Isopropyl 2-ethylhexanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 to 13 October 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl 2-ethylhexanoate

EC Number:

266-549-5

EC Name:

Isopropyl 2-ethylhexanoate

Cas Number:

67024-46-8

Molecular formula:

C11H22O2

IUPAC Name:

isopropyl 2-ethylhexanoate

Test material form:

liquid

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: EpiSkinTM Small Model (EpiSkinTMSM), manufactured by EPISKIN SNC Lyon, France.

Vehicle:

unchanged (no vehicle)

Details on test system:

Disks of EPISKIN (three units) were treated with test item and incubated for 15 minutes at room temperature. Exposure to the test item was terminated by rinsing with PBS 1x solution. Epidermis units were then incubated at 37°C for 42 hours in an incubator with 5 % CO2, ≥95% humidified atmosphere. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light, ≥95% humidified atmosphere. The precipitated formazan was then extracted using acidified isopropanol and quantified spectrophotometrically.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

A volume of 10 μL test item was applied evenly to the epidermal surface of each of the three test skin units.

Duration of treatment / exposure:

The plates with the treated epidermis units were incubated for the exposure time of 15 minutes (± 0.5 min) at room temperature.

Duration of post-treatment incubation (if applicable):

After rinsing the units were placed into the plate wells with fresh pre-warmed “maintenance medium” (2 mL/well) below them and then incubated for 42 hours (± 1h) at 37°C in an incubator with 5 % CO2, ≥95% humidified atmosphere.

Number of replicates:

Three replicates were used for the test item and controls, respectively

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Run 1, 82% viability; Run 2, 107% viability; Run 3, 79% viability.

Value:

90

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The results obtained from this in vitro skin irritation test, using the EPISKIN model, indicated that the test item has no skin irritation potential under the testing conditions used. The test item Isopropyl 2-ethylhexanoate is considered to be non-irritant to skin and is therefore not classified (UN GHS No Category / CLP not classified).