title: Mouse lymphoma thymidine kinase gene mutation assay: meeting of the International Workshop on Genotoxicity Testing, San Francisco, 2005, recommendations for 24-h treatment.
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.
authors.affiliation: National Center for Toxicological Research, Food and Drug Administration, Jefferson, AR 72079, USA. Martha.Moore@fda.hhs.gov
authors.forename: Martha M
authors.initials: MM
authors.lastname: Moore
authors.forename: Masamitsu
authors.initials: M
authors.lastname: Honma
authors.forename: Julie
authors.initials: J
authors.lastname: Clements
authors.forename: George
authors.initials: G
authors.lastname: Bolcsfoldi
authors.forename: Brian
authors.initials: B
authors.lastname: Burlinson
authors.forename: Maria
authors.initials: M
authors.lastname: Cifone
authors.forename: Jane
authors.initials: J
authors.lastname: Clarke
authors.forename: Philip
authors.initials: P
authors.lastname: Clay
authors.forename: Rupa
authors.initials: R
authors.lastname: Doppalapudi
authors.forename: Michael
authors.initials: M
authors.lastname: Fellows
authors.forename: Bhaskar
authors.initials: B
authors.lastname: Gollapudi
authors.forename: Saimei
authors.initials: S
authors.lastname: Hou
authors.forename: Peter
authors.initials: P
authors.lastname: Jenkinson
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Muster
authors.forename: Kamala
authors.initials: K
authors.lastname: Pant
authors.forename: Darren A
authors.initials: DA
authors.lastname: Kidd
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Lorge
authors.forename: Melvyn
authors.initials: M
authors.lastname: Lloyd
authors.forename: Brian
authors.initials: B
authors.lastname: Myhr
authors.forename: Michael
authors.initials: M
authors.lastname: O'Donovan
authors.forename: Colin
authors.initials: C
authors.lastname: Riach
authors.forename: Leon F
authors.initials: LF
authors.lastname: Stankowski
authors.forename: Ajit K
authors.initials: AK
authors.lastname: Thakur
authors.forename: Freddy
authors.initials: F
authors.lastname: Van Goethem
mesh_terms: D000818:Animals; D008223:Lymphoma / Q000235:genetics*; D051379:Mice; D009152:Mutagenicity Tests / Q000379:methods*; D009153:Mutagens / Q000633:toxicity; D009154:Mutation; D013937:Thymidine Kinase / Q000235:genetics*; D013997:Time Factors
chemical_list: D009153:Mutagens; D013937:Thymidine Kinase