title: Toxicological Evaluation of β-Caryophyllene Oil: Subchronic Toxicity in Rats.
abstract: In a subchronic toxicity study, administration of β-caryophyllene (BCP) oil by oral gavage to Wistar rats at dosages of 0, 150, 450, or 700 mg/kg/d for 90 days, including a 21-day recovery period, did not produce any significant toxicologic manifestations. The study design also included a 28-day interim sacrifice in the control and high-dose groups. The BCP oil test article was well tolerated as evidenced by the absence of major treatment-related changes in the general condition and appearance of the rats, neurobehavioral end points, growth, feed and water intake, ophthalmoscopic examinations, routine hematology and clinical chemistry parameters, urinalysis, and necropsy findings. The no observed adverse effect level was the highest dosage level administered of 700 mg/kg body weight/d for both male and female rats. The study was conducted as part of an investigation to examine the safety of BCP oil for its proposed use in medical food products.
authors.affiliation: ToxStrategies, Inc, Naperville, IL, USA dschmitt@toxstrategies.com.
authors.forename: D
authors.initials: D
authors.lastname: Schmitt
authors.affiliation: Primus Pharmaceuticals, Inc, Scottsdale, AZ, USA.
authors.forename: R
authors.initials: R
authors.lastname: Levy
authors.affiliation: Primus Pharmaceuticals, Inc, Scottsdale, AZ, USA.
authors.forename: B
authors.initials: B
authors.lastname: Carroll
mesh_terms: D000818:Animals; D001835:Body Weight; D004195:Disease Models, Animal; D004353:Drug Evaluation, Preclinical; D005260:Female; D007928:Lethal Dose 50; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D000081223:Polycyclic Sesquiterpenes; D051381:Rats; D017208:Rats, Wistar; D012717:Sesquiterpenes / Q000627:therapeutic use* / Q000633:toxicity*; D059550:Toxicity Tests, Subchronic; D016482:Urinalysis
chemical_list: D000081223:Polycyclic Sesquiterpenes; D012717:Sesquiterpenes; C024714:caryophyllene
keywords: subchronic toxicity; β-caryophyllene; β-caryophyllene oil