Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
(1993; 94 pages)
Table of Contents
View the documentFOREWORD
Open this folder and view contents1. INTRODUCTION
Open this folder and view contents2. GENERAL CONSIDERATIONS IN HERBAL MEDICINE RESEARCH
Open this folder and view contents3. RESEARCH STUDIES
Close this folder4. USING THE GUIDELINES
Open this folder and view contentsA. GUIDELINES FOR QUALITY SPECIFICATIONS OF PLANT MATERIALS AND PREPARATIONS
Open this folder and view contentsB. GUIDELINES FOR PHARMACODYNAMIC AND GENERAL PHARMACOLOGICAL STUDIES OF HERBAL MEDICINES
Close this folderC. GUIDELINES FOR TOXICITY INVESTIGATION OF HERBAL MEDICINES
View the documentACUTE TOXICITY TEST
View the documentLONG-TERM TOXICITY TEST
View the documentLOCAL TOXICITY TEST
View the documentSPECIAL TOXICITY TESTS
Open this folder and view contentsANNEXES
View the documentNOTES
View the documentBIBLIOGRAPHY
View the documentSELECTED WHO PUBLICATIONS OF RELATED INTEREST
 

ACUTE TOXICITY TEST

Animal species

Some regulatory agencies require that at least two species be used, one of them to be selected from rodents and the other from non-rodents.

Sex

In at least one of the species, males and females should be used.

Number of animals

In the case of rodents, each group should consist of at least five animals per sex. In the case of non-rodents, each group should consist of at least two animals per sex.

Route of administration

Ordinarily, the oral route is sufficient as this is the normal route of clinical administration. However, some regulatory agencies suggest in addition a parenteral route of administration.

In cases where it is proposed to administer the herbal preparation to a human subject by the parenteral route, it may be sufficient to use this route alone for animal testing

Dose levels

A sufficient number of dose levels should be used in rodents to determine the approximate lethal dose In non-rodents, sufficient dose levels should be used for the observation of overt toxic signs.

Frequency of administration

The test substance should be administered in one or more doses during a 24-hour period

Observation

Toxic signs and the severity, onset, progression and reversibility of the signs should be observed and recorded in relation to dose and time As a general rule, the animals should be observed for at least seven to fourteen days

Animals dying during the observation period, as well as rodents surviving to the end of the observation period should be autopsied.

If necessary, a histopathological examination should be conducted on any organ or tissue showing macroscopic changes at autopsy.

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