Silane, triethyl[[4-(triethylsilyl)-3-butyn-1-yl]oxy]-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 May 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study described in this report has been correctly reported and was conducted in compliance with: The Organization for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP) (as revised in 1997) ENV/MC/CHEM (98) 17.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

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)

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

triethyl({[4-(triethylsilyl)but-3-yn-1-yl]oxy})silane

EC Number:

605-200-7

Cas Number:

160194-28-5

Molecular formula:

C16H34OSi2

IUPAC Name:

triethyl({[4-(triethylsilyl)but-3-yn-1-yl]oxy})silane

Details on test material:

- Name of test material (as cited in study report): Bis-Tes (dried)
- Molecular formula (if other than submission substance): C16H34OSi2
- Molecular weight (if other than submission substance): 298

Test animals / tissue source

Species:

other: bovine cornea

Details on test animals or tissues and environmental conditions:

Bovine eyes were used as soon as possible after slaughter on the same day.

Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's
Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse
employee as soon as possible after slaughter.

Transport: Eyes were collected and transported in physiological saline in a suitable container
under cooled conditions.

The isolated corneas were stored in a petri dish with cMEM (Eagle’s Minimum Essential Medium containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum. The isolated corneas were mounted in a corneal holder (one cornea per holder) of MC2 with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32 +/- 1C. The corneas were incubated for the minimum of 1 hour at 32 +/- 1 C.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: positive and negative controls

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750µl

Duration of treatment / exposure:

10 ± 1 minutes at 32± 1˚C

Observation period (in vivo):

none

Details on study design:

REMOVAL OF TEST SUBSTANCE
-After exposure the cornea was thoroughly rinsed to remove the test substance and incubated for 2 hours with fresh medium

SCORING SYSTEM: 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)
Additionally the opacity and permeability values were evaluated independently to determine whether the test substance induced irritation through only one of the two endpoints.

TOOL USED TO ASSESS SCORE: . Opacity measurement and the permeability of the corneas was determined after a 90 minutes incubation
period with sodium fluorescein.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 10 minutes

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within: 10 mins

Remarks on result:

other: BCOP

Irritant / corrosive response data:

The corneas treated with Bis-Tes (dried) showed opacity values ranging from 0 to 2 and permeability
values ranging from 0.001 to 0.002. The corneas were clear after the 10 minutes of treatment with BisTes
(dried). No pH effect of the test substance was observed on the rinsing medium. Hence, the in
vitro irritancy scores ranged from 0.0 to 2.0 after 10 minutes of treatment with Bis-Tes (dried).

Other effects:

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 126
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.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It is concluded that this test is valid and that Bis-Tes (dried) is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
Since Bis-Tes (dried) induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.

Executive summary:

Screening for the eye irritancy potential of Bis-Tes (dried) using the Bovine Corneal Opacity and

Permeability test (BCOP test).

This report describes the ocular irritation properties of Bis-Tes (dried) on an isolated bovine cornea.

The possible ocular irritancy of Bis-Tes (dried) was tested through topical application for

10 ± 1 minutes.

The study procedures described in this report were based on the most recent OECD and EC

guidelines.

Batch 209-3 of Bis-Tes (dried) was a pale yellow liquid. 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 126

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.

Bis-Tes (dried) did not induce ocular irritation through both endpoints, resulting in a mean in vitro

irritancy score of 1.0 after 10 minutes of treatment.

Finally, it is concluded that this test is valid and that Bis-Tes (dried) is not irritant or corrosive in the

Bovine Corneal Opacity and Permeability test under the experimental conditions described in this

report.

Since Bis-Tes (dried) induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye

damage.