010	1.947
6		0.493	0.430
MV		1.427	1.364
7	Test item	0.083	0.020
8		0.072	0.009
9		0.025	-0.038
MV		0.060	-0.003

MV = mean value

 

Table 3. In Vitro Irritation Score

Cornea No.	Test item	Corrected Opacity	Corrected OD490 Value	IVIS
1	Negative Control	3.00	0.043	2.28
2		0.00	0.082
3		1.00	0.065
MV		1.33	0.063
4	Positive Control	51.67	1.715	72.12
5		54.67	1.947
6		48.67	0.430
MV		51.67	1.364
7	Test item	-0.33	0.020	-1.05
8		-1.33	0.009
9		-1.33	-0.038
MV		-1.00	-0.003

MV = mean value

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the evaluation criteria the test item bis[2-(2-butoxyethoxy)ethyl]butanedioate is classified into UN GHS No Category.

Executive summary:

The eye irritancy potential of bis[2-(2-butoxyethoxy)ethyl]butanedioate was investigated in the bovine corneal opacity and permeability assay.

Preparation of the test item was tested as provided by the sponsor (undiluted, 97.1% purity).The assay used three isolated corneas per group obtained as a by-product from animals freshy slaughtered, and both opacity and permeability were measured after 10 minutes incubation at 32+1°C of 750 µL of test/control substance and washing/2h incubation of the epithelium with RPMI medium at 32+1°C. The Mean in vitro irritation score (IVIS) for the tested group was -1.05, which was <3.

The in vitro irritation score obtained with the positive control fell within the expected ranges (<3 and >55, respectively).

According to the evaluation criteria the test item bis[2-(2-butoxyethoxy)ethyl]butanedioate is not classified by the UN GHS or EU CLP criteria.