Investigation into the oral toxicity profile of TruCBN™.
TruCBN™ showed no adverse effects in rats at doses up to 400 mg/kg/day, but its safety in humans remains unverified.
Where it sits
this study against the rest of the liraglutide corpusSummary and findings
The study investigated the oral toxicity profile of TruCBN™, a proprietary form of cannabinol (CBN), in male and female Sprague-Dawley rats. The doses administered were 0 (vehicle control), 100, 200, and 400 mg/kg/day over 14-day and 90-day periods. No adverse effects were observed at any dose level.
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 CB<sub>1</sub> and CB<sub>2</sub> receptors, with a greater affinity for CB<sub>2</sub>. 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.
Background
This paper addresses the safety profile of TruCBN™, a high-purity cannabinol isolate. Prior knowledge indicates that CBN is a decomposition product of CBD and THC, with potential therapeutic properties. Understanding its toxicity is crucial for evaluating its safety in potential applications.
Methods
The study utilized GLP-compliant 14-day and 90-day repeat-dose oral toxicity studies in male and female Sprague-Dawley rats. Doses were administered at 0, 100, 200, and 400 mg/kg/day. Primary outcomes included clinical signs, body weight, food consumption, functional observations, motor activity, and pathological changes.
Results
The primary endpoint indicated a NOAEL for TruCBN™ of 400 mg/kg/day in the 90-day study. No adverse effects were reported across all measured parameters, including clinical signs, body weight, and pathology.
Interpretation
The findings suggest that TruCBN™ does not exhibit toxicity at the tested doses in rats, aligning with limited existing literature on CBN's safety. However, the absence of adverse effects does not confirm safety in humans, and the effect size is not clinically relevant outside of the animal model. The study's reliance on rodent data limits the applicability of results to human populations.
Key findings
- NOAEL for TruCBN™ of 400 mg/kg/day in 90-day study.
- No adverse effects observed in clinical signs, body weight, food consumption, functional observations, or motor activity.
- No clinical pathology, macroscopic, or microscopic changes attributable to the administration of the test substance.
Limitations
- Conducted in rats, unclear relevance to humans.
- No long-term follow-up data.
- No human data reported.
- Single-site study.
- Industry-funded research.