2-[3-(9-butyl-1,1,3,3,5,5,7,7,9,9-decamethylpentasiloxanyl)propoxy]ethyl methacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 July, 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Version / remarks:

(2009)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Version / remarks:

(2010)

Deviations:

no

Principles of method if other than guideline:

- The Ocular Toxicity Working Group (OTWG) of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Interagency Centre for the Evaluation of Alternative Toxicological Methods (NICEATM), Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The Bovine Corneal Opacity and Permeability (BCOP) Test Method, March 2006.
- In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006.
- 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.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[3-(9-butyl-1,1,3,3,5,5,7,7,9,9-decamethylpentasiloxanyl)propoxy]ethyl methacrylate

EC Number:

801-072-3

Cas Number:

1052075-57-6

Molecular formula:

C23H54O7Si5

IUPAC Name:

2-[3-(9-butyl-1,1,3,3,5,5,7,7,9,9-decamethylpentasiloxanyl)propoxy]ethyl methacrylate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): KF-1622
- Description: Clear colourless liquid

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 32 ± 1

Test system

Amount / concentration applied:

TEST MATERIAL
- Amount applied (volume): approx. 750 µL per cornea

NEGATIVE CONTROL
- Amount applied (volume): 750 µL of physiological saline per cornea

POSITIVE CONTROL
Amount applied (volume): 750 µL per cornea
Concentration: 10% (w/v) Benzalkonium Chloride

Duration of treatment / exposure:

10 minutes

Details on study design:

TEST SITE
- Isolated bovine cornea. Three corneas were selected at random for each treatment group.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 10 minutes

SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.

- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:

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


TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader

DATA EVALUATION:
A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant

Results and discussion

In vivo

Results

Irritation parameter:

other: In vitro irritancy score (IVIS)

Basis:

mean

Time point:

other: 10 minutes

Score:

0

Remarks on result:

other: The mean in vitro irritancy score of the negative control was 0 and that of the positive control (10% (w/v) Benzalkonium Chloride) was 145.

Irritant / corrosive response data:

The corneas treated with KF-1622 showed opacity values ranging from -1 to 1 and permeability values ranging from -0.001 to 0.002. The corneas were clear after the 10 minutes of treatment with KF-1622. No pH effect of the test substance was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -1 to 1 after 10 minutes of treatment with KF-1622.

Any other information on results incl. tables

Historical control data were included. The negative control responses of the opacity and permeability values 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 IVIS of the positive control (10% (w/v) Benzalkonium Chloride) was 145 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance KF-1622 is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test performed according to OECD 437 guideline and GLP principles.

Executive summary:

The substance KF-1622 was screened for the eye irritancy potential using the BCOP test performed according to OECD 437 guideline and GLP principles.

The negative control responses of the opacity and permeability values 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 IVIS of the positive control (10% (w/v) Benzalkonium Chloride) was 145 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

The substance did not induce ocular irritation through both endpoints, resulting in a mean IVIS of 0 after 10 minutes of treatment.

Based on the results it is concluded that the substance is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test.

Acceptability test and interpretation results:

The BCOP test method is recommended by authorities to identify the eye hazard potential of a test chemical. This test method is also recommended to identify chemicals that do not require classification for eye irritation or serious eye damage, as defined by the UN GHS, in case IVIS ≤ 3.

As in the present study with KF-1622 an IVIS of 0 was obtained, indicating no irritating properties for KF-1622, further testing for eye irritating properties is considered redundant and ethically not justified.