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| Toxicological aspects of LactosporeÒ In general, no toxic effects of Lactobacillus administration have been reported, except for metabolic acidosis in cases of ingestion of Lactobacillus preparations with the D (-) optical isomer of lactic acid, especially in association with unbalanced diets. A limit of 200 ml per 10 kg body weight of this isomer per day has therefore been recommended for young children. No adverse reaction to L. sporogenes has been observed in either clinical or nonclinical studies. L. sporogenes produces only the L (+) optical isomer of lactic acid. 1. Acute toxicity studies: Acute toxicity studies77 with L. sporogenes were performed in male mice fed 1, 3 or 5 g/kg/day of LACRIS FOR ANIMAL USE powder containing not less than 5 x 109 spores of L. sporogenes per gram (infused into the stomach as a 10% suspension in water). The mice were observed for 7 days. No deaths occurred, nor was there any abnormality such as diarrhea. A few of the mice receiving 5 g/kg showed slight distension of the stomach which reverted to normal after a few hours. 2. Sub-acute toxicity studies: Male rats were fed LACRIS FOR ANIMAL USE 77 (containing 5 x 10 spores of L. sporogenes per gram) orally (in drinking water) at the level of 0.3, 3 and 5 g/kg/day for 15 months. Body weight gains for treated groups were similar to those for the control group. Changes in organ weight showed no significant differences between treated and control groups. Dogs (2 subjects), rabbits (3 subjects) and guinea pigs (15 subjects) were tested with orally administered maximum ingestible single daily doses (10g/kg for dogs, 30g/kg for rabbits and 50 g/kg for guinea pigs) for 7 days. No abnormalities were observed during the period of medication as well as for 10 days subsequent to the withdrawal of medication. |
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