10/07/2008

Toxicity and Safety -Toxicity in vitro

• Preliminar Toxicity - Mitochondria

 

In a preliminary toxicity study on cellular membranes, oxidative phosphorylation and calcium transport in rat liver mitochondria was studied. No changes in these parameters at 100 ug/mL of P-MAPA was observed, indicating no mitochondria dysfunction at this level.

 

• Cytotoxicity -V79 cell line

 

Cytotoxicity experiments based on survival curves in Chinese Hamster fibroblast V-79 cell line, showed that at 0.83 uM (120 ug/mL) of P-MAPA was non toxic to the cells. Even at this concentration the ID50 value was not reached.

 

• Chromosomal Aberrations

Lymphocytes cytogenic changes induced by mutagenic, carcinogenic and by toxic environmental pollutants are usually monitored by the number of sister chromatid exchanges, chromosomal aberrations, mitotic index and by cell cycle progression.

 

The analysis did not show any significative differences between the control and treated cultures with P-MAPA.

 

The numerical and structural aberrations frequency were within the normal values as described in the literature.

 

Therefore, under the experimental conditions used in the present study, P-MAPA appears to be a nongenotoxic drug, since it did not induce any chromosomal aberrations when used up to 100 ug/mL concentration