scholarly journals Safety Evaluation of Oral Toxicity ofCarica papayaLinn. Leaves: A Subchronic Toxicity Study in Sprague Dawley Rats

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Zakiah Ismail ◽  
Siti Zaleha Halim ◽  
Noor Rain Abdullah ◽  
Adlin Afzan ◽  
Badrul Amini Abdul Rashid ◽  
...  

The subchronic toxicity effect of the leaf extract ofCarica papayaLinn. in Sprague Dawley (SD) rats was investigated in this study. The extract was prepared by dissolving the freeze dried extract of the leaves in distilled water and was administered orally to SD rats (consisted of 10 rats/sex/group) at 0 (control), 0.01, 0.14, and 2 g/kg body weight (BW) for 13 weeks. General observation, mortality, and food and water intake were monitored throughout the experimental period. Hematological and biochemical parameters, relative organ weights, and histopathological changes were evaluated. The study showed that leaf extract when administered for 13 weeks did not cause any mortality and abnormalities of behavior or changes in body weight as well as food and water intake. There were no significant differences observed in hematology parameters between treatment and control groups; however significant differences were seen in biochemistry values, for example, LDH, creatinine, total protein, and albumin. However, these changes were not associated with histopathological changes. In conclusion, the results suggested that daily oral administration of rats withC. papayaleaf extract for 13 weeks at a dose up to fourteen times the levels employed in traditional medicine practice did not cause any significant toxic effect.

Author(s):  
I-Chen Li ◽  
Bi-Hua Yang ◽  
Jing-Yi Lin ◽  
Shan Lin ◽  
Chin-Chu Chen

Lignosus rhinocerotis (Tiger’s Milk mushroom) is a novel mushroom with sclerotium belonging to the Polyporaceae family and has been reported widely to possess anti-cancer, anti-cough, antioxidant, gastro-protective, immuno-modulating, and neurite-stimulating properties. As numerous studies have proven the tremendous medicinal values of L. rhinocerotis, it is necessary to understand its nutrition as well as its safety for the recipient. Previous research on L. rhinocerotis has mainly focused on the naturally occurring sclerotium and may have overlooked mushroom mycelia from submerged liquid fermentation, which ensures a high uniform quantitative biomass production as well as a high biological value. Hence, this is the first report on the evaluation of nutrition and 13-week repeated oral toxicity of L. rhinocerotis mycelium (LRM). The LRM powder contained 9.0 ± 4.2% moisture, 1.9 ± 1.3% ash, 1.6 ± 2.2% crude lipid, 8.4 ± 5.3% crude protein, 79.3 ± 4.6% carbohydrate, and 364 kcal/100 g energy. The total free amino acid ranged from 349 to 5636 mg/100 g and the umami index of freeze-dried LRM powder was 0.37. For safety assessment, ninety-six rats were divided into four groups, each consisting of twelve male and twelve female rats. Test articles were administered by oral gavage to rats at 850, 1700, and 3400 mg/kg body weight/day for 13 weeks and reverse osmosis water was used as the control. All animals survived to the end of the study. During the experiment period, no abnormal changes were observed in clinical signs, body weight, or ophthalmological examinations. No adverse or test article-related differences were found in urinalysis, hematology, or serum biochemistry parameters between the treatment and control groups. Necropsy and histopathological examination indicated no treatment-related changes. According to the above results, the no-observed-adverse-effect level (NOAEL) of L. rhinocerotis was identified to be greater than 3400 mg/kg body weight (BW)/day in Sprague–Dawley rats.


PeerJ ◽  
2020 ◽  
Vol 8 ◽  
pp. e8805 ◽  
Author(s):  
Hidayat Ullah Khan ◽  
Khurram Aamir ◽  
Sreenivas Patro Sisinthy ◽  
Narendra Babu Shivanagere Nagojappa ◽  
Aditya Arya

Background Lauric acid (LA), a common constituent of coconut oil, is used as food additives and supplements in various formulations. Despite various potential pharmacological properties, no scientific evidence on its dose-related toxicity and safety is available till date. Objective The current study was conducted to evaluate acute oral toxicity of LA on normal rats. Methods The study was conducted in accordance with the Organization for Economic Co-operation and Development guidelines (OECD 423) with slight modifications. LA was administered orally to female Sprague Dawley (SD) rats (n = 6/group) at a single dose of 300 and 2,000 mg/kg body weight, respectively, while normal control received vehicle only. Animals from all the three groups were monitored for any behavioural and toxicological changes and mortality for two weeks. Food and fluid consumption, body weight was monitored on daily basis. At the end (on day 15th) of the experimental period, blood was collected for haematological and biochemical analysis. Further, all the animals were euthanized, and internal organs were harvested for histopathological investigation using four different stainings; haematoxylin and eosin, Masson trichrome, Periodic Acid Schiff and Picro Sirius Red for gross pathology through microscopical observation. Results The study results showed no LA treatment-related mortality and morbidity at two different dosages. Daily food and water consumption, body weight, relative organ weight, haematological, and biochemical analysis were observed to be normal with no severe alterations to the internal tissues. Conclusion The current finding suggests that single oral administration of LA, even up to 2,000 mg/kg body weight, did not exhibit any signs of toxicity in SD rats; thus, it was safe to be used on disease models in animals.


2009 ◽  
Vol 28 (4) ◽  
pp. 278-293 ◽  
Author(s):  
M. Gary I. Riley ◽  
M. Cristina Castelli ◽  
Ellen Angela Paehler

Salcaprozate sodium (SNAC) (sodium 8-((2-hydroxybenzoyl) amino) octanoate, CAS RN 203787-91-1) is classified as an oral absorption promoter, and its potential therapeutic applications as a delivery agent for oral forms of heparin and insulin have been explored in a number of clinical investigations. However, limited information about its nonclinical safety is available in the published scientific literature. As part of a larger study exploring the safety of SNAC in combination with heparin, Sprague-Dawley (SD) rats (20/sex/group) received SNAC alone at 2000 mg/kg/d orally (gavage) for 13 weeks (females were terminated after 10 weeks). In a separate study assessing the safety of SNAC in combination with ibandronate, Wistar rats (10/sex/group) received SNAC alone at levels of 100, 500, or 1000 mg/kg/d orally for 13 weeks. SNAC-related mortality was evident only at the 2000-mg/kg/d level, 20% among males and 50% among females; no clear cause of death was evident. No mortality was seen in the Wistar rat study at doses up to 1000 mg/kg/d. Some differences in clinical pathology parameters, including slightly altered electrolyte levels and lower globulin levels, were seen in SD and Wistar rats. Although these differences reached statistical significance, parameters were within historical control ranges. Liver and kidney weights were slightly higher in SNAC-treated animals of both strains, with no corresponding histopathological changes. These changes may therefore constitute an adaptive response. Histopathological changes were seen in the stomach in both studies, probably secondary to irritation caused by the dosing method. Based on the results of these studies, a no-observed-adverse-effect level (NOAEL) cannot be given for SD rats. The NOAEL for SNAC in Wistar rats was considered to be 1000 mg/kg/d.


1969 ◽  
Vol 3 (2) ◽  
pp. 350-355
Author(s):  
MEENA GUL ◽  
MUHAMMAD MAZHAR HUSSAIN ◽  
AYESHA BABER ◽  
AMJAD ZAMAN ◽  
MUSRAT ZAHRA

BACKGROUND: Managing diabetes is difficult due to the number of side effects associated with drugsused for its treatment. There it is a need of an hour to look for indigenous plants which are safe and costeffective. Present study was planned to determine the effect of Aloe vera whole leaf extract and/orRosiglitazone on plasma glucose, insulin and insulin resistance in type 2 diabetic Sprague-Dawley rats.DESIGN: Randomized control trailPLACE AND DURATION OF STUDY: This study was conducted from April 2009 to Oct 2010 at theDepartment of Physiology Army Medical College, Rawalpindi in collaboration with National Institute ofHealth (NIH) Islamabad.MATERIAL AND METHOD: Type 2 DM was induced in 60 healthy Sprague-Dawley rats by feedinghigh fat diet for 2 weeks and injecting a low dose (35mg/kg) of streptozotocin intra peritoneally. Type 2diabetic rats were randomly divided into four groups, each group having 15 rats and were labeled as diabeticgroup, Aloe vera group, rosiglitazone group and combined group. The diabetic group was injected normalsaline, Aloe vera group was treated with Aloe vera whole leaf extract in dose of 300mg/kg body weight,rosiglitazone group was given 5mg/kg body weight of rosiglitazone I/P and combined group diabetic ratswere treated with 150mg/kg body weight of Aloevera extract and 2.5mg/kg body weight of rosiglitazone(halfof their effective dose) for 21 days.RESULTS: A significant reduction (p<0.001) in plasma glucose (73%), insulin (32%) and TG/HDL ratio(81%) was analyzed in combined groupascompared to diabetic control group. \CONCLUSION: The maximum impact in lowering plasma glucose, insulin and TG/HDL ratio wasrecorded in combined group, followed by rosiglitazone group and then Aloevera group.KEYWORDS:T2DM. Aloe vera, insulin resistance


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 684-684
Author(s):  
Maria Amelita Estacio ◽  
Liezl Atienza ◽  
Roxanne Gapasin ◽  
Jonna Rose Maniwang ◽  
James Ryan Aranzado ◽  
...  

Abstract Objectives “Bignay” (Antidesma bunius), “lipote” (Syzygium polycephaloides) and “duhat” (Syzgium cumini) are indigenous berries in the Philippines that are known to contain high antioxidant properties and other health-promoting and disease-preventing compounds. However, oral toxicity studies on these berries are not yet explored. Hence, this study evaluated the acute oral toxicity of these berries in freeze-dried forms using 6-week old ICR mice following the OECD guidelines 425 (up and down method). Methods Treatment groups were administered with freeze-dried powders of “bignay”, “lipote” and “duhat” reconstituted in distilled water at various doses: 55 mg/kg body weight (BW), 175 mg/kg BW, 550 mg/kg BW, 2000 mg/kg BW and 5000 mg/kg BW while control group was administered with distilled water. Body weight, feed and water intake were obtained daily. Biochemical profiles were measured prior to administration of reconstituted berries at day 1 and prior to euthanasia. Toxicity, morbidity and mortality cases were observed daily. Euthanasia and necropsy were performed to check for gross organ abnormalities. Results Mice that received the different concentrations of “bignay”, “lipote” and “duhat” had normal feed and water consumption and gained weight during the test period. No clinical and behavioral signs of toxicity were observed and there was zero morbidity and mortality. Post-mortem evaluation showed no lesions on various organs examined. Blood ALT, BUN and creatinine levels were within normal published values. Conclusions These results show that different concentrations of freeze-dried “bignay”, “lipote” and “duhat” are non-toxic using ICR mice and therefore have high potential to be developed into food supplements and nutraceuticals. Funding Sources Philippine Council for Health Research and Development - Department of Food Science and Technology Enhanced Creative Work and Research Grant - Office of Vice Chancellor for Academic Affairs, University of the Philippines.


2016 ◽  
Vol 78 (5-5) ◽  
Author(s):  
Norazlanshah Hazali ◽  
Nurul Nadia Mohd Nazri ◽  
Muhammad Ibrahim ◽  
Mashita Masri

Acalypha indica is one of the medicinal plants that have been used since ages to treat various diseases such as pneumoniae, asthma and skin diseases. This study aimed to explore the subchronic toxicity effect of Acalypha indica on Sprague Dawley rats based on haematological and biochemical parameters. The extract of Acalypha indica was prepared by aqueous extraction technique. 48 Sprague Dawley rats aged 7 weeks, weighing 150-200g were randomly divided into four groups, 6 animals per gender. A control group received water vehicle while three treated groups received the extract at dosage of 100 (low dosage group), 200 (medium dosage group) and 300 (high dosage group) mg/kg body weight. The sample was administered orally by using oral gavage daily for 90 days. No sign of toxicity and mortality was recorded in all groups throughout the study. There were no significant different (p>0.05) in body weight gain, food and water intake between control and treatment group. However, there was significant different in uric acid between control and high dosage group of male and female rats but the mean were in normal range. There were also reduced in mean of urea and creatinine in all dosage group of male and urea for all dosage group of female. Statistically significant reduced in urea was recorded between control and high dosage group of male only. Other parameters showed no significant different between control and treatment groups. Therefore, Acalypha indica is safe for human consumption and might be potential in reducing kidney damage problem.


2013 ◽  
Vol 2013 ◽  
pp. 1-14 ◽  
Author(s):  
Kwan Yuet Ping ◽  
Ibrahim Darah ◽  
Yeng Chen ◽  
Subramaniam Sreeramanan ◽  
Sreenivasan Sasidharan

DespiteEuphorbia hirtaL. ethnomedicinal benefits, very few studies have described the potential toxicity. The aim of the present study was to evaluate thein vivotoxicity of methanolic extracts ofE. hirta. The acute and subchronic oral toxicity ofE. hirtawas evaluated in Sprague Dawley rats. The extract at a single dose of 5000 mg/kg did not produce treatment related signs of toxicity or mortality in any of the animals tested during the 14-day observation period. Therefore, the LD 50 of this plant was estimated to be more than 5000 mg/kg. In the repeated dose 90-day oral toxicity study, the administration of 50 mg/kg, 250 mg/kg, and 1000 mg/kg/day ofE. hirtaextract per body weight revealed no significant difference (P>0.05) in food and water consumptions, body weight change, haematological and biochemical parameters, relative organ weights, and gross findings compared to the control group. Macropathology and histopathology examinations of all organs including the liver did not reveal morphological alteration. Analyses of these results with the information of signs, behaviour, and health monitoring could lead to the conclusion that the long-term oral administration ofE. hirtaextract for 90 days does not cause sub-chronic toxicity.


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