3-(1-ethoxyethyl)-5-methyl-oxazolidin-2-one

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:

2017

Report date:

2017

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-(1-ethoxyethyl)-5-methyl-oxazolidin-2-one

EC Number:

814-994-6

Cas Number:

123403-95-2

Molecular formula:

C8H15NO3

IUPAC Name:

3-(1-ethoxyethyl)-5-methyl-oxazolidin-2-one

Test material form:

liquid

In vitro test system

Test system:

human skin model

Vehicle:

unchanged (no vehicle)

Details on test system:

Three-dimensional human epidermis model
The EpiDermTM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, 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. The EpiDermTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm diameter) and commercially available as kits (EpiDerm™ 200) containing 24 tissues on shipping agarose.
Tissue model: EPI-200
Tissue Lot Number: 25800
Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
Several test substances were tested in parallel within the present test (test no. 90) by using the same control tissues (NC and PC).
Corrosion test:
From the day of arrival in the laboratory, tissues were kept in the refrigerator. At least 1 hour, but not more than 1.5 hours before test substance application, tissues were transferred to 6-well plates with 0.9 mL assay medium and preconditioned in the incubator at 37°C. The preincubation
medium was replaced by fresh medium immediately before application.
Two tissues per exposure time (3 minutes at room temperature or 1 hour in the incubator as a rule) and test group (test material, negative control and positive control; 12 tissues per test) were used.
Fifty microliters (50 μL) undiluted liquid test substance were applied by using a pipette. Control tissues were concurrently treated with 50 μL deionized water (NC) or with 50 μL 8 N potassium hydroxide (PC).
The tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after start of the application treatment.
Rinsed tissues were kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time were dosed and rinsed. The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours.
After incubation, the tissues were washed with PBS to stop the MTT incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol. The optical density at a wavelength of 570 nm (OD570) of the extracts was
spectrophotometrically determined. Blank values were established of 4 microtiter wells filled with isopropanol for each microtiter plate.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

2 tissues were incubated for 3 minutes (corrosion test)

Value:

99.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

2 tissues were incubated for 1 h (corrosion test)

Value:

68.9

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Exposure period: 3 min (corrosion test)
Test substance identification		tissue 1	tissue 2	mean	SD	CV [%]
NC	mean OD570	1.610	1.671	1.641
	viability               [% of NC]	98.2	101.8	100.0	2.6	2.6
17/0010-1	mean OD570	1.615	1.652	1.634
	viability             [% of NC]	98.4	100.7	99.6	1.6	1.6
PC	mean OD570	0.114	0.216	0.165
	viability                [% of NC]	7.0	13.2	10.1	4.4	43.6

Exposure period: 1 h (corrosion test)
Test substance identification		tissue 1	tissue 2	mean	SD	CV [%]
NC	mean OD570	1.794	1.664	1.729
	viability            [% of NC]	103.8	96.2	100.0	5.3	5.3
17/0010-1	mean OD570	1.006	1.377	1.192
	viability            [% of NC]	58.2	79.7	68.9	15.2	22.0
PC	mean OD570	0.097	0.087	0.092
	viability           [% of NC]	5.6	5.0	5.3	0.4	7.7

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results observed and by applying the evaluation criteria described, it was concluded that 3-(1-Ethoxyethyl)-5-methyloxazolidin-2-on does not show a skin corrosion potential in the EpiDerm™ in vitro skin corrosion test under the test conditions chosen.