The potential probiotic bacteria Lactobacillus salivarius CECT5713 has recently been isolated from human milk and characterized. The objective of the present study was to evaluate the oral toxicity of this potential probiotic bacteria in mice. With this aim, 50 Balb/C mice were divided in 5 groups (n = 10). Three of these groups were treated orally with different doses of L. salivarius CECT5713: 5 x 10(8), 2 x 10(9), or 10(10) cfu/mouse per d for 28 d. One additional group was administered the vehicle alone and was used as a control. The last group were injected intraperitoneally with 10(8) cfu/mouse in a single dose and killed 2 (n = 5) and 5 (n = 5) d after intraperitoneal injection. Food intake, body weight, bacterial translocation, serum alpha-amyloid protein, and different biochemical parameters were analyzed. Oral administration of L. salivarius CECT5713 to mice had no adverse effects on mouse body weight or food intake. No bacteremia was shown and there was no treatment-associated bacterial translocation to the liver or spleen. Intraperitoneal administration caused a significant bacterial translocation to the liver and spleen, but not to the blood. However, this translocation was not related to illness or death at either d 2 or d 5, although an increase in plasma serum alpha-amyloid protein was observed at d 2. These results suggest that the strain L. salivarius CECT5713 is nonpathogenic for mice, even in doses 10,000 times higher (expressed per kilograms of body weight) than those normally consumed by humans. Thus, this strain is likely to be safe for human consumption.