Octanoic acid, 2-phenoxyethyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 - 28 Nov 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Version / remarks:

adopted 2004

Deviations:

yes

Remarks:

interference with MTT not determined

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Version / remarks:

adopted 2016

Deviations:

not specified

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EU Method B.40 (In Vitro Skin Corrosion: Human Skin Model Test)

Version / remarks:

adopted May 2008

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-phenoxyethyl octanoate

EC Number:

607-240-0

Cas Number:

23511-73-1

Molecular formula:

C16H24O3

IUPAC Name:

2-phenoxyethyl octanoate

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Source strain:

other: EpiDerm™; reconstructed three-dimensional human epidermis (EPI-200)

Vehicle:

unchanged (no vehicle)

Details on test system:

HUMAN SKIN MODEL TEST
- Model used: EpiDerm™ (Epi-200)
- Tissue batch number(s): 11208 kit H

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37.0 ± 1.0 °C (actual range 35.9 - 37.2 °C)

REMOVAL OF TEST MATERIAL AND CONTROLS
-Number of washing steps: 1

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 1 h
- Spectrophotometer: Multiskan Spectrum (Thermo Labsystems)
- Wavelength: 540 nm

REDUCTION OF MTT BY THE TEST SUBSTANCE
To assess the ability of the test substance to reduce MTT, approximately 100 µL of the test substance was added to a 24-well plate filled with 1 mL MTT medium. The mixture was incubated for approximately 1 h at room temperature in the dark. A negative control (sterile Milli-Q water) was tested concurrently.

FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
Negative control: 3 min treatment (range: 1.153 - 2.003; mean: 1.61; SD: 0.22; n = 36); 1 h treatment (range: 1.298 - 2.007; mean: 1.60; SD: 0.19; n = 36)
Positive control: 3 min treatment (range: 0.075 - 0.156; mean: 0.11; SD: 0.02; n = 36); 1 h treatment (range: 0.059 - 0.178; mean: 0.09; SD: 0.02; n = 36)

NUMBER OF REPLICATE TISSUES: duplicates per incubation time and for controls

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 min exposure is less than 50%, or if the viability after 3 min exposure is greater than or equal to 50% and the viability after 1 h exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 min exposure is greater than or equal to 50% and the viability after 1 h exposure is greater than or equal to 15%.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied: 50 µL

NEGATIVE CONTROL
- Amount(s) applied: 50 µL

POSITIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: 8N

Duration of treatment / exposure:

3 min and 1 h

Number of replicates:

2

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min application with the test substance

Value:

93

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 h application with the test substance

Value:

113

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The relative mean tissue viability obtained after the 3-min and 1-h treatments with the test substance was 93% and 113%, respectively, compared with the negative control tissues.

Any other information on results incl. tables

In Table 1 the raw data are presented. Table 2 shows the mean tissue viability obtained after 3-min and 1-h treatments compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance.

Table 1: Mean absorption at 540 nm

	A	B	Mean	±SD	A	B	Mean	± SD
Negative control (water)	1.613	1.815	1.714	0.143	1.558	1.443	1.501	0.082
Positive control (8 N KOH)	0.082	0.091	0.086	0.007	0.064	0.075	0.070	0.008
Test substance	1.619	1.556	1.587	0.045	1.758	1.697	1.697	0.087

Values are corrected for background absorption.

SD: standard deviation

A and B: duplicate cultures

Table 2: Mean tissue viability

	Viability [% of control]
	3 min	1 h
Negative control (water)	100	100
Positive control (8 N KOH)	5	5
Test substance	93	113

The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The mean relative tissue viability following 3-min exposure to the positive control was 5%. The maximum inter-tissue variability in viability between two tissues treated identically was less than 15% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 8%. It was therefore concluded that the test system functioned properly.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008

Conclusions:

Under the conditions of the RHE test method the test substance did not show corrosive properties.