2-Propenoic acid, (2,2-dimethyl-1,3-dioxolan-4-yl)methyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(2,2-dimethyl-1,3-dioxolan-4-yl)methyl prop-2-enoate

EC Number:

814-155-4

Cas Number:

13188-82-4

Molecular formula:

C9H14O4

IUPAC Name:

(2,2-dimethyl-1,3-dioxolan-4-yl)methyl prop-2-enoate

Test material form:

liquid

In vitro test system

Test system:

human skin model

Source species:

human

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 that found in vivo. The EpiDermTM tissues (surface 0.6 cm²) are cultured on cell culture inserts (MILLICELLs, 10 mm ∅) specially prepared and available commercially as kits (EpiDerm™ 200) containing 24 tissues on shipping agarose.
Tissue model: EPI-200
Tissue Lot Number: 28646 (Certificate of Analysis see Appendix)
Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia

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 pre-incubation medium was replaced with 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. In addition, two killed control tissues per exposure time were treated with the test substance and the NC, respectively, to detect direct MTT reduction. Fifty microliters (50 μL) undiluted liquid test substance were applied using a pipette. Control tissues were treated concurrently with 50 μL deionized water (NC, NC KC) or with 50 μL 8 N potassium hydroxide solution (PC) or test substance (KC). 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 with MTT solution, and the tissues were incubated for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT incubation. The formazan that was produced metabolically 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 determined spectrophotometrically. 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:

3 minutes corrosion test

Value:

91

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour corrosion test

Value:

47.4

Any other information on results incl. tables

Exposure period: 3 min
Test substance		tissue 1	tissue 2	Mean	SD	CV[%]
NC	mean OD570	2.071	2.098	2.084
	viability [% of NC]	99.4	100.6	100.0	0.9	0.9
18/0019245-1	mean OD570	2.032	1.761	1.897
	viability [% of NC]	97.5	84.5	91.0	9.2	10.1
PC	mean OD570	0.167	0.235	0.201
	viability [% of NC]	8.0	11.3	9.6	2.3	23.8

Exposure period: 1 h
Test substance		tissue 1	tissue 2	Mean	SD	CV[%]
NC	mean OD570	2.043	2.084	2.063
	viability [% of NC]	99.0	101.0	100.0	1.4	1.4
18/0019245-1	mean OD570	1.023	0.932	0.977
	viability [% of NC]	49.6	45.1	47.4	3.1	6.6
PC	mean OD570	0.122	0.139	0.130
	viability [% of NC]	5.9	6.7	6.3	0.6	9.5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results observed and by applying the evaluation criteria, it was concluded that Laromer IPGA shows not a skin corrosion potential in the EpiDerm™ in vitro corrosion test under the test conditions chosen.