While the local lymph node assay (LLNA) is the preferred method in European regulatory toxicology for testing for skin sensitization, a major issue for debate is the degree to which it is associated (like other test protocols) with ‘false’ positive and ‘false’ negative outcomes. A recent analysis by a team of international experts provides further insight into this difficult area, giving examples of where the scientists believe the LLNA has produced false positive results, as well as cases where correct data interpretation has presented scientific challenges. The researchers feel that data obtained with the LLNA should be “interpreted intelligently, using scientific analysis of results and considering the weight of evidence, before decisions are made on which substances should be classified as representing a skin sensitization hazard.” In conclusion, they recommend that for those chemical classes where the LLNA has been shown to be inappropriate, other standardized test methods should be considered as the first choice assay (Basketter D. et al., Regulatory Toxicology and Pharmacology 2009, 55, 90; http://dx.doi.org/10.1016/j.yrtph.2009.06.005). {183106}

The above item was taken from the November 2009 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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