2-Propenoic acid, 2-methyl-, tetracosyl ester, branched

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 15 November 2017 to 23 January 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, 2-methyl-, tetracosyl ester, branched

EC Number:

292-146-9

EC Name:

2-Propenoic acid, 2-methyl-, tetracosyl ester, branched

Cas Number:

90552-24-2

Molecular formula:

C28H54O2

IUPAC Name:

2-Propenoic acid, 2-methyl-, tetracosyl ester(branched)

Test material form:

liquid

In vitro test system

Test system:

human skin model

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm (EPI-200) Reconstituted Human Epidermis
- Tissue batch number(s): 25864

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

FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Optical Density (O.D.) values: 1.601 ± 0.007 (mean and SD of MTT value of 3 tissues exposed to H2O). Acceptance range: [1.0 - 3.0]- PASS
- Barrier function: ET 50% of tissues exposed to 100 µL Triton X-100 1% (n=3): 5.84 h. Acceptance range: [4.77h- 8.72h] - PASS
- Morphology: Tissue thickness: 128 µm. Acceptance range: >70 µm and <130 µm - PASS
- Contamination: No contamination reported - PASS

NUMBER OF REPLICATE TISSUES:
Triplicate

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 μL neat substance
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL

Duration of treatment / exposure:

60 ± 1 minute (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, ≥95% RH)

Duration of post-treatment incubation (if applicable):

42 ± 4h post-treatment incubation (at 37°C, 5% CO2, ≥ 95% RH)

Number of replicates:

Triplicate

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Mean value

Value:

128.113

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: None reported
- Direct-MTT reduction: No direct reduction
- Colour interference with MTT: No colour interference

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) did not reduce the tissue viability. The test substance does not meet the criteria for classification as irritant to the skin according to Regulation (EC) No.1272/2008.

Executive summary:

The in vitro skin irritation of 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) was determined in accordance with the OECD Guideline for Testing of Chemicals 439 during a GLP-compliant study. This in vitro risk assessment assay predicts the Skin irritation potential of a chemical by measurement of its cytotoxic effect on the EpiDerm™ tissue model.

Prior to testing, the test substance was checked for interference with water and/or MTT. No interference was identified.

Skin irritation of the test substance and controls was evaluated in triplicate. After 60±1 minutes exposure on the surface of the EpiDerm™ reconstructed human epidermis and a 42±4h post-exposure incubation time, viability of the tissues was assessed and compared to the negative control.

The percentage of viability obtained with 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) was 128.113%, therefore it was considered as non-irritant to the skin according to the criteria laid down in the OECD Guideline for Testing of Chemicals 439.

The test item did not meet the criteria for classification as irritant to the skin according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.