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Diss Factsheets

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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.

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