Isodecyl acrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 August 2012 to 09 January 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isodecyl acrylate

EC Number:

215-542-5

EC Name:

Isodecyl acrylate

Cas Number:

1330-61-6

Molecular formula:

C13H24O2

IUPAC Name:

2-methyloctyl prop-2-enoate

Test material form:

liquid

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: skin model EpiDerm SIT (EPI-200).

Vehicle:

unchanged (no vehicle)

Details on test system:

EpiDerm SIT (EPI-200): A three-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum was supplied by MatTek corporation, Ashland, Massachusetts, USA.

Amount/concentration applied:

30 µL of either negative/ positive control or test article.

Duration of treatment / exposure:

The tissues were incubated at 37°C, 5% carbon dioxide for a 35 minute period.
The plates were then removed from the incubator and placed into a sterile hood for the remaining 60 minutes.

Duration of post-treatment incubation (if applicable):

Following treatment, the substances were removed by washing the tissues. The tissues were then placed on the appropriate medium and incubated for 42 hours.

Number of replicates:

3

Test system

Details on study design:

At the end of the 42-hour incubation period, tissue viability was assessed by MTT assay. Following rinsing, tissues were placed on 0.3 mL of MTT solution (1 mg/mL) and incubated for 3 hours. Once complete, the tissues were removed from the MTT solution and any resultant colour formed in the tissues by the MTT assay was extracted.
Extraction was achieved by flooding the tissue with 2 mL isopropanol, sealing the plate to avoid any evaporation occurring, and then shaking at 150 rpm for 2 hours, protected from light.
Upon completion of the extraction, each tissue was pierced using a hypodermic needle so that the extract could run through the tissue. Once drained, the tissue was discarded and the extract mixed by shaking at 150 rpm for 15 minutes. Three 200 µL aliquots of each resultant extract were placed into a 96-well plate for spectrophotometric determination of optical density at 570 nm using extraction solution as blank.
Tissue viability was calculated for each tissue as a percentage of mean of the negative control tissues.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

114

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The group mean viability for the test article was 114.2%
The group mean viability for the negative control was 100%
The goup mean viability for the positive control was 3.5%

In vivo

Other effects:

no

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article, Isodecyl Acrylate, was considered not to be irritating to the in vitro skin model EpiDerm SIT (EPI-200).

Executive summary:

This study was conducted to determine whether the test article, Isodecyl Acrylate, causes dermal irritation in the in vitro skin model EpiDerm SIT (EPI-200).

EpiDerm SIT (EPI-200) inserts were treated with test article, negative control (phosphate buffered saline (PBS)) and positive control (5% w/v sodium dodecyl sulphate (SDS)) for 60 minutes. At the end of the treatment period, the tissues were washed with PBS and cell viability was assessed using the MTT assay. The skin irritation potential was classified according to the remaining cell viability obtained after test article treatment.

The group mean viability for the test article was 114.2%, for the negative control was 100% and for the positive control was 3.5%.

The test article, Isodecyl Acrylate, was considered not to be irritant to the in vitro skin model EpiDerm SIT (EPI-200).