An Assessment of the Genotoxicity and Subchronic Toxicity of a Supercritical Fluid Extract of the Aerial Parts of Hemp
| Autor: | Adél Vértesi, Robin A Reddeman, Ilona Pasics Szakonyiné, Erzsébet Béres, Róbert Glávits, John R. Endres, Tennille K. Marx, Amy E. Clewell, Gábor Hirka |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Pharmacology Article Subject Biology Toxicology medicine.disease_cause Body weight Reverse mutation Supercritical fluid Subchronic toxicity 03 medical and health sciences Recovery period 030104 developmental biology 0302 clinical medicine Animal science lcsh:RA1190-1270 In vivo medicine Micronucleus 030217 neurology & neurosurgery Genotoxicity lcsh:Toxicology. Poisons Research Article |
| Zdroj: | Journal of Toxicology Journal of Toxicology, Vol 2018 (2018) |
| ISSN: | 1687-8205 1687-8191 |
| Popis: | A battery of toxicological studies was conducted on a supercritical CO2 extract of the aerial parts of the Cannabis sativa plant, containing approximately 25% cannabinoids. No evidence of genotoxicity was found in a bacterial reverse mutation test (Ames), in an in vitro mammalian chromosomal aberration test, or in an in vivo mouse micronucleus study. A 14-day repeated oral dose-range finding study conducted in Wistar rats at 1000, 2000, and 4000 mg/kg bw/day resulted in effects where a NOAEL could not be concluded. Based on those results, a 90-day repeated dose oral toxicity study was performed in rats using doses of 100, 360, and 720 mg/kg bw/day, followed by a 28-day recovery period for two satellite groups. Significant decreases in body weight, body weight gain, and differences in various organ weights compared to controls were observed. At the end of the recovery period, many of the findings were trending toward normal; thus, the changes appeared to be reversible. The NOAEL for the hemp extract in Hsd.Han Wistar rats was considered to be 100 mg/kg bw/day for males and 360 mg/kg bw/day for females. |
| Databáze: | OpenAIRE |
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