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Toxicological Evaluation of β-Caryophyllene Oil: Subchronic Toxicity in Rats
International Journal of Toxicology
|July 1, 2016
Summary
Beta-caryophyllene (BCP) oil showed no significant toxicity in Wistar rats during a 90-day study. The highest dose of 700 mg/kg/day was well-tolerated, establishing it as the no observed adverse effect level.
Area of Science:
- Toxicology
- Pharmacology
- Natural Products
Background:
- Beta-caryophyllene (BCP) is a natural compound found in various plants.
- BCP is being considered for use in medical food products.
- Comprehensive safety data is crucial for regulatory approval and consumer trust.
Purpose of the Study:
- To evaluate the subchronic toxicity of beta-caryophyllene (BCP) oil.
- To determine the safety profile of BCP oil for potential use in medical foods.
- To establish the no observed adverse effect level (NOAEL) for BCP oil.
Main Methods:
- A 90-day oral gavage study was conducted on Wistar rats.
- Doses administered were 0, 150, 450, and 700 mg/kg/day.
- Included a 21-day recovery period and a 28-day interim sacrifice in control and high-dose groups.
Main Results:
- No significant toxicologic manifestations were observed across all dose groups.
- BCP oil was well-tolerated, with no major treatment-related changes noted.
- The no observed adverse effect level (NOAEL) was determined to be 700 mg/kg body weight/day for both sexes.
Conclusions:
- Beta-caryophyllene (BCP) oil demonstrates a favorable safety profile in Wistar rats.
- The study supports the safety of BCP oil for its intended use in medical food products.
- No adverse effects were noted up to the highest tested dose of 700 mg/kg/day.
