Saganuwan, S. A., 2017.

Toxicity studies of drugs and chemicals in animals: an overview.

Bulg. J. Vet. Med., 20, No 4, 291–318.       DOI: 10.15547/bjvm.983

Toxicity study is the investigation of either short or long-term toxic effects of a drug or chemical on animals. The toxicity is dose-dependent as asserted by Paracelsus over 500 years ago. However, short-term toxic effect is determined using median lethal dose (LD₅₀) first introduced by Trevan in 1927 and revised many times. Presently there is a growing preponderance of rejection of scientific papers on acute toxicity study, simply because of the belief that in the current hazard and safety assessment of drugs and chemicals, LD₅₀ values are no longer used. In view of this, literature search was carried out with a view to investigating the relevance of LD₅₀ in development and assessment of drugs and chemicals. The findings revealed that in the past, many animals had been used for LD₅₀ determination. OECD has reduced the number of test animals to 5–15 and presently it is further reduced to 2–6. Acute toxicity study is being carried out in medicinal plants research and in the study of patent medicine. Although the application of LD₅₀ has been drastically reduced, it is still applied and accepted in some parts of the world. Moreover, animals on which LD₅₀ tests are conducted, should be allowed to die to see the end effect of the test drug or chemical because euthanisia of test animals may mask some toxicity signs of the test agents. Therefore, toxicity study of drugs and chemicals is a scientific process necessary for discovery and development of drugs as well as identification of potential toxicants.

Key words: median lethal dose, Paracelsus, therapeutic agent, toxicant, toxicity