Mutagenicity and genotoxicity of ClearTaste

Soni, B.K.; Langan, J.P.

doi:10.1016/j.toxrep.2017.12.015

Cited by 4 publications

(2 citation statements)

References 19 publications

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“…Mutagenic studies on extracts from the plant Euphorbia triaculeata showed that it is not mutagenic and provides protection from the mutagenic effects of cyclophosphamide [31]. A study on a novel taste modulating powder derived from Cordyceps sinensis showed this product was not mutagenic in the Ames test and these results were supported in the micronucleus assay [32]. In a study on the genotoxicity of CBD in Caco-2 cells, 10 μM of CBD did not significantly cause DNA damage after 24 hours of incubation, and CBD was also shown in the comet assay to protect Caco-2 cells from hydrogen peroxide-induced DNA damage [33].…”

Section: Discussionmentioning

confidence: 99%

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

Dziwenka¹,

Coppock²,

Alexander³

et al. 2020

Toxicology Reports

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Keywords:Cannabis sativa cannabinoids cannabidiol CBD toxicology olive oil hemp extract CYP liver mutagenicity CW hemp Charlotte's Web, Inc. A B S T R A C TCannabinoids 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.

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Section: Discussionmentioning

confidence: 99%

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

Dziwenka¹,

Coppock²,

Alexander³

et al. 2020

Toxicology Reports

View full text Add to dashboard Cite

show abstract

“…BM-104 mutagenic potential was assessed by detection of mutations in five histidine-dependent Salmonella typhimurium strains [23]. Putative revertant cells (his− to his+) were detected on the basis of their ability to grow in the absence of histidine (required by the parent test strain) after incubation for 48 h with BM-104 (at concentrations from 50 to 5000 μg/plate) or with its potential metabolites that were produced by pre-incubation with a rat liver S9 fraction.…”

Section: Methodsmentioning

confidence: 99%