Toxicological safety assessment of HempChoice® hemp oil extract; a proprietary extract consisting of a high concentration of cannabidiol (CBD) in addition to other phytocannabinoids and terpenes derived from Cannabis sativaL

HempChoice® Hemp Oil Extract (Geocann, LLC) is an extract of the aerial parts of hemp (Cannabis sativa L.) primarily comprised of 55–75% cannabidiol (CBD), 1–15% other phytocannabinoids and 1–15% terpenes. The results of multiple safety studies demonstrated that it was non-mutagenic in an Ames and m...

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Main Authors: Margitta Dziwenka, Robert Coppock, Michael H. Davidson, Marc A. Weder
Format: Article
Language:English
Published: Elsevier 2023-06-01
Series:Heliyon
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2405844023041208
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author Margitta Dziwenka
Robert Coppock
Michael H. Davidson
Marc A. Weder
author_facet Margitta Dziwenka
Robert Coppock
Michael H. Davidson
Marc A. Weder
author_sort Margitta Dziwenka
collection DOAJ
description HempChoice® Hemp Oil Extract (Geocann, LLC) is an extract of the aerial parts of hemp (Cannabis sativa L.) primarily comprised of 55–75% cannabidiol (CBD), 1–15% other phytocannabinoids and 1–15% terpenes. The results of multiple safety studies demonstrated that it was non-mutagenic in an Ames and mammalian cell micronucleus.test and was well tolerated in a 14-day range-finding study at dose levels up to 96.03.mg/kg BW/day. In the 90-day study, no HempChoice® Hemp Oil Extract-related significant changes were noted in weekly BW, daily BW gain, food consumption, functional observational battery or motor activity assessment. In addition, no HempChoice® Hemp Oil Extract related mortalities, abnormal clinical observations and ophthalmological changes were reported. Some HempChoice® Hemp Oil Extract-related changes were reported in the hematology and clinical chemistry parameters evaluated. These changes were not outside the normal range and were considered reversible during the 28-day recovery period. No macroscopic findings were reported, and histopathological changes related to HempChoice® Hemp Oil Extract exposure were limited to adaptive changes in the liver which were not observed in the recovery group animals. The no observed adverse effect level (NOAEL) for HempChoice® Hemp Oil Extract was determined to be 185.90 mg/kg BW/day in male and female Sprague-Dawley rats.
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spelling doaj.art-c2f9ae99cec646bf8f96d5a87a790a3e2023-06-04T04:24:18ZengElsevierHeliyon2405-84402023-06-0196e16913Toxicological safety assessment of HempChoice® hemp oil extract; a proprietary extract consisting of a high concentration of cannabidiol (CBD) in addition to other phytocannabinoids and terpenes derived from Cannabis sativaLMargitta Dziwenka0Robert Coppock1Michael H. Davidson2Marc A. Weder3GRAS Associates Nutrasource Pharmaceutical and Nutraceutical Services, 120 Research Lane, Suite 101, Guelph, Ontario, Canada, N1G 0B4; Corresponding author.Toxicologist and Associates Ltd., PO Box 2031, Vegreville, AB T9C 1T2, CanadaGeocann, Innovation, Technology, & Clinical Research Dept., 320 E Vine Drive, Suite 207, Fort Collins, CO, 80524, USAVesifact AG, Joechlerweg 4, 6340, Baar, SwitzerlandHempChoice® Hemp Oil Extract (Geocann, LLC) is an extract of the aerial parts of hemp (Cannabis sativa L.) primarily comprised of 55–75% cannabidiol (CBD), 1–15% other phytocannabinoids and 1–15% terpenes. The results of multiple safety studies demonstrated that it was non-mutagenic in an Ames and mammalian cell micronucleus.test and was well tolerated in a 14-day range-finding study at dose levels up to 96.03.mg/kg BW/day. In the 90-day study, no HempChoice® Hemp Oil Extract-related significant changes were noted in weekly BW, daily BW gain, food consumption, functional observational battery or motor activity assessment. In addition, no HempChoice® Hemp Oil Extract related mortalities, abnormal clinical observations and ophthalmological changes were reported. Some HempChoice® Hemp Oil Extract-related changes were reported in the hematology and clinical chemistry parameters evaluated. These changes were not outside the normal range and were considered reversible during the 28-day recovery period. No macroscopic findings were reported, and histopathological changes related to HempChoice® Hemp Oil Extract exposure were limited to adaptive changes in the liver which were not observed in the recovery group animals. The no observed adverse effect level (NOAEL) for HempChoice® Hemp Oil Extract was determined to be 185.90 mg/kg BW/day in male and female Sprague-Dawley rats.http://www.sciencedirect.com/science/article/pii/S2405844023041208Cannabis sativaHemp extractCannabidiolToxicityMutagenicityGeocann
spellingShingle Margitta Dziwenka
Robert Coppock
Michael H. Davidson
Marc A. Weder
Toxicological safety assessment of HempChoice® hemp oil extract; a proprietary extract consisting of a high concentration of cannabidiol (CBD) in addition to other phytocannabinoids and terpenes derived from Cannabis sativaL
Heliyon
Cannabis sativa
Hemp extract
Cannabidiol
Toxicity
Mutagenicity
Geocann
title Toxicological safety assessment of HempChoice® hemp oil extract; a proprietary extract consisting of a high concentration of cannabidiol (CBD) in addition to other phytocannabinoids and terpenes derived from Cannabis sativaL
title_full Toxicological safety assessment of HempChoice® hemp oil extract; a proprietary extract consisting of a high concentration of cannabidiol (CBD) in addition to other phytocannabinoids and terpenes derived from Cannabis sativaL
title_fullStr Toxicological safety assessment of HempChoice® hemp oil extract; a proprietary extract consisting of a high concentration of cannabidiol (CBD) in addition to other phytocannabinoids and terpenes derived from Cannabis sativaL
title_full_unstemmed Toxicological safety assessment of HempChoice® hemp oil extract; a proprietary extract consisting of a high concentration of cannabidiol (CBD) in addition to other phytocannabinoids and terpenes derived from Cannabis sativaL
title_short Toxicological safety assessment of HempChoice® hemp oil extract; a proprietary extract consisting of a high concentration of cannabidiol (CBD) in addition to other phytocannabinoids and terpenes derived from Cannabis sativaL
title_sort toxicological safety assessment of hempchoice r hemp oil extract a proprietary extract consisting of a high concentration of cannabidiol cbd in addition to other phytocannabinoids and terpenes derived from cannabis satival
topic Cannabis sativa
Hemp extract
Cannabidiol
Toxicity
Mutagenicity
Geocann
url http://www.sciencedirect.com/science/article/pii/S2405844023041208
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