Ozonized sunflower oil

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vitro

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 442E (In Vitro Skin Sensitisation assays addressing the key event on activation of dendritic cells on the Adverse Outcome Pathway for skin sensitisation)

Version / remarks:

30 June 2022

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guideline No. 497: Defined Approaches for Skin Sensitisation - Annex I. Prediction model for the individual in chemico/in vitro tests with multiple runs for use in 2o3 DA

Version / remarks:

14 June 2021

GLP compliance:

yes

Type of study:

human Cell Line Activation Test (h-CLAT)

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

In vitro test system

Details of test system:

THP-1 cell line [442E]

Vehicle / solvent control:

DMSO

Negative control:

other: DMSO

Positive control:

dinitrochlorobenzene (DNCB) [442E]

Results and discussion

In vitro / in chemico

Results

Key result

Group:

test chemical

Run / experiment:

run/experiment 1

Parameter:

CV70 [442E]

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

not determinable

Remarks:

Since no cytotoxicity was observed either no CV75 value was calculated

Outcome of the prediction model:

negative [in vitro/in chemico]

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on these results, the OECD 442E and OECD 497 prediction models, the test item “Ozonia 3000 Sunflower (Ozonized Sunflower Seed Oil)” was shown to be negative and demonstrated in vitro non-sensitising potential under the experimental conditions of the human Cell Line activation Test.

Executive summary:

In the course of this study the skin sensitisation potential of “Ozonia 3000 Sunflower (Ozonized Sunflower Seed Oil)” was examined.

The extent of cytotoxicity induced on THP-1 cells by the test item was studied in two runs of the dose finding test. The maximal final concentrations used on the plates for the test item previously dissolved in DMSO were 1000.0 μg/mL (first run) and 1001.0 μg/mL (second run). Since no cytotoxicity was observed in the first run, the same concentration range was used in the second run and start from the highest allowed concentration (1000 μg/mL). Since in the second run no cytotoxicity was observed either, no CV75 value was calculated. Based on the results of two runs of the dose finding test, eight doses between 1000.0 μg/mL – 279.1 μg/mL (nominal concentrations) were used for the main test in two independent runs. Both runs were concluded valid.

The increase in CD86 marker expression (RFI) was lower than 150 % at all tested doses (with > 50 % of cell viability) compared to the respective negative controls in both valid runs. Moreover, according to the OECD Test Guideline 497 prediction model, the increase in CD86 marker expression (RFI) was below the borderline range (122-184 %) at all tested concentrations compared to the respective negative controls in all independent runs. Also, no cytotoxicity was observed at any tested concentrations in either independent run. Based on the two valid concordant negative runs, CD86 marker expression was concluded to be negative. Effective concentration for CD86 expression (EC150) was not determined, since a negative result was obtained.

The increase in CD54 marker expression (RFI) was lower than 200 % at all tested concentrations compared to the respective negative controls in both independent valid runs. Moreover, according to the OECD Test Guideline 497 prediction model, the increase in CD54 marker expression (RFI) was below the borderline range (157-255 %) at all tested concentrations compared to the respective negative controls in both independent runs. Furthermore, no cytotoxicity was observed at any tested concentrations in either independent run.

Based on the two valid concordant negative runs, CD54 marker expression was concluded to be negative. Effective concentration for CD54 expression (EC200) was not determined, since a negative result was obtained.

 

Since both CD86 and CD54 marker expressions gave negative results, the overall h-CLAT prediction was also concluded to be negative.