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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:
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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.