Ozonized sunflower oil

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Irritation / corrosion parameter:

% tissue viability

Value:

> 50

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes

Irritation parameter:

percent tissue viability 

Value:

> 50

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

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 eye irritation or serious eye damage (GHS no category).

Executive summary:

The purpose of the test is to identify chemical substances that do not require classification for eye irritation or serious eye damage (No Category) or requiring classification for eye irritation (Category 2) or requiring classification for serious eye damage (Category 1) according to the UN GHS hazard classification system. The procedure is carried out based on the method described in the OECD 492 guideline. This test makes use of commercially available three-dimensional RICE tissues that are produced using human immortalized corneal epithelial cells (SkinEthic't" HCE).
The evaluation of cell survival after three different time exposures to the substance is made by MIT assay, a colorimetric assay that is based on the ability of the mitochondrial succinate dehydrogenase enzyme of metabolic active cells, to reduce a yellow tetrazolium salt (MIT) to purple formazan crystals, that can be measured by spectrophotometer reading.
Chemicals substances not requiring classification and labeling according to UN GHS (No Category) are identified as those that do not decrease tissue viability below a defined threshold (50%) at all time treatments. Instead, chemicals substances are identified inducing serious eye damage (UN GHS Category 1) if the mean percent tissue viability after exposure is less than or equal to the established percentage (50%) at all time treatments. Chemicals substances are identified as chemical inducing eye irritation according to UN GHS (Category 2) if the combination of mean percent tissue viability within all time treatment fall outside of the criteria established to identify the test chemical as a No Category or Category 1.
The test item "OZONIA 3000 SUNFLOWER (OZONIZED SUNFLOWER SEED OIL)" in the experimental conditions here described, showed a mean cell survival of 98.6% (14.3) after 5 minutes treatment, of 102.9% (±8.9) after 16 minutes treatment and of 102.6% (13.8) after 2 hours treatment. These results suggest that test item DOES NOT REQUIRE CLASSIFICATION FOR EYE IRRITATION OR SERIOUS EYE DAMAGE (UN-GHS — No Category), because its cell viability is higher than 50% at all time treatments.
The positive control Methyl acetate showed a mean cell viability of 27.6% (10.8) after 5 minutes treatment, of 91.1% (t1.7) after 16 minutes treatment and of 97.6% (19.0) after 2 hour treatment. These results are keeping with the acceptance criteria required for the positive control. All other acceptance criteria were met, therefore the test can be considered qualified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)