ANBUTA PLUS – safety, toxicity, mutagenicity, and mitogenicity tests

It was analyzed the toxicity of MODUL8 (ANBUTA PLUS) with K562 (immortalized from human myelogenous leukemia) by flow citometry. It was used the kit from BIOPharmigen, Annexin V-FITC Apoptosis Detection, and it was also used Propidium Iodide (PI) to evaluate cell viability and DNA content in cell cycle. PI is an intercalating DNA agent and a fluorescent molecule. All experiments were performed at least three times, and data, representative of three independent experiments, was performed in a double-bind manner with ANOVA and Tukey test.

Table with results about apoptosis and cell viability of k-562 cell line after modul8 treatment (*p<0,05)

	Viable	Necrosis	Early apoptosis	Late apoptosis
Control	85,705	11,00667	0,826667	2,456667
Hidro-alcoholic solution	85,22167	11,74167	1,126667	1,91
Modul8	87,46333	9,128333	1,281667	2,126667

The percentage of viable cells is about 85% and there is no significance between groups after treatment.

There is no difference between G1, S and G2 phases of cell cycle between treated and control cells.

Conclusion: The medication does not interfere in cell cycle, does not damage DNA molecule and does not induce apoptosis. Briefly, it is neither toxic, nor mitogenic, or mutagenic.