Methyl [3-(trimethoxysilyl)propyl]carbamate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2014-10-14 to 2014-10-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

(2013)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Methyl [3-(trimethoxysilyl)propyl]carbamate

EC Number:

245-659-7

EC Name:

Methyl [3-(trimethoxysilyl)propyl]carbamate

Cas Number:

23432-62-4

Molecular formula:

C8H19NO5Si

IUPAC Name:

methyl N-[3-(trimethoxysilyl)propyl]carbamate

Details on test material:

- Name of test material (as cited in study report): Methyl [3-(trimethoxysilyl)propyl]carbamate
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: at RT, protect from light, avoid humidity

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: human-derived epidermal keratinocytes (EpiDerm)

Justification for test system used:

This test uses the EpiDerm(TM) reconstructed human epidermis model (MatTek) which consists of human keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological porperties of the upper part of the human, i.e. the epidermis.

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm(TM) tissues were provided as kits (EPI-200-SIT, MatTek)

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C
- Temperature of post-treatment incubation: 37 ± 1°C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: washed intensively with DPBS for 1 min
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: none

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/mL
- Incubation time: 3 h
- Spectrophotometer: plate spectrophometer
- Wavelength: 550 nm


NUMBER OF REPLICATE TISSUES: 3


NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1

DECISION CRITERIA
- The test substance is considered to be irritant to skin if the viability after 15 minutes exposure and 42 hours post-exposure is less than or equal to 50%.
- The test substance is considered to be not irritant to skin if the viability after 15 minutes exposure 42 hours post-exposure is greater than 50% and the viability.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: 30 µL

NEGATIVE CONTROL
- Amount applied: 30 µL DBPS

POSITIVE CONTROL
- Amount applied: 30 µL
- Concentration: 5% (v/v)

Duration of treatment / exposure:

60 min

Duration of post-treatment incubation (if applicable):

42 h

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

test group

Value:

96.2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no

DEMONSTRATION OF TECHNICAL PROFICIENCY: yes

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes

Any other information on results incl. tables

EXPERIMENTAL RESULTS:

	Negative control			Positive control			Test item
Tissue sample	1	2	3	1	2	3	1	2	3
OD550	1.592 1.564	1.451 1.499	1.449 1.391	0.044 0.044	0.038 0.037	0.037 0.038	1.540 1.563	1.429 1.395	1.343 1.340
OD550(mean)	1.578	1.475	1.420	0.044	0.038	0.038	1.552	1.412	1.342
SD	0.080			0.003			0.107
OD550(mean values of replicates)	1.491			0.040			1.435
Viability (%)	100			2.7			96.2

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In an in vitro skin irritation human skin model test (EpiDerm) according to OECD guideline 439 and in compliance with GLP, a cell viability of 96.2% was measured after 60 min exposure and 42 h post-exposure time when compared to the untreated control. Therefore, the test item should be classified as non-irritant to the skin.