Author(s):
Merina Benny, Benny Antony, Binu T Kuruvilla, Nishant Kumar Gupta
Email(s):
research@arjunanatural.com
DOI:
10.52711/0974-360X.2024.00752 
Address:
Merina Benny*, Benny Antony, Binu T Kuruvilla, Nishant Kumar Gupta
Arjuna Innovation Zone, Arjuna Natural Private Ltd., Erumathala PO, Aluva, Kerala, India – 683112.
*Corresponding Author
Published In:
Volume - 17,
Issue - 10,
Year - 2024
ABSTRACT:
The current study sought to assess the safety of amla extract (Tri-Low®) in rats by acute and repeated dose (90-days) administration as per the OECD (Organisation for Economic Co-operation and Development) guidelines 423 and 408, respectively. In acute toxicity, amla extract was given to overnight starved rats as single dose (2000 mg/kg). Daily clinical symptoms of abnormality/mortality were studied by a veterinarian for 2 weeks period. In the repeated dose study (90 days; sub chronic) amla extract was orally given to rats at low (100mg/kg), medium (500 mg/kg) and high (1000 mg/kg) dose for 3 months. Hematological and biochemical markers were measured after 90 days of feeding. The histopathology of all main organs was also investigated. No death or clinical abnormalities were found in the acute toxicity investigation at 2000 mg/kg; thus, LD50 in rats was recorded as >2000mg/kg (GHS category 5). In the sub-chronic study, there were no visible adverse effects at any dose after repeated feeding of amla extract for 90 days. The hematological and biochemistry data of all the rats were in normal range and there was no statistically significant difference between control and amla extract fed rats (p>0.05). The histology of all the organs was normal for all the groups. The NOAEL (No-Observed-Adverse-Effect-Level) for amla extract in this investigation was established as 1000mg/kg daily. It can be inferred that Tri-Low® is safe to use as a daily food supplement for the management of cardiac and metabolic health.
Cite this article:
Merina Benny, Benny Antony, Binu T Kuruvilla, Nishant Kumar Gupta. Safety Evaluation of Amla extract by Acute and Sub-chronic exposure in rats. Research Journal of Pharmacy and Technology. 2024; 17(10):4887-4. doi: 10.52711/0974-360X.2024.00752
Cite(Electronic):
Merina Benny, Benny Antony, Binu T Kuruvilla, Nishant Kumar Gupta. Safety Evaluation of Amla extract by Acute and Sub-chronic exposure in rats. Research Journal of Pharmacy and Technology. 2024; 17(10):4887-4. doi: 10.52711/0974-360X.2024.00752 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2024-17-10-37
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