[No public or meaningful name is available]

Endpoint summary

Description of key information

The acute oral median lethal dose (LD50) of the substance in Sprague Dawley rats is > 2000 mg/kg bw.

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:

April 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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

Batch No.: OP.1501019

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Six female rats aged between 9 and 10 weeks are used to perform the test. The animals were nulliparous and non-pregnant.
The rats were provided with feed (1334 P Maintenance diet Rat/mice) and water (UV sterilized water filtered through Reverse Osmosis water filtration system) ad libitum. Moreover, environmental conditions were strictly controlled: the temperature was between 20 to 23 °C with a relative humidity of 57-66% and a minimum 15 air changes/hour.

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Individual dose volume was adjusted according to body weight and dose level. All rats were dosed by oral gavage (day 0) using a BD 1 mL disposable syringe. Rats were fasted overnight prior to dosing and until approximately three hours post-dosing.

Doses:

Dose of 2000 mg/kg bw was tested on all six animals

No. of animals per sex per dose:

All six female rats were treated with 2000 mg of the substance

Control animals:

no

Details on study design:

Two sets were performed: during set I a single dose of 2000 mg/kg bw was given to three female rats. Since no mortality was observed at this dose level, during set II the same dose level was given to other three female rats.
The rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 5 h post-administration on the day of dosing. Subsequently, the rats were observed twice a day for morbidity and mortality for a period of 14 days following oral dosing. The clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.
Moreover, rats at the end of the 14-day observation period were euthanised by carbon dioxide asphyxiation and were subjected to a gross pathological examination consisting of an external examination and opening of abdominal and thoracic cavities.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in rats treated with 2000 mg /kg bw of test item.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

A normal gain in body weight was observed in all rats treated with 2000 mg /kg bw of test item.

Gross pathology:

External examination of terminally sacrificed rats did not reveal any abnormality in rats treated with 2000 mg /kg bw of test item.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the acute oral median lethal dose (LD50) of test item in Sprague Dawley rats is >2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on data available, the substance has not to be classified under CLP Regulation.