Syrian Hamster Embryonic (SHE) cell pH 7.0 Cell Transformation Assay Prevalidation study Report
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چکیده
Philippe Vanparys ALTOXICON BVBA (Vosselaar, Belgium) Leonard Schechtman Innovative Toxicology Consulting LLC (Lake Worth, Florida, USA) Marilyn Aardema Marilyn J. Aardema Consulting LLC (Fairfield, Ohio, USA) Makoto Hayashi Biosafety Research Center, Foods, Drugs and Pesticides (Shizuoka, Japan) Sebastian Hoffmann she consulting + services (Köln, Germany) Laura Gribaldo ECVAM (Ispra, Italy) Raffaella Corvi ECVAM (Ispra, Italy)
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Syrian Hamster Embryonic (SHE) cell pH 7.0 Cell Transformation Assay Prevalidation study Report
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Syrian Hamster Embryonic (SHE) cell pH 6.7 Cell Transformation Assay Prevalidation study Report
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eCVAM coordinated a formal prevalidation study of the SHe
As part of the human safety assessment of new chemical compounds, carcinogenicity testing currently is based on the standard 2-year rodent assay (OeCD, 2008). However, this assay is time-consuming, costly, and requires a large number of animals. the in vitro Cell transformation Assay (CtA) has been proposed as a valuable alternative to the bioassay. the CtA recapitulates critical stages of in v...
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A prevalidation study on the cell transformation assays in SHE cells at pH 6.7, SHE cells at pH 7.0 and Balb/c 3T3 cell line was coordinated by ECVAM focussing on issues of standardisation of protocols, within-laboratory reproducibility, test method transferability and between-laboratory reproducibility. The Validation Management Team concluded that standardised protocols are now available that...
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The implementation of the Syrian hamster embryo cell transformation assay (SHE CTA) into test batteries and its relevance in predicting carcinogenicity has been long debated. Despite prevalidation studies to ensure reproducibility and minimise the subjective nature of the assay's endpoint, an underlying mechanistic and molecular basis supporting morphological transformation (MT) as an indicator...
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