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

J 2025

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

DEHNER, Jan; Hana HOLCOVÁ POLANSKÁ; Kateřina HÖNIGOVÁ; Sanja Cavar ZELJKOVIC; Tibor BERES et al.

Základní údaje

Originální název

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

Autoři

DEHNER, Jan; Hana HOLCOVÁ POLANSKÁ; Kateřina HÖNIGOVÁ ; Sanja Cavar ZELJKOVIC; Tibor BERES; Michal HENDRYCH; Jan STORCH; Petr TARKOWSKI; Michal MASAŘÍK; Petr BABULA a Jan VACEK

Vydání

Toxicology and applied pharmacology, SAN DIEGO, ACADEMIC PRESS INC ELSEVIER SCIENCE, 2025, 0041-008X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.400 v roce 2024

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/25:00142342

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

cannabis; CBD hemp extract; Sub-chronic toxicity; Safety; Biodistribution; Organ accumulation; Cross-gender study

Štítky

14110112, 14110515, 14110518, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 2. 2. 2026 12:17, Mgr. Eva Suchánková

Anotace

V originále

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 < 0.05) decrease in the number of leukocytes for both sexes, and a significant difference (p < 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 < 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 < 0.01). CBD was quantified in treated animals in a dose-dependent manner, with statistical significance varying from p < 0.05 to 0.0001. The accumulation of CBD in the individual tissues increased in the order: brain < serum < liver < heart << kidney <<< muscle and skin. The results indicated sex-dependent latent disruption of kidney and liver homeostasis, most likely reversible in nature.

Návaznosti

MUNI/A/1587/2023, interní kód MU

Název: Patofyziologie vybraných komplexních nemocí od molekulární do systémovou úroveň

Investor: Masarykova univerzita, Patofyziologie vybraných komplexních nemocí od molekulární do systémovou úroveň

MUNI/A/1790/2024, interní kód MU

Název: Patofyziologie běžných komplexních nemocí: od molekuly k organizmu

Investor: Masarykova univerzita, Patofyziologie běžných komplexních nemocí: od molekuly k organizmu

NW24-09-00244, projekt VaV

Název: Zdravotní rizika fytokanabinoidů při subchronické aplikaci

Investor: Ministerstvo zdravotnictví ČR, Zdravotní rizika fytokanabinoidů při subchronické aplikaci, Podprogram 1 - standardní

Citovat

DEHNER, Jan; Hana HOLCOVÁ POLANSKÁ; Kateřina HÖNIGOVÁ; Sanja Cavar ZELJKOVIC; Tibor BERES; Michal HENDRYCH; Jan STORCH; Petr TARKOWSKI; Michal MASAŘÍK; Petr BABULA a Jan VACEK. Safety assessment on CBD-rich hemp extract in sub-chronic cross-sex study with rats. Toxicology and applied pharmacology. SAN DIEGO: ACADEMIC PRESS INC ELSEVIER SCIENCE, 2025, roč. 495, February 2025, s. 1-12. ISSN 0041-008X. Dostupné z: https://doi.org/10.1016/j.taap.2024.117218.

@article{2527881,
   author = {Dehner, Jan and Holcová Polanská, Hana and Hönigová, Kateřina and Zeljkovic, Sanja Cavar and Beres, Tibor and Hendrych, Michal and Storch, Jan and Tarkowski, Petr and Masařík, Michal and Babula, Petr and Vacek, Jan},
   article_location = {SAN DIEGO},
   article_number = {February 2025},
   doi = {https://doi.org/10.1016/j.taap.2024.117218},
   keywords = {cannabis; CBD hemp extract; Sub-chronic toxicity; Safety; Biodistribution; Organ accumulation; Cross-gender study},
   language = {eng},
   issn = {0041-008X},
   journal = {Toxicology and applied pharmacology},
   title = {Safety assessment on CBD-rich hemp extract in sub-chronic cross-sex study with rats},
   url = {https://www.sciencedirect.com/science/article/pii/S0041008X24004174?pes=vor&utm_source=clarivate&getft_integrator=clarivate},
   volume = {495},
   year = {2025}
}

TY  - JOUR
ID  - 2527881
AU  - Dehner, Jan - Holcová Polanská, Hana - Hönigová, Kateřina - Zeljkovic, Sanja Cavar - Beres, Tibor - Hendrych, Michal - Storch, Jan - Tarkowski, Petr - Masařík, Michal - Babula, Petr - Vacek, Jan
PY  - 2025
TI  - Safety assessment on CBD-rich hemp extract in sub-chronic cross-sex study with rats
JF  - Toxicology and applied pharmacology
VL  - 495
IS  - February 2025
SP  - 1-12
EP  - 1-12
PB  - ACADEMIC PRESS INC ELSEVIER SCIENCE
SN  - 0041008X
KW  - cannabis
KW  - CBD hemp extract
KW  - Sub-chronic toxicity
KW  - Safety
KW  - Biodistribution
KW  - Organ accumulation
KW  - Cross-gender study
UR  - https://www.sciencedirect.com/science/article/pii/S0041008X24004174?pes=vor&utm_source=clarivate&getft_integrator=clarivate
N2  - 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 < 0.05) decrease in the number of leukocytes for both sexes, and a significant difference (p < 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 < 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 < 0.01). CBD was quantified in treated animals in a dose-dependent manner, with statistical significance varying from p < 0.05 to 0.0001. The accumulation of CBD in the individual tissues increased in the order: brain < serum < liver < heart << kidney <<< muscle and skin. The results indicated sex-dependent latent disruption of kidney and liver homeostasis, most likely reversible in nature.
ER  -

DEHNER, Jan; Hana HOLCOVÁ POLANSKÁ; Kateřina HÖNIGOVÁ; Sanja Cavar ZELJKOVIC; Tibor BERES; Michal HENDRYCH; Jan STORCH; Petr TARKOWSKI; Michal MASAŘÍK; Petr BABULA a Jan VACEK. Safety assessment on CBD-rich hemp extract in sub-chronic cross-sex study with rats. \textit{Toxicology and applied pharmacology}. SAN DIEGO: ACADEMIC PRESS INC ELSEVIER SCIENCE, 2025, roč.~495, February 2025, s.~1-12. ISSN~0041-008X. Dostupné z: https://doi.org/10.1016/j.taap.2024.117218.

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