Safety assessment on CBD-rich hemp extract in sub-chronic cross-sex study with rats

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15640%2F25%3A73633870" target="_blank" >RIV/61989592:15640/25:73633870 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/67985858:_____/25:00605597 RIV/00216224:14110/25:00142342 RIV/61989592:15110/25:73633870 RIV/00159816:_____/25:00082331 RIV/00027006:_____/25:10177981

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/pii/S0041008X24004174?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0041008X24004174?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.taap.2024.117218" target="_blank" >10.1016/j.taap.2024.117218</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Safety assessment on CBD-rich hemp extract in sub-chronic cross-sex study with rats

Popis výsledku v původním jazyce

Cannabidiol (CBD) is a phytocannabinoid from Cannabis sativa L., in which there is currently growing interest for medicinal use. Here, we focused on the safety and pharmacokinetics of a CBD-rich (77 %, w/w) full-spectrum hemp extract in male and female rats. A 90-day sub-chronic toxicity assay was conducted with doses of 0.5, 5, 10, and 35 mg CBD extract/kg/day administered orogastrically. No adverse effects or disruption in organ or body weight, behaviour, locomotion, food intake, or impact on morbidity/mortality were observed. Pathomorphological examination showed no gastrointestinal or liver changes. Blood cell analysis showed a significant (p &lt; 0.05) decrease in the number of leukocytes for both sexes, and a significant difference (p &lt; 0.01 or 0.05) between the control and treated animals for mean corpuscular haemoglobin concentration, mean corpuscular volume of erythrocytes, and percentage of neutrophils and monocytes. However, blood cell analysis revealed significant (p &lt; 0.05) sex-dependent differences, such as haematocrit and erythrocyte count. The levels of ions (Ca2+, Na+, K+ and Cl-), alkaline phosphatase activity, and creatinine level in treated animals were also observed for both sexes. Males exhibited decreased alanine transaminase activities, and females exhibited hyperalbuminemia (p &lt; 0.01). CBD was quantified in treated animals in a dose-dependent manner, with statistical significance varying from p &lt; 0.05 to 0.0001. The accumulation of CBD in the individual tissues increased in the order: brain &lt; serum &lt; liver &lt; heart &lt;&lt; kidney &lt;&lt;&lt; muscle and skin. The results indicated sex-dependent latent disruption of kidney and liver homeostasis, most likely reversible in nature.

Název v anglickém jazyce

Safety assessment on CBD-rich hemp extract in sub-chronic cross-sex study with rats

Popis výsledku anglicky

Cannabidiol (CBD) is a phytocannabinoid from Cannabis sativa L., in which there is currently growing interest for medicinal use. Here, we focused on the safety and pharmacokinetics of a CBD-rich (77 %, w/w) full-spectrum hemp extract in male and female rats. A 90-day sub-chronic toxicity assay was conducted with doses of 0.5, 5, 10, and 35 mg CBD extract/kg/day administered orogastrically. No adverse effects or disruption in organ or body weight, behaviour, locomotion, food intake, or impact on morbidity/mortality were observed. Pathomorphological examination showed no gastrointestinal or liver changes. Blood cell analysis showed a significant (p &lt; 0.05) decrease in the number of leukocytes for both sexes, and a significant difference (p &lt; 0.01 or 0.05) between the control and treated animals for mean corpuscular haemoglobin concentration, mean corpuscular volume of erythrocytes, and percentage of neutrophils and monocytes. However, blood cell analysis revealed significant (p &lt; 0.05) sex-dependent differences, such as haematocrit and erythrocyte count. The levels of ions (Ca2+, Na+, K+ and Cl-), alkaline phosphatase activity, and creatinine level in treated animals were also observed for both sexes. Males exhibited decreased alanine transaminase activities, and females exhibited hyperalbuminemia (p &lt; 0.01). CBD was quantified in treated animals in a dose-dependent manner, with statistical significance varying from p &lt; 0.05 to 0.0001. The accumulation of CBD in the individual tissues increased in the order: brain &lt; serum &lt; liver &lt; heart &lt;&lt; kidney &lt;&lt;&lt; muscle and skin. The results indicated sex-dependent latent disruption of kidney and liver homeostasis, most likely reversible in nature.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

10608 - Biochemistry and molecular biology

Projekt

<a href="/cs/project/NW24-09-00244" target="_blank" >NW24-09-00244: Zdravotní rizika fytokanabinoidů při subchronické aplikaci</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

TOXICOLOGY AND APPLIED PHARMACOLOGY

ISSN

0041-008X

e-ISSN

1096-0333

Svazek periodika

495

Číslo periodika v rámci svazku

Feb

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

12

Strana od-do

"117218(1)"-"117218(12)"

Kód UT WoS článku

001399809500001

EID výsledku v databázi Scopus

2-s2.0-85214006967