Safety Assessment of a Hemp Extract using Genotoxicity and Oral Repeat-Dose Toxicity Studies in Sprague-Dawley Rats

Dziwenka, Margitta; Coppock, Robert; Alexander, McCorkle; Palumbo, Eddie; Ramirez, Carlos; Lermer, Stephen

Recently, there has been an increasing interest regarding the health benefits of CBD and other phytocannabinoids and with this increased interest, more research is also being conducted to assess the safety of these compounds for human consumption. The current studies were performed to better understand the toxicological profile of a CBD rich proprietary hemp extract and to assess the results in tandem with information currently available regarding the toxicity and safety of CBD. Marx et al. [4] reports on a battery of GLP compliant toxicological studies which were conducted on a supercritical CO 2 extract of the aerial parts of the C. sativa plant. Assay of the extract was 61% edible fatty acids, 26% phytocannabinoids (approximately 96% is CBD, < 1% THC) and 13% other plant chemicals including fatty alkanes, plant sterols, triterpenes, and tocopherols. In the 14-day repeated oral doserange finding study reported by Marx et al. [4] , a No Observed Adverse Effect Level (NOAEL) could not be determined, however, the results of a 90-day repeated dose study with a 28-day recovery period in Wistar rats was also reported. In this study, doses of 0 (sunflower oil vehicle), 100, 360 and 720 mg extract/kg bw per day were used. Significant decreases in body weight, body weight gain, and differences in various organ weights, compared to controls, were reported at the mid and high dose levels, but the authors concluded that many of the findings were reversible as they were trending towards normal at the end of the recovery period. A NOAEL for the hemp extract in Wistar rats in the 90day study was determined to be 100 mg/ kg bw per day and 360 mg/kg bw per day for males and females, respectively.