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, for both the 14-day study and the 90-day study was mixed, weight to volume (w/v), in olive oil (Sigma-Aldrich, St. Louis, MO and O-Live & Co, Norwalk, CT) to obtain the desired concentrations. Fresh formulations containing 200, 400, and 800 mg/mL of the test article in olive oil were prepared daily. The formulations were stirred at ambient temperature to achieve a homogenous mixture. For the 90-day study, there were no analytical differences between the neat test article collected at the beginning of dosing regimens and the test article collected at the end of the dosing regimens. For the Ames tests, the same test article which was used for the animal studies was tested as well as undiluted extract produced using two different manufacturing methods; isopropanol extraction and supercritical CO 2 extraction.