Hexan-4-olide

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

GLP compliance:

yes (incl. QA statement)

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

Specific details on test material used for the study:

Test Item
Designation in Test Facility: 17092503G
Date of Receipt: 25. Sep. 2017
Condition at Receipt: Room temperature, in proper conditions
Specification
The following information concerning identity and composition of the test item was provid-ed by the sponsor.
Name gamma-Dodecalactone
Batch no. 050170905
Appearance clear, colorless liquid
Composition gamma-Dodecalactone
Purity 99.02%
Homogeneity homogeneous
Expiry date 28. Dec. 2018
Storage Room Temperature: (20 ± 5°C)

The following additional information, provided by the sponsor too, was relevant to the conduct of the study, according to OECD 431:
CAS No. 2305-05-7
EINECS-No. 218-971-6
Stability H2O: unknown; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Solubility H2O: unknown; EtOH: 0.1 - 1 g/L; acetone: unknown; CH3CN: unknown; DMSO: unknown
Structural Formula not stated
SMILES Code not stated

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Details on animal used as source of test system:

Specification
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 arranged in patterns analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell cultures inserts.
Origin
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SCT
Day of delivery: 28. Nov. 2018
Batch: 28671

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

50ul

Duration of treatment / exposure:

3min and 1h

Number of replicates:

3

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 Minutes Experiment

Value:

ca. 113.3

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: non-corrosive to skin

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 h Experiment

Value:

ca. 113.9

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: non-corrosive to skin

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The mean value of relative tissue viability of the test item was increased to 113.3% after 3 minutes treatment. This value is above the threshold for corrosivity (50%). After 1 hour treatment, the mean value of relative tissue viability of the test item was increased to 113.9%, lying above the threshold for corrosivity (15%). Therefore, the test item is consid-ered as non-corrosive to skin.