About: Safety Assessment of a Hemp Extract using Genotoxicity and Oral Repeat-Dose Toxicity Studies in Sprague-Dawley Rats

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An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Safety Assessment of a Hemp Extract using Genotoxicity and Oral Repeat-Dose Toxicity Studies in Sprague-Dawley Rats
Creator	Coppock, Robert Dziwenka, Margitta Lermer, Stephen Palumbo, Eddie Ramirez, Carlos Mccorkle, Alexander
topic	covid:140ab046d55c6618aa71fea9e48b7971a7e4b60e#this
source	Elsevier; Medline; PMC
abstract	Cannabinoids are extracted from Cannabis sativa L. and are used for a variety of medicinal purposes. Recently, there has been a focus on the cannabinoid Cannabidiol (CBD) and its potential benefits. This study investigated the safety of a proprietary extract of C. sativa, consisting of 9% hemp extract (of which 6.27% is CBD) and 91% olive oil. The mutagenic potential of the hemp extract was evaluated with the AMES assay inclusive of a hepatic drug metabolizing mix (S9) rich in CYP enzymes. The test article did not elicit evidence of bacterial mutagenicity. GLP compliant 14-day and a 90-day toxicity study were conducted. Olive oil was used as a control. The 90-day study had a 28-day recovery period. Treatments for the 14-day non-recovery range-finding study were 0, 1000, 2000 and 4000 mg test article/kg body weight (bw)/day for 14 days. There was a non-statistically significant (p > 0.05) decrease in body weights for the male and female rats receiving the test article. Hypoactivity, hyperactivity, reduced food consumption and piloerection were observed in the rats receiving 4000 mg test article/kg bw. Histopathology showed an increase in the size of liver cells (hypertrophy) around the central vein (centrilobular) in Groups 3 (3/10) and 4 (5/10) that correlated with increased liver weights. In the 90-day study, 8 groups of rats were dosed with 0, 200, 400 and 800 mg test article/kg bw/day. Groups 5 to 8 had a 28-day recovery. There were no test article-linked changes in clinical observations, physical examinations, Functional Observation Battery, ophthalmology, Motor Activity Assessment, hematology, clinical chemistries and macropathology (all groups). With the exception of the liver and adrenal gland, no test article-linked pathology was observed. For all rats receiving the test article, histopathology showed hypertrophy of liver cells around the central vein. The increase of liver weight is most likely caused by hypertrophy due to up-regulation of the hepatic drug metabolizing enzymes. The hepatocellular hypertrophy was completely reversed in 28 days and was not considered to be an adverse effect. Vacuolization of the adrenal zona fasciculata was observed in the control and 800 mg test article/kg bw groups. The vacuolization of the zona fasciculata was of the same incidence and severity in treatment and control male rats and correlated with an increased in the weights of the adrenal glands. In addition, a statistically significant increase (p<0.05) in adrenal-to-body weight ratios was observed for females receiving 800 mg test article/kg bw. This increase in adrenal-to-body weight ratio did not correlate with any of the pathology findings. The NOAEL for the test article is 800 mg/kg bw/day for female and 400 mg/kg bw/day for male Sprague Dawley rats.
has issue date	2020-02-20(xsd:dateTime)
bibo:doi	10.1016/j.toxrep.2020.02.014
bibo:pmid	32123668
has license	cc-by-nc-nd
sha1sum (hex)	140ab046d55c6618aa71fea9e48b7971a7e4b60e
schema:url	https://doi.org/10.1016/j.toxrep.2020.02.014
resource representing a document's title	Safety Assessment of a Hemp Extract using Genotoxicity and Oral Repeat-Dose Toxicity Studies in Sprague-Dawley Rats
has PubMed Central identifier	PMC7036713
has PubMed identifier	32123668
schema:publication	Toxicol Rep
resource representing a document's body	covid:140ab046d55c6618aa71fea9e48b7971a7e4b60e#body_text
is http://vocab.deri.ie/void#inDataset of	proxy:http/ns.inria.fr/covid19/140ab046d55c6618aa71fea9e48b7971a7e4b60e
is schema:about of	named entity 'LIVER' named entity '27S' named entity 'CANNABIDIOL' named entity 'cannabinoids' named entity 'Toxicity' covid:arg/140ab046d55c6618aa71fea9e48b7971a7e4b60e named entity 'DOSE' named entity 'GENOTOXICITY' named entity 'CBD' named entity 'HEMP' named entity 'TOXICOLOGY' named entity 'WEB' named entity 'EXTRACT' named entity 'SAFETY' named entity 'USING' named entity 'TOXICITY' named entity 'STUDIES' named entity 'SPRAGUE-DAWLEY RATS' named entity 'REPEAT' named entity 'ORAL' named entity 'CHARLOTTE' named entity 'MUTAGENICITY' named entity 'INC' named entity 'CYP' named entity 'HEMP' named entity 'CANNABIS SATIVA' named entity 'ASSESSMENT' named entity 'EXTRACT' named entity 'OLIVE OIL' named entity 'CANNABINOIDS' named entity 'cannabidiol' named entity 'Safety' named entity 'CBD' named entity 'cannabidiol' named entity 'cannabinoids' named entity 'Safety Assessment' named entity 'St. Louis' named entity 'Laboratory Animals' named entity 'current Good Manufacturing Practices' named entity 'C. sativa' named entity 'vacuolization' named entity 'convulsions' named entity 'toxicological studies' named entity 'square root' named entity 'Parvovirus' named entity 'hypertrophy' named entity 'nutrient broth' named entity 'Virus' named entity 'Shapiro-Wilk test' named entity 'glucose' named entity 'active ingredient' named entity 'histopathology' named entity 'human consumption' named entity 'gavage' named entity 'CBD' named entity 'bacterial strain' named entity 'Histopathology' named entity 'autonomic function' named entity 'hypertrophy' named entity 'hematoxylin and eosin' named entity 'olive oil' named entity 'dose-dependent' named entity 'EDTA' named entity 'San Diego' named entity 'body weight' named entity 'feed efficiency' named entity 'potable water' named entity 'delta-9-tetrahydrocannabinol' named entity 'supercritical' named entity '37°C' named entity 'hepatocytes' named entity 'body weight' named entity 'liver' named entity 'hypertrophy'

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