Toxicological assessment of dihydroberberine

Kara D Lewis; Michael Falk

doi:10.1016/j.fct.2022.113301

Toxicological assessment of dihydroberberine

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

Authors

Kara D Lewis¹, Michael Falk²

Affiliations

¹ LSRO Solutions LLC, 2286 Dunster Lane, Rockville, MD, 20854, USA.
² LSRO Solutions LLC, 2286 Dunster Lane, Rockville, MD, 20854, USA. Electronic address: falkm@lsro.org.

PMID: 35868606
DOI: 10.1016/j.fct.2022.113301

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.

MeSH terms

Animals
Berberine* / analogs & derivatives
Berberine* / toxicity
Female
Lethal Dose 50
Male
Mice
Micronucleus Tests
No-Observed-Adverse-Effect Level
Rats
Rats, Sprague-Dawley

Substances

Berberine
dihydroberberine