Toxicological safety assessment of HempChoice® hemp oil extract; a proprietary extract consisting of a high concentration of cannabidiol (CBD) in addition to other phytocannabinoids and terpenes derived from CannabissativaL

HempChoice® Hemp Oil Extract (Geocann, LLC) is an extract of the aerial parts of hemp (Cannabis sativa L.) primarily comprised of 55–75% cannabidiol (CBD), 1–15% other phytocannabinoids and 1–15% terpenes. The results of multiple safety studies demonstrated that it was non-mutagenic in an Ames and mammalian cell micronucleus. test and was well tolerated in a 14-day range-finding study at dose levels up to 96.03. mg/kg BW/day. In the 90-day study, no HempChoice® Hemp Oil Extract-related significant changes were noted in weekly BW, daily BW gain, food consumption, functional observational battery or motor activity assessment. In addition, no HempChoice® Hemp Oil Extract related mortalities, abnormal clinical observations and ophthalmological changes were reported. Some HempChoice® Hemp Oil Extract-related changes were reported in the hematology and clinical chemistry parameters evaluated. These changes were not outside the normal range and were considered reversible during the 28-day recovery period. No macroscopic findings were reported, and histopathological changes related to HempChoice® Hemp Oil Extract exposure were limited to adaptive changes in the liver which were not observed in the recovery group animals. The no observed adverse effect level (NOAEL) for HempChoice® Hemp Oil Extract was determined to be 185.90 mg/kg BW/day in male and female Sprague-Dawley rats. •HempChoice® Hemp Oil Extract was non-mutagenic a bacterial reverse mutation assay and an in vitro micronucleus assay.•There were no HempChoice® exposure-related mortalities, abnormal clinical observations, or ophthalmological changes.•The NOAEL of HempChoice® was 185.90 mg/kg body weight, the highest dose tested, in male and female SD rats.