Control of test substances.

Abstract

The efficient control of chemicals during a nonclinical laboratory study is of the utmost importance from three main points of view: (1) integrity of the experiment, (2) safety of personnel, and (3) protection of the environment. While the general principles involved in chemical control may be set forth in formal GLPs, detailed problems concerning individual test substances can only be resolved by utilizing the competency and judgment of a researcher who possesses adequate analytical chemical methods. Integrity of an experiment requires knowledge of the identity, purity, and stability of the test substance, as well as its proper handling and storage and a knowledge of its chemical properties. Assurance of homogeneity, stability, and proper concentration of the chemical in the dosage form is also of primary importance. The development and use of adequate analytical chemical procedures for determining the test agent in human samples, air, clothing, and on work surfaces is necessary for the initiation of surveillance procedures to assure safety of personnel from exposure to the test substances. The environment must be protected from hazardous test substances by using adequate disposal techniques for the chemical and all contaminated materials. This usually involves development of wastewater cleanup systems and continuous monitoring of the effluent to prevent discharge of hazardous substances. Incineration is the most useful method for disposal of solids and highly contaminated liquids. Work from our laboratory, done during the past 5 years, provides an illustration of the important principles, problems, and pitfalls encountered in chemical control.