Ozonized sunflower oil

Eye irritation

Administrative data

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

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 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

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 parameter:

percent 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 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.