N-[3-(Triethoxysilyl)propyl]formamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

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

Qualifier:

according to guideline

Guideline:

other: OECD 439 ( In vitro skin irritation: Reconstructed human epidermis test method)

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
- Physical state: liquid
- 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

Species:

human

Details on test animals or test system and environmental conditions:

TEST SYSTEM:
EpiSkin™ Kit Lot No.: 11-EKIN-041
Source: SkinEthic Laboratories (69007 Lyon, France).
Cells: Normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
Culture: The EpiSkin™ tissues (surface 0.38 cm²) are cultured on specially prepared cell culture inserts.

ENVIRONMENTAL CONDITIONS
EpiSkin™ tissues were shipped with ice packs on medium-supplemented agarose gels in a 12-well plate and reached Harlan CCR on November 08, 2011. On day of experiment EpiSkin™ tissues were transferred to 12-well plates with maintenance medium.

Test system

Type of coverage:

open

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL

Duration of treatment / exposure:

15 ± 1 min

Observation period:

42 hours further incubation after washing off residual test item

Number of animals:

Triplicates

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: after 15 minutes incubation

SCORING SYSTEM:
Cell viability was assessed by the OD derived by the MTT-Assay. The mean OD of the three negative control tissues was calculated. This value corresponds to 100% tissue viability in the current test. For each individual tissue treated with the test item or the positive control the individual relative tissue viability is calculated according to the following formula:
Relative viability [%] = (OD test item/OD negative control ) x 100

For the current test, an irritation potential of a test item according to EU classification R38 (according to directive 67/548/EEC), H315 (according to regulation (EC) 1272/2008) is recommended if the mean relative tissue viability of three individual tissues is reduced below 50% of the negative control.

CONTROLS:
Negative control: deionised water
Positive control: 5% Sodium lauryl sulfate

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: relative absorbance values

Value:

88.9

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 15 min. Max. score: 100.0. Reversibility: other: not applicable. (migrated information)

Any other information on results incl. tables

Table 1: Results after treatment with Y-15864 and controls

Dose group	Treat-ment Interval	Absorbance 570 nm Tissue 1*	Absorbance 570 nm Tissue 2*	Absorbance 570 nm Tissue 3*	Mean Absorbance of 3 Tissues	Relative Absorbance [%] Tissue 1, 2 + 3**	Standard Deviation [%]	Rel. Absorbance [% of Negative Control]***
Negative Control	15 min	1.335	1.251	1.299	1.295	103.1 96.6 100.3	3.3	100.0
Positive Control	15 min	0.277	0.254	0.271	0.268	21.4 19.6 21.0	0.9	20.7
Test Item	15 min	1.077	1.210	1.168	1.151	83.2 93.4 90.2	5.2	88.9

* Mean of two replicate wells after blank correction

** relative absorbance per tissue (rounded values)

*** relative absorbance per treatment group (rounded values)

The positive and negative control values were within the ranges of historical control data fromJuly 2007 – May 2011.

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:

An in vitro skin irritation test was performed according to OECD guideline 439 (In vitroSkin Irritation: Reconstructed Human Epidermis Test Method). Tissue samples were treated in triplicates with Y-15864, deionised water (negative control) and 5% sodium lauryl sulfate (positive control) for 15 minutes. Test items were washed off and after further 42 hours incubation the viability of the cells was determined by the OD570 in a MTT-Assay. After treatment with the test item Y-15864 the relative absorbance values decreased to 88.9%. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.