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. 2022 Oct:168:113301.
doi: 10.1016/j.fct.2022.113301. Epub 2022 Jul 19.

Toxicological assessment of dihydroberberine

Kara D Lewis  1 , Michael Falk  2
Affiliations

Toxicological assessment of dihydroberberine

Kara D Lewis et al. Food Chem Toxicol. 2022 Oct.

Abstract

A battery of studies was conducted to examine the toxicological potential of dihydroberberine (DHBBR), a derivative of berberine (BBR). The genotoxicity studies conducted on DHBBR, including the bacterial reverse mutation test, the mouse lymphoma assay, and the in vivo micronucleus test, showed that DHBBR is non-mutagenic and non-clastogenic. An acute oral toxicity study revealed that the LD50 of DHBBR in female Sprague Dawley rats was greater than 2000 mg/kg bw. In a 14-day oral dose range finding study, the maximum tolerated dose was the high dose, 120 mg/kg bw/day. Based on a 90-day oral toxicity study in male and female Sprague Dawley rats, it was concluded that the NOAEL for DHBBR is 100 mg/kg bw/day, the highest dose tested.

Keywords: Berberine; Dihydroberberine; Toxicity.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Michael Falk reports financial support was provided by Nanjing Nutrabuilding Bio-Tech Co., Ltd. Michael Falk reports a relationship with Nanjing Nutrabuilding Bio-Tech Co., Ltd. that includes: consulting or advisory. Kara D. Lewis reports a relationship with Nanjing Nutrabuilding Bio-Tech Co., Ltd. that includes: consulting or advisory.

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