| Sumario: | LN20188 is a botanical combination composed of extracts derived from Withania somnifera (L.) Dunal root and Abelmoschus esculentus (L.) Moench fruit. Our earlier investigations revealed the benefits of LN20188 in promoting gut motility and reducing constipation. The current investigation presents the toxicological profile of LN20188 following OECD guidelines for chemical testing. In an acute oral toxicity (AOT) study involving Sprague Dawley rats, no significant signs of toxicity or morbidity were observed, and the lethal dose (LD50) was determined to be greater than 2000 mg/kg body weight (b.w). Gross pathological findings further confirmed the safety of LN20188. In a repeated‐dose subchronic toxicological investigation, rats were administered either 500, 1000, or 1500 mg/kg b.w of LN20188 for 90 consecutive days. LN20188 was found to be safe, where data on body weight, food consumption, organ weights, hematology, clinical biochemistry, and biomarkers were comparable to those of vehicle controls. The estimated no‐observed‐adverse‐effect level (NOAEL) for LN20188 in male and female rats is determined to be 1500 mg/kg b.w. Genotoxicity studies, including bacterial reverse mutation, in vitrochromosomal aberration (CA), and in vivo micronucleus test (MNT) in mouse bone marrow erythrocytes, indicated no clastogenic or mutagenic activity. Results of the bacterial reverse mutation assay showed that LN20188 did not exhibit a notable increase in colony count (mutagenicity) up to 5000 μg/plate. In CA assay, LN20188 concentrations of up to 1000 μg/mL in the short term and 500 μg/mL in continuous exposure did not induce any chromosomal aberrations. Additionally, in vivo MNT showed that LN20188, up to 2000 mg/kg b.w, did not elevate the frequency of micronucleated PCEs (MNPCEs). Overall, these studies demonstrate that oral administration of LN20188 does not result in toxicity or genotoxic effects.
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