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

. 2025 Feb ; 495 () : 117218. [epub] 20241225

Jazyk angličtina Země Spojené státy americké Médium print-electronic

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid39730029
Odkazy

PubMed 39730029
DOI 10.1016/j.taap.2024.117218
PII: S0041-008X(24)00417-4
Knihovny.cz E-zdroje

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.

1st Department of Pathology St Anne's University Hospital and Faculty of Medicine Masaryk University Pekarska 664 53 602 00 Brno Czech Republic

Czech Advanced Technology and Research Institute Palacky University Slechtitelu 27 783 71 Olomouc Czech Republic

Czech Advanced Technology and Research Institute Palacky University Slechtitelu 27 783 71 Olomouc Czech Republic; Centre of the Region Hana for Biotechnological and Agricultural Research Department of Genetic Resources for Vegetables Medicinal and Special Plants Crop Research Institute Slechtitelu 29 783 71 Olomouc Czech Republic

Department of Advanced Materials and Organic Synthesis Institute of Chemical Process Fundamentals of the Czech Academy of Sciences v v i Rozvojova 135 165 02 Prague Czech Republic

Department of Medical Chemistry and Biochemistry Faculty of Medicine and Dentistry Palacky University Hnevotinska 3 775 15 Olomouc Czech Republic

Department of Medical Chemistry and Biochemistry Faculty of Medicine and Dentistry Palacky University Hnevotinska 3 775 15 Olomouc Czech Republic; Czech Advanced Technology and Research Institute Palacky University Slechtitelu 27 783 71 Olomouc Czech Republic

Department of Pathophysiology Faculty of Medicine Masaryk University Kamenice 753 5 625 00 Brno Czech Republic

Department of Physiology Faculty of Medicine Masaryk University Kamenice 753 5 625 00 Brno Czech Republic

Department of Physiology Faculty of Medicine Masaryk University Kamenice 753 5 625 00 Brno Czech Republic; Department of Pathophysiology Faculty of Medicine Masaryk University Kamenice 753 5 625 00 Brno Czech Republic; International Clinical Research Center St Anne's University Hospital Pekarska 664 53 602 00 Brno Czech Republic

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