C16-18 (even numbered) and C18 (unsaturated) triglycerides, hydroxylated, oxidatively cleaved, hydrolised (glycerol free).

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 9th, 2021 to June 2nd, 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 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Version / remarks:

July 2015

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

C16-18 (even numbered) and C18 (unsaturated) triglycerides, hydroxylated, oxidatively cleaved, hydrolised (glycerol free).

EC Number:

701-347-7

Molecular formula:

From C9H1802 to C24H48O2

IUPAC Name:

C16-18 (even numbered) and C18 (unsaturated) triglycerides, hydroxylated, oxidatively cleaved, hydrolised (glycerol free).

In vitro test system

Test system:

artificial membrane barrier model

Justification for test system used:

The test method utilizes an artificial membrane designed to respond to corrosive chemicals in a manner similar to animal skin in situ.

Vehicle:

unchanged (no vehicle)

Details on test system:

SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Corrositex® test kit procured by Romer Labs Deutschland GmbH.
- Preparation of the test system: The biobarrier was produced adding slowly the biobarrier diluent vial to the matrix powder to ensure complete and uniform solubilisation. The vial containing the solution was placed in a water bath on a heating plate set to 68 °C and stirred for 20 min to solubilise the biobarrier matrix. Then, the heating plate was switched off and the solution was left to stand for 10 minutes. After that, 200 μL of the solubilised matrix were pipetted onto the membrane discs and were stored in the fridge for (2 - 8 °C) at least 2 h before use.
- Samples:
• 1 Negative control (10% citric acid solution)
• 1 Positive control (sodium hydroxide, used as solid)
• 1 Blank for Chemical Detection System (CDS)
• 4 Test item
-Conduct of Assay: Before use and for better handling, the neat test item was scraped off the test vessel and after weighting the defined amount of test item, it was cooled in the refrigerator (2 - 8 °C) for 60 minutes. As it was possible to shape the test item, it was moulded to a small plate. Four replicates were tested, the solid test item was applied directly to the biobarrier and gently pressed down so that the biobarrier was evenly covered. In average, 500 mg of the solid test item were applied to each biobarrier and observed for possible penetration. First, one vial was exposed to the test item and a stop watch was started. The vial was observed for 3 minutes continuously. Since no colour change or any other change in the CDS was visible within 3 minutes, the remaining 3 vials were exposed to the test item in 1-min. intervals.
For the blank, a membrane disc coated with the biobarrier was placed into a vial containing the CDS and was observed parallel with the negative control.
For the negative control, 500 μL 10% citric acid solution was pipetted on the biobarrier and the stop watch was started.
The blank and the negative control were observed parallel for 61 minutes.
For the positive control, 116.9 mg of sodium hydroxide were applied on the biobarrier and the stop watch was started. The vial was observed continuously until a breakthrough occurred. The time of the colour change (breakthrough) was recorded in minutes.

METHOD OF DETECTION
The Chemical Detection System (CDS) is an indicator solution with a pH indicator combination of dyes that will show a colour change in response to the presence of the test item or other types of chemical or electrochemical reactions.

DECISION CRITERIA based on GHS classification:
Corrosive 1A: Mean Time 0-3 min
Corrosive 1B: Mean Time > 3-30 min
Corrosive1C: Mean Time > 30-60 min
Non corrosive: > 60 min

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL: 500 mg/biobarrier

NEGATIVE CONTROL: 500 μL 10% citric acid solution/biobarrier

POSITIVE CONTROL
116.9 mg of sodium hydroxide/biobarrier

Duration of treatment / exposure:

The blank and the negative control were observed parallel for 61 minutes.
For the positive control, the vial was observed continuously until a breakthrough occured.
For the test item, the observation time lasted 60 minuets.

Number of replicates:

4

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Value:

> 60

Negative controls validity:

valid

Remarks:

Penetration time: No break-through after 61 min (Critetion: no break through after 60 min according to GHS Criterion).

Positive controls validity:

valid

Remarks:

Pentration time: 14 min (Criterion between 8.7 and 18.3 min).

Applicant's summary and conclusion

Interpretation of results:

other: Non corrosive to skin according to the CLP Regulation (EC) No. 1272/2008.

Conclusions:

Based on the results of the test, the test item is considered as non corrosive to skin.

Executive summary:

The in vitro membrane barrier test method for skin corrosion (Corrositex® - Test) was used to evaluate the corrosiveness of the test item, following the OECD Guideline 435. Four replicates of the test item were tested. 10% Citric acid was used as negative control, sodium hydroxide (NaOH) was used as positive control. The controls showed the expected results. No breakthrough of the test item was observed within the observation time of 60 minutes. In conclusion, it can be stated that, under the experimental conditions of the study, the test item did not show skin corrosion potential and shall, therefore, be not classified as corrosive to skin according to the CLP Regulation (EC) No. 1272/2008.