L-Ornithine Monohydrochloride

L-ornithine monohydrochloride was evaluated in two in vitro genotoxicity and rat 90-day oral toxicity study. No evidence of genotoxicity in the bacterial reverse mutation assay or the chromosomal aberration test in doses up to 5000 micrograms / plate or 1.686 ug / ml, respectively observed both in the presence and absence of activation metabolic. Rats received doses of 0 (basal diet) 1.25%, 2.5% and 5.0%, respectively, for 90 days monohydrochloride L-Ornithine in food. No change in body weight, food consumption, ophthalmoscopy or hematology were observed. temporary increases in water intake and urine volume and decreased specific gravity was observed in the male monohydrochloride 5.0% receiving L-ornithine; However, these were probably due to the central role of ornithine in the urea cycle and the consequent increase of urea production. A decrease in serum chloride concentration and an increase in urine output chloride were observed; However, they were mostly on the administration of ornithine hydrochloride and are not considered by any toxicological significance. No significant results were found at autopsy. Based on the results of the study, a no observed adverse effect level (NOAEL) of 3445 and 3986 mg / kg bw / day was established for male and female rats.