Acute and 28-day repeated-dose oral toxicity of a synthetic 3-hydroxyindolin-2-one derivative in BALB/c mice
- 1Department of Pharmacology, SRM College of Pharmacy, Faculty of Medicine and Health Sciences, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu, Tamil Nadu, 603203, India
- 2Corresponding author.
Abstract
Preclinical safety evaluation of newly synthesized bioactive molecules is a crucial step in the drug development process. The acute and subacute oral toxicity of the synthesized 3-Hydroxyindolin-2-one derivative, 7-bromo-3-hydroxy-3-(2-oxo-2-(p-tolyl)ethyl)indolin-2-one (4b), was evaluated in BALB/c mice using a sequential-dose acute oral toxicity/tolerability assessment and a 28-day repeated-dose study. For the acute oral assessment, compound 4b was administered sequentially at 2000, 1000, and 300 mg/kg body weight, followed by a 14-day observation period. Mortality was observed at 2000 and 1000 mg/kg, whereas no mortality was observed at 300 mg/kg, and subacute toxicity was determined by oral doses of 15, 30, and 60 mg/kg per day for 28 days. To determine the body weight, hematological parameters, biochemical parameters, gross pathological examination, and histopathological evaluation of major organs were performed for the synthesized compound. No mortality was observed at 300 mg/kg during the acute observation period or during the 28-day repeated-dose study, and no treatment-related gross pathological changes were observed at the examined doses. Several statistically significant differences and deviations from the reference intervals were observed among individual hematological and biochemical parameters following repeated administration. However, these changes did not demonstrate a consistent dose-response pattern across sexes and were not accompanied by concordant clinical, gross pathological, or histopathological findings. Histopathological evaluation of selected organs in the vehicle-control and high-dose groups showed well-preserved tissue architecture, with no treatment-related lesions identified in the examined tissues. Together, these results indicate that the synthesized compound 4b caused no mortality or clear treatment-related hematological, biochemical, gross pathological, or histopathological effects at the administered doses.
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BibTeX
@article{mondal2026acute,
title = {{Acute and 28-day repeated-dose oral toxicity of a synthetic 3-hydroxyindolin-2-one derivative in BALB/c mice}},
author = {Nakibul Islam Mondal and Chitra Vellapandian},
journal = {Toxicology Reports},
year = {2026},
month = oct,
doi = {10.1016/j.toxrep.2026.102354},
url = {https://doi.org/10.1016/j.toxrep.2026.102354},
note = {CC BY},
}
RIS
TY - JOUR
TI - Acute and 28-day repeated-dose oral toxicity of a synthetic 3-hydroxyindolin-2-one derivative in BALB/c mice
AU - Nakibul Islam Mondal
AU - Chitra Vellapandian
PY - 2026
DA - 2026/10/15
JO - Toxicology Reports
DO - 10.1016/j.toxrep.2026.102354
UR - https://doi.org/10.1016/j.toxrep.2026.102354
AB - Preclinical safety evaluation of newly synthesized bioactive molecules is a crucial step in the drug development process. The acute and subacute oral toxicity of the synthesized 3-Hydroxyindolin-2-one derivative, 7-bromo-3-hydroxy-3-(2-oxo-2-(p-tolyl)ethyl)indolin-2-one (4b), was evaluated in BALB/c mice using a sequential-dose acute oral toxicity/tolerability assessment and a 28-day repeated-dose study. For the acute oral assessment, compound 4b was administered sequentially at 2000, 1000, and 300 mg/kg body weight, followed by a 14-day observation period. Mortality was observed at 2000 and 1000 mg/kg, whereas no mortality was observed at 300 mg/kg, and subacute toxicity was determined by oral doses of 15, 30, and 60 mg/kg per day for 28 days. To determine the body weight, hematological parameters, biochemical parameters, gross pathological examination, and histopathological evaluation of major organs were performed for the synthesized compound. No mortality was observed at 300 mg/kg during the acute observation period or during the 28-day repeated-dose study, and no treatment-related gross pathological changes were observed at the examined doses. Several statistically significant differences and deviations from the reference intervals were observed among individual hematological and biochemical parameters following repeated administration. However, these changes did not demonstrate a consistent dose-response pattern across sexes and were not accompanied by concordant clinical, gross pathological, or histopathological findings. Histopathological evaluation of selected organs in the vehicle-control and high-dose groups showed well-preserved tissue architecture, with no treatment-related lesions identified in the examined tissues. Together, these results indicate that the synthesized compound 4b caused no mortality or clear treatment-related hematological, biochemical, gross pathological, or histopathological effects at the administered doses.
SN - 2214-7500
ER -