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Journal of Toxicology
Volume 2018, Article ID 8143582, 26 pages
https://doi.org/10.1155/2018/8143582
Research Article

An Assessment of the Genotoxicity and Subchronic Toxicity of a Supercritical Fluid Extract of the Aerial Parts of Hemp

1AIBMR Life Sciences, Inc., 2800 E Madison St., Suite 202, Seattle, WA 98112, USA
2Toxi-Coop Zrt., Magyar Jakobinusok Tere 4/B, Budapest 1122, Hungary

Correspondence should be addressed to John R. Endres; moc.rmbia@nhoj

Received 6 December 2017; Revised 6 March 2018; Accepted 7 May 2018; Published 7 June 2018

Academic Editor: Lucio Guido Costa

Copyright © 2018 Tennille K. Marx et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A battery of toxicological studies was conducted on a supercritical CO2 extract of the aerial parts of the Cannabis sativa plant, containing approximately 25% cannabinoids. No evidence of genotoxicity was found in a bacterial reverse mutation test (Ames), in an in vitro mammalian chromosomal aberration test, or in an in vivo mouse micronucleus study. A 14-day repeated oral dose-range finding study conducted in Wistar rats at 1000, 2000, and 4000 mg/kg bw/day resulted in effects where a NOAEL could not be concluded. Based on those results, a 90-day repeated dose oral toxicity study was performed in rats using doses of 100, 360, and 720 mg/kg bw/day, followed by a 28-day recovery period for two satellite groups. Significant decreases in body weight, body weight gain, and differences in various organ weights compared to controls were observed. At the end of the recovery period, many of the findings were trending toward normal; thus, the changes appeared to be reversible. The NOAEL for the hemp extract in Hsd.Han Wistar rats was considered to be 100 mg/kg bw/day for males and 360 mg/kg bw/day for females.