Escin

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: literature

Adequacy of study:

weight of evidence

Study period:

1974

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Data source

Reference

Reference Type:

secondary source

Title:

kiso to rinsho. Clinical report

Author:

Yubunsha

Year:

1974

Bibliographic source:

Clinical report Vol.8, page 118

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The main test consists of a single ordered dose progression in which animals are dosed , one at a time , at a minimum of 48-hour intervals.
The first animal receives a dose a step below the level of the best estimate of the LD50 . If the animal survives, the dose for the next animal is increased by 2-3 times the original dose ;
if it dies, the dose for the next animal is decreased by a sim ilar dose progression. (Note: 3.2 is the default factor corresponding to a dose progression of one half log unit) .
Each animal should be observed carefully for up to 48 hours before making a decision on whether and how much to dose the next animal. That decision is based on the 48-hour survival pattern of all the animals up to that time.
A combination of stopping criteria is used to keep the number of animals low while adjusting the dosing pattern to reduce the effect of a poor starting value or low slope.
Dosing is stopped when one of these criteria is satisfied, at which time an estimate of the LD50 and a confidence interval are calcu lated for the test based on the status of all the animals at termination.
For most applications, testing will be completed with only 4 animals after initial reversal in animal outcome. The LD50 is calculated using th e method of maximum likelihood

Test material

Test material information

Constituent 1

Reference substance name:

Escin

EC Number:

229-880-6

EC Name:

Escin

Cas Number:

6805-41-0

Molecular formula:

C110H172O48

IUPAC Name:

(2S,3S,4S,5R,6R)-6-{[(3S,4S,4aR,6aR,6bS,8R,8aR,9R,10R,12aS,14aR,14bR)-9-(acetyloxy)-8-hydroxy-4,8a-bis(hydroxymethyl)-4,6a,6b,11,11,14b-hexamethyl-10-[(2-methylbutanoyl)oxy]-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,11,12,12a,14,14a,14b-icosahydropicen-3-yl]oxy}-4-hydroxy-3,5-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxane-2-carboxylic acid; (2S,3S,4S,5R,6R)-6-{[(3S,4S,4aR,6aR,6bS,8R,8aR,9R,10R,12aS,14aR,14bR)-9-(acetyloxy)-8-hydroxy-4,8a-bis(hydroxymethyl)-4,6a,6b,11,11,14b-hexamethyl-10-{[(2E)-2-methylbut-2-enoyl]oxy}-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,11,12,12a,14,14a,14b-icosahydropicen-3-yl]oxy}-4-hydroxy-3,5-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxane-2-carboxylic acid

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

833 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria