Ozonized sunflower oil

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Route of administration:

oral: gavage

Vehicle:

vegetable oil

Remarks:

Helianthi annui oleum raffinatum

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat. (dissolved fraction)

Remarks:

The dose was formulated in the vehicle. Concentration of formulations was adjusted to maintain a treatment volume of 10 mL/kg body weight. The test item was applied in a concentration of 200 mg/mL. Formulations were prepared just before the administration

Mortality:

Not observed

Clinical signs:

other: Not observed

Body weight:

other body weight observations

Remarks:

The mean body weight of the animals corresponded to their species and age throughout the study.

Gross pathology:

All animals survived until the scheduled necropsy on Day 15.
No pathological changes were found related to the effect of the test item during the macroscopic examination of animals treated with 2000 mg/kg bw dose.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

the LD50 of the test item Ozonia 3000 Sunflower (Ozonized Sunflower Seed Oil) is above 2000 mg/kg body weight by oral route in the rat, because no animals died in the first and the second step after a single dose of 2000 mg/kg body weight. The GHS category is 5. The CLP category is “not classified”.

Executive summary:

Starting dose was selected on the basis of the available information about the test item. The LD50 >2000 mg/kg bw on basis of safety data sheet. A limit test was performed at 2000 mg/kg bw dose.
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg body weight test item as the starting dose in three female rats in parallel. No animal died in the first step at 2000 mg/kg body weight dose level, therefore treatment with 2000 mg/kg body weight was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 was met. Animals were weighed, observed for lethality and toxic symptoms for 14 days after dosage. Gross pathological examination was carried out on the 15th day after dosage.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw