Allyltrimethylsilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 to 08 March 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

29 July 2016

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Allyltrimethylsilane

EC Number:

212-104-5

EC Name:

Allyltrimethylsilane

Cas Number:

762-72-1

Molecular formula:

C6H14Si

IUPAC Name:

allyltrimethylsilane

Test material form:

liquid

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: Human donors

Source strain:

not specified

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Reconstructed Human Epidermis Model Kit
- Tissue batch number(s): 28686
- Delivery date: 05 March 2019
- Date of initiation of testing: 06 March 2019

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

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Rinsing was achieved by filling and emptying each tissue under a constant soft stream of Dulbecco's Phosphate Buffered Saline (DPBS) (without Ca++ Mg++) for approximately 40 seconds, to gently remove any residual test item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL MTT solution
- Incubation time: 3 hours
- Spectrophotometer: yes
- Wavelength: 570 nm
- Filter: Yes
- Filter bandwidth: 10 nm

NUMBER OF REPLICATE TISSUES: The test was performed on a total of 6 tissues for each test item and for the negative and positive controls, with 2 replicates for each treatment period (3 min and 60 min).

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
Three independent experiments were conducted with the following exposure periods: 3 min and 60 min

PREDICTION MODEL / DECISION CRITERIA
A substance was considered corrosive if tissue viabilities were < 50% after 3 min exposure or if tissue viabilities were ≥ 50% after 3 min exposure AND < 15% after 60 min exposure. If a substance was considered corrosive, it was classified as Category 1A if tissue viabilities were < 20% after 3 min exposure. It was classified as Category 1B/1C if tissue viabilities were ≥ 25% after 3 min exposure. A substance was considered non-corrosive if tissue viabilities were ≥ 50% after 3 min exposure AND ≥ 15% after 60 min exposure.

The test meets acceptance criteria if:
- The mean OD570 of the two negative control tissues was between ≥ 0.8 and ≤ 2.8 for each exposure time.
- The mean relative tissue viability of the 60-minute positive control is < 15%.

In the range 20 and 100% viability, the Coefficient of Variation between tissue replicates should be ≤ 30%.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied: 50 µL
- Concentration: undiluted

NEGATIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: undiluted

POSITIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: 8.0N Potassium Hydroxide

Duration of treatment / exposure:

3 min or 60 min

Duration of post-treatment incubation (if applicable):

3 hours

Number of replicates:

The test was performed on a total of 6 tissues for each test item, negative control, and positive control, 2 replicates for each treatment period (3 min and 60 min).

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min

Value:

87.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 min

Value:

98.4

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: The test item showed no visible damage to the test system.
- Direct-MTT reduction: The test item showed no non-specific MMT-reducing potential.
- Colour interference with MTT: The solution containing the test item did not become colored. This was taken to indicate the test item did not have the potential to cause color interference.

DEMONSTRATION OF TECHNICAL PROFICIENCY: The test item showed no corrosive effects. All test acceptance criteria were met. Positive and negative controls responded appropriately. The maximum inter-tissue viability difference of replicate tissues fell within the acceptance criteria.

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD570 for the negative control treated tissues was 2.469 for the 3-Minute exposure period and 2.314 for the 60-Minute exposure period. The negative control acceptance criteria were therefore satisfied.
- Acceptance criteria met for positive control: The relative mean tissue viability for the positive control treated tissues was 2.5% relative to the negative control following the 60-Minute exposure period. The positive control acceptance criterion was therefore satisfied.
- Acceptance criteria met for variability between replicate measurements: In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.

Applicant's summary and conclusion

Interpretation of results:

other: Non-corrosive according to Regulation (EC) No 1272/2008

Conclusions:

In an in vitro skin corrosion human skin model test according to OECD guideline 431 and in compliance with GLP, cell viabilities of 98.4% after 60 minutes of exposure, and 87.5% after 3 minutes of exposure were measured when compared to the untreated control. Therefore, the test item should not be classified as corrosive.