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

Sprague-Dawley male and female rats (Charles River CD® 1 IGS, Stone Ridge, NY and Raleigh, NC) were used in the 14-day and the 90day studies. For both studies, the rats were 6 weeks of age at the start of the conditioning interval. The acclimation period was 6 days for the 14day study and 12 days for the 90-day study. Criteria used for selecting animals for both studies were adequate body weight gain, absence of clinical signs of disease or injury, and a body weight within ± 20% of the mean within a sex. For the 14-day study, 40 rats were distributed to treatment groups according to stratification by body weight so that there was no statistically significant difference among group body weight means within a sex (Table 3) . Sixty male rats weighing 224-286 g and 60 female rats weighing 170-218 g were distributed to treatment groups stratified by body weight among the dose and control groups (Table 4 ). For both the 14-day and the 90-day studies, body weights were recorded twice during the acclimation period and weekly for the duration of the study. Feed intake was determined at the same day body weights were determined. Filtered potable water and feed (2016CM Certified Envigo Teklad Global Rodent Diet 2 ) were provided ad libitum. Feed and water were assayed for detrimental substances and none were found at levels that would alter study results. In the 90-day study, sentinel rats were kept in the animal rooms. Serology done on samples collected at the end of the study from the sentinel rats were negative for Rat Parvovirus, Toolan's Virus (H-1), Kilham Rat Virus, Rat Minute Virus, Parvovirus NS-1, Rat Coronavirus, Rat Theilovirus, and Pneumocystis carinii.