N-[3-(Triethoxysilyl)propyl]formamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 Oct 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD 437

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hess. Ministerium für Umwelt, Landwirtschaft und Forsten, Mainzer Straße 80, D-65189 Wiesbaden, Germany

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(triethoxysilyl)propyl]formamide

EC Number:

700-340-6

Cas Number:

76524-94-2

Molecular formula:

C10H23NO4Si

IUPAC Name:

N-[3-(triethoxysilyl)propyl]formamide

Details on test material:

- Name of test material (as cited in study report): Y-15864
- Analytical purity: 97.5 - 99.5%
- Lot/batch No.: TER00010-68-31
- Expiration date of the lot/batch: September 12, 2012
- Storage condition of test material: at room temperature in a closed container

Test animals / tissue source

Species:

other: isolated corneas from bovine

Strain:

other: isolated corneas from bovine

Details on test animals or tissues and environmental conditions:

not applicable

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: 3 corneas as negative controls treated with physiological saline 0.9% NaCl; 3 corneas as positive control treated with 2-Ethoxyethanol

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL

Duration of treatment / exposure:

First treatment: 10 min ± 30 sec
Second treatment: 120 min

Observation period (in vivo):

130 min
Reading time points: 10 min and 130 min

Number of animals or in vitro replicates:

other:
3 isolated corneas from bovine for the test item were used

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item were rinsed off from the application side with saline.
- Time after start of exposure: after 10 min

SCORING SYSTEM: The following formula was used to determine the in vitro score:
In vitro score = Mean Opacity Value + (15 x Mean OD490 Value)

Evaluation of the BCOP assay:
A mean in vitro Irritation Score > 55.1 leads to a classification as corrosive / severe irritant according to OECD guideline 437.

TOOL USED TO ASSESS SCORE: opacitometer / spectrophotometer / fluorescein

Additional information:
After the first incubation phase (10 min) the test item, the positive, and the negative controls were each rinsed from the corneae. The corneae were incubated for another 120 minutes at 32 ± 1 °C in complete medium, and opacity was measured a second time (t130).
After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrcally the transfer of fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

3/3

Time point:

other: 10 minutes

Score:

18.51

Reversibility:

other: not applicable

Irritant / corrosive response data:

Relative to the negative control, the test item did not cause a relevant increase of the corneal opacity or permeability. The positive control (2-Ethoxyethanl) showed clear opacity and distinctive permeability of the corneae.

Any other information on results incl. tables

Table 1: Results after 10 minutes incubation time

Test Group	Opacity value = Difference (t130-t0) of Opacity		Permeability at 490 nm (OD490)		In vitro Score	Mean in vitro Irritation Score	Proposed in vitro Irritation Score
		Mean		Mean
Negative Control	0	0.00	0.086	0.066	1.29	0.99	Non corrosive
	1		0.056		1.84
	-1		0.056		-0.16
Positive Control	63.00*		0.960*		77.40	71.07	Corrosive
	62.00*		0.401*		68.02
	51.00*		1.119*		67.79
Test item	21.00*		0.018*		21.27	18.51	Non corrosive
	14.00*		0.051*		14.77
	18.00*		0.099*		19.49

*corrected values

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Executive summary:

The eye irritancy potential of Y-15864 was investigated in the bovine corneal opacity and permeability assay according to OECD guideline 437. The test item was tested undiluted. A mean in vitro irritation score of 18.51 was calculated. Relative to the negative (mean in vitro irritation score = 0.99) and positive (mean irritation score = 71.07) control, the test item did not cause a relevant increase of the corneal opacity or permeability.

According to OECD 437 the test item is classified as not corrosive / not severe irritant to the eye.