An In Chemico Test to Identify Dermal Corrosives

Abstract a Exposure to dermal corrosives can occur during production, transport, use, and disposal of chemicals and products. Such goods are manufactured and transported all over the world to different destinations, and the transport of hazardous materials increases the likelihood of injury to the skin through improper chemical release. New laws are being implemented that ban or severely limit the use of live animals for routine product testing. Available nonanimal tests do not accurately identify dermal corrosives and no test for corrosives is either high throughput or can be used in the field. There is thus a need for a nonanimal high-throughput laboratory and field test to identify dermal corrosives; the subject of this proposal. Our preliminary research discovered that a measurable change in the molecular structure of a marker protein predicts if a material has the potential to damage and degrade human skin. Based on this finding, an "in chemico" (cell free, shelf stable) test chemistry was developed, a patent application has been submitted, and preliminary "kits" have been assembled (both a field test "kit" and a high-throughput laboratory test "kit"). The procedure involves adding the material to be tested to a tube filled with a proprietary molecular marker for skin corrosion, incubating the material at room temperature, and then adding a colorimetric reagent to measure the extent of conformational change of the molecular marker and quantification using either a laboratory plate reader (high-throughput laboratory method) or a portable spectrophotometric pipette (field method). This measured change is then compared with the controls, and a "corrosion score" is calculated. The corrosion score is then applied to a prediction model, and the test material is classified as a skin corrosive or noncorrosive. Initial studies comparing results from the in chemico test with historical databases of live animal skin corrosion studies ("Draize Test" data) indicate the test has very high predictivity. This project will confirm the accuracy and configuration of the test as a portable kit, and a transferability study will be conducted by three laboratories. The outcome of this project will be a new, rapid, easy-to-use method that does not use animals and will accurately determine if an unknown chemical or material corrodes and damages the skin.