Fatty acids, C16 and C18-unsaturated, methyl esters, chlorinated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

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:

2022

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, palm-oil (C16-C18), Me esters, chlorinated (35-45 % w/w)

EC Number:

953-553-3

Cas Number:

95009-45-3

Molecular formula:

It cannot be provided.

IUPAC Name:

Fatty acids, palm-oil (C16-C18), Me esters, chlorinated (35-45 % w/w)

Test material form:

liquid

Details on test material:

Batch number: SV210723R 4001

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: Reconstructed Human Epidermis (RHE), 3D tissue model consisting of normal, human-derived epidermal keratinocytes (NHEK).

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

About 50 mg of the test substance are weighed on a glass weighing boat. Then the sample is evenly poured on the tissue. The exact weight of the sample is not a critical factor, but it is necessary to cover all the surface of the tissue homogeneously.

Duration of treatment / exposure:

60 minutes

Duration of post-treatment incubation (if applicable):

After 24±2 hours of incubation, the tissues were transferred to new plates containing 0.9 mL of fresh medium in each well and incubated for an additional 18±2 hours (37 °C, 5% CO2).

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 Vitality tests

Value:

ca. 96.7

Vehicle controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The average OD for negative control (C-) was f 1.257. This value corresponds to 100% vitality of the tissues.
The vitality of tissues trated with positive control was 3.5%.
The vitality of tissues trated with test item was 96.7% with SD 3.8%.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is considered not irritant for human skin.

Executive summary:

The test substance was tested through a validated in vitro skin irritation study in accordance with  bottom-up approach. Under the test conditions, the test substance was not irritant for Reconstructed Human Epidermis (RHE) as % tissue viability was about 96.7. Overall, the test substance is not considered as a skin irritant.