scholarly journals Ninety-Day Oral Toxicity Assessment of an Alternative Biopolymer for Controlled Release Drug Delivery Systems Obtained from Cassava Starch Acetate

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Douglas Rossi Jesus ◽  
Lorena Neris Barbosa ◽  
Thiago Bruno Lima Prando ◽  
Leonardo Franco Martins ◽  
Francielli Gasparotto ◽  
...  

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.

1970 ◽  
Vol 56 (6) ◽  
pp. 325-334 ◽  
Author(s):  
Giuseppe Della Porta ◽  
José R. Cabral ◽  
Giorgio Parmiani

In a previous paper (Fd Cosmet. Toxicol., 6: 707–715, 1968) it was reported that hexamethylenetetramine (HMT) had no carcinogenic activity in long-term experiments in mice and rats. In the present study, 12 ♀ and 6 ♂ Wistar rats were given 1% HMT in the drinking water starting 2 weeks before mating. The females were kept under treatment during pregnancy and lactation. A similar untreated group of 12 ♀ and 6 ♂ served as control. Twelve treated females and eleven controls became pregnant and gave birth to 124 and 118 babies respectively; no malformations were noted. From these animals, 24 for each sex were continued on the 1% HMT up to the 20th week of age or were kept untreated. The body weight of treated animals was significantly lower than that of controls one, only up to the 9th week of age for the males and up to the 13th week for the females. At the end of the treatment both groups were sacrificed; the weight of organs was identical in the treated and control animals; there were no gross or histological pathology. In a second experiment, rats were given 1% HMT in the drinking water for 3 successive generations, up to the age of 40 weeks in the F1 and F2 groups and of 20 weeks for F3. The three groups were composed of 13 ♂ and 7 ♀, 15 ♂ and 11 ♀, 12 ♂ and 12 ♂, respectively. In addition, a group of 16 ♂ and 16 ♀ descendants of 2% HMT treated parents, were given 2% HMT for 50 weeks. A group of 48 ♂ and 48 ♀ served as untreated controls. All groups were kept under observation for over 2 years of age. No evidence of carcinogenicity was found in any of the HMT-treated groups.


2020 ◽  
Vol 19 (3) ◽  
pp. 617-622
Author(s):  
Razack Osseni ◽  
Azonbakin Simon ◽  
Diallo Aboudoulatif ◽  
Habib Ganfon ◽  
Adjagba Marius ◽  
...  

Purpose: To evaluate the 90 day sub-chronic toxicity of aqueous extract of Gmelina arborea leaves in Wistar rats. Methods: Rats were submitted to repeated daily oral administration of extract (250, 62.5 and 15.62 mg/kg) of Gmelina arborea leaves. The control groups were given distilled water and the rats were monitored for any toxicity symptoms as well as body and organs weights, water and food intake changes. The biochemical, haematological and histolopathological parameters were analysed. Results: The 90 days administration of the aqueous extract did not produce any toxicity signs or mortality. In addition, no significant alteration in water or food intake by the rats was observed. Although there were no changes in the body weights, significant decrease in the weight of the kidneys of the rats was observed at 250 mg/kg. Biological parameters as well as the histopathology of liver and kidneys were not significantly affected. Significant decreases were noted in glucose level at the three dose levels. In addition, significant difference in the levels of transaminases, glucose and platelets were observed. Conclusion: The 90-days subchronic toxicity test on Gmelina arborea did not produce any toxic effects. This confirms the safety of the plant leaves by traditional medicine practitioners. Keywords: Gmelina arborea, Subchronic toxicity, Wistars rats, Biological parameters


Author(s):  
Shruti Ramesh Shettigar ◽  
Vanita G. Kanase

Evaluation of anti-hyperuricemic activity of alcoholic extract of Capparis moonii Wight fruits in Wistar rats, by utilizing Indian caper typically occurring in the Konkan area which grows full-fledged in the hot and dry atmosphere that can be generally found throughout asia. The dried fruits of Capparis moonii W. were extracted using absolute ethanol to get an alcoholic extract. Acute oral toxicity studies were performed to decide the doses. The anti-hyperuricemic activity was estimated by the phenol red excretion in rats and the potassium oxonate induced hyperuricemia models respectively. The alcoholic extract showed dose-dependent mode of action where the higher concentration of 200 mg/kg showed higher amount of retention of phenol red in the blood suggesting that it has better ability to secrete urate out of the body of rats as compared to 100mg/kg. Also in potassium oxonate induced hyperuricemia, similar results were obtained with significant reduction in serum uric acid levels and serum creatinine levels as compared to 100mg/kg. The conclusion of this study was that; it proved that Capparis moonii W. alcoholic extract of the fruits can be beneficial as anti-hyperuricemic treatment agent. It would be encouraging to undertake further studies in future to decode the exact mechanism.


2021 ◽  
Vol 29 (6) ◽  
pp. 47-53
Author(s):  
M. A. Zemlyanova ◽  
M. S. Stepankov ◽  
A. M. Ignatova

Introduction. Active use in various spheres of economic activity and the large-scale nature of production determine the relevance of studying the effects of copper (II) oxide nanoparticles (CuO NPs) on the body during the oral route of intake. Material and methods. Particle size was determined by scanning electron microscopy and dynamic laser light scattering; specific surface area - Brunauer, Emmett and Teller; total pore volume - Barrett, Joyner and Khalenda. Acute oral toxicity of CuO NPs was studied in Wistar rats in accordance with GOST 32644-2014, multiple oral toxicity was studied by the Lim method. After repeated exposure, the biochemical and hematological parameters of the blood, the concentration of copper in the organs, and pathomorphological changes in the tissues of the organs were determined. Results. The size of CuO NPs in the composition of the native powder was 45.86 nm, in the aqueous suspension - 307.40 nm, the specific surface area was 17.70 m2/g, and the total pore volume was 0.056 cm3/g. According to the results of a single oral exposure, the LD50 value was > 2000 mg / kg body weight, which corresponds to 3 (GOST 12.1.007-76) and 4 (GOST 32644-2014) hazard classes. With repeated oral exposure, an increase in the levels of activity of ALT, AST, ALP, LDH, amylase, AOA and MDA was noted; the relative number of segmented neutrophils is increased, the number of leukocytes is increased, the relative number of lymphocytes is reduced. The concentration of copper under the action of NPs increases in the lungs, liver, stomach, intestines, kidneys, brain and blood. Pathomorphological changes in the tissues of the liver, kidneys, stomach, small and large intestines and lungs were established. Conclusion. The results obtained prove the presence of toxic properties of CuO NPs and can be used in the development of preventive measures for workers and consumers in contact with products containing CuO NPs.


2013 ◽  
Vol 33 (10) ◽  
pp. 1165-1179 ◽  
Author(s):  
Shailendra Pratap Singh ◽  
Monika Kumari ◽  
Srinivas I. Kumari ◽  
Mohammed F. Rahman ◽  
M. Mahboob ◽  
...  

2021 ◽  
Vol 99 (12) ◽  
pp. 1438-1445
Author(s):  
Natalia N. Belyaeva ◽  
Valery N. Rakitskii ◽  
Natalia I. Nikolaeva ◽  
Marina V. Vostrikova ◽  
Tatiana E. Veshchemova

Introduction. The literature analysis of structural and functional indices clearly shows no scientifically based set of quantitative indices. It fails to allow statistical data processing and makes it challenging to assess various levels of impact objectively. The goal was to analyze the literature to select structural and functional criteria-significant indicators and develop their quantitative and point assessment. Material and methods. Based on the literature review, the authors identified indices on the analysis of the histological picture. We developed quantitative morphometric, stereometric, and point scores for various systems of the body including the heart and vascular state in the organs under investigation, small and large intestine, stomach, liver, pancreas, adrenal and thyroid, glands, lungs and bronchi, kidney, testis, spleen, thymus. There were used microscopes with the ability to transmit images to a computer screen display. Authors analyzed 6-month oral exposure of the pesticide carbamate class in doses of 2.5, 5.0, and 20 mg/kg. Results. Based on the literature review, significant structural and functional criteria indices were selected. Authors developed a quantitative assessment for them. For each body, a table is proposed to allow digital input data about indices and their statistical processing. When analyzing the effects of the pesticide on rats at a dose of 20 mg/kg, target organs were identified: the liver, which develops both damage responses and compensatory alterations, and the stomach, which is a violation of the structure of the organ. Moreover, a trend towards changes in the indices in the lungs and colon was also noted. The pesticide doses of 5 and 2.5 mg/kg for these indices of the studied organs were invalid. Conclusion. Quantitative structural and functional indices for the cardiovascular, digestive, pulmonary, excretory, endocrine, immune, and reproductive systems of rats were developed to assess toxic effects.


2020 ◽  
Vol 11 (SPL4) ◽  
pp. 2637-2643
Author(s):  
Kirti G Sahu ◽  
Manish P Deshmukh ◽  
Sukeshini B Lote ◽  
Ashish B Budrani ◽  
Deepak S Khobragade

The iron-21 syrup is used for iron deficiency anaemia which supplies iron and calories a provide iron and calorie nutriment to recompense haemoglobin deprivation. The objective of this study is to determine acute oral toxicity of Iron-21 syrup in vivo in Wistar rats. Iron-21 Syrup formulation was given through the oral route. The syrup formulation was administered in three increasing doses of 3, 6 and 12 ml/kg body weight for concentration of 500, 1000 and 2000mg/kg respectively. The other group of rats designated as a control group was given the only vehicle orally. The test and control group contains five rats each. Tests, as well as control group rats, were sacrificed on the fifteenth day of treatment. The blood and tissue samples of test animals were sent for histopathological studies examination. Four parameters were observed throughout the study, and they are cage side observation, the effect to the body weight, haematological parameter and histopathology. All animals were survived till they sacrificed. No notable changes were found in behaviour, haematological and histopathology studies. The oral administration of Iron-21 Syrup is not shown any toxic effect in the animal at a given dose. Therefore, it is a safe remedy for human use.


2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Chia Ju Chang ◽  
Thing-Fong Tzeng ◽  
Shorong-Shii Liou ◽  
Yuan-Shiun Chang ◽  
I-Min Liu

The objective of this study was to evaluate the acute and subacute toxicity (28 days) of the ethanol extract ofZ. zerumbetrhizomes (EEZZ) via the oral route in Wistar rats of both sexes. In the acute toxicity study, Wistar rats were administered a single dose of 15 g kg−1of body weight by gavage, and were monitored for 14 days. EEZZ did not produce any toxic signs or deaths; the 50% lethal dose must be higher than 15 g kg−1. In the subchronic toxicity study, EEZZ was administered by gavage at doses of 1000, 2000 and 3000 mg/kg daily for 4 weeks to Wistar rats. The subacute treatment with EEZZ did not alter either the body weight gain or the food and water consumption. The hematological and biochemical analysis did not show significant differences in any of the parameters examined in female or male groups. Necropsy and histopathological examination, did not reveal any remarkable and treatment related changes. A no-observed adverse-effect level for EEZZ is 3000 mg kg−1for rats under the conditions of this study. Hence, consumption of EEZZ for various medicinal purposes is safe.


2013 ◽  
Vol 2013 ◽  
pp. 1-12 ◽  
Author(s):  
Chantel B. Westley ◽  
Kirsten Benkendorff ◽  
Cassandra M. McIver ◽  
Richard K. Le Leu ◽  
Catherine A. Abbott

Marine molluscs from the family Muricidae are under development as a potential medicinal food for the prevention of colon cancer and treatment of gynaecological cancers. Here we report the outcome of the firstin vivotoxicity assessment on an anticancer extract from a muricid mollusc containing brominated indole derivatives. Mice received the concentrated lipophilic extract by daily oral gavage over a two-week period. Mortality or clinical toxicity symptoms resulting from the extract were not detected during the trial, and there was no difference in the body weight of treated and control mice at the end of the trial. Histological analysis revealed some evidence for mild, idiosyncratic effects on the gastrointestinal tract and liver, including necrosis, fatty change, and inflammation in a small proportion (<40%) of mice. This is likely to result from first-pass hepatic metabolism of tyrindoxyl sulphate combined with second-pass metabolism of indoles. Overall however, oral administration of muricid extract containing brominated indoles does not result in severe clinical toxicity.


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