Mouse lymphoma thymidine kinase gene mutation assay: meeting of the International Workshop on Genotoxicity Testing, San Francisco, 2005, recommendations for 24-h treatment.
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.
Moore
Martha M
MM
National Center for Toxicological Research, Food and Drug Administration, Jefferson, AR 72079, USA. Martha.Moore@fda.hhs.gov
Honma
Masamitsu
M
Clements
Julie
J
Bolcsfoldi
George
G
Burlinson
Brian
B
Cifone
Maria
M
Clarke
Jane
J
Clay
Philip
P
Doppalapudi
Rupa
R
Fellows
Michael
M
Gollapudi
Bhaskar
B
Hou
Saimei
S
Jenkinson
Peter
P
Muster
Wolfgang
W
Pant
Kamala
K
Kidd
Darren A
DA
Lorge
Elisabeth
E
Lloyd
Melvyn
M
Myhr
Brian
B
O'Donovan
Michael
M
Riach
Colin
C
Stankowski
Leon F
LF
Thakur
Ajit K
AK
Van Goethem
Freddy
F
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
D009153:Mutagens; D013937:Thymidine Kinase