Regulatory agencies in most countries require testing of consumer products, medicines, and industrial and agricultural chemicals to identify potential health and safety hazards,thereby enabling appropriate hazard classification and labeling, which in turn enables apprised decisions about responsible use, storage, and disposal. All toxicity test methods utilized for regulatory purposes must be predicated on sound science and able to adequately identify hazards.
Besides the major concern of ethics, there are few more disadvantages of animal experimentation like requisite of adept manpower, time consuming protocols and high cost. Also the pain, distress and death experienced by the animals during scientific experiments have been a debating issue
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For example, in vitro cell culture is a good way to screen the compounds at early stages. Utilization of the human hepatocyte culture gives the information about how a drug would be metabolized and eliminated from the body. Inclusion of such method in study design avails to eliminate unsuitable compounds in preliminary stages only and minimizes the utilization of animals in further tastings (Kimber et al., 2001). Live animals and embryos are utilized to study effects of some compounds on embryo development. In vitro embryonic stem cell culture test avails to reduce the number of live embryo used and the compounds which are toxic toward developing …show more content…
The in vitro models provide the opportunity to study the cellular replication in a closed system, where the experimental conditions are maintained. Such models provide preliminary information for outcome of an experiment in vivo. For example, computer models were acclimated to study the working of the heart and to cull the potential drug candidates. An example is, extraction of insulin from the pancreas of pigs and cow, but now it is obtained from the bacterial cultures which are lifeline drugs for diabetic patients. This extracted insulin needs to be checked for its purity, efficacy and dose. Utilization of animals was routine for such checking, but now chromatography techniques are utilized for checking the purity, efficacy and calculation of dosages of drugs (Foreman et al., 1996). Overall, replacement substantially reduces the utilization of animals in various processes. Several alternative methods, which were scientifically validated and accepted by competent regulatory bodies, can be utilized for regulatory toxicology purposes, thus reducing or plenarily replacing living animals in toxicology experimentation. The acceptance of the alternative methods as valuable tools of modern toxicology has been recognized by regulators, including OECD, FDA and EPA.(Interdiscip Toxicol. 2011 Sep; 4(3):