The ICH S1B (R1) appendix has been recently revised to supplement the overall S1 guidelines and used in close conjunction with ICH S1A, S1B, and S1C. This appendix is intended to provide an integrated approach to provide a specific weight of evidence (WoE) for determining whether a 2-year rat carcinogenicity study provides value in performing a human carcinogenic risk assessment. The OECD tried to allow to use the described method as part of a weight of evidence approach in the testing of substances for carcinogenic potential, and proposed a cell transformation assay using Bhas 42 cells. Cell transformation assays were evaluated using Bhas42 cells, and the number of foci with malignant transformation was counted. Transformed foci appeared in the positive material treated group, and it was confirmed that there was a statistically significant increase in the positive material treated group compared to the solvent control group. Before animal experiments for carcinogenicity detection, data from the Bhas 42 cell transformation assay may be considered, if available. In addition, cell transformation assay can morphologically confirm the carcinogenic effects at the initiation.
1. Introduction
2. Materials and Methods
3. Results
4. Discussion
Acknowledgements
Conflict of interests
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References
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