4-formyl-2-methoxyphenyl isobutyrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 February - 8 July 2014

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-formyl-2-methoxyphenyl isobutyrate

EC Number:

243-956-6

EC Name:

4-formyl-2-methoxyphenyl isobutyrate

Cas Number:

20665-85-4

Molecular formula:

C12H14O4

IUPAC Name:

4-formyl-2-methoxyphenyl 2-methylpropanoate

Test material form:

other: liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Isobutavan
- Physical state: colourless to pale yellow liquid
- Lot/batch No.: SC00010048
- Expiration date of the lot/batch: December 17, 2015

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: EpiSkinTM three-dimensional human skin model

Cell source:

other: Reconstructed epidermis with a functional stratum corneum supplied by SkinEthic Laboratories, Lyon, France.

Vehicle:

unchanged (no vehicle)

Details on test system:

The test article was used as supplied.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

A volume of 40 μL of the undiluted test article was added topically to the tissues. A volume of 40 μL of the positive and negative control solutions was used.

Duration of treatment / exposure:

Exposure was for 15 minutes after which the tissues were washed using PBS and dried using cotton wool buds to remove residual material before being transferred to a new well containing 2 mL pre-warmed maintenance medium.

Duration of post-treatment incubation (if applicable):

The tissues were then incubated at 37°C for the 42 hour recovery time period.

Number of replicates:

The test was performed on a total of three tissues per test article, negative and positive control.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Experiment 1

Value:

64

Negative controls validity:

valid

Remarks:

100% viability

Positive controls validity:

valid

Remarks:

4.6% viability

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Experiment 2

Value:

56.1

Negative controls validity:

valid

Remarks:

100% viability

Positive controls validity:

valid

Remarks:

6.3 % viability

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article, Isobutavan, was considered not to be irritant in the in vitro skin model EpiSkin.

Executive summary:

This study was conducted to determine whether the test article causes irritation in the in vitro skin model EpiSkinTM. EpiSkinTM inserts were treated with Isobutavan, negative control (phosphate buffered saline (PBS)) and positive control (5% w/v sodium dodecyl sulphate (SDS)) for 15 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 56.1%, for the negative control was 100% and for the positive control was 6.3%. The test article, Isobutavan, was considered not to be irritant in the in vitro skin model EpiSkinTM.