Recommended protocol for the BALB/c 3T3 cell transformation assay.
The present protocol has been developed for the BALB/c 3T3 cell transformation assay (CTA), following the prevalidation study coordinated by the European Centre for the Validation of Alternative Methods (ECVAM) and reported in this issue (Tanaka et al. [16]). Based upon the experience gained from this effort and as suggested by the Validation Management Team (VMT), some acceptance and assessment criteria have been refined compared to those used during the prevalidation study. The present protocol thus describes cell culture maintenance, the dose-range finding (DRF) experiment and the transformation assay, including cytotoxicity and morphological transformation evaluation. Use of this protocol and of the associated photo catalogue included in this issue (Sasaki et al. [17]) is recommended for the future conduct of the BALB/c 3T3 CTA.
Food and Drug Safety Center, Hadano, Kanagawa, Japan. sasaki.k@fdsc.or.jp
Kiyoshi
K
Sasaki
Susanne
S
Bohnenberger
Kumiko
K
Hayashi
Thorsten
T
Kunkelmann
Dai
D
Muramatsu
Pascal
P
Phrakonkham
Albrecht
A
Poth
Ayako
A
Sakai
Susan
S
Salovaara
Noriho
N
Tanaka
B Claire
BC
Thomas
Makoto
M
Umeda
D000826:Animal Testing Alternatives / Q000379:methods; D000818:Animals; D041702:BALB 3T3 Cells; D015197:Carcinogenicity Tests / Q000379:methods*; D002273:Carcinogens / Q000633:toxicity; D018929:Cell Culture Techniques; D002471:Cell Transformation, Neoplastic; D051379:Mice; D012107:Research Design / Q000592:standards
D002273:Carcinogens