scholarly journals Toxicity Evaluation of a Traditional Polyherbal Unani Formulation Jawarish Shahi in Rats

2018 ◽  
Vol 7 (5) ◽  
pp. 412-418
Author(s):  
Mohd Urooj ◽  
◽  
Mohammad Ahmed Khan ◽  
G. Thejaswini ◽  
Munawwar Husain Kazmi ◽  
...  

Jawarish Shahi (JS) is a compound polyherbal Unani pharmacopoeial formulation indicated for Khafqan (Palpitation), Nafkh-e-Shikam (Flatulence) and Waswas (Insanity; false perception and hallucinations). Jawarish Shahi contains herbs like Halela (Terminalia chebula), Amla (Emblica officinalis), Kishneez (Coriandrum sativum), Elaichi Khurd, (Elettaria cardamomum), and Bed Mushk (Salix caprea). The present study was carried out as per OECD 408 guidance to evaluate 90 days repeated oral dose toxicity in male and female Sprague Dawley rats. The study was performed at dose levels 1028 and 2000 mg/kg bw. No adverse effects were reported with respect to body weight, feed intake, behavior and clinical signs indicative of systemic toxicity. The expected growth pattern was observed in body weight and feed intake as compared to control group at both dose levels in male and female rats. There were few significant alterations with respect to hematology, and clinical biochemistry, however the results were within normal range thus considered toxicologically insignificant. The microscopic examination of different organ/tissue showed that no histopathological changes were observed. The findings of the study showed that No Observed Adverse Effect Level (NOAEL) for JS is greater than 2000 mg/kg body weight

Author(s):  
Masud Shaikh ◽  
Syed Shoeb Ahmed ◽  
Mohd Urooj ◽  
Uzma Viquar ◽  
Munawwar Husain Kazmi ◽  
...  

Majoon-e-Nisyan (MJN) is a polyherbal semisolid compound formulation. Its description is present in various Unani literatures. It is used in Unani medicine for its therapeutic efficacy against amnesia. There is no report regarding its safety on long term administration. Therefore, toxicological evaluation of MJN is carried out in rats. Majoon-e-Nisyan was subjected to 90-days repeated oral dose toxicity studies as per OECD guide line 408. Wistar rats were treated at three dose levels i.e., 500, 1000 and 2000 mg/kg bw and one vehicle treated group. MJN and vehicle were orally administered daily for 90 days and animal were observed for clinical signs of toxicity, mortality, body weight and feed consumption. On completion of 90-days, blood samples were collected and analyzed for hematology and biochemistry. Necropsy was performed on all survived animals and vital organs were collected and subjected to histopathology. No post dose adverse effect was reported on survival of both male and female rats after oral administration of MJN for 90 days. No incidence of mortality was reported in MJN treated male and female rats at all tested dose levels. No abnormal clinical signs were observed in MNJ treated animals at 500, 1000 and 2000 mg/kg bw as compared to animals of control group. No significant changes were observed in biochemistry, hematology and histopathological examination. No incidence of mortality, adverse changes in clinical signs of toxicity or body weight gain of rats was noted. No changes in clinical chemistry, hematology, and histopathology were observed in MJN-treated or control group. Therefore, NOAEL for MJN may be considered more than 2000 mg/kg bw in rats. Subject Classification Numbers: Pharmacology, Toxicology.


Author(s):  
Liza Meutia Sari ◽  
Frans D Suyatna ◽  
Gus Permana Subita ◽  
Elza Ibrahim Auerkar

ABSTRACTObjective: Areca catechu Linn. or biji pinang is one of the most widely used psychoactive substance with several hundred million users worldwide,predominantly in Southern Asia. However, details of the dermal toxicity of A. catechu L. are still undiscovered. The objective of this study is toinvestigate the in vivo acute dermal toxicity of aqueous extract of A. catechu L. at dose 15,000 mg/kg body weight in Sprague-Dawley rats.Methods: The acute dermal toxicity of A. catechu L. nut extract was investigated in rats, as per OECD Guidelines 402 for acute toxicity protocols. Thebody weight, possibility of death, general signs, and behavior activity parameters were measured for 14 days to ascertain the median lethal dose(LD50) of the extract. At the end of the study, all the animals in all the treated group were sacrificed.Results: The LD50 was found to be >15,000 mg/kg body weight. There was significant weight increase (p<0.05) in treated group when comparedto control group. No mortality was observed during whole 14 days study period. A single dose of 15,000 mg/kg of body weight did not producetreatment-related signs of toxicity in any of animal tested.Conclusion: A single dermal dose to A. catechu L. aqueous extract had no toxic effects on mortality, clinical signs, body weight changes, and grossfindings in female rats at a dose of 15,000 mg/kg of body weight. Subsequently, the concentrate can be employed for pharmaceuticals nutrient plants.Keywords: A. catechu L., Acute dermal toxicity, LD50.


1988 ◽  
Vol 7 (5) ◽  
pp. 675-685 ◽  
Author(s):  
J.F. Borzelleca ◽  
L.W. Condie ◽  
J.L. Egle

To assess adverse effects that might be caused by an event resulting in high levels of barium in drinking water, rats were gavaged with barium chloride (BaCl2 at dosage levels of 30, 100, and 300 mg/kg in a 1-day study and at 100, 145, 209, and 300 mg/kg for 10 days, and the effects were determined. LD50 values for male and female rats were found to be 419 (352–499) and 408 (342–487) mg/kg BaCl2, respectively. In the 1-day exposure study, decreases in body weight and liver/brain weight ratios and increase in kidney weight as a percentage of body weight appeared to be related to barium ingestion at 300 mg/kg. After 10 days of exposure to barium, survival of females was substantially lower at 300 mg/kg. A reduction in ovaries/brain ratio at 300 mg/kg appeared to be barium-induced. There was a decrease in BUN at 300 mg/kg in males and at all dose levels in females. No other effects were attributed to barium. Histopathological findings were negative in both the 1-and 10-day studies. It is concluded that short-term oral exposure to BaCl2 at doses up to 209 mg/kg produces no significant adverse health effects.


2004 ◽  
Vol 23 (2) ◽  
pp. 101-105 ◽  
Author(s):  
Shoji Tsubuku ◽  
Kazuhisa Hatayama ◽  
Kazunori Mawatari ◽  
Miro Smriga ◽  
Takeshi Kimura

The amino acid l-arginine (Arg) has been used extensively in dietary and pharmacological products. This study evaluated toxicological and behavioral effects of Arg produced by Ajinomoto Co. (Tokyo, Japan) during a dosing study with male and female Sprague-Dawley rats. The amino acid was incorporated into a standard diet at doses equal to 1.25%, 2.5%, and 5.0% ( w/w). A control group of rats received only a standard diet. All diets were administered ad libitum for 13 continuous weeks. To examine recoverability of any potential effects, the administration period was followed by a 5-week-long recovery, during which only a standard diet was provided. In male and female rats in each concentration group, treatment-related changes were not observed for clinical signs, body weights, diet consumption, ophthalmology, gross pathology, organ weight, or histopathology. An elevated level of plasma glucose was detected in some male rats (5.0%, w/ w) during the analysis conducted in the fifth week of administration; however, the degree of the change was within the physiological range, and no changes were observed at the end of the administration period. In the same group, an increase in hemoglobin, together with a tendency toward an increase in the red blood cell counts, was found, but the change was considered toxicologically insignificant. The no-observed-adverse-effect level (NOAEL) for Arg was estimated at 5.0% ( w/w) for both genders (males, 3.3 ±0.1 g/kg/day; females, 3.9 ±0.2 g/kg/day).


1992 ◽  
Vol 73 (2) ◽  
pp. 446-451 ◽  
Author(s):  
H. S. Sekhon ◽  
W. M. Thurlbeck

Postpneumonectomy compensatory lung response and normal lung growth in the early postnatal period were studied in male and female rats. Four-week-old litter-matched male and female Sprague-Dawley rats were subjected to left pneumonectomy or sham operation and followed for 3 wk. In both sexes after pneumonectomy, lung weight (WL), lung volume (VL), alveolar surface area (Sw), total alveolar number (N(at)), and the amount of DNA and protein increased significantly. In both males and females, WL, VL, and Sw matched those of both lungs of the sham-operated group, but N(at) and the amount of DNA and protein did not. Female pneumonectomy and sham-operated rats were smaller in body weight than males. Absolute WL, VL, Sw, N(at), and the amount of DNA and protein were significantly lower, but specific parameters (per unit body weight) were significantly greater in females than in males. After pneumonectomy, the postcaval lobe increased most in volume (70 and 73% in males and females, respectively). Mean linear intercept and mean chord length of alveoli increased, and the number of alveoli per unit volume decreased more in the postcaval and middle lobes than in upper and lower lobes in both sexes. Postpneumonectomy, loss of elastic lung recoil was observed in females. We conclude that, in certain aspects (WL, VL), compensatory growth matched both lungs of controls, but in others (biochemical, morphometric) it did not. There was evidence of alveolar multiplication, but the dominant effect was enlargement of air spaces.(ABSTRACT TRUNCATED AT 250 WORDS)


2004 ◽  
Vol 23 (2) ◽  
pp. 113-118 ◽  
Author(s):  
Shoji Tsubuku ◽  
Masahiro Mochizuki ◽  
Kazunori Mawatari ◽  
Miro Smriga ◽  
Takeshi Kimura

l-Lysine hydrochloride (Lys) is an essential amino acid in humans and animals, and it is used in animal feeds, in prevention of herpes simplex recurrence, and cereal fortification in some developing countries. This study evaluated toxicological and behavioral effects of Lys during a dosing study with male and female Sprague-Dawley rats. The amino acid was incorporated into a standard diet at doses equal to 1.25%, 2.5%, and 5.0% ( w/ w). A control group of rats received a standard diet. All diets were administered ad libitum for 13 consecutive weeks. To examine stability of any potential effects, the administration period was followed by a 5-week recovery period, during which only the standard diet was provided to all animals. In male and female rats in each concentration group, treatment-related changes were not observed in the clinical signs, body weights, diet consumption, water intake, ophthalmology, gross pathology, organ weights, or histology. A Lys-related drop in serum concentration and an increase in urine excretion of chlorides was a compensatory reaction to the ingested hydrochloride. No functional, biochemical, or histological changes in renal function were found. The no-observed-adverse-effect level (NOAEL) for Lys was estimated at 5.0% for both genders (male, 3.36 ± 0.12 g/kg/day; female, 3.99 ± 0.28 g/kg/day).


2016 ◽  
Vol 85 (1) ◽  
pp. 99-104
Author(s):  
Branislav Gálik ◽  
Daniel Bíro ◽  
Milan Šimko ◽  
Miroslav Juráček ◽  
Marcela Capcarová ◽  
...  

The aim of this study was to analyse the effects of different daily intakes of rapeseed bee pollen on the growth and biochemical blood serum indicators in male and female rats. A total of 40 clinically healthy male and female Wistar rats were randomly divided into four groups. In the control group (C) rats were fed a standard complete diet; in the experimental groups standard diets were supplemented with different doses of bee pollen. Treatment group T1 was given standard diet with the addition of bee pollen at a 0.3% concentration; in group T2 the addition was 0.5%; and in group T3 it was 0.75%. The experimental period lasted for 90 days. A significant effect (P < 0.05) of bee pollen on the body weight gain and feed conversion ratio of female rats was found. Significantly (P < 0.05) higher cholesterol concentration in blood serum of male rats was found in the groups with bee pollen addition (groups T2 and T3) compared to the control group. Lower triglyceride serum content in all female experimental groups (T1 and T3) was observed in comparison to the control. Higher serum cholesterol content in the experimental female rats was detected; significant differences were analysed in groups T1 and T3 compared to the control female group. Rapeseed bee pollen at concentrations of 0.5 and 0.75% positively affected the body weight gain of female rats, however, with higher feed consumption (P < 0.05). Rapeseed bee pollen reduced the triglycerides serum content in female rats and increased the cholesterol serum content in male and female rats (P < 0.05).


2017 ◽  
Vol 24 (02) ◽  
pp. 216-220
Author(s):  
Faizania Shabbir ◽  
M. Mazhar Hussain ◽  
Tausif Ahmed Rajput ◽  
Alamgir Khan

Objectives: To observe the effect of obesity and subsequent atorvastatinadministration on MPV in high fat diet induced obese male and female Sprague Dawley rats.Study Design: Randomized control trial (RCT). Setting: Department of Physiology, Army MedicalCollege, Rawalpindi. Animal procurement and blood sampling was done at National Instituteof Health (NIH), Islamabad and biochemical assays were performed at Centre for Research inExperimental and Applied Medicine (CREAM), Army Medical College, Rawalpindi. Period: Thestudy was completed in 12 months. Material and Methods: Ninety healthy Sprague Dawley(male and female) rats were purchased and divided randomly into three equal groups. Ratsin normal control group (Group I) were given normal chow diet for three weeks. Rats in obesecontrol group (Group II) were given high fat diet for three weeks. Rats in obese treated group(Group III) were administered atorvastatin for three weeks in a dose of 10 mg/kg/day orally bygavage method after obesity induction. Terminal sampling was done at the end of the studyby intra-cardiac puncture. MPV is a part of blood complete picture that was analysed by KX 21Sysmex Hematology Analyzer. Results: High fat diet induced obesity resulted in a significant(p < 0.05) increase in MPV. The MPV was significantly (p < 0.05) decreased after atorvastatinadministration. The result was comparable for both genders. Conclusions: Obesity increasesMPV and hence the risk of adverse cardiovascular outcome. Atorvastatin apart from its knownlipid lowering effect, decreases MPV and can play a beneficial role in decreasing cardiovascularmorbidity and mortality. 


2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Sekar Sathiya ◽  
Murugan Ganesh ◽  
Periyathambi Kalaivani ◽  
Vijayan Ranju ◽  
Srinivasan Janani ◽  
...  

Use of antiepileptic drugs (AEDs) in pregnancy warrants various side effects and also deleterious effects on fetal development. The present study was carried out to assess the effects of prenatal exposure to lamotrigine (LTG) on postnatal development and behavioural alterations of offspring. Adult male and female Sprague Dawley rats weighing 150–180 g b. wt. were allowed to copulate and pregnancy was confirmed by vaginal cytology. Pregnant rats were treated with LTG (11.5, 23, and 46 mg/kg, p.o) from gestational day 3 (GND 3) and this treatment continued till postnatal day 11 (PND 11). Offspring were separated from their dam on day 21 following parturition. LTG, at 46 mg/kg, p.o, produced severe clinical signs of toxicity leading to death of dam between GND 15 and 17. LTG, at 11.5 and 23 mg/kg, p.o, showed significant alterations in offspring’s incisors eruption and vaginal opening when compared to age matched controls. LTG (23 mg/kg, p.o) exposed female offspring expressed hyperactive behaviour and decreased GABA-A receptor expression when compared to control rats. These results reveal that prenatal exposure to LTG may impart differential postnatal behavioural alterations between male and female rats which paves way for further investigations.


2005 ◽  
Vol 24 (4_suppl) ◽  
pp. 61-89 ◽  
Author(s):  
Takahiro Kurosaki ◽  
Masafumi Maeno ◽  
John H. Mennear ◽  
Bruce K. Bernard

The objective of these studies was to assess the effects of the tripeptides, L-valyl-L-prolyl-L-proline (VPP) and L-isoleucyl-L-prolyl-L-proline (IPP), on reproductive capabilities of male and female rats. The specific goals of the experiments were (1) to determine the effects of orally administered tripeptides on (a) fertility and reproductive behavior in both sexes of rats, (b) embryo-fetal development in pregnant rats, and (c) pre- and postnatal development of rats exposed to tripeptides in utero and during lactation; and (2) to estimate the no-observable-adverse-effect doses of tripeptides in maternal and fetal rats. During the conduct of these classical segment I, II, and III studies, the test material was powdered Lactobacillus helveticus-fermented milk (FM), which contains the tripeptides, VPP and IPP. FM (0, 500, 1000 or 2000 mg/kg body weight [BW]/day—equivalent to 0, 0.8, 1.6, or 3.3 mg/kg BW/day of VPP plus IPP) was administered to males by oral gavage from 4 weeks prior to mating until sacrifice, and to females from 2 weeks prior to mating through day 20 of lactation. Evaluative parameters included monitoring grossly observable clinical signs; food consumption and body weight gains; mating behavior and fertility indices of both sexes; implantation and maintenance of embryos; sex ratio of live pups ; fetal viability; incidences of external, visceral or skeletal variations; growth and behavioral development; as well as reproductive capabilities of Fi offspring exposed to FM during gestation and lactation. All animals were subjected to macroscopic examination at termination of their segment of the studies. Clinical signs, body weights, and food consumption were unaffected by administration of FM. During segment I, the test agent had no effect on estrus cycle, mating behavior, fertility index, or reproductive competence of either males or females. The results of segment II experiments revealed no effects of FM on postimplantation survival-loss, sex ratio or birth weights of live fetuses, and there was no evidence of treatment-associated developmental or teratological effects. During segment III, FM was without effect on pup viability, behavioral and sexual maturation, and reproductive capability of the F1 generation. Under the conditions of these experiments, the no-observable-adverse-effect level (NOAEL) of FM on reproductive performance in male and female rats is greater than 2000 mg/kg BW/day, the equivalent of 3.3 mg/kg BW/day of VPP plus IPP.


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