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
 

LOCAL TOXICITY TEST

Skin sensitization test

Dermatological preparations to be tested

• solid preparations:

To be prepared by wetting the preparation with water or a suitable solvent to provide a uniform application.



• semi-solid preparations:

To be tested as undiluted preparations.



• liquid preparations:

To be tested as undiluted preparations However, an aerosol agent can be diluted if necessary.

Experimental animals

Use a species with high susceptibility Guinea-pigs are considered the most suitable experimental animals

Test methods (in alphabetical order)

1 Adjuvant and patch test
2 Buehler test
3 Draize test
4 Freund’s complete adjuvant test
5 Maximization test
6 Open epicutaneous test
7. Optimization test
8. Split adjuvant test

It is recognized that the above-mentioned methods differ in their probability and degree of response to sensitizing substances. However, it is generally accepted that the use of Freund’s complete adjuvant increases sensitivity and therefore the possibility of detecting substances with weak sensitizing potential.

Evaluation of test results

The skin reaction of each animal should be evaluated according to the assessment standard of the particular test method used.

Other local toxicity tests

Other local toxicity tests may be conducted if the herbal medicine is intended for such use i.e. vaginal, rectal, respiratory, etc. irritations tests.

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