article · BULGARIAN JOURNAL OF VETERINARY MEDICINE
This overview examines toxicity studies, which investigate the short or long-term toxic effects of drugs and chemicals on animals. It highlights that toxicity is dose-dependent, a principle established centuries ago. The paper discusses the median lethal dose (LD50) method, introduced in 1927, noting its historical use of many animals and subsequent reduction in animal numbers by organisations like OECD. Despite a growing rejection of acute toxicity studies using LD50 in some scientific circles, the method remains applied and accepted in certain parts of the world, particularly in medicinal plant and patent medicine research. The review suggests that animals in LD50 tests should be allowed to die to fully observe end effects, as euthanasia might mask toxicity signs. Overall, toxicity studies are deemed crucial for drug discovery, development, and identifying potential toxicants.
Understanding toxicity studies is vital for ensuring the safety of new drugs and chemicals before they reach the public. This research clarifies the ongoing relevance and methodological considerations of animal testing, particularly the LD50 method, in assessing potential harm and guiding the development of safer products.
The abstract does not indicate a direct application pathway, specific user, or readiness level for commercialisation. It focuses on the methodology and relevance of toxicity studies in drug and chemical assessment.
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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 (LD 50 ) 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, LD 50 values are no longer used. In view of this, literature search was carried out with a view to investigating the relevance of LD 50 in development and assessment of drugs and chemicals. The findings revealed that in the past, many animals had been used for LD 50 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 LD 50 has been drastically reduced, it is still applied and accepted in some parts of the world. Moreover, animals on which LD 50 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.
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DOI: 10.15547/bjvm.983
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