A 90-day subchronic toxicity study and reproductive toxicity studies on ACE-inhibiting lactotripeptide

2007 ◽  
Vol 45 (8) ◽  
pp. 1468-1477 ◽  
Author(s):  
M.P. Dent ◽  
S. O’Hagan ◽  
W.H. Braun ◽  
P. Schaetti ◽  
A. Marburger ◽  
...  
2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Mun Fei Yam ◽  
Chung Pin Lim ◽  
Lee Fung Ang ◽  
Lip Yee Por ◽  
Siew Tung Wong ◽  
...  

The present study evaluated the antioxidant activity and potential toxicity of 50% methanolic extract ofOrthosiphon stamineus(Lamiaceae) leaves (MEOS) after acute and subchronic administration in rats. Superoxide radical scavenging, hydroxyl radical scavenging, and ferrous ion chelating methods were used to evaluate the antioxidant properties of the extract. In acute toxicity study, single dose of MEOS, 5000 mg/kg, was administered to rats by oral gavage, and the treated rats were monitored for 14 days. While in the subchronic toxicity study, MEOS was administered orally, at doses of 1250, 2500, and 5000 mg/kg/day for 28 days. From the results, MEOS showed good superoxide radical scavenging, hydroxyl radical scavenging, ferrous ion chelating, and antilipid peroxidation activities. There was no mortality detected or any signs of toxicity in acute and subchronic toxicity studies. Furthermore, there was no significant difference in bodyweight, relative organ weight, and haematological and biochemical parameters between both male and female treated rats in any doses tested. No abnormality of internal organs was observed between treatment and control groups. The oral lethal dose determined was more than 5000 mg/kg and the no-observed-adverse-effect level (NOAEL) of MEOS for both male and female rats is considered to be 5000 mg/kg per day.


Author(s):  
MANOHAR REDDY ◽  
RAJA SUNDARARAJAN

Objective: The fundamental reason for this examination was to look at the acute and subchronic toxicity studies of chloroform and methanol extracts of Barleria buxifolia Linn. (Acanthaceae) on creature models according to the OECD rules 407 and 425, respectively. Methods: In acute oral toxicity, study a single oral dosages of 5000 mg/kg body weight of chloroform and methanol extracts was given individually to rats and watched them for 2 weeks for the discovery of acute changes and for its mortality any. During acute oral toxicity study period, no mortality was seen without any signs of intense changes. Further, it was executed the subchronic toxicity of extracts. Barleria buxifolia extracts (chloroform and methanol) were independently given every day at dosages of 250 and 500 mg/kg body weight for 90 days to recognize the progressions any at subchronic poisonousness levels. Towards the finish of the experimentation the serum tests of trail creatures were gathered and watched for any progressions in haematological, biochemical and histopathological boundaries Results: All parameters of treated group were shown unaltered changes throughout the study period when compared with that of normal group. The outcomes propose that the oral organization of chloroform and methanol extracts of Barleria buxifolia did not raise any huge poisonous impacts when contrasted with that of control animals. Conclusion: Hence, the extracts may be safe for therapeutic use and as an alternative system of medicine.


2004 ◽  
Author(s):  
D. Arfsten ◽  
A. Thitoff ◽  
E. Johnson ◽  
A. Jung ◽  
W. Jederberg ◽  
...  

2021 ◽  
pp. 109158182098607
Author(s):  
Narendra S. Deshmukh ◽  
Shailesh Gumaste ◽  
Silma Subah ◽  
Nathasha Omal Bogoda

Palmitoylethanolamide (PEA) is an endogenous ethanolamine playing a protective and homeodynamic role in animals and plants. Prenatal developmental toxicity of PEA was tested following oral administration to pregnant female Wistar rats, from days 0 to 19 of gestation, at dosage of 250, 500, or 1,000 mg/kg body weight, according to Organisation for Economic Co-operation and Development Test Guideline No. 414. On gestation day 20, cesarean sections were performed on the dams, followed by examination of their ovaries and uterine contents. The fetuses were further examined for external, visceral, and skeletal abnormalities. Palmitoylethanolamide did not cause any alterations at any of the given dosages in the measured maternal parameters of systemic toxicity (body weight, food consumption, survival, thyroid functions, organ weight, histopathology), reproductive toxicity (preimplantation and postimplantation losses, uterus weight, number of live/dead implants and early/late resorptions, litter size and weights, number of fetuses, their sex ratio), and fetal external, visceral, or skeletal observations. Any alterations that were recorded were “normal variations” or “minor anomalies,” which were unrelated to treatment with PEA. Under the condition of this prenatal study, the no-observed-adverse-effect level of PEA for maternal toxicity, embryotoxicity, fetotoxicity, and teratogenicity in rats was found to be >1,000 mg/kg body weight/d. It indicates that PEA is well tolerated by and is safe to pregnant rats even at a high dose of 1,000 mg/kg body weight/d, equivalent to a human dose of greater than 9.7 g/d. This prenatal developmental toxicity study contributes greatly in building a robust safety profile for PEA.


2020 ◽  
Vol 8 (5) ◽  
pp. 2242-2250
Author(s):  
Hyun‐Yong Kim ◽  
Guanglei Zuo ◽  
Soo Kyeong Lee ◽  
Soon Sung Lim

Author(s):  
Meenakshi Sundaram Malayappan ◽  
Gayathri Natarajan ◽  
Logamanian Mockaiyathevar ◽  
Meenakumari Ramasamy

Abstract Objectives Madhulai Manappagu – a well-known sastric and widely prescribed Siddha herbal syrup formulation indicated for treating Veluppu Noi (Anaemia especially Iron deficiency Anaemia) has been in day today practice in Tamil Nadu for a quite longer decades. The syrup is a herbal preparation which has a sweet pleasant odour and a palatable taste, contain the juice of pomegranate (Punica granatum L.) as the main ingredient. Though the formulation is a fruit juice, the safety profile of the syrup is not established and is being marketed without toxicological evaluation. The study is aimed at ascertaining the acute and sub-acute toxicity assessment of Madhulai Manappagu in Wistar Albino rats. Methods The acute and sub-acute (28day repeated oral) toxicity studies were performed as per the guidelines mentioned in the Organization for Economic Cooperation and Development (OECD) 423 (adopted on December 2001) and TG 407 (adopted on October 2008) with slight modifications respectively. For acute toxicity study, three female rats were randomly selected as control; three female rats were randomly selected and were administered a single dose of 5,000 mg/kg body weight per oral route. For sub-acute (28day repeated oral) toxicity studies, three doses of test drug MM of 500 mg/kg/day (low dose), 750 mg/kg/day (intermittent dose) and 1,000 mg/kg/day (high dose) were selected for administration. Both sexes of Wistar Albino rats were randomized into four groups of 10 animals each (five males, five females). Group I was kept as control group. Group II, III and IV served as low, intermittent and high doses of MM respectively. Animals were observed for mortality, morbidity, body weight changes, feed and water intake. Haematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight and histopathological examination were performed. Results In the acute toxicity study, rats showed no toxicological signs on behavior, gross pathology and body weight of rats when treated with a single dose of 5,000 mg/kg body weight per oral route. In the subacute (28 days repeated oral) toxicity study, rats have showed no significant changes on behavior, gross pathology, body weight, and hematological and biochemical parameters when treated with Madhulai Manappagu in three different doses. Conclusions The toxicity studies which include both acute and 28 days repeated (subacute) oral toxicity studies, revealed no observed adverse effect level (NOAEL) of Madhulai Manappagu in animals. Thus the safety of the drug in human usage was ensured.


2020 ◽  
pp. 019262332094671
Author(s):  
Brian Short

Ocular toxicity studies are the bedrock of nonclinical ocular drug and drug–device development, and there has been an evolution in experience, technologies, and challenges to address that ensures safe clinical trials and marketing authorization. The expectations of a well-designed ocular toxicity study and the generation of a coherent, integrative ocular toxicology report and subreports are high, and this article provides a pathology/toxicology consultant’s perspective on achieving that goal. The first objective is to cover selected aspects of study designs for ocular toxicity studies including considerations for contract research organization selection, minipig species selection, unilateral versus bilateral dosing, and in-life parameters based on fit-for-purpose study objectives. The main objective is a focus on a high-quality ocular pathology report that includes ocular histology procedures to meet regulatory expectations and a report narrative and tables that correlate microscopic findings with key ophthalmic findings and presents a clear interpretation of test article-, vehicle-, and procedure-related ocular and extraocular findings with identification of adversity and a pathology peer review. The last objective covers considerations for a high-quality ophthalmology report, which in concert with a high-quality pathology report, will pave the way for a best quality toxicology report for an ocular toxicity study.


2012 ◽  
Vol 62 (2) ◽  
pp. 221-230 ◽  
Author(s):  
Shuai Zhang ◽  
Lingli Zheng ◽  
Lina Xu ◽  
Huijun Sun ◽  
Hua Li ◽  
...  

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