[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 December 2021

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Enzymatically produced steviol glycosides

IUPAC Name:

Enzymatically produced steviol glycosides

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled water

Doses:

300 mg/kg b.w.
2000 mg/kg b.w.

No. of animals per sex per dose:

The animals were dosed in a stepwise procedure with three female animals per step. A starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight since the LD50 of test item is not available.
A total of 12 females (3 females for each Step-I, Step-I confirmation, Step-II and Step-II confirmation) were used for the experiment. All the animals of Step-I, Step-I confirmation were administered with 300 mg/kg body weight of the test item and Step-II, Step-II confirmation animals were administered with 2000 mg/kg body weight of the test item through oral route.

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Clinical Signs of Toxicity and Mortality
No clinical signs of toxicity and mortality was observed in any of the dosed animals.

Body Weight
No changes were observed in body weight and percent change in body weight with respect to day 1. All the animals revealed physiologically normal increase in the body weight.

Pathology
No gross pathological changes were observed in any of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the experiment, it is concluded that the LD50 cut off value for the test item Enzymatically Produced Steviol Glycosides is 5000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat as per OECD Guidelines for Testing of Chemicals (No. 423, Section 4: Health Effects) on conduct of “Acute Oral Toxicity - Acute Toxic Class Method” and “Category 5 or unclassified (2000 < ATE ≤ 5000 mg/kg body weight)” as per the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).