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Cell Transformation Assay Based on the Bhas 42 Cell Line

Topic : Carcinogenicity

Test Method Number: TM2012-06 (EU)
Short Name of TM: Bhas 42 CTA
Year received: 2012
Responsible Organisation: EURL ECVAM - European Union '
Protocol(s)/SOP(s): 156
General Comments:

The validation of this assay was coordinated by the Japanese Center for the Validation of Alternative Methods (JaCVAM), while the peer review was conducted by ESAC.

Method Description

The in vitro CTA using Bhas 42 cell line is aimed at detecting the carcinogenic potential of chemicals. The assay is based on the change of the phenotypic features of cells undergoing the first steps of the conversion from normal cells to neoplastic-like cell foci with oncogenic properties. Carcinogenesis is a complex multistage process by which normal cells are transformed into cancer cells characterised by an accumulation of changes at the cellular, genetic and epigenetic level. In vitro CTAs such as the Bhas 42 CTA have been shown to recapitulate a multistage process that closely models some stages of in vivo carcinogenesis. Cell transformation in all the systems studied to-date involves changes at each stage in order for progression to the next stage in the transformation process to occur. A minimum of four phenotypic stages appears to be involved in cell transformation. These include (from primary to fully malignant cells):

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Track Approval Status

  • Submission
  • Validation
  • Peer-review
  • Recommendation
  • Regulatory acceptance/Standards
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