Safety assessment of a medicinal extract from Caesalpinia paraguariensis bark in a sub-chronic oral toxicity study in rodents

SGARIGLIA M.A.; HONORÉ, S.M.; SOBERÓN, J.R.; SÁNCHEZ, S.S.; SAMPIETRO, D.A.; VATTUONE, M.A.

La Habana

Congreso; Latinfarma Habana 2013: XX Congreso Latinoamericano de Congreso Latinoamericano de Farmacología y Terapéutica; 5to Congreso Iberoamericano de Farmacología; 5to Congreso Internacional y 11no Congreso Nacional de Sociedad Cubana de Farmacología; 2013

Latinfarma

Introduction: Caesalpinia paraguariensis Burk. (Caesalpiniae) bark is used in Argentine traditional medicine to treat diabetes, atherosclerosis and skin affections. This specie is frequently used in Northern Argentine as ?mate? additive. Although the absence of acute toxicity was determined already, nothing is known about adverse effects that could result from sustained consumption. Aim of the study: The present study of toxicity was conducted to evaluate the safety of the use of bark infusion of C. paraguariensis (CPBI) by repeated-dose oral administration in rodents. Methodology: the animals used in this study were free zoonosis and mycobacteria Wistar rats, of both sexes, obtained from Fcen/ICBME-HI (Bs.As, Argentina); OECD-408 criteria (repeated dose 90-day oral toxicity study) were followed and randomized complete block designs applied. Briefly, rats (N=18) at 9 weeks old, weighing 140?207 g, were housed in cages and divided into three blocks defined by weight range (G0, G1 and G2). CPBI doses, 9 mg/kg WB (D1) and 45 mg/kg (D2), were administered individually and daily for 90 days, while control rats (C) received the vehicle only. The behavior, body weight, food and water intakes were followed weekly. Haematological, biochemical and organ parameters were determined at the end of the 90-day administration. Some bioactive components (ellagic derivatives and others phenolics) present in CPBI were quantified by RP-HPLC. Results: NOAEL of CPBI was D1, and LOAEL was D5. The daily oral administration of CPBI did not result in death or significant changes in body weight, haematological or biochemical parameters in respect of control group (P < 0.05). Liver, kidney, lung and pancreas histopathology did not reveal significant morphological alterations. Conclusions: The results showed that CPBI had no toxicity after oral sub-chronic low dose administration (D1) and indicate that the plant could be considered safe for oral medication.