In vitro and in vivo safety evaluation of Dipteryx alata Vogel extract

Vegetal drugs of D. alata barks were submitted to quality control assays and further to the safety assays under 1) in vitro parameter by Salmonella (Ames) mutagenicity, and 2) in vivo parameter on the pregnancy of rats.The extract was non-mutagenic to any of the assessed strains TA97a, TA98, TA100 and TA102 even after metabolic activation (+S9). All in vivo parameters (reproductive ability evaluation, physical development of rat offsprings, and neurobehavioral development assays) showed no changes related to control group.D. alata barks extract is neither mutagenic by the Ames test nor toxic in the pregnancy of rats, with no physical-neurobehavioral consequences on the rat offsprings development.Dipteryx alata Vogel belongs to Leguminosae family, popularly known as "baru" [1]. Its fruits are consumed by cattle and wild animals [2] and as sweetmeat by humans [3]. Its seeds are edible, nutritive and the oil has medicinal properties [1,2,4], whereas other parts from plant are popularly used as anti rheumatic, tonic and menstrual regulator [5].One in five individuals taking prescriptions also use herbal remedies or nutritional supplements [6], despite the risks for adverse drug reactions resulting from interactions between herbal remedies and prescription pharmaceuticals. In addition, there are some herbs that are known as teratogens that should under no circumstances be taken during pregnancy, such as Semen crotonis, Semen pharbitidis, Radix euphorbiae, Radix phytolaccae, Rhizoma sparganii, and Rhizoma zedoariae; whereas other herbs are recognized as potentially dangerous for fetuses, such as Semen persicae and Radix aconiti [7]. Recently, a new pharmacological anti snake venom was attributed to D. alata [8].All these properties make D. alata very attractive for food consumption and medicinal use, although there is no information concerning its safety. In previous studies [9] the IC50 was determined and the obtained value was used to calculate the LD50. Here, we used i