2-(2-methoxyethoxy)ethyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-methoxyethoxy)ethyl methacrylate

EC Number:

256-190-2

EC Name:

2-(2-methoxyethoxy)ethyl methacrylate

Cas Number:

45103-58-0

Molecular formula:

C9H16O4

IUPAC Name:

2-(2-methoxyethoxy)ethyl 2-methylprop-2-enoate

Test material form:

liquid

Specific details on test material used for the study:

2-(2-methoxyethoxy)ethyl methacrylate

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: Cultured human skin cells

Cell source:

other: Cultured human skin cells

Justification for test system used:

The EpiDerm™ Skin Model closely parallels human skin, and is recommended by test guidelines. Validation studies have reported that tests employing human skin models are able to reliably discriminate between known skin corrosives and non-corrosives.

Vehicle:

unchanged (no vehicle)

Details on test system:

EpiDerm™ tissues, Lot No. 27973 Kit D, were received from MatTek Corporation (Ashland, MA) on 06 Mar 2018 and refrigerated at 2-8°C.Before use, tissues were incubated (37±1°C, 5±1% CO2) with assay medium (MatTek) for a one-hour equilibration. Equilibration medium was replaced with fresh medium before dosing.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

50 µl of the test article were applied to the top of each EpiDerm™ tissue. A negative control (50 µl of TCH2O) and a positive control (50 µl of KOH) were tested in the same manner. Each treatment with test article or control was conducted in duplicate.

Duration of treatment / exposure:

MatTek EpiDerm™ tissues were treated in duplicate with the test article, negative control and positive control for 3 minutes and 60 minutes

Number of replicates:

Two

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

2-(2-methoxyethoxy)ethyl methacrylate (mean viability, 3 mins)

Value:

84.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

2-(2-methoxyethoxy)ethyl methacrylate (mean viability, 60 mins)

Value:

68.4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Skin Corrosion is defined as the production of irreversible tissue damage in skin following the application of test material. The percent viability calculated was used to determine corrosivity potential in the following manner:
Mean Viability (3 min.) < 50% = corrosive, Mean Viability (60 mins): Not applicable. From this predicted corrosivity = corrosive
Mean viability (3 min) ≥ 50 % = corrosive, Mean Viability (60 mins): < 15 % . From this predicted corrosivity = corrosive
Mean viability ( 3 min) ≥ 50 % = non-corrosive, Mean Viability (60 mins) :≥ 15 % . From this predicted corrosivity = non-corrosive

Predicted Corrosivity (60 min.) <50% Not Applicable Corrosive ≥50% <15% Corrosive ≥50% ≥15% Non-Corrosive

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

2-(2-methoxyethoxy)ethyl methacrylate was not corrosive under the conditions of the OECD TG 431 in vitro study.

Executive summary:

In accordance with  OECD TG 431, using a three dimensional human epidermis model, following GLP conditions, the skin corrosion potential of 2-(2-methoxyethoxy)ethyl methacrylate is not corrosive.