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

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 aberrat...

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Main Authors: Tennille K. Marx, Robin Reddeman, Amy E. Clewell, John R. Endres, Erzsébet Béres, Adél Vértesi, Róbert Glávits, Gábor Hirka, Ilona Pasics Szakonyiné
Format: Article
Language:English
Published: Wiley 2018-01-01
Series:Journal of Toxicology
Online Access:http://dx.doi.org/10.1155/2018/8143582
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author Tennille K. Marx
Robin Reddeman
Amy E. Clewell
John R. Endres
Erzsébet Béres
Adél Vértesi
Róbert Glávits
Gábor Hirka
Ilona Pasics Szakonyiné
author_facet Tennille K. Marx
Robin Reddeman
Amy E. Clewell
John R. Endres
Erzsébet Béres
Adél Vértesi
Róbert Glávits
Gábor Hirka
Ilona Pasics Szakonyiné
author_sort Tennille K. Marx
collection DOAJ
description 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.
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publishDate 2018-01-01
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spelling doaj-art-4b2ef34744ad4c698001b6cec2099a432025-02-03T01:26:47ZengWileyJournal of Toxicology1687-81911687-82052018-01-01201810.1155/2018/81435828143582An Assessment of the Genotoxicity and Subchronic Toxicity of a Supercritical Fluid Extract of the Aerial Parts of HempTennille K. Marx0Robin Reddeman1Amy E. Clewell2John R. Endres3Erzsébet Béres4Adél Vértesi5Róbert Glávits6Gábor Hirka7Ilona Pasics Szakonyiné8AIBMR Life Sciences, Inc., 2800 E Madison St., Suite 202, Seattle, WA 98112, USAAIBMR Life Sciences, Inc., 2800 E Madison St., Suite 202, Seattle, WA 98112, USAAIBMR Life Sciences, Inc., 2800 E Madison St., Suite 202, Seattle, WA 98112, USAAIBMR Life Sciences, Inc., 2800 E Madison St., Suite 202, Seattle, WA 98112, USAToxi-Coop Zrt., Magyar Jakobinusok Tere 4/B, Budapest 1122, HungaryToxi-Coop Zrt., Magyar Jakobinusok Tere 4/B, Budapest 1122, HungaryToxi-Coop Zrt., Magyar Jakobinusok Tere 4/B, Budapest 1122, HungaryToxi-Coop Zrt., Magyar Jakobinusok Tere 4/B, Budapest 1122, HungaryToxi-Coop Zrt., Magyar Jakobinusok Tere 4/B, Budapest 1122, HungaryA 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.http://dx.doi.org/10.1155/2018/8143582
spellingShingle Tennille K. Marx
Robin Reddeman
Amy E. Clewell
John R. Endres
Erzsébet Béres
Adél Vértesi
Róbert Glávits
Gábor Hirka
Ilona Pasics Szakonyiné
An Assessment of the Genotoxicity and Subchronic Toxicity of a Supercritical Fluid Extract of the Aerial Parts of Hemp
Journal of Toxicology
title An Assessment of the Genotoxicity and Subchronic Toxicity of a Supercritical Fluid Extract of the Aerial Parts of Hemp
title_full An Assessment of the Genotoxicity and Subchronic Toxicity of a Supercritical Fluid Extract of the Aerial Parts of Hemp
title_fullStr An Assessment of the Genotoxicity and Subchronic Toxicity of a Supercritical Fluid Extract of the Aerial Parts of Hemp
title_full_unstemmed An Assessment of the Genotoxicity and Subchronic Toxicity of a Supercritical Fluid Extract of the Aerial Parts of Hemp
title_short An Assessment of the Genotoxicity and Subchronic Toxicity of a Supercritical Fluid Extract of the Aerial Parts of Hemp
title_sort assessment of the genotoxicity and subchronic toxicity of a supercritical fluid extract of the aerial parts of hemp
url http://dx.doi.org/10.1155/2018/8143582
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