National Toxicology Program

Performance Standards

The LLNA was the first alternative test method evaluated and recommended by ICCVAM. Based on the recommendations of ICCVAM and an independent scientific review panel, the LLNA has been accepted by U.S. and international regulatory authorities for assessing the potential of a substance to induce allergic contact dermatitis.

ICCVAM currently routinely develops performance standards for test methods. Peformance standards can be used to evaluate the reliability and accuracy of proposed test methods that are based on scientific principles similar to those of an established method and measure or predict the same biological or toxic effect. Because the current concept of performance standards was not developed by ICCVAM until 2003, performance standards for the LLNA were not developed during the 1998 ICCVAM evaluation. When ICCVAM endorsed the CPSC LLNA nomination in 2007, they also decided to develop performance standards to facilitate evaluation of modified LLNA protocols compared to the traditional LLNA.

ICCVAM has prepared draft performance standards for the LLNA and requests public comments on this draft document. These draft test method performance standards are proposed to evaluate the performance of LLNA test methods that incorporate specific modifications to the measurement of lymphocyte proliferation in the traditional LLNA. These modifications focus specifically on the measuring the incorporation of non-radioactive reagents in procedures to evaluate lymphocyte proliferation in the draining auricular lymph nodes rather than incorporation of radioactivity (³H-thymidine), which is used in the traditional LLNA.

ICCVAM will consider the report of the March 2008 Peer Review Panel meeting and public and SACATM comments in preparing final LLNA performance standards.