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

For both studies, individual doses were calculated using the most recent weekly body weights. All doses were adjusted with the olive oil vehicle and all rats received a volume of 5 mL/kg. The formulated test substances were administered orally at approximately the same time ( ± 2 hours) each day by gavage using an accepted procedure. Treatments for the 14-day non-recovery range-finding study were 0, 1000, 2000 and 4000 mg test article/kg body weight (bw)/day for 14 days (Table 3 ). The control groups received 5 ml/kg bw of the olive oil vehicle. For the 90-day study, the rats were dosed with 0, 200, 400 and 800 mg test article/kg bw/day (Table 4 ). In the 90-day study, rats in CBDcannabidiol; CBD-A = cannabidiolic acid; THCdelta-9-tetrahydrocannabinol. THC-A = tetrahydrocannabinolic acid. 1 ®Charles River. 2 ®Envigo Teklad, Inc. 3 Diplomat, American College of Veterinary Ophthalmologists (DACVO).