Toxicology Studies of Xenobiotics in the Surrounding Environment

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The word “toxicity” describes the extent to which a xenobiotic can cause adverse side effects. Toxicology studies is the branch of science that is concerned with the study of adverse or toxic effects of chemical, physical or biological agents on living organisms and the ecosystem, including the prevention and amelioration of such adverse effects. A toxic endpoint is a specific toxic response to a toxic agent, e.g. skin sensitivity. Toxicity is the leading cause of failure of new medical devices and pharmaceutical drugs. The success of a medicinal product, pharmaceutical drug or a medical device depends not only on its efficacy but also on its chemical composition. Xenobiotic exposure through pharmaceutical drugs happens directly by oral consumption. Medical devices, on the other hand, cause indirect exposure because of leaching and migration of chemicals from the device material to the human body. Pharmaceutical drugs and medical devices, therefore, need to undergo a rigorous regulatory risk assessment procedure before they obtain marketing approval. Chemical risk assessment or evaluation of the extent of toxic effects associated with xenobiotic exposure is, therefore, necessary for protection of human and environmental health.

The extent of risk exerted by a xenobiotic is determined by its absorption, distribution, metabolism, elimination and toxicological properties, commonly referred to as the ADMET profile. Absorption is the process of transfer of drug from the site of administration into the systemic circulation. Distribution is the process of reversible transfer of drug from blood to different parts of the body and its transportation to the site of action. Xenobiotic distribution is dependent on several factors like physicochemical properties of the xenobiotic (e.g. solubility), physiological factors (e.g. permeability of tissue membranes) and xenobiotic interactions in the blood and tissues (e.g. binding to carrier proteins). Metabolism, also referred to as biotransformation, is the process of transformation of the xenobiotic inside the body into an easily excrete-able form. Sometimes it may also involve biochemical transformation of an inactive xenobiotic into an active metabolite. The process of metabolism usually takes place in the liver. Elimination is the process of irreversible removal of the xenobiotic and the metabolites from the body. Elimination can happen by metabolism and excretion. The knowledge of ADME parameters is useful in predicting xenobiotic concentration in the body at any point of time and its potential side-effects. It is a fine optimization of a chemical’s potency and its ADMET properties that ultimately leads to the selection and clinical development of chemical components of a potential medicinal product. In toxicology studies,Chemical risk assessment early in the pharmaceutical or device development is, therefore, important in understanding human biological response to a xenobiotic.