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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:
2014-2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD and GLP guidelines, and was 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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: The Ocular Toxicity Working Group (OTWG) of the ICCVAM and the(NICEATM),Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The BCOP Test Method, March 2006.
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006.
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992.
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Reaction mass of (1,1’ oxybis(ethylbenzene) and styrene, oligomers
IUPAC Name:
Reaction mass of (1,1’ oxybis(ethylbenzene) and styrene, oligomers
Constituent 2
Reference substance name:
SMPO Heavy Ends
IUPAC Name:
SMPO Heavy Ends
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): SMPO Heavy Ends; Reaction mass of (1,1’ oxybis(ethylbenzene) and styrene, oligomers

- Substance type: UVCB
- Physical state: Brown liquid
- Analytical purity: 100%
- Purity test date: No data
- Lot/batch No.: BC604 17-10-2014
- Expiration date of the lot/batch: No data
- Stability under test conditions: Not indicated
- Storage condition of test material: At room temperature protected from light

Test animals / tissue source

Species:
other: in vitro

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL undiluted

Results and discussion

In vivo

Results
Irritation parameter:
other: mean IVIS (in vitro irritancy score)
Basis:
mean
Time point:
other: 10 minutes
Score:
17.9
Remarks on result:
other: 17.9 >3; = 55: no prediction on the classification can be made.

Any other information on results incl. tables

SMPO Heavy Ends was tested neat.

Table 1 summarizes the opacity, permeability and in vitro irritancy scores of SMPO Heavy Ends and the controls. The opacity, permeability and in vitro scores of the individual corneas are shown in Table 2-5.

The individual in vitro irritancy scores for the negative controls ranged from -3.0 to 1.0. The individual positive control in vitro irritancy scores ranged from 131 to 153 for Benzalkonium Chloride. The corneas treated with the positive control substance were turbid after the 10 minutes of treatment.

The corneas treated with SMPO Heavy Ends showed opacity values ranging from 14 to 17 and permeability values ranging from 0.018 to 0.465. The corneas were turbid after the 10 minutes of treatment with SMPO Heavy Ends. No pH effect of the test substance was observed on the rinsing medium, however the test substance was difficult to remove. Hence, the in vitro irritancy scores ranged from 15.5 to 21.0 after 10 minutes of treatment with SMPO Heavy Ends.

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.

The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 144 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

SMPO Heavy Ends induced ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 17.9 after 10 minutes of treatment.

Since SMPO Heavy Ends induced an IVIS > 3 = 55, no prediction on the classification can be made.

 

Table 1. Summary of opacity, permeability andin vitroscores

Treatment

Mean

Opacity1

Mean

Permeability1

Mean In vitro

Irritation Score1, 2

Negative control

-1

0.000

-0.7

Positive control

(Benzalkonium Chloride)

91

3.571

144.2

SMPO Heavy Ends

15

0.172

17.9

 

1Calculated using the negative control mean opacity and mean permeability values.

2In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).

 

Table 2. Opacity score

Eye

Opacity before treatment

Opacity after treatment

Final Opacity1

Negative control corrected Final Opacity2

Mean Opacity

Negative control

1

3

0

-3

-3

 

-1

2

0

0

0

0

3

3

4

1

-1

 

Mean final opacity: -1

 

Positive control

4

1

86

85

85

 

91

5

1

106

105

105

6

1

83

82

82

SMPO Heavy Ends

16

0

14

14

14

 

15

17

2

17

15

15

18

0

17

17

17

 

1Final Opacity = Opacity after treatment – Opacity before treatment.

2Negative control corrected Final Opacity = Final opacity – Mean final opacity negative control.

 

Table 3. Permeability score individual values (uncorrected)

Eye

Dilution factor

OD490

1

OD490

2

OD490

3

Average OD

Final OD1

Mean final negative control

Negative control

1

1

0.006

0.012

0.004

0.007

0.007

0.007

2

1

0.005

0.005

0.006

0.005

0.005

 

3

1

0.009

0.008

0.009

0.009

0.009

 

Positive control (Benzalkonium Chloride)

 

4

6

0.520

0.522

0.524

0.522

3.132

 

5

6

0.525

0.468

0.470

0.488

2.926

 

6

6

0.795

0.790

0.806

0.797

4.782

 

SMPO Heavy Ends

 

16

1

0.477

0.464

0.474

0.472

0.472

 

17

1

0.039

0.041

0.040

0.040

0.040

 

18

1

0.025

0.025

0.025

0.025

0.025

 

 

1Final OD = Average OD x Dilution factor.

 

Table 4. Permeability score individual values (corrected)

Eye

Dilution factor

Negative control corrected OD490 11

Negative control corrected OD490 21

Negative control corrected OD490 31

Negative control corrected OD490

Average

Negative control corrected final OD490

Average

OD

Negative control

1

1

-0.001

0.005

-0.03

0.000

0.000

 

0.000

2

1

-0.002

-0.002

-0.01

-0.002

-0.002

3

1

0.002

0.001

0.002

0.002

0.002

Positive control (Benzalkonium Chloride)

4

6

0.513

0.515

0.517

0.515

3.089

 

3.571

 

5

6

0.518

0.461

0.463

0.481

2.883

6

6

0.788

0.783

0.799

0.790

4.739

SMPO Heavy Ends

16

1

0.470

0.457

0.467

0.465

0.465

 

0.172

17

1

0.032

0.034

0.033

0.033

0.033

18

1

0.018

0.018

0.018

0.018

0.018

 

1OD490 values corrected for the mean final negative control permeability (0.007).

 

 

Table 5.In vitroirritancy score

Eye

Negative control corrected Final Opacity

Negative control corrected Final OD490

In vitroIrritancy Score1

Negative control

1

-3

0.000

-3.0

2

0

-0.002

0.0

3

1

0.002

1.0

Positive control (Benzalkonium Chloride)

4

85

3.089

131.3

5

105

2.883

148.3

6

82

4.739

153.1

SMPO Heavy Ends

16

14

0.465

21.0

17

15

0.033

15.5

18

17

0.018

17.3

 

1In vitro irritancy score (IVIS) = opacity value + (15 x OD490 value).

Applicant's summary and conclusion

Interpretation of results:
other: no prediction on the classification can be made
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Since SMPO Heavy Ends induced an IVIS > 3 = 55, no prediction on the classification can be made in this BCOP test .
Executive summary:

Screening for the eye irritancy potential of SMPO Heavy Ends using the Bovine Corneal Opacity and Permeability test (BCOP test).The substance was tested through topical application for 10 ± 1 minutes. Batch BC604 14-10-2014 of SMPO Heavy Ends was a brown liquid with a purity of 100%. The test substance was applied as it is (750 µL) directly on top of the corneas.

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% w/v) Benzalkonium Chloride) was 144 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

SMPO Heavy Ends induced ocular irritation throughout both endpoints, resulting in a mean in vitro irritancy score of 17.9 after 10 minutes of treatment. Since SMPO Heavy Ends induced an IVIS > 3 = 55, no prediction on the classification can be made.

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