Kaur-16-en-18-oic acid, 13-[(O-β-D-glucopyranosyl-(1.fwdarw.2)-O-[β-D-glucopyranosyl-(1.fwdarw.3)]-β-D-glucopyranosyl)oxy]-, β-D-glucopyranosyl ester, (4α)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 02, 2021

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

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:

(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl (1R,4S,5R,9S,10R,13S)-13-{[(2S,3R,4S,5R,6R)-5-hydroxy-6-(hydroxymethyl)-3,4-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxan-2-yl]oxy}-5,9-dimethyl-14-methylidenetetracyclo[11.2.1.0¹,¹⁰.0⁴,⁹]hexadecane-5-carboxylate

EC Number:

611-696-6

Cas Number:

58543-16-1

Molecular formula:

C44H70O23

IUPAC Name:

(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl (1R,4S,5R,9S,10R,13S)-13-{[(2S,3R,4S,5R,6R)-5-hydroxy-6-(hydroxymethyl)-3,4-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxan-2-yl]oxy}-5,9-dimethyl-14-methylidenetetracyclo[11.2.1.0¹,¹⁰.0⁴,⁹]hexadecane-5-carboxylate

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:

Purified water (Fresh prepared)

Doses:

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

No. of animals per sex per dose:

The dose level of 300 mg/kg b.w. was selected as the starting dose from one of four fixed dose levels (5, 50, 300, 2000 mg/kg b.w.), and 3 animals were used in each step. The first step dosing was 300 mg/kg b.w. and no animals died. According to this result, 300 mg/kg b.w was selected as the second step dosing, and no animals died. According to this result, 2000 mg/kg b.w. was selected as the third step dosing, and no animals died. According to this result, 2000 mg/kg b.w. was selected as the fourth step dosing, and no animals died.

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

Mortality
Dose Level-The first dosing (300 mg/kg b.w.): All animals showed no deaths or moribund status during the test.
Dose Level-The second dosing (300 mg/kg b.w.): All animals showed no deaths or moribund status during the test.
Dose Level-The third dosing (2000 mg/kg b.w.): All animals showed no deaths or moribund status during the test.
Dose Level-The fourth dosing (2000 mg/kg b.w.): All animals showed no deaths or moribund status during the test.

Clinical Observations
Dose Level-The first dosing (300 mg/kg b.w.): All animals showed no abnormal symptoms during the test.
Dose Level-The second dosing (300 mg/kg b.w.): All animals showed no abnormal symptoms during the test.
Dose Level-The third dosing (2000 mg/kg b.w.): All animals showed no abnormal symptoms during the test.
Dose Level-The fourth dosing (2000 mg/kg b.w.): All animals showed no abnormal symptoms during the test.

Body Weights
All of the surviving animals gained body weights during the test.

Necropsy
All animals under test showed no abnormalities at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results, the acute oral LD50 in rats for Rebaudioside A was estimated to be more than 2000 mg/kg b.w., and the cut-off value of LD50 was estimated to be 5000 or ∞ mg/kg b.w.. According to the GHS’s classification criteria for acute oral toxicity, the test item was classified as “Category 5” or “Unclassified”.