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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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:
α-acetyl-γ-butyrolactone

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.