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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:
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

Constituent 1
Chemical structure
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.

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