【国外标准】 Standard Practice for Assessing the Comparative Efficacy of Products Used for the Decontamination of Chemical Warfare Agents (CWAs) on Skin

4.1 This practice specifies an in-vivo measurement of CWA decontamination on the skin.4.2 CWA skin decontaminants will have different modes of action including absorption, adsorption, removal, chemical neutralization or some combination of the above. There is, therefore, no single representative in-vitro method for validation of decontamination efficacy of products for skin decontamination. For example, measuring the presence of a radiolabelled chemical warfare agent after chemical neutralization, may give a false positive results. It has been shown that if the agent has been chemically neutralized, the radiolabel may still be present in a non-toxic molecule. In addition, some chemical neutralization methods may break down the original agent, but the breakdown product is highly toxic. In the case of VX, hydrolysis produces a highly toxic product, EA2192 (S-(2-diisopropylaminoethyl) methylphosphonothioic acid (8).4.3 This standard practice is of significance in that efficacy is thoroughly evaluated to the extent possible to represent use on human skin. In-vivo studies have demonstrated that simple chemical monitoring for disappearance of the chemical agent may not be sufficient to measure decontamination and neutralization effectiveness. A standard practice is needed for determining actual decontamination and neutralization by measuring the decrease in mortality or lesion size caused by the agent.1.1 This practice establishes an in-vivo method for assessing the comparative efficacy of products used for the decontamination of chemical warfare agents (CWAs) on the skin.1.2 This practice provides a quantitative efficacy comparison of different skin decontamination products.1.3 To minimize the number of animals used, this in-vivo practice should be performed only after rigorous in-vitro studies of the candidate decontaminant, which can show the implied claims including chemical neutralization, decontamination studies on surfaces and appropriate testing such as cytotoxicity.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 This standard does not purport to address all of the safety concerns, if any, associated with the use of decontamination products or CWAs. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.