Propyl oleate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Propyl (9Z,12Z)-octadeca-9,12-dienoate

Molecular formula:

C21H38O2

IUPAC Name:

Propyl (9Z,12Z)-octadeca-9,12-dienoate

Constituent 2

Reference substance name:

Propyl oleate

EC Number:

203-885-3

EC Name:

Propyl oleate

Cas Number:

111-59-1

Molecular formula:

C21H40O2

IUPAC Name:

propyl oleate

Constituent 3

Reference substance name:

Propyl stearate

EC Number:

222-855-0

EC Name:

Propyl stearate

Cas Number:

3634-92-2

Molecular formula:

C21H42O2

IUPAC Name:

propyl stearate

Constituent 4

Reference substance name:

Heptadecanoic acid, propyl ester

Cas Number:

propyl heptadecanoate

Molecular formula:

C20H40O2

IUPAC Name:

Heptadecanoic acid, propyl ester

Constituent 5

Reference substance name:

Propyl (9Z)-9-hexadecenoate

Molecular formula:

C19H36O2

IUPAC Name:

Propyl (9Z)-9-hexadecenoate

Constituent 6

Reference substance name:

Propyl palmitate

EC Number:

218-803-1

EC Name:

Propyl palmitate

Cas Number:

2239-78-3

Molecular formula:

C19H38O2

IUPAC Name:

propyl palmitate

Constituent 7

Reference substance name:

Pentadecanoic acid, propyl ester

Molecular formula:

C18H36O2

IUPAC Name:

Pentadecanoic acid, propyl ester

Constituent 8

Reference substance name:

Propyl myristate

EC Number:

238-241-0

EC Name:

Propyl myristate

Cas Number:

14303-70-9

Molecular formula:

C17H34O2

IUPAC Name:

propyl myristate

Constituent 9

Reference substance name:

Propyl laurate

EC Number:

222-961-7

EC Name:

Propyl laurate

Cas Number:

3681-78-5

Molecular formula:

C15H30O2

IUPAC Name:

propyl laurate

Test material form:

liquid

Details on test material:

Name: 9-Octadecenoic acid (9Z)-, propyl ester
Product Description: Propyl oleate
CAS No.: 111-59-1
Physical state: colourless to yellow liquid at 20 °C
Batch No.: 37584
Re-certification date of batch: 08 March 2018
Purity: > 95 % (mono constituent substance, water content 0.33 % (w/w))
Free Fatty Acid, % Oleic: 0,1
Color, Gardner: 3
Iodine Value, cg I2/g 75
Cloud Point, degrees C 0
Saponification Number, mg KOH/g 177
Moisture, % 0,07
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light

Specific details on test material used for the study:

Name: 9-Octadecenoic acid (9Z)-, propyl ester
Product Description: Propyl oleate
CAS No.: 111-59-1
Physical state: pale yellow to yellow liquid at 20 °C
Batch No.: 37584
Re-certification date of batch: 08 March 2018
Purity: > 99 % (fatty acid propyl esters, max water content 0.3 % (w/w))
Free Fatty Acid, % Oleic: 0.1
Color, Gardner: 3
Iodine Value, cg I2/g 75
Cloud Point, degrees C 0
Saponification Number, mg KOH/g 177
Moisture, % 0,07
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: not specified

Vehicle:

unchanged (no vehicle)

Amount/concentration applied:

The test item was applied undiluted. 30 µL (47 µL/cm2) of the test item was dispensed directly atop the EpiDerm tissue. The test item was gently spread to match size of the tissue using a bulb-headed Pasteur pipette.

Duration of treatment / exposure:

In the present study the test item was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay.

Duration of post-treatment incubation (if applicable):

In the present study the test item was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay.

Number of replicates:

3 replicate tissues per group

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean relative tissue viability [%]

Value:

113.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Remarks:

Dulbecco’s phosphate buffered saline (DPBS)

Positive controls validity:

valid

Remarks:

5% sodium dodecyl sulfate in H2O

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Pre-Experiments

The mixture of 30 µL test item per 1 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%. The mixture of 30 µL of the test item per 300 µL aqua dest. and per 300 µL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSC equalled 0%.

Results

Table 1: Result of the Test Item

Name	NC			PC			Test item
Tissue	1	2	3	1	2	3	1	2	3
absolute OD570	1.923 1.901	2.198 2.146	2.195 2.236	0.100 0.099	0.125 0.128	0.132 0.131	2.391 2.323	2.466 2.424	2.343 2.293
OD570 (blank-corrected)	1.882 1.860	2.156 2.195	2.154 2.195	0.059 0.058	0.084 0.087	0.091 0.090	2.350 2.281	2.425 2.383	2.302 2.252
mean OD570 of the duplicates (blank-corrected)	1.871	2.131	2.174	0.059	0.085	0.090	2.316	2.404	2.277
total mean OD570 of 3 replicate tissues (blank-corrected)	2.059*			0.078			2.332
relative tissue viability [%]	90.9	103.5	105.6	2.8	4.1	4.4	112.5	116.8	110.6
SD OD570	0.164			0.017			0.065
mean relative tissue viability [%]	100.0			3.8**			113.3
SD tissue viability [%]***	8.0			0.8			3.2
CV [% viabilities]	8.0			21.8			2.8

* Blank-corrected mean OD570 nm of the negative control corresponds to 100% absolute tissue viability.

** Mean relative tissue viability of the three positive control tissues is <= 20%.

*** Standard deviation (SD) obtained from the three concurrently tested tissues is ≤ 18%

Discussion

The potential of the test item to induce skin irritation was analysed by using the three-dimensional human epidermis model EpiDerm comprising a reconstructed epidermis with a functional stratum corneum. In the present study the test item was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS.

The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (113.3%) after 60 min treatment and 42 h post-incubation. The controls confirmed the validity of the study. The mean absolute OD570 of the three negative control tissues was >= 0.8 and ≤ 2.8. The mean relative tissue viability (% negative control) of the positive control was <= 20% (3.8%). Standard deviation of viability of replicate tissues of all dose groups was ≤ 18% (0.8% - 8.0%).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the OECD 439 study under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.

Executive summary:

In the in vitro skin irritation study (OECD 439) under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.