2-ethyl-4-hydroxy-5-methylfuran-3(2H)-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

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:

2-ethyl-4-hydroxy-5-methylfuran-3(2H)-one

EC Number:

248-514-6

EC Name:

2-ethyl-4-hydroxy-5-methylfuran-3(2H)-one

Cas Number:

27538-10-9

Molecular formula:

C7H10O3

IUPAC Name:

2-ethyl-4-hydroxy-5-methylfuran-3(2H)-one

In vitro test system

Test system:

human skin model

Source species:

other: Reconstructed human Epidermis

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Duration of treatment / exposure:

60 minutes

Duration of post-treatment incubation (if applicable):

42 hours and 25 minutes

Number of replicates:

6

Test animals

Species:

other: human-derived epidermal keratinocytes

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Controls:

yes, concurrent positive control

yes, concurrent negative control

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

11.4

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

One valid experiment was performed.
Three tissues of the human skin model EpiDermTM were treated with Furanone Homo for
60 minutes.
The test item was applied directly to each tissue and spread to match the tissue size (0.63
cm2; as indicated by the supplier).
DPBS-buffer was used as negative control and 5% SDS solution was used as positive
control.
After treatment with the negative control, the mean absorbance values was within the required
acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.6. The positive control
showed clear irritating effects. The mean value of relative tissue viability was reduced to
3.4% (required:  20%).
The variation within the tissue replicates of negative control, positive control and test item
was acceptable (required: ≤ 18%).
After the treatment with the test item, the mean value of relative tissue viability was reduced
to 11.4%. This value is below the threshold for skin irritation potential (50%). Test
items that induce values below the threshold of 50% are considered irritant to skin.
Therefore, Furanone Homo is considered irritant to skin in the Reconstructed human
Epidermis (RhE) Test Method.