Heptan-4-olide

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

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dihydro-5-octylfuran-2(3H)-one

EC Number:

218-971-6

EC Name:

Dihydro-5-octylfuran-2(3H)-one

Cas Number:

2305-05-7

Molecular formula:

C12H22O2

IUPAC Name:

Dihydro-5-octylfuran-2(3H)-one

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.

Source strain:

not specified

Vehicle:

unchanged (no vehicle)

Details on test system:

The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

30 µL of the test item were pipetted onto a nylon mesh on a microscope slide.

Duration of treatment / exposure:

1 hour

Duration of post-treatment incubation (if applicable):

23 hours 35 minutes

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Reconstructed human Epidermis (RhE) Test Method following EU-Method B.46 resp. OECD 439

Value:

ca. 4.2

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The mean value of relative tissue viability of the test item was reduced to 4.2 % after the treatment. This value is below the threshold for skin irritation (50%). Therefore, the test item is considered as irritant to skin.