α-acetyl-γ-butyrolactone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: 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:

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)

Version / remarks:

adopted in 2015

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

α-acetyl-γ-butyrolactone

EC Number:

208-235-2

EC Name:

α-acetyl-γ-butyrolactone

Cas Number:

517-23-7

Molecular formula:

C6H8O3

IUPAC Name:

3-acetyloxolan-2-one

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

commercially available test method

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied: 30 µL

NEGATIVE CONTROL
- Amount(s) applied: 30 μL

POSITIVE CONTROL
- Amount(s) applied: 30 μL
- Concentration: 5% aqueous solution

Duration of treatment / exposure:

60 min (35 min at 37 °C and 25 min at room temperature)

Duration of post-treatment incubation (if applicable):

42 h

Number of replicates:

triplicates for treatment and control groups

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

38.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:

other: positive

Conclusions:

In this in vitro skin irritation test in EpiDerm™ tissue in accordance with OECD 439 and in compliance with GLP, the mean cell viability compared to the negative control was 38.5% after 60 min exposure with the test substance. All validity criteria were within acceptable limits. In conclusion, the test substance was irritating to human epidermis tissue. However, since the RhE test method cannot resolve between irritation and corrosion, further information on skin corrosion would be required to decide on its final classification or hazard potential.

Executive summary:

A study was performed for the assessment of the skin irritancy of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method EpiDerm™.

The study was conducted in accordance with OECD TG 439 and EU Test Method B.46. The mean value of cell viability was recorded to be 39 % (rounded). The test item was thus shown to be irritating

to reconstructed human skin in vitro.