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

Three Ames tests, one on the extract diluted in olive oil and two on undiluted extracts, and two oral (gavage) dosing studies in rats were completed. The preclinical studies included a 14-day range finding study (14-day study) and a 90-day study with a 28-day recovery period (90-day study). All studies were compliant with the US FDA Good Laboratory Practices, and the preclinical studies were also compliant with the OECD Principles of Good Laboratory [12] [13] [14] [15] . Animal housing and care was in compliance with the Guide for the Care and Use of Laboratory Animals [16] . The current state of scientific knowledge does not provide acceptable alternatives to the use of live animals to accomplish the objective of this study. CBDcannabidiol; CBD-A = cannabidiolic acid; THCdelta-9-tetrahydrocannabinol; THC-A = tetrahydrocannabinolic acid; HPLC = high pressure liquid chromatography; NLT = not less than; NMT = not more than; USP -United States Pharmacopeia.