General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
(2000; 80 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentForeword
Open this folder and view contentsIntroduction
Open this folder and view contents1. Methodologies for Research and Evaluation of Herbal Medicines
Open this folder and view contents2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
Open this folder and view contents3. Clinical Research
Open this folder and view contents4. Other Issues and Considerations
View the documentReferences
Open this folder and view contentsAnnexes
Open this folder and view contentsAnnex I. Guidelines for the Assessment of Herbal Medicinesa
Close this folderAnnex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicinesa
View the documentDefinition of Terms
View the documentGuidelines for Toxicity Investigation of Herbal Medicines
View the documentAcute Toxicity Test
View the documentLong-Term Toxicity Test
Open this folder and view contentsAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
Open this folder and view contentsAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Open this folder and view contentsAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
Open this folder and view contentsAnnex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Productsa
Open this folder and view contentsAnnex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplementsa
Open this folder and view contentsAnnex VIII. Guideline for Good Clinical Practicea
Open this folder and view contentsAnnex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scalesa
View the documentAnnex X. Participants in the WHO Consultation on Methodologies for Research and Evaluation of Traditional Medicine
 

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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