Biology subjects

Hirka, G.

Publications and source records attributed to Hirka, G..

2 recordsLinked to original sources

bioRxiv2025

An evaluation of genotoxicity and 90-day repeated-dose toxicity in rats of a Dracocephalum moldavica powdered extract

The safety of a powdered extract of Dracocephalum moldavica (Dracobelle Nu sd) was examined through a battery of in vitro and in vivo toxicological studies including a bacterial reverse mutation test, an in vivo mammalian micronucleus assay in male NMRI mice, and a subchronic toxicity study in Han:Wist rats. No mutagenic activity was observed in any of the tested bacterial strains with or without metabolic activation in the reverse mutation test, and no evidence of clastogenic or aneugenic activity was observed in the in vivo mouse micronucleus test. In the 90-day repeated dose oral toxicity study conducted in 80 (40 male/40 female) rats at dose levels of 0 (control), 250, 500, and 1000 mg/kg bw/day, no treatment related mortality or clinical signs of toxicity were observed, and no significant adverse effects attributable to the test item were found in any of the examined parameters in accordance with the OECD guidelines. The No Observed Adverse Effect Level (NOAEL) was determined to be 1000 mg/kg bw/day in male and female rats, the highest dose tested.

pharmacology and toxicology↗

bioRxiv2025

A Comprehensive Toxicological Safety Evaluation of Anaerostipes caccae

Anaerostipes caccae CLB101 (CLB101) is an obligate, anaerobic bacteria that was isolated from the stool of a healthy infant. Due to its ability to produce butyrate and its potential promotion of microbiome health through multiple homeostatic interactions there is interest in its consumption by humans. No toxicity data are publicly available for any strain of A. caccae. Therefore, its genotoxic and toxicological potential was investigated in the current study. Due to its anaerobic nature, a genotoxicity evaluation was performed using the in vivo comet assay and the in vivo mammalian micronucleus assay, which found no evidence of clastogenicity or aneugenicity. General toxicity and potential target organs were assessed in a 90-day, repeated-dose, oral toxicity study using 0, 250, 500, and 1000 mg/kg bw/day in Wistar rats. CLB101 exposure did not result in adverse effects in male or female rats when evaluated for clinical signs, body weight, food consumption, clinical pathology, organ weight, and histopathology after administration, at any dose. Therefore, a NOAEL of 1000 mg/kg bw/day, equivalent to 1.9 x 1011 CFU/kg bw/day, was determined in both male and female Wistar rats.

pharmacology and toxicology↗