Reaction mass of oxybispropanediol and tetraglycerol and triglycerol, esterification products with lactic acid and lauric acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Experiment Start : March 09, 2021 Experiment Completion : March 12, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

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:

Reaction mass of oxybispropanediol and tetraglycerol and triglycerol, esterification products with lactic acid and lauric acid

Molecular formula:

not applicable - UVCB substance

IUPAC Name:

Reaction mass of oxybispropanediol and tetraglycerol and triglycerol, esterification products with lactic acid and lauric acid

Specific details on test material used for the study:

Test Item Name Finester 2009
IUPAC Name Information not provided by the Sponsor
C.A. Name 1,2,3-Propanetriol, homopolymer, dodecanoate 2-hydroxypropanoate
INCI Name Polyglycerin-3 (and) Polyglyceryl-3 Lactate/Laurate
CAS Number 2225876-48-0
Water Solubility Soluble in water
Molecular Formula C12H22O8
Molecular Weight 294.30
Batch /Lot Number 3253082031
Analyzed Purity 100% Active
Saponification Value: 45.87
Date of Manufacture August 27, 2020
Date of Expiry August 26, 2021
Appearance Pale yellow viscous liquid
Storage Temperature : Room temperature (15 to 30 °C)
Storage Condition : Kept away from light, moisture, and oxidizing-reducing chemicals

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Details on test system:

The test system used for the in vitro skin irritation test was reconstructed human epidermis
(SkinEthicTM RhE) as recommended by the OECD 439 guideline. The SkinEthicTM RhE model
consists of normal human keratinocytes cultured for 17-days on an insert of 0.5 cm2 polycarbonate
filter at the air-liquid interface in a chemically defined growth medium. The cells form a
multilayered, highly differentiated and stratified epidermis model of the human epidermis that
consists of main basal, supra basal, spinous and granular layers and a functional stratum corneum.
Reconstructed human epidermis tissues, SkinEthicTM RhE model, were procured from SkinEthic
Laboratories, Episkin 4, Rue Alexander Fleming, 69366 Lyon Cedex 07, France and were used in the
study. The certificate of analysis for the batch of tissues used in the study (Lot N° 21-RhE-026), demonstrated that this batch of tissue met the acceptance criteria as per the
recommendations of SkinEthic Laboratories (SkinEthic, 2009).

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

16 μL/0.5 cm2 of negative control and positive control
16 mg (± 2 mg) of test item

Duration of treatment / exposure:

42 minutes

Duration of post-treatment incubation (if applicable):

180 minutes

Number of replicates:

duplicate

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean

Value:

100.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

Colour Interference Test
There was no difference in the absorbance observed, between the negative control (isopropanol) and the test item, Finester 2009. Therefore, there was no evidence of colour interference due to the test item and no need for additional control

Direct MTT Reduction Test
Finester 2009 did not produce any colour change when compared with that of the concurrent
negative control (distilled water). Therefore, there was no evidence of direct MTT reduction due to
the test item and no need for additional control tissues

Mesh Compatibility Test
The result shows that there was no interaction of the test item with mesh and negative control
(distilled water), when observed under a light microscope and the un-aided eyes.

Interpretation of Results
Since there was no colour interference or direct MTT reduction observed in the pre-tests, adapted
controls were not included in the main study.
As the negative and positive control optical density values met the assay acceptance criteria, as
described in the OECD 439 guideline, they were considered acceptable for addition in the historical control. The efficiency of the test system was demonstrated, and all criteria for
a valid study were met.
The mean percent viability of the positive control, after exposure and post-treatment incubation, was less than 50% and correctly predicts SDS (5% aq) as irritant to skin (UN GHS Category 1 or 2).
Since the mean percent viability of Finester 2009 treated tissues, after exposure and post-treatment
incubation, was more than 50%, the in vivo prediction for the test item is non-irritant to skin (UN
GHS No Category “Non-Irritant”), as per the “United Nations Globally Harmonized System of
Classification and Labelling of Chemicals”.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this in vitro study in reconstructed human epidermis (SkinEthicTM RhE
model), Finester 2009 is predicted to be a non-irritant to skin.

Executive summary:

This study was performed to evaluate the skin irritation potential of Finester
2009, using a reconstructed human epidermis (RhE) tissue. This test procedure can identify irritant test chemicals (classified as UN GHS Category 1 or 2) or non-irritant test chemicals (UN GHS No Category).
Tissues were exposed to the negative control [Dulbecco’s Phosphate Buffered Saline (DPBS)], positive control [sodium dodecyl sulfate, 5% aqueous (SDS)] and Finester 2009 in triplicate for 42 minutes, at room temperature. After exposure, the tissues were rinsed, dried and incubated for 42 hours in growth medium.
The tissues were then incubated with MTT solution for 180 minutes and the blue formazan salt was extracted and the optical density (OD) measured. The OD values obtained with test item were used to calculate the mean percentage tissue viability (after exposure and post-treatment incubation) and provide the in vivo
prediction.
The mean percent cell viability in tissues treated with the test item and positive control, normalised to the negative control.

The negative and positive controls met the acceptance criteria, as described in the study plan, and confirmed the reliability of the test procedure. The mean % viability score for the test item was more than the established tissue viability cut-off value of >50%, and the test item is considered as non-irritant to skin in accordance with UN GHS No Category.
Based on the results of this in vitro study in reconstructed human epidermis (SkinEthicTM RhE model), Finester 2009 is predicted to be a non-irritant to skin.