Dziwenka Margitta, Coppock Robert, Davidson Michael H, Weder Marc A
GRAS Associates Nutrasource Pharmaceutical and Nutraceutical Services, 120 Research Lane, Suite 101, Guelph, Ontario, Canada, N1G 0B4.
Toxicologist and Associates Ltd., PO Box 2031, Vegreville, AB T9C 1T2, Canada.
Heliyon. 2023 Jun 2;9(6):e16913. doi: 10.1016/j.heliyon.2023.e16913. eCollection 2023 Jun.
HempChoice® Hemp Oil Extract (Geocann, LLC) is an extract of the aerial parts of hemp ( 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® 大麻油提取物（Geocann有限责任公司）是大麻（属）地上部分的提取物，主要成分包括55 - 75%的大麻二酚（CBD）、1 - 15%的其他植物大麻素和1 - 15%的萜类化合物。多项安全性研究结果表明，在艾姆斯试验和哺乳动物细胞微核试验中，它无致突变性，并且在剂量高达96.03毫克/千克体重/天的14天剂量探索研究中耐受性良好。在90天研究中，未观察到HempChoice® 大麻油提取物对每周体重、每日体重增加、食物消耗、功能性观察组合或运动活动评估有显著相关变化。此外，未报告与HempChoice® 大麻油提取物相关的死亡、异常临床观察和眼科变化。在评估的血液学和临床化学参数中报告了一些与HempChoice® 大麻油提取物相关的变化。这些变化未超出正常范围，并且在28天恢复期内被认为是可逆的。未报告宏观检查结果，与接触HempChoice® 大麻油提取物相关的组织病理学变化仅限于肝脏的适应性变化，在恢复期动物中未观察到。确定HempChoice® 大麻油提取物对雄性和雌性斯普拉 - 道利大鼠的无观察到有害作用水平（NOAEL）为185.90毫克/千克体重/天。
