Safety Evaluation of an Apitherapy Formulation, Bao-Yuan-Ling: Acute and Sub-acute Oral Toxicity in Wistar Rats

2017 ◽  
Vol 17 (1) ◽  
pp. 85-92
Author(s):  
Sun Yanru ◽  
Shen Zhenhuang ◽  
Jia Zhe ◽  
Miao Xiaoqing
Keyword(s):  
Acute Toxicity ◽  
Toxicity Test ◽  
Wistar Rats ◽  
Lethal Dose ◽  
Drug Effects ◽  
Female Rats ◽  
Male Rats ◽  
Acute Toxicity Test ◽  
Weight Changes ◽  
Oral Toxicity

Bao-Yuan-Ling (BYL) is an apitherapy formulation which is composed of royal jelly, propolis and bee venom. Cardioprotective effects of BYL has been demonstrated, while the toxicity of BYL was not clear. In this study, acute and sub-acute toxicity test of BYL was processed following Organization for Economic Co-operation and Development (OECD) 423 and OECD 407, respectively, in Wistar rats. In acute toxicity test, rats were orally treated with BYL at the single dose of 2000 mg/kg and 5000 mg/kg. No death occurred in the acute toxicity test for 7 days, which indicated the lethal dose 50% value exceeded 5000 mg/kg. In sub-acute toxicity study, rats were treated with BYL at the dose of 250 mg/kg, 500 mg/kg and 1000 mg/kg in a daily base for continuous 28 days. Results showed that female rats were more likely to be affected by BYL in body weight changes, while biochemical indicators of blood serum in male rats were more susceptible to drug effects. However, neither female nor male rats were affected by BYL administration significantly on the organs via hematoxylin-eosin staining analysis. Results suggested that BYL was slightly toxic and clinical use was safe and reliable.

scholarly journals Acute and sub-acute oral toxicity of aqueous whole leaf and green rind extracts of Aloe vera in Wistar rats

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Florence Nalimu ◽  
Joseph Oloro ◽  
Emanuel L. Peter ◽  
Patrick Engeu Ogwang
Keyword(s):  
Toxicity Test ◽  
Wistar Rats ◽  
Leaf Extract ◽  
Aloe Vera ◽  
Female Rats ◽  
Male Rats ◽  
Aqueous Extracts ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
Leaf Extracts

Abstract Background Several local communities in Central, Western, Eastern, and Northern regions of Uganda have been using the whole leaf extracts of Aloe vera (L.) Burm. f. (Asphodelaceae) in the treatment of various ailments. Also, several commercial companies sell A. vera as soft drinks in Uganda. However, there are inadequate reports on the toxicities of such preparations. This paper reports the acute and sub-acute oral toxicity of aqueous extracts of whole leaf and green rind of A. vera in Wistar rats. Methods Acute oral toxicity test was carried out in female Wistar rats at doses of 175, 550, 1750, and 5000 mg/kg, p.o. The animals were observed for signs of toxicity for 14 days. Similarly, a sub-acute oral toxicity test was performed in both sexes of rats at doses of 200, 400, and 800 mg/kg, p.o. daily for 28 days. All the groups of animals were monitored for behavioral, morphological, biochemical, and physiological changes, including mortality and compared with respective controls. Body weights were measured weekly while the animals’ relative organ weights, hematological, biochemical, gross, and microscopic pathology were examined on day 29. Results There was no mortality or apparent behavioral changes at the doses tested in acute and sub-acute oral toxicity tests. Thus, the Median Lethal Dose (LD50) of green rind and whole leaf aqueous extracts was above 5000 mg/kg. Gross anatomy revealed that the rats’ relative spleen weight in green rind extract at 200 mg/kg significantly decreased compared to the control group. The creatinine levels in female rats that received green rind extract and the chloride ion levels in male rats administered whole leaf extract were significantly elevated. Conversely, Mean Corpuscular Hemoglobin Concentration (MCHC) levels significantly decreased at lower doses of the green rind extract compared to the control. Histopathology of the kidney revealed the renal interstitium’s inflammation at doses of 200 and 800 mg/kg of the whole leaf extract. Conclusion The findings demonstrated that A. vera green rind and whole leaf extracts are non-toxic at relatively high doses when used for a short duration. Prolonged use of the aqueous whole leaf extract might be associated with kidney toxicity.

scholarly journals Acute Toxicity Testing of White Turmeric Extract (Curcuma zedoaria) on Histopathological Imaging of the Lungs

2021 ◽  
Vol 2 (4) ◽  
pp. 195-200
Author(s):  
Ainge Rasbina Br Saragih ◽  
Fiska Maya Wardhani ◽  
Erny Tandanu ◽  
Rico Alexander
Keyword(s):  
Acute Toxicity ◽  
Toxicity Test ◽  
Ordinal Data ◽  
Wistar Rats ◽  
Lethal Dose ◽  
Control Group ◽  
Acute Toxicity Test ◽  
Curcuma Zedoaria ◽  
Control Group Design ◽  
Turmeric Extract

White turmeric (Curcuma zedoaria) is a type of plant whose extract contains compounds that can inhibit carcinogenesis. Acute toxicity test was conducted to determine the safe dose and lethal dose (LD) 50 from the use of a drug substance. This research aimed to determine the effect of the acute toxicity test of white turmeric extract on the histopathological imaging of the lungs. This study is an experimental study with a post test only control group design. A total of 30 Wistar rats was divided into six groups. Data analysis was using one-way ANOVA statistical test, while for lung histopathology using ordinal data which were analyzed descriptively. In conclusion, the acute toxicity test of white turmeric extract on Wistar rats was not toxic and there was no death and no toxic symptoms and no necrosis, congestion and inflammation were found on the histopathological picture of the lungs.

THE HEMATOLOGIC PROFILE IN THE ACUTE TOXICITY TEST OF COGON GRASS ROOTS ETHANOL EXTRACT IN WISTAR RATS

2020 ◽  
pp. 72-75
Author(s):  
VANESSA AYU SUMIRAT ◽  
IRMA MELYANI PUSPITASARI ◽  
NENI ANGGRAENI ◽  
MAS RIZKY ANGGUN ADIPURNA SYAMSUNARNO
Keyword(s):  
Acute Toxicity ◽  
Toxicity Test ◽  
Wistar Rats ◽  
Ethanol Extract ◽  
Female Rats ◽  
Control Group ◽  
High Dose ◽  
Acute Toxicity Test ◽  
Grass Roots ◽  
Hematologic Profile

Objective: This study aimed to investigate the hematologic profile of Wistar rats in the acute toxicity test of Cogon grass roots ethanol extract (CGEE). Methods: Cogon grass roots were dissolved in 70% ethanol. An acute toxicity test was conducted based on The National Agency of Drug and Food Control of the Republic of Indonesia. Five female rats in the treatment group were administered a single high dose of 5000 mg/kg body weight (BW) of CGEE in 200 μl of 0.5% carboxymethyl cellulose (CMC), and the 5 female rats in the control group were administered 200 μl of 0.5% CMC. After 14 d, blood samples were collected, and 18 hematologic parameters were measured with a hematology analyzer. Statistical analyses were performed to compare the parameters between the two groups with the independent t-test for normally distributed data and the Mann Whitney test for non-normally distributed data. Results: None of the hematologic parameters in the treatment group significantly differed from those in the control group after 14 d of observation (P>0.05). Conclusion: A single high dose of 5000 mg/kg BW of CGEE did not change the hematologic profile of Wistar rats. These results indicate that CGEE does not have an acute hemotoxic effect, at least for hematologic parameters.

Acute Oral Safety Study of Sodium Caseinate Glycosylated via Maillard Reaction with Galactose in Rats

2014 ◽  
Vol 77 (3) ◽  
pp. 472-479
Author(s):  
ARTURO ANADÓN ◽  
MARIA A. MARTÍNEZ ◽  
IRMA ARES ◽  
VICTOR CASTELLANO ◽  
MARIA R. MARTÍNEZ-LARRAÑAGA ◽  
...  
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Maillard Reaction ◽  
Lethal Dose ◽  
Sodium Caseinate ◽  
Biological Properties ◽  
Female Rats ◽  
Weight Changes ◽  
Safety Study ◽  
Male And Female Rats

In order to potentially use sodium caseinate (SC) glycated with galactose (Gal) in the food industry as a new functional ingredient with proved technological and biological properties, an evaluation of oral acute toxicity has been carried out. An acute safety study with SC-Gal glycoconjugates in the Wistar rat with a single oral gavage dose of 2,000 mg/kg of body weight was conducted. The SC-Gal glycoconjugates were well tolerated; no adverse effects or mortality was observed during the 2-week observation period. No abnormal signs, behavioral changes, body weight changes, or alterations in food and water consumption occurred. After this period, no changes in hematological and serum chemistry parameters, organ weights, or gross pathology or histopathology were detected. It was concluded that SC-Gal glycoconjugates obtained via the Maillard reaction were well tolerated in rats at an acute oral dose of 2,000 mg/kg of body weight. The SC-Gal glycoconjugates have a low order of acute toxicity, and the oral 50% lethal dose for male and female rats is in excess of 2,000 mg/kg of body weight.

scholarly journals Acute toxicity assessment for TiO2 photocatalyst (GST) made from wastewater using TiCl4 in rat

2021 ◽  
Vol 36 (3) ◽  
pp. e2021019
Author(s):  
Ja Kyung Seol ◽  
Myeongkyu Park ◽  
Jae Min Im ◽  
Heung Sik Seo ◽  
Hee Ju Park ◽  
...  
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
High Efficiency ◽  
Lethal Dose ◽  
Clinical Signs ◽  
Body Weight Loss ◽  
Toxicity Assessment ◽  
Female Rats ◽  
Sprague Dawley ◽  
Weight Changes

TiO2 was a photocatalyst that used to the most common product because of the high efficiency. TiO2 (P-25, commercial nanomaterial product) is the most typical photocatalyst product and TiO2 (GST) was a sludge recycling product. This study was reported to evaluate an acute toxicity of TiO2 (P-25 and GST) according to OECD test guideline 402 and 423 in Sprague-Dawley (SD) female rats via route of oral and dermal. There was investigated the lethal dose (LD50), and mortality, clinical signs, body weight changes and gross findings were continually monitored for 14 days following the single administration. After administration, TiO2 (P-25) was calculated that LD50 was considered to be a dose of over 2000 mg/kg body weight for both different route of exposure, and TiO2 (GST) was the same. Other items were no observed an adverse effect between P-25 and GST; no mortality and clinical signs, accidental body weight loss, no gross findings. On the basis of the above results, the toxicity of the GST was almost equal to that of the commercial product, P-25 and there was no toxicological evidence.

scholarly journals 14-Day Repeated Intraperitoneal Toxicity Test of Ivermectin Microemulsion Injection in Wistar Rats

2020 ◽  
Vol 7 ◽  
Author(s):  
Zhen Dong ◽  
Shou-ye Xing ◽  
Ji-yu Zhang ◽  
Xu-zheng Zhou
Keyword(s):  
Toxicity Test ◽  
Wistar Rats ◽  
Histopathological Examination ◽  
Clinical Chemistry ◽  
Female Rats ◽  
Male Rats ◽  
High Dose ◽  
Toxic Injury ◽  
Male And Female Rats ◽  
Initial Stage

To evaluate the safety of ivermectin microemulsion injection, 100 Wistar rats were injected intraperitoneally at 0.38 g/kg, 0.19 g/kg, and 0.1 g/kg for 14 days. The 14-day repeated toxicity test of ivermectin microemulsion injection was systematically evaluated by clinical observation, organ coefficient, hematological examination, clinical chemistry examination, and histopathological examination. The results showed that no rats died during the test. At the initial stage of treatment, the rats in the high dose group had mild clinical reaction, which disappeared after 4 days. Clinical chemistry showed that the high dose of ivermectin microemulsion could cause significant changes in ALT and LDH parameters in male rats; high and medium doses could increase the liver coefficients of male and female rats. The toxic target organ may be the liver as indicated by histopathological findings. No significant toxic injury was found in the heart, liver, spleen, lung, kidney, brain, ovary, and testes of all groups of rats. No drug-related toxic effects were found at low doses, and thus the NOVEL of ivermectin microemulsion injection was 0.19 g/kg.

scholarly journals Toxicopathological Evaluation of Hydroethanol Extract ofDianthus basuticusin Wistar Rats

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Anofi Omotayo Tom Ashafa ◽  
Mutiu Idowu Kazeem
Keyword(s):  
Acute Toxicity ◽  
Oral Administration ◽  
Toxicity Test ◽  
Wistar Rats ◽  
Acute Toxicity Test ◽  
Toxicity Profile ◽  
Subacute Toxicity ◽  
Whole Plant ◽  
Single Oral Administration ◽  
Treatment Of Diabetes

Background. Dianthus basuticusis a commonly used medicinal plant in Basotho traditional medicine for the treatment of diabetes, but there is no report on its safety or toxicity. Therefore, we evaluated the toxicity profile of the hydroethanol whole plant extract ofDianthus basuticusin Wistar rats.Methods.Acute toxicity test was performed with single oral administration of 100–3200 mg/kg body weight ofD. basuticusextract to rats and the animals were observed for 14 days for signs of toxicity. The subacute toxicity experiment was conducted by oral administration of graded doses (200, 400, and 800 mg/kg) ofD. basuticusextract daily for 28 days. Behavioural changes as well as haematological, biochemical, and histological parameters were then evaluated.Results.There was no observable sign of toxicity in the acute toxicity test. There were significant decreases (P<0.05) in the feed and water intake as well as total cholesterol and triglycerides of theD. basuticusextract-treated rats in subacute toxicity study. There were no treatment related differences in the haematological, biochemical, and histopathological evaluations.Conclusions.Administration of hydroethanol extract ofD. basuticusmay be safe at the dosages tested in this study but its continuous usage can cause anorexia.

scholarly journals Toxicological implications of the fruit of Harungana madagascariensis on wistar rats

2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Olusayo Aderonke Shorinwa ◽  
Barizonmdu Monsi
Keyword(s):  
Acute Toxicity ◽  
Blood Cell ◽  
Total Protein ◽  
Toxicity Test ◽  
Wistar Rats ◽  
Control Group ◽  
Acute Toxicity Test ◽  
Phytochemical Screening ◽  
Fruit Extract ◽  
Liver And Kidney

Abstract Background The unopened buds of the fruit of Harungana madagascariensis is used in the treatment of anaemia and skin diseases in traditional medicine. Hence, this study aims to scientifically evaluate the effects of oral administration of the fruit extract of Harungana madagascariensis on haematological, biochemical and histological parameters in Wistar rats. Methods Phytochemical screening of the ethanol fruit extract of H. madagascariensis was carried out. Acute toxicity test was done using Lorke’s method. Sub-acute toxicity studies were done using 24 rats of both sexes which were randomized into four groups of six rats each. Animals in groups A, B, C were administered with the extract at doses of 250, 500 and 1000 mg/kg, respectively while group D animals were given distilled water (5 mg/kg) and served as the control group. All administrations were done through the oral route for 30 consecutive days. Body weights of the animals were taken weekly during the study. The animals were sacrificed under diethyl ether anaesthesia and blood samples collected for evaluation of haematological (red blood cell, haemoglobin, packed cell volume and white blood cell) and biochemical (alanine transferase, alanine aminotransferase, alkaline phosphatase, urea, creatinine, total cholesterol and total protein) parameters. Histological examination was conducted on the liver and kidney of the animals. Results Preliminary phytochemical screening of the extract revealed the presence of alkaloids, anthraquinones, steroidal nucleus, saponins, carbohydrates, flavonoids, and tannins. Acute toxicity test showed that the LD50 was greater than 5000 mg/kg. There was no statistically significant (P < 0.05) difference in the RBC, HB, PCV and WBC of the extract treated groups when compared to the control group. There was however, a statistically significant (P < 0.05) difference in the creatinine level of the 500 mg/kg extract –treated group and the control. There was no statistically significant (P < 0.05) difference in other biochemical parameters of the extract treated groups and the control group except for a marginal increase in the total protein in the group treated with 1000 mg/kg of the extract (60 g/L) compared with control (54.80 g/L). Histopathological examination showed alterations in the morphology of the liver and kidney in extract treated groups as compared to the control groups. Conclusion The findings have revealed that the ethanol fruit extract of H. madagascariensis should be used with caution especially during prolonged usage as the histology showed it has nephrotoxic and hepatotoxic potentials. Further studies will be done to establish the effects of the extract on white blood cells.

scholarly journals A 90-Day Oral Toxicity Study of an Ethanolic Root Extract of Caesalpinia bonduc (L.) Roxb. in Wistar Rats

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Mariette Sindete ◽  
Adam Gbankoto ◽  
Razack Osseni ◽  
Nounagnon Darius Tossavi ◽  
Simon Azonbakin ◽  
...  
Keyword(s):  
Body Weight ◽  
Wistar Rats ◽  
Body Weight Gain ◽  
Clinical Signs ◽  
Relative Weight ◽  
Drug Effects ◽  
Root Extract ◽  
Weight Changes ◽  
Oral Toxicity ◽  
Urinary Parameters

Background. Plant medicine is the oldest form of health care known to mankind; hence, studies on their safety for use are essential for the control of adverse drug effects. In Benin, Caesalpinia bonduc is one of many medicinal plants used as aphrodisiac, and for treatment of various ailments including prostatic hyperplasia. Despite its numerous ethnomedicinal benefits, toxicological information associated with its chronic use is currently limited. Objective. The present study therefore assessed the toxicity of an ethanolic root extract of Caesalpinia bonduc in Wistar rats. Methods. Caesalpinia bonduc root extract was administered by oral gavage at doses of 31.25, 125, and 500 mg/kg/day for 90 days to male Wistar rats, after which body weight changes, food consumption, urinary parameters, hematological and blood biochemical parameters, organ weights changes, gross pathology, and histopathology of vital organs were assessed. Results. There were no death or abnormal clinical signs, no significant changes in body weight gain or urinary parameters, and no changes in necropsy and histopathology findings of vital organs associated with extract treatment. However, some indices such as erythrocytes, total cholesterol, and aspartate amino transferase increased in rats treated with high doses of the extract, as well as relative weight of testes, followed by a decrease in food intake and prostate relative weight. Conclusion. The results indicate that an ethanolic root extract of Caesalpinia bonduc does not cause significant adverse effects and suggest its tolerability up to 500 mg/kg for daily administration of 90 days.

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