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

The test article was supplied by Charlotte's Web, Inc. (2425 55 th Street, Suite 100, Boulder, CO 80301) and is a proprietary blend of 9% hemp extract and 91% organic extra virgin olive oil, which is produced by an isopropanol extraction method under current Good Manufacturing Practices (CGMP). Fatty acids comprise approximately 88.70% of this extract, while the phytocannabinoid content is 6.96% (of this, 6.27% is CBD); the remaining 4.34% consists of fatty alkanes, sterols, terpenes and tocopherols. Therefore, approximately 100% of the constituents of this proprietary hemp extract are accounted for. An Ames test was conducted on this test article and two additional Ames tests were conducted on undiluted extract, one an isopropanol extract and the other a supercritical CO 2 extract. This was done to determine the impact, if any, of the olive oil on the results. Additionally, this product meets the Federal requirements for hemp products under the Agriculture Improvement Act in regard to THC. The test article used in these studies met the specifications outlined in Table 1 and the cannabinoid content is listed in Table 2 . For the 14-day study, concentration verifications were conducted on study day 1. For the 90-day study, concentration verification analysis samples were collected from the preparations on day 1, day 46 and Day 94, and assayed for the hemp extract.