Ozonized sunflower oil

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2022

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

Test material

Test material information

Constituent 1

Reference substance name:

sunflower oil (Helianthus annuus L.), reaction products with ozone

EC Number:

924-751-7

IUPAC Name:

sunflower oil (Helianthus annuus L.), reaction products with ozone

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

> 50

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the experimental conditions and according to the results, the test item OZONIA 3000 SUNFLOWER (OZONIZED SUNFLOWER SEED OIL) does not require classification for skin irritation or skin corrosion (GHS no category).

Executive summary:

Purpose of the study is to evaluate the skin irritation potential on Reconstructed Human Epidermis (RHE SkinEthic) of the test item "OZONIA 3000 SUNFLOWER (OZONIZED SUNFLOWER SEED OIL)" according to the method described in OECD 439 and in compliance with Good Laboratory Practice. This method uses human artificial skin models to assess the skin irritation of chemical substances and mixtures and to properly label them to this respect, if applicable. The test is based on the evaluation of cell survival after the exposure to the test item through MTT assay and by comparison with epidermis treated with phosphate buffer only (negative control). The MTT method is a colorimetric assay that allows to determinate the percentage of cells alive within an in vitro cultured tissue. This assay is based on the ability of the mitochondria, succinate dehydrogenase enzyme to metabolise the nitro-blue tetrazolium salt, giving a coloured compound that can be measured by spectrophotometer reading. The test item "OZONIA 3000 SUNFLOWER (OZONIZED SUNFLOWER SEED OIL)" in the experimental conditions here described, showed a mean cell survival of 102.4% (±3.0), so it resulted a NOT SKIN IRRITANT (UN-GHS - no Category), because its cell viability is higher than 50%

The positive control Sodium Dodecyl Sulphate (SDS) showed a mean cell viability of 1.0% (±0.0), so it gave the expected results. All the acceptance criteria were passed.