For the prediction of skin sensitization potential of substances, the murine local lymph node assay (LLNA) is an alternative to the widely used guinea pig tests. For more than 10 years, this method has undergone extensive development, evaluation, and validation. In this review, the validation status of the LLNA is considered, specifically with regard to its use for regulatory identification of skin sensitization hazards. The LLNA is a method for the predictive identification of chemicals that have a potential to cause skin sensitization. Activity is measured as a function of lymph node cell proliferative responses stimulated by topical application of test chemicals. The LLNA has successfully passed all reasonable validation stages. It provides a reliable and relevant source of predictive skin sensitization data, which unlike results from guinea pig tests, are reproducible from laboratory to laboratory. In summary, the LLNA is now ready for acceptance as a viable and complete alternative to traditional methods, offering a substantial reduction in animal numbers and refinement opportunities without compromising the standards for the identification of important skin sensitizers.
Background: Today, because of the wide variety of infectious agents encountered in the health care environment, clinicians must be particularly concerned about the potential for small-sized virus penetration through glove defects.
Objective: To describe a method for testing gloves that evaluates the entire glove and allows for detection of low levels of virus penetration. Ten sets of 10 different gloves from 4 manufacturers were evaluated using this method.
Methods: Barrier properties were evaluated using the bacteriophage, phiX174. Gloves were filled with surfactant solution placed in flasks containing 10(6) viruses per mL. Flasks were agitated at 37 degrees C +/- 2 degrees C and assayed for 180 minutes.
Results: Virus penetration was detected in 8% of the 100 gloves tested using the quantitative assay. The qualitative assay determined that 14% of the gloves tested allowed penetration.
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