<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Enkhmaa Gonchig</style></author><author><style face="normal" font="default" size="100%">Chimgee Tserendash</style></author><author><style face="normal" font="default" size="100%">Maral-Erdene Gerelt-Od</style></author><author><style face="normal" font="default" size="100%">Batdavaa Batbayar</style></author><author><style face="normal" font="default" size="100%">Mend-Amar Batbaatar</style></author><author><style face="normal" font="default" size="100%">Perleidulam Bunddulam</style></author><author><style face="normal" font="default" size="100%">Enerel Yeruult</style></author><author><style face="normal" font="default" size="100%">Narankhajid Myadagsuren</style></author><author><style face="normal" font="default" size="100%">Otgonbat Altangerel</style></author><author><style face="normal" font="default" size="100%">Yeruult Chultemsuren</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Preclinical Safety Assessment of a Polyherbal Formulation: Acute, Subchronic, and Mutagenic Evaluation</style></title><secondary-title><style face="normal" font="default" size="100%">Pharmacognosy Journal</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">acute toxicity; mutagenicity; phytochemicals; polyherbal formulation; safety evaluation; subchronic toxicity</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2025</style></year><pub-dates><date><style  face="normal" font="default" size="100%">December 2025</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">17</style></volume><pages><style face="normal" font="default" size="100%">322-328</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p class=&quot;rtejustify&quot;&gt;&lt;strong&gt;Introduction:&lt;/strong&gt; Before market approval, novel herbal medicines and bioactive compounds require rigorous genotoxicity and safety evaluations. A polyherbal formulation derived from &lt;em&gt;Dasiphora fruticosa, Cynara scolymus&lt;/em&gt;, and &lt;em&gt;Rosa acicularis&lt;/em&gt; has previously demonstrated antioxidant and nephroprotective properties. However, comprehensive toxicological and mutagenicity evaluations are needed to support its clinical development. In this study, we aimed to evaluate the acute and subchronic toxicities and mutagenic potential of this polyherbal formulation.&lt;strong&gt; Methods: &lt;/strong&gt;Acute oral toxicity was assessed in C57BL/6 mice using a two-phase protocol based on Lorke's method. Subchronic toxicity was evaluated in Wistar rats following OECD guideline 407, with daily oral administration of the polyherbal formulation at doses of 500 and 1,000 mg/kg for 28 days. Mutagenicity was assessed using the Muta-Chromoplate (Ames test) kit according to OECD guideline 471. &lt;strong&gt;Results: &lt;/strong&gt;Acute toxicity evaluation determined that the median lethal dose (LD&lt;sub&gt;50&lt;/sub&gt;) of the polyherbal formulation exceeds 5,000 mg/kg, categorising it as practically nontoxic. The subchronic toxicity assessment revealed that doses of 500 and 1,000 mg/kg had no significant effects on body and organ weight, haematological and biochemical parameters, and histopathological features compared with the controls. Furthermore, the Ames test confirmed that the polyherbal formulation had no mutagenic activity. &lt;strong&gt;Conclusions:&lt;/strong&gt; The polyherbal formulation exhibited no acute toxicity at doses up to 5,000 mg/kg, and no adverse effects were observed in a 28-day subchronic toxicity study. Furthermore, its favourable safety profile was further confirmed by its lack of mutagenic potential. Collectively, these findings provide a robust foundation for continued preclinical and clinical development of the polyherbal formulation&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">6</style></issue><work-type><style face="normal" font="default" size="100%">Original Article</style></work-type><section><style face="normal" font="default" size="100%">322</style></section><auth-address><style face="normal" font="default" size="100%">&lt;p class=&quot;rtejustify&quot;&gt;&lt;strong&gt;Enkhmaa Gonchig&lt;sup&gt;1&lt;/sup&gt;, Chimgee Tserendash&lt;sup&gt;1&lt;/sup&gt;, Maral-Erdene Gerelt-Od&lt;sup&gt;1&lt;/sup&gt;, Batdavaa Batbayar&lt;sup&gt;1&lt;/sup&gt;, Mend-Amar Batbaatar&lt;sup&gt;1&lt;/sup&gt;, Perleidulam Bunddulam&lt;sup&gt;2&lt;/sup&gt;, Enerel Yeruult&lt;sup&gt;2&lt;/sup&gt;, Narankhajid Myadagsuren&lt;sup&gt;3&lt;/sup&gt;, Otgonbat Altangerel&lt;sup&gt;4*&lt;/sup&gt;, Yeruult Chultemsuren&lt;sup&gt;1*&lt;/sup&gt; &lt;/strong&gt;&lt;/p&gt;

&lt;p class=&quot;rtejustify&quot;&gt;&lt;sup&gt;1&lt;/sup&gt;Department of Pharmacology, School of Biomedicine, Mongolian National University of Medical Sciences, Zorig street, post office 48/111, Ulaanbaatar 14210, MONGOLIA.&lt;/p&gt;

&lt;p class=&quot;rtejustify&quot;&gt;&lt;sup&gt;2&lt;/sup&gt;School of Regional Innovation and Social Design Engineering, Kitami Institute of Technology, Hokkaido 090-8507, JAPAN.&lt;/p&gt;

&lt;p class=&quot;rtejustify&quot;&gt;&lt;sup&gt;3&lt;/sup&gt;Department of Biology, School of Biomedicine, Mongolian National University of Medical Sciences, Zorig street, post office 48/111, 14210 Ulaanbaatar, MONGOLIA.&lt;/p&gt;

&lt;p class=&quot;rtejustify&quot;&gt;&lt;sup&gt;4&lt;/sup&gt;Department of Hematology, School of Medicine, Mongolian National University of Medical Sciences, Zorig street, post office 48/111, 14210 Ulaanbaatar, MONGOLIA.&lt;/p&gt;
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