AI Article Synopsis

  • The Mouse Lymphoma Assay (MLA) Workgroup, consisting of global experts, met on September 9, 2005, to reach consensus on the 24-hour treatment protocol in genotoxicity testing.
  • Recommendations were made regarding acceptable values for negative and positive controls, including mutant frequency and cloning efficiency.
  • The Workgroup supported the inclusion of 24-hour treatments without S-9 in the MLA assay when shorter treatments yielded negative results, aligning with International Committee on Harmonization guidelines.

Article Abstract

The Mouse Lymphoma Assay (MLA) Workgroup of the International Workshop on Genotoxicity Testing (IWGT), comprised of experts from Japan, Europe and the United States, met on September 9, 2005, in San Francisco, CA, USA. This meeting of the MLA Workgroup was devoted to reaching a consensus on issues involved with 24-h treatment. Recommendations were made concerning the acceptable values for the negative/solvent control (mutant frequency, cloning efficiency and suspension growth) and the criteria to define an acceptable positive control response. Consensus was also reached concerning the use of the global evaluation factor (GEF) and appropriate statistical trend analysis to define positive and negative responses for the 24-h treatment. The Workgroup agreed to continue their support of the International Committee on Harmonization (ICH) recommendation that the MLA assay should include a 24-h treatment (without S-9) in those situations where the short treatment (3-4 h) gives negative results.

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http://dx.doi.org/10.1016/j.mrgentox.2006.08.013DOI Listing

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