Trimethylvinylsilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10-13.10.2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Version / remarks:

29 July, 2016

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Method B.40 BIS: “In Vitro Skin Corrosion: Human Skin Model Test”

Version / remarks:

May 30, 2008

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

Trimethylvinylsilane

EC Number:

212-042-9

EC Name:

Trimethylvinylsilane

Cas Number:

754-05-2

Molecular formula:

C5H12Si

IUPAC Name:

trimethylvinylsilane

Specific details on test material used for the study:

purity: 99.59%

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: human-derived epidermal keratinocytes

Source strain:

other: not applicable

Vehicle:

unchanged (no vehicle)

Details on test system:

- Source: MatTek Corporation (82105 Bratislava, Slovakia).
- The EpiDerm™ tissue: normal, human-derived epidermal keratinocytes which have been cultured to
form a multilayered, highly differentiated model of the human epidermis.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

- Negative control: 50 µL distilled water
- Positive control: 50 µL 8 N KOH
- Test Item: 50 µL (undiluted)

Duration of treatment / exposure:

3 minutes treatment and 1 hour treatment

Number of replicates:

4 tissues per dose group, 2 replicates for each treatment period (3 min and 60 min exposure time)

Test system

Details on study design:

Details of the test procedure:
- Pre-incubation: the inserts containing the tissues were set into the incubator at 37 ± 1°C and 5.0% CO2 for 1 hour.
- For each experiment (“3 minutes” and “1 hour”), the plates were stored in the incubator at 37 ± 1°C
and 5.0% CO2.
- MTT medium: the tissues were incubated with MTT medium for 3 hours at 37 ± 1°C and 5.0%
CO2.

Data Analysis:
Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after 3 min and 60 min treatment compared to the negative control tissues concurrently treated with Aqua dest (= 100%) according to the Prediction Model (see table below).

Test Acceptance Criteria:
The test meets acceptance criteria if:
- mean OD570 nm of the two negative control tissues of the 3 min and 60 min treatment period is between 0.8 and 2.8,
- mean relative tissue viability of the two positive control tissues of the 60 min treatment period is < 15%,
- coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is <= 30%.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min treatment

Value:

96.1

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 min treatment

Value:

100.8

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The controls confirmed the validity of the study. The mean OD570 of the two negative control tissues was >= 0.8 and ≤ 2.8 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was < 15% (5.2%) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of all dose groups was <= 30% (0.3% - 8.0%).

Any other information on results incl. tables

Results of the 3 min Experiment

Name	Negative Control		Test Item		Positive Control
Tissue	1	2	1	2	1	2
Absolute OD570	1.356	1.554	1.422	1.405	0.22	0.235
	1.471	1.616	1.474	1.491	0.236	0.231
	1.479	1.639	1.479	1.498	0.231	0.235
OD570- Blank Corrected	1.312	1.51	1.378	1.361	0.176	0.191
	1.427	1.572	1.43	1.447	0.192	0.187
	1.435	1.595	1.435	1.454	0.187	0.191
Mean OD570of 3 Aliquots (blank corrected)	1.391	1.559	1.415	1.421	0.185	0.189
SD OD570 of 3 Aliquots	0.068	0.046	0.037	0.052	0.025	0.024
Total Mean OD570of 2 Replicate Tissues (Blank Corrected)	1.475^*		1.418		0.187
SD OD570 of 2 Replicate Tissues	0.119		0.004		0.003
Mean Relative Tissue	100		96.1		12.7^**
Viability [%]
Coefficient Of Variation [%]^***	8		0.3		1.7

^* corrected mean OD₅₇₀of the negative control corresponds to 100% absolute tissue viability.

^***  coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is <= 30%.

Results of the 60 min Experiment

Name	Negative Control		Test Item		Positive Control
Tissue	1	2	1	2	1	2
Absolute OD570	1.48	1.638	1.641	1.593	0.095	0.147
	1.542	1.686	1.643	1.569	0.148	0.102
	1.533	1.674	1.593	1.589	0.099	0.148
OD570- Blank Corrected	1.437	1.595	1.597	1.55	0.052	0.104
	1.499	1.643	1.6	1.525	0.105	0.059
	1.49	1.631	1.55	1.546	0.056	0.105
Mean OD570of 3 Aliquots (blank corrected)	1.475	1.623	1.583	1.541	0.071	0.089
SD OD570 of 3 Aliquots	0.034	0.033	0.034	0.026	0.035	0.034
Total Mean OD570of 2 Replicate Tissues (Blank Corrected)	1.549		1.562		0.08
SD OD570 of 2 Replicate Tissues	0.105		0.03		0.013
Mean Relative Tissue	100		100.8		5.2^**
Viability [%]
Coefficient Of Variation [%]^***	6.8		1.9		16.4

^* corrected mean OD₅₇₀of the negative control corresponds to 100% absolute tissue viability.

^** mean relative tissue viability of the 60 min positive control < 15%,

^*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is <= 30%.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.

Executive summary:

The potential of the test item vinyltrimethyl silane to induce skin corrosion was analysed by using the three-dimensional human skin model EpiDerm, comprising a reconstructed epidermis with a functional stratum corneum. The study was performed according to OECD TG 431 an in compliance to GLP.

In the present study vinyltrimethyl silane was applied topically to the EpiDerm tissue for 3 min and 60 min followed by immediate determination of cytotoxic effects via MTT reduction assay.

Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods had been compared to the corresponding negative control tissues.

The test item has no non-specific MTT-reducing or colouring potential, therefore no additional controls were necessary.

The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was >= 50% (96.1%) after 3 min treatment and >= 15% (100.8%) after 60 min treatment.

The controls confirmed the validity of the study. The mean OD₅₇₀of the two negative control tissues was >= 0.8 and ≤ 2.8 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was < 15% (5.2%) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of all dose groups was <= 30% (0.3% - 8.0%).

In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.