title: Ninety-Day Oral Toxicity Assessment of an Alternative Biopolymer for Controlled Release Drug Delivery Systems Obtained from Cassava Starch Acetate.
abstract: The large consumption of biodegradable films from cassava starch acetate (FCSA) as ingredients in food and pharmaceutical products requires the assessment of the possible toxicity of these products. The aim of this study was to investigate the toxicity of biodegradable film from cassava starch acetate after oral exposure of Wistar rats for 90 days. The amount of food consumed and the body weight were weekly monitored. Blood and urine samples were obtained for the assessment of serum parameters and renal function. Histopathological analyses in target organs were also performed. No evidence of clinical toxicity in hematological, biochemical, or renal parameters in the FCSA-treated animals was found. In addition, relative organ weight and histopathological evaluations did not differ between groups treated with FCSA and control. Data obtained suggest that the subchronic exposure to FCSA does not cause obvious signs of toxicity in Wistar rats, indicating possible safety of this biofilm.
authors.affiliation: Laboratory of Toxicology and Pharmacology of Natural Products, Paranaense University, P.O. Box 224, 87502-210 Umuarama, PR, Brazil.
authors.forename: Douglas Rossi
authors.initials: DR
authors.lastname: Jesus
authors.affiliation: Department of Pharmacology, Federal University of Paraná, P.O. Box 19031, 81531-990 Curitiba, PR, Brazil.
authors.forename: Lorena Neris
authors.initials: LN
authors.lastname: Barbosa
authors.affiliation: Laboratory of Toxicology and Pharmacology of Natural Products, Paranaense University, P.O. Box 224, 87502-210 Umuarama, PR, Brazil.
authors.forename: Thiago Bruno Lima
authors.initials: TB
authors.lastname: Prando
authors.affiliation: Laboratory of Toxicology and Pharmacology of Natural Products, Paranaense University, P.O. Box 224, 87502-210 Umuarama, PR, Brazil.
authors.forename: Leonardo Franco
authors.initials: LF
authors.lastname: Martins
authors.affiliation: University Center Cesumar, P.O. Box 447, 87050-900 Maringá, PR, Brazil.
authors.forename: Francielli
authors.initials: F
authors.lastname: Gasparotto
authors.affiliation: Laboratory of Toxicology and Pharmacology of Natural Products, Paranaense University, P.O. Box 224, 87502-210 Umuarama, PR, Brazil.
authors.forename: Karla Moraes Rocha
authors.initials: KM
authors.lastname: Guedes
authors.affiliation: Laboratory of Toxicology and Pharmacology of Natural Products, Paranaense University, P.O. Box 224, 87502-210 Umuarama, PR, Brazil.
authors.forename: Douglas Cardoso
authors.initials: DC
authors.lastname: Dragunski
authors.affiliation: Laboratory of Toxicology and Pharmacology of Natural Products, Paranaense University, P.O. Box 224, 87502-210 Umuarama, PR, Brazil.
authors.forename: Emerson Luiz Botelho
authors.initials: EL
authors.lastname: Lourenço
authors.affiliation: Department of Pharmacology, Federal University of Paraná, P.O. Box 19031, 81531-990 Curitiba, PR, Brazil.
authors.forename: Paulo Roberto
authors.initials: PR
authors.lastname: Dalsenter
authors.affiliation: Laboratory of Cardiovascular Pharmacology, Faculty of Health Sciences, Federal University of Grande Dourados, Rodovia Dourados-Itahum, km 12, P.O. Box 533, 79.804-970 Dourados, MS, Brazil.
authors.forename: Arquimedes
authors.initials: A
authors.lastname: Gasparotto Junior