Acute oral toxicity study of novel polyherbal formulations by using wistar rats and Swiss albino mice as per OECD 425 TG
Hydaljss08 is a new semisolid fermented hydroalcoholic polyherbal formulation containing crude drug substances. Immunoboost Tab is a novel polyherbal dosage form that is incorporated isolated, and fractionated phytochemical substances. Acute oral toxicity is a primary safety profile of the novel polyherbal formulations. The novelty of our work is developed a novel polyherbal formulations (Hydaljss08 & Immunoboost-Tab) cause of the Immunostimulant and Anti-viral effects (COVID-19). As a part of our study, we estimated acute toxicity safety profile of novel dosage forms by a Swiss albino mice and Wistar rats. According to the OECD 425 test guideline., the study aims to estimate acute toxicity tests of the “Hydaljss08, and Immunoboost Tab” dosage forms in rats and mice to assess the safety profile. Mice and rats are normally used in safety studies because of their susceptibility to toxic challenges, tumor induction, and carcinogenicity. 1% CMC, Hydaljss08, Immunoboost-Tab polyherbal formulations, female rats, and albino mice. Animals were divided into the control groups, and treated groups with test dosage forms. At the end of the study, animals were euthanized by using the CO 2 asphyxiation technique and subjected to gross pathological examinations. According to the assessment of the experimental data, the single-dose acute toxicity study of Hydaljss08 and Immunoboost-Tab formulations in mice and rats was fine. No signs of toxicity were observed in the animals treated at (2000 mg/kg.b. wt, Po), and revealed dullness, causing lethargy, and piloerections, which only persisted on the 1 st day. At the end of the study, mild congestion in the liver, and lungs was observed in animals, treated with “Hydaljss08 formulation” compared to the vehicle control groups. The estimated LD 50 of Hydaljss08, and Immunoboost-Tab polyherbal formulations in rats and mice by oral route was found more than 2000 mg/kg, b.wt.
Authors
- T. Ganesh
- Pradhib Venkatesan (ORCID: https://orcid.org/0000-0001-5420-2247)
- Jubie Selvaraj (ORCID: https://orcid.org/0000-0002-4633-6621)
- S. P. Dhanabal
- Ramkishan Jatoth (ORCID: https://orcid.org/0000-0002-3607-7419)
- Senthil Venkatachalam (ORCID: https://orcid.org/0000-0003-3110-1229)
Institutions
- Lovely Professional University (IN)
- JSS Academy of Higher Education and Research (IN)
- Shri Dharmasthala Manjunatheswara College of Ayurveda and Hospital (IN)
- Biotech Park (IN)
- SRM University (IN)
Publication Details
- Journal
- Phytomedicine Plus
- Published
- 2024-11-08
- DOI
- https://doi.org/10.1016/j.phyplu.2024.100672
- Citations
- 5
- Primary Topic
- Natural Antidiabetic Agents Studies
- Type
- article
- Field-Weighted Citation Impact
- 1.79