-
Something wrong with this record ?
Safety assessment on CBD-rich hemp extract in sub-chronic cross-sex study with rats
J. Dehner, HH. Polanska, K. Petrlakova, SC. Zeljkovic, T. Beres, M. Hendrych, J. Storch, P. Tarkowski, M. Masarik, P. Babula, J. Vacek
Language English Country United States
Document type Journal Article
- MeSH
- Cannabis * chemistry MeSH
- Cannabidiol * toxicity pharmacokinetics MeSH
- Rats MeSH
- Rats, Sprague-Dawley MeSH
- Plant Extracts * toxicity MeSH
- Sex Factors MeSH
- Toxicity Tests, Subchronic MeSH
- Dose-Response Relationship, Drug MeSH
- Animals MeSH
- Check Tag
- Rats MeSH
- Male MeSH
- Female MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
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.
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc25010055
- 003
- CZ-PrNML
- 005
- 20250429135100.0
- 007
- ta
- 008
- 250415e20241225xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1016/j.taap.2024.117218 $2 doi
- 035 __
- $a (PubMed)39730029
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Dehner, Jan $u 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 (CATRIN), Palacky University, Slechtitelu 27, 783 71 Olomouc, Czech Republic
- 245 10
- $a Safety assessment on CBD-rich hemp extract in sub-chronic cross-sex study with rats / $c J. Dehner, HH. Polanska, K. Petrlakova, SC. Zeljkovic, T. Beres, M. Hendrych, J. Storch, P. Tarkowski, M. Masarik, P. Babula, J. Vacek
- 520 9_
- $a 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.
- 650 _2
- $a zvířata $7 D000818
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 12
- $a Cannabis $x chemie $7 D002188
- 650 12
- $a kanabidiol $x toxicita $x farmakokinetika $7 D002185
- 650 12
- $a rostlinné extrakty $x toxicita $7 D010936
- 650 _2
- $a krysa rodu Rattus $7 D051381
- 650 _2
- $a vztah mezi dávkou a účinkem léčiva $7 D004305
- 650 _2
- $a testy subchronické toxicity $7 D059550
- 650 _2
- $a sexuální faktory $7 D012737
- 650 _2
- $a potkani Sprague-Dawley $7 D017207
- 655 _2
- $a časopisecké články $7 D016428
- 700 1_
- $a Polanska, Hana Holcova $u Department of Physiology, Faculty of Medicine, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic
- 700 1_
- $a Petrlakova, Katerina $u Department of Pathophysiology, Faculty of Medicine, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic
- 700 1_
- $a Zeljkovic, Sanja Cavar $u Czech Advanced Technology and Research Institute (CATRIN), 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
- 700 1_
- $a Beres, Tibor $u Czech Advanced Technology and Research Institute (CATRIN), Palacky University, Slechtitelu 27, 783 71 Olomouc, Czech Republic
- 700 1_
- $a Hendrych, Michal $u First Department of Pathology, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Pekarska 664/53, 602 00 Brno, Czech Republic
- 700 1_
- $a Storch, Jan $u 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
- 700 1_
- $a Tarkowski, Petr $u Czech Advanced Technology and Research Institute (CATRIN), 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
- 700 1_
- $a Masarik, Michal $u 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
- 700 1_
- $a Babula, Petr $u Department of Physiology, Faculty of Medicine, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic
- 700 1_
- $a Vacek, Jan $u Department of Medical Chemistry and Biochemistry, Faculty of Medicine and Dentistry, Palacky University, Hnevotinska 3, 775 15 Olomouc, Czech Republic. Electronic address: jan.vacek@upol.cz
- 773 0_
- $w MED00010691 $t Toxicology and applied pharmacology $x 1096-0333 $g Roč. 495 (20241225), s. 117218
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/39730029 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20250415 $b ABA008
- 991 __
- $a 20250429135055 $b ABA008
- 999 __
- $a ok $b bmc $g 2311428 $s 1247136
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2025 $b 495 $c - $d 117218 $e 20241225 $i 1096-0333 $m Toxicology and applied pharmacology $n Toxicol Appl Pharmacol $x MED00010691
- LZP __
- $a Pubmed-20250415
