Mouse lymphoma thymidine kinase gene mutation assay: International Workshop on Genotoxicity Tests Workgroup report--Plymouth, UK 2002.
The Mouse Lymphoma Assay (MLA) Workgroup of the International Workshop on Genotoxicity Tests (IWGT) met on June 28th and 29th, 2002, in Plymouth, England. This meeting of the MLA group was devoted to discussing the criteria for assay acceptance and appropriate approaches to data evaluation. Prior to the meeting, the group conducted an extensive analysis of data from both the microwell and soft agar versions of the assay. For the establishment of criteria for assay acceptance, 10 laboratories (6 using the microwell method and 4 using soft agar) provided data on their background mutant frequencies, plating efficiencies of the negative/vehicle control, cell suspension growth, and positive control mutant frequencies. Using the distribution curves generated from this data, the Workgroup reached consensus on the range of values that should be used to determine whether an individual experiment is acceptable. In order to establish appropriate approaches for data evaluation, the group used a number of statistical methods to evaluate approximately 400 experimental data sets from 10 laboratories entered into a database created for the earlier MLA Workshop held in New Orleans [Environ. Mol. Mutagen. 40 (2002) 292]. While the Workgroup could not, during this meeting, make a final recommendation for the evaluation of data, a general strategy was developed and the Workgroup members agreed to evaluate this new proposed approach using their own laboratory data. This evaluation should lead to a consensus global approach for data evaluation in the near future.
Moore
Martha M
MM
National Center for Toxicological Research, Food and Drug Administration, HFT-120, 3900 NCTR Road, Jefferson, AR, USA. mmmoore@nctr.fda.gov
Honma
Masamitsu
M
Clements
Julie
J
Bolcsfoldi
George
G
Cifone
Maria
M
Delongchamp
Robert
R
Fellows
Michael
M
Gollapudi
Bhaskar
B
Jenkinson
Peter
P
Kirby
Paul
P
Kirchner
Stephan
S
Muster
Wolfgang
W
Myhr
Brian
B
O'Donovan
Michael
M
Oliver
Jo
J
Omori
Takashi
T
Ouldelhkim
Marie-Claude
MC
Pant
Kamala
K
Preston
Robert
R
Riach
Colin
C
San
Richard
R
Stankowski
Leon F
LF
Thakur
Ajit
A
Wakuri
Shinobu
S
Yoshimura
Isao
I
D000818:Animals; D001681:Biological Assay / Q000592:standards*; D008223:Lymphoma / Q000378:metabolism*; D051379:Mice; D009152:Mutagenicity Tests / Q000592:standards; D013937:Thymidine Kinase / Q000032:analysis*
D013937:Thymidine Kinase