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Investigation into the oral toxicity profile of TruCBN™
Mark R Bauter1, Vaughn Hartung2, Celeste Dunn1
1Product Safety Labs, Dayton, NJ 08810, USA.
Abstract:
Floraworks TruCBN™ is a proprietary form of cannabinol (CBN), a high-purity CBN isolate processed to be substantially free of THC. CBN is derived from the Cannabis sativa plant, and is unique among cannabinoids, as it is not produced directly through the cannabis plant's metabolic processes; instead, it forms as an oxidative decomposition product of cannabidiol (CBD) and tetrahydrocannabinol (THC). CBN acts as a low affinity partial agonist at both CB1 and CB2 receptors, with a greater affinity for CB2. Therapeutic properties of CBN include potential efficacy in the treatment of ocular disease, neuroprotection, antimicrobial, anti-inflammatory, and immunosuppressive effects, as well as ongoing investigations for relevance to sleep quality as an alternative to traditional sleep aids, such as melatonin. The safety of TruCBN™ was examined comprehensively through GLP studies conducted to assess the safety profile, including its toxicologic potential. In 14-day and 90-day repeat-dose oral toxicity studies, at dose levels of 0 (vehicle control), 100, 200, and 400 mg/kg/day in male and female Sprague-Dawley rats, no adverse effects were observed. Specifically, there were no clinical signs, body weight, food consumption, functional observations, or motor activity effects, and no clinical pathology, macroscopic, or microscopic changes attributable to the administration of the test substance. The 90-day toxicity study supports a NOAEL for TruCBN™ of 400 mg/kg/day.
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