Toxicity Evaluation of a Non-Pain Pharmacopuncture Extract Using a Bacterial Reverse Mutation Test

Abstract

Objectives: The objective of this study was to assess the genotoxicity of a no-pain pharmacopuncture (NPP) extract developed in 2022 using a bacterial reverse mutation assay, aiming to further substantiate the safety profile of NPP. Methods: The genotoxicity evaluation involved a bacterial reverse mutation assay to assess the mutagenic potential of NPP extracts with and without metabolic activation. Histidine- requiring Salmonella typhimurium strains (TA98, TA100, TA1535, and TA1537) and tryptophan-requiring Escherichia coli strains (WP2uvrA) were used in the assay. Results: The NPP extract did not induce a revertant colony count exceeding two times that of the negative control at any dose level in any of the tested strains, both with and without metabolic activation. Additionally, no growth inhibition or precipitation was observed in the presence of NPP. Conclusion: Based on the findings, it can be concluded that the NPP extract exhibited no mutagenic potential in the in vitro genotoxicity tests conducted. © 2024 Korean Pharmacopuncture Institute. All rights reserved.