In Vitro Genotoxic Potential of D-003 on the Blood Lymphocytes Chromosomal Aberration Test

Background: D-003, a mixture of very high molecular weight aliphatic acids purified from sugarcane wax, has been shown antioxidant, lipid-modifying and antiosteoporotic properties in preclinical and clinical studies. Objective: This study investigated the in vitro genotoxic potential of D-003 to produce chromosomal aberrations (CA) in peripheral blood lymphocytes.Methods: Fresh suspensions of D-003 were added (1 000, 2 500 and 5 000 g/mL) to cultures with (microsomal liver fraction S9 mix) or without metabolic activation. Concurrent negative (Tween/water vehicle) and positive controls (cyclophosphamide 15 g/mL and mitomicyn-C 0.3 g/mL in the tests with and without metabolic activation, respectively) were included. Two hundred (200) metaphases by group were examined and the numbers and frequencies of cells with aberrations and the mitotic index were quantified. Results: D-003 added up to 5 000μg/mL of culture did not induce chromosomal aberrations in presence or not of S9 mix compared with negative controls and no trends with the doses were observed. Positive controls evidenced increases of the numbers and frequencies of CA. Mitotic indexes were unchanged with the treatment, which indicates that D-003 does not affect cell proliferation. Conclusions: D-003 added in vitro (1 000-5 000 -μg/mL) to peripheral blood lymphocyte cultures did not show evidences of cytotoxic or genotoxic potential in the CA test.