- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Safety and Efficacy
(1993; 94 pages)
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.
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.