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

Result code in 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>

Alternative codes found

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

Result on the web

<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>

Result language

angličtina

Original language name

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

Original language description

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.

Czech name

—

Czech description

—

Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

10608 - Biochemistry and molecular biology

Project

<a href="/en/project/NW24-09-00244" target="_blank" >NW24-09-00244: Health risk of sub-chronic phytocannabinoids application</a><br>

Continuities

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

Publication year

2025

Confidentiality

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

Name of the periodical

TOXICOLOGY AND APPLIED PHARMACOLOGY

ISSN

0041-008X

e-ISSN

1096-0333

Volume of the periodical

495

Issue of the periodical within the volume

Feb

Country of publishing house

US - UNITED STATES

Number of pages

12

Pages from-to

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

UT code for WoS article

001399809500001

EID of the result in the Scopus database

2-s2.0-85214006967