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Mouse lymphoma thymidine kinase gene mutation assay: Meeting of the International Workshop on Genotoxicity Testing, San Francisco, 2005, recommendations for 24-h treatment

2006; Elsevier BV; Volume: 627; Issue: 1 Linguagem: Inglês

10.1016/j.mrgentox.2006.08.013

1879-3592

Martha M. Moore, Masamitsu Honma, Julie Clements, George Bölcsföldi, Brian Burlinson, Maria Grazia Cifone, Jane J. Clarke, P. Clay, Rupa S. Doppalapudi, Michael Fellows, B. Bhaskar Gollapudi, Sai‐Mei Hou, Peter Jenkinson, Wolfgang Muster, Kamala Pant, Darren Kidd, Elisabeth Lorge, Melvyn Lloyd, B. Myhr, Michael R. O’Donovan, Colin Riach, Leon F. Stankowski, Jr., Ajit Kumar Thakur, Freddy Van Goethem,

Molecular Biology Techniques and Applications

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.