Evaluación de la toxicidad por dosis única de la vacuna antidiftérica-antitetánica en ratas Sprague-Dawley.

The present paper evaluates the toxicity by single dose of the diphtheria-tetanus vaccine (VA-DIFTET®) in Sprague Dawley rats. Its administration was carried out by intramuscular route because this is the one proposed for use in humans. 0.3 mL of the vaccine or its components was administered to a total of 20 animals per group (10 per each sex). These animals were daily observed and, water and food intake was measured on alternate days determining their body weight with week intervals. The anatomopathological analysis of animals was included at the end of the study. No animal died during the assay or clinical symptoms were observed either. No statistically significant differences (p>0,1) were detected regarding water-food intake and body weight. In the anatomopathological study, macrophagic granulomatous lesions were observed in the rats treated with the vaccine or placebo; this finding is characteristic of vaccines adjuvated with aluminum hydroxide. Results suggested that VA-DIFTET® is potentially innocuous when administering the single dose by intramuscular route. [ABSTRACT FROM AUTHOR]