Subchronic and Reproductive/Developmental Toxicity Studies of Tetrahydrocurcumin in Rats
Toxicological Research 2019;35:65−74
Published online January 15, 2019;  https://doi.org/10.5487/TR.2019.35.1.065
© 2019 Korean Society of Toxicology.

Muhammed Majeed, Sankaran Natarajan, Anjali Pandey, Sarang Bani and Lakshmi Mundkur

Sami Labs Limited, Karnataka, India
Anjali Pandey, Sami Labs Limited, #19/1, 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore 560 058, Karnataka, India, E-mail: anjalipandey@samilabs.com
Received: June 22, 2018; Revised: August 14, 2018; Accepted: September 7, 2018
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Tetrahydrocurcumin (THC) is a major metabolite of curcumin, which is obtained from Curcuma longa. THC has various benefits and overcomes the bioavailability issue of curcumin. To establish it as a pharmacologically active molecule, its safety profile has to be determined. Thus, the present study aimed to determine the preclinical safety profile of THC in a 90-day subchronic and reproductive/developmental toxicity study in Wistar rats. THC at oral doses of 100, 200, and 400 mg/kg was administered daily for 90 days. Rats in the recovery group were kept for 14days after treatment termination. The animals were observed for treatment-related morbidity, mortality, and changes in clinical signs, clinical pathology, and histopathology. In the reproductive/developmental toxicity study, THC at 100, 200, and 400 mg/kg was administered orally to rats and the reproductive/developmental parameters in adult male and female rats and pups were observed. THC at up to 400 mg/kg/day of did not have any significant effect on all parameters in male and female rats in both toxicity studies. Thus, 400 mg/kg/day can be considered as the no-observed-adverse-effect-level of THC in rats.
Keywords : Tetrahydrocurcumin, Toxicity, Subchronic, Reproductive/developmental


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