In vitro and in vivo safety evaluation of Dipteryx alata Vogel extract.
BACKGROUND
Dipteryx alata Vogel popularly known as "baru" is an important commercial leguminous tree species from the Brazilian Cerrado, which possess medicinal properties, besides its fruits consumption by animals and humans. The use of the "naturally occurring plants" as herbal remedies and foods mainly from leaves, seeds, flowers and roots of plants or extracts require precautions before ensuring these are safe and efficacious. The objective of this study was to evaluate the safety of D. alata barks extract.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
School of Pharmacy, University of Sorocaba, UNISO, Rodovia Raposo Tavares km 92.5, Zip code: 18023-000 Sorocaba, SP, Brazil.
Natália Mencacci
NM
Esteves-Pedro
Thaisa
T
Borim
Virginia Sbrugnera
VS
Nazato
Magali Glauzer
MG
Silva
Patricia Santos
PS
Lopes
Márcio Galdino
MG
dos Santos
Cháriston André
CA
Dal Belo
Cássia Regina
CR
Primila Cardoso
Eliana Aparecida
EA
Varanda
Francisco Carlos
FC
Groppo
Marli
M
Gerenutti
Yoko
Y
Oshima-Franco
D000818:Animals; D000831:Animals, Newborn; D046914:Dipteryx / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D009153:Mutagens; D024301:Plant Bark; D010936:Plant Extracts / Q000009:adverse effects*; D011247:Pregnancy / Q000187:drug effects; D051381:Rats; D017208:Rats, Wistar; D012098:Reproduction / Q000187:drug effects; D012475:Salmonella / Q000187:drug effects
D009153:Mutagens; D010936:Plant Extracts