Prevalidation study of the Syrian hamster embryo (SHE) cell transformation assay at pH 7.0 for assessment of carcinogenic potential of chemicals.
The European Centre for the Validation of Alternative Methods (ECVAM) has organised an interlaboratory prevalidation study on the Syrian hamster embryo (SHE) cell transformation assay (CTA) at pH 7.0 for the detection of rodent carcinogens. The SHE CTA at pH 7.0 has been evaluated for its within-laboratory reproducibility, transferability and between-laboratory reproducibility. Four laboratories using the same basic protocol with minor modifications participated in this study and tested a series of six coded-chemicals: four rodent carcinogens (benzo(a)pyrene, 3-methylcholanthrene, 2,4-diaminotoluene and o-toluidine HCl) and two non-carcinogens (anthracene and phthalic anhydride). All the laboratories found the expected results with coded chemicals except for phthalic anhydride which resulted in a different call in only one laboratory. Based on the outcome of this study, it can be concluded that a standardised protocol is available that should be the basis for future use. This protocol and the assay system itself are transferable between laboratories and the SHE CTA at pH 7.0 is reproducible within- and between-laboratories.
Université Paul Verlaine de Metz, Metz, France. marie-aline.maire@univ-metz.fr
Marie-Aline
MA
Maire
Kamala
K
Pant
Albrecht
A
Poth
Karl-Rainer
KR
Schwind
Claudine
C
Rast
Shannon W
SW
Bruce
Jamie E
JE
Sly
Susanne
S
Kunz-Bohnenberger
Thorsten
T
Kunkelmann
Günter
G
Engelhardt
Markus
M
Schulz
Paule
P
Vasseur
D000818:Animals; D015197:Carcinogenicity Tests / Q000379:methods* / Q000592:standards; D002273:Carcinogens / Q000633:toxicity; D002471:Cell Transformation, Neoplastic; D006224:Cricetinae; D006863:Hydrogen-Ion Concentration; D011237:Predictive Value of Tests; D015203:Reproducibility of Results
D002273:Carcinogens