Journal du métabolisme des médicaments et de la toxicologie
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Genotoxicity and subchronic oral toxicity studies of L-carnitine and L-carnitine L-tartrate

Aouatef Bellamine* and Shane Durkee

L-Carnitine is an endogenous substance that is biosynthesized from theamino acids lysine and methionine, and is also obtained from an omnivorous diet. The safety of L-carnitine and L-carnitine L-tartrate, as a dietary source of L-carnitine, was assessed in a subchronic toxicity study and in two genotoxicity assays. In a 90-day subchronic study, rats received diets containing 0, 2,500, 12,500, or 50,000 ppm L-carnitine L-tartrate for a period of 90 days, followed by a four-week recovery period. No treatment-related effects were noted on mortality, ophthalmology, hematology, gross pathology, or histopathology. Increases observed in food and water consumption, changes in absolute and relative seminal vesicle weights, and effects noted in urinalysis evaluations were deemed to be of no toxicological significance, as they were either considered to be a physiological response, were transient and disappeared at the end of the recovery period, or were not accompanied by any microscopic changes. L-carnitine displayed no mutagenic activity in various bacterial strains at concentrations up to 5,000 μg/plate both in the presence or absence of metabolic activation, nor did it induce chromosome aberrations in human lymphocytes. The results of these experiments support the safety of L-carnitine and L-carnitine L-tartrate as a dietary source of L-carnitine.