Propane-1,2,3-triyl trinonan-1-oate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Remarks:

in vitro

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)

Version / remarks:

Adopted on 28 July 2015

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,2,3-triyl trinonan-1-oate

EC Number:

204-791-5

EC Name:

Propane-1,2,3-triyl trinonan-1-oate

Cas Number:

126-53-4

Molecular formula:

C30H56O6

IUPAC Name:

1,3-bis(nonanoyloxy)propan-2-yl nonanoate

Test material form:

liquid

Details on test material:

Purity > 96%

In vitro test system

Test system:

human skin model

Source species:

other: Reconstructed Human Epidermis TestMethod: EPISKIN™

Cell type:

other: epidermis keratinocytes as cell source and use of representative tissue and cytoarchitecture

Cell source:

other: Reconstructed Human Epidermis TestMethod: EPISKIN™ - Batch 18-EKIN-002

Source strain:

not specified

Vehicle:

unchanged (no vehicle)

Details on test system:

In the Main Assay, alive tissues were treated with the test item (20 microliters), positive and negative controls.
D-BPS was used as negative control and 5% (w/v) of sodium dodecyl sulphate (SDS) solution was instead used as positive control.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

20 microliters of test item; 20 microliters of the solution as positive control; 20 microliters of D-PBS.

Duration of treatment / exposure:

15 +/- 0.5 minutes in a ventilated cabinet at room temperature

Duration of post-treatment incubation (if applicable):

A 42 ± 1 hour recovery period was allowed by incubation at 37°C, 5% CO2 and saturated humidity.

Number of replicates:

3 replicated for each tested item

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: Colour observation

Run / experiment:

Preliminary test - Direct MTT reduction test

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Colourless drops, no colour change (no interaction)

Results 2

Irritation / corrosion parameter:

other:

Run / experiment:

Colouring potential test

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Colourless solution (no interaction)

Results 3

Irritation / corrosion parameter:

other: Optical Density

Run / experiment:

Main assay

Value:

0.747

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

The test item did not induce cell death in any replicate, the mean cell viability after the blank subtraction was 110% when compared to the negative control

Other effects / acceptance of results:

The negative control gave the expected baseline value (Optical Density values of the three replicates higher than 0.6) and variability [Standard Deviation (SD) of % viability lower or equal to 18], in agreement with the guideline indications. According to the method, the
negative control mean value is considered the baseline value of the experiment and thus represents 100% of cell viability. The positive control caused the expected cell death (2% of cell viability when compared to the negative control) and variability (SD of % viability equal to 0.5). Based on the stated criteria
(mean viability ≤ 40% and SD of % viability ≤ 18), the assay was regarded as valid. The test item did not induce cell death in any replicate, the mean cell viability after the blank subtraction was 110% when compared to the negative control. Intra-replicate variability was acceptable with a SD of % viability value equal to 16.6 (lower than 18, as stated in the Study Protocol).

Any other information on results incl. tables

MAIN ASSAY

BLANK              Negative Control

	OD			OD	OD-blank                                             Viability(%)
	0.0043	N1 -1		0.742	0.7023                           0.6988             109.1
	0.041	N1 -2		0.735	0.6453
	0.035	N2 -1		0.685	0.6453                        0.6453              102 .1
	0.041	N2 -2		0.703	0.6633
	0.038	N3 -1		0.609	0.5693                         0.5693                 88.8
	0.040	N3 -2		0.609	0.5693
Mean	0.040	Mean		0.681	Mean	0.6	100
SD	0.003	SD		0.1	SD	0.07	10.3
CV(%)	7.1	CV(%)		8.7	CV(%)	10.3	10.3

 

Positive Control	OD	OD-blank	Viability(%)   0.0108                         1.7      0.0083 1.3                            0.0143 2.2
P1-1	0.052	0.0123
P1-2	0.049	0.0093
P2-1	0.044	0.0043
P2-2	0.052	0.0123
P3-1	0.053	0.0133
P3-2	0.055	0.0153
Mean	0.051		Mean	0.011	2
SD	0.004		SD	0.003	0.2
CV(%)	7.6		CV(%)	27.0	27.0

 

Test Item	OD	OD-blank	Viability(%)   0.8083                         126.1     0.7168                        111.9     0.5963                        93
A1-1	0.844	0.8043
A1-2	0.852	0.8123
A2-1	0.752	0.7123
A2-2	0.761	0.7213
A3-1	0.635	0.5953
A3-2	0.637	0.5973
Mean	0.747		Mean	0.7	110
SD	0.10		SD	0.11	16.6
CV(%)	12.7		CV(%)	15.0

DISCUSSION

The mean Optical Density of Blank Controls was 0.040, lower than the maximum acceptable value (0.1). The negative control gave the expected baseline value (Optical Density values of the three replicates higher than 0.6) and variability (Standard Deviation of the % viability lower or equal to 18), in agreement with guideline indications. According to the method, the mean value is considered the baseline value of the experiment and thus represents 100% of cell viability.

Positive control results indicated an appropriate cell death with an acceptable relative cell viability (2% of the negative control value). Variability between replicates gave also the expected value (SD of%viability = 0.5). Based on the stated criteria, mean viability, expressed as percentage of the negative control, lower or equal to 40% and standard deviation of % viability equal or lower than 18, the study was accepted as valid.

The test item did not induce cell death in any replicate, the mean cell viability after the blank subtraction was 110% when compared to the negative control. Intra-replicate variability was acceptable with a SD of % viability value equal to 16.6 (lower than 18, as stated in the Study Protocol).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Tripelargonin is considered as "not corrosive in the human Skin Model Test"

Executive summary:

The study was followed in according to OECD guideline and GLP without significate deviations.

The negative control gave the expected baseline value (Optical Density values of the three replicates higher than 0.6) and variability [Standard Deviation (SD) of % viability lower or equal to 18], in agreement with the guideline indications. According to the method, the negative control mean value is considered the baseline value of the experiment and thus represents 100% of cell viability. The positive control caused the expected cell death (2% of cell viability when compared to the

negative control) and variability (SD of % viability equal to 0.5). Based on the stated criteria (mean viability ≤ 40% and SD of % viability ≤ 18), the assay was regarded as valid. The test item did not induce cell death in any replicate, the mean cell viability after the blank subtraction was 110% when compared to the negative control. Intra-replicate variability was acceptable with a SD of % viability value equal to 16.6 (lower than 18, as stated in the Study Protocol).

Based on the results obtained, the test item Tripelargonin is classified as non-irritant to the skin (UN GHS No Category).