PRENATAL DEVELOPMENTAL TOXICITY STUDY OF POLYPHENOLS-BASED STANDARDIZED CINNAMON BARK EXTRACT IN RATS

PRASAD THAKURDESAI; MADHURA KARVE; PALLAVI DESHPANDE

doi:10.22159/ijpps.2025v17i6.54184

Authors

PRASAD THAKURDESAI Indus Biotech Limited, 1, Rahul Residency, Off Salunke Vihar Road, Kondhwa, Pune-411048, India https://orcid.org/0000-0002-9144-6600
MADHURA KARVE Indus Biotech Limited, 1, Rahul Residency, Off Salunke Vihar Road, Kondhwa, Pune-411048, India https://orcid.org/0009-0008-9223-845X
PALLAVI DESHPANDE Indus Biotech Limited, 1, Rahul Residency, Off Salunke Vihar Road, Kondhwa, Pune-411048, India https://orcid.org/0000-0002-9859-0170

DOI:

https://doi.org/10.22159/ijpps.2025v17i6.54184

Keywords:

Cinnamon bark, Developmental toxicity, Polyphenols, Prenatal exposure, Standardized extract

Abstract

Objective: To evaluate developmental toxicity of the polyphenol-based standardized cinnamon bark extract (IND02) during the gestational period in pregnant rats using “Organization for Economic Co-operation and Development” (OECD) Test No. 414.

Methods: Pregnant female rats were daily administered IND02 via gavage (125, 250, or 500 mg/kg) from Gestational Days (GD) 05 to GD19, except for the Vehicle Control (VC) group. On GD20, the dams underwent cesarean section, and observations were made of the uteri and fetuses of the dams.

Results: Prenatal oral administration of IND02 during gestation period in female rats did not show detrimental effects on maternal (body weight, uterine weight, uterine morphology, and gross pathology) or fetal development parameters (crown-rump length, sex ratio, and occurrence of anomalies) compared with VC, indicating normal fetal development. A few skeletal and visceral malformations that were noted were infrequent, incidental, and without toxicological significance.

Conclusion: Prenatal oral exposure of rats to IND02 did not result in developmental toxicity (fetotoxicity or teratogenicity). “No-Observed-Adverse-Effect Level” (NOAEL) and “Human Equivalent Dose” (HED) of IND02 in rats at prenatal oral exposure was more than 500 mg/kg/d and 4.86 g/d respectively.

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