scholarly journals A Toxicological Evaluation of Chlamydomonas reinhardtii, a Green Algae

2018 ◽  
Vol 37 (1) ◽  
pp. 53-62 ◽  
Author(s):  
Timothy S. Murbach ◽  
Róbert Glávits ◽  
John R. Endres ◽  
Gábor Hirka ◽  
Adél Vértesi ◽  
...  
Keyword(s):  
Chlamydomonas Reinhardtii ◽  
Green Algae ◽  
Micronucleus Test ◽  
Repeated Dose ◽  
Continuous Exposure ◽  
Oral Toxicity ◽  
Food Ingredient ◽  
Toxicological Evaluation ◽  
Dose Oral

There is a current worldwide interest in developing novel sustainable nonanimal nutritional sources, and one such source is the green algae Chlamydomonas reinhardtii, the only green algae that has been studied as a model organism for many biological processes ranging from photosynthesis to flagellar movement. However, its potential as a safe nutritional source for use in various foods has not been thoroughly investigated. To assess the safety of C reinhardtii for use as a nutritional human food ingredient, in accordance with internationally accepted standards, the genotoxic potential and repeated-dose oral toxicity of the dried C reinhardtii (THN 6) algal biomass was investigated. The following studies were conducted: (1) a bacterial reverse mutation test, (2) an in vitro mammalian chromosomal aberration test, (3) an in vivo mammalian micronucleus test, and (4) a 28-day repeated-dose oral toxicity study in rats. No evidence of mutagenicity or genotoxic activity was observed in the first 3 tests under the applied test systems. In the 28-day study, male and female Hsd.Han Wistar rats were exposed to daily doses of 0, 1,000, 2,000, and 4,000 mg/kg bw by gavage. Following 28 days of continuous exposure, no mortality or treatment-related adverse effects were observed and no target organs were identified. Therefore, a no observed adverse effect level was concluded as 4,000 mg/kg bw/day, the highest dose tested.

scholarly journals A Toxicological Evaluation of Germanium Sesquioxide (Organic Germanium)

2020 ◽  
Vol 2020 ◽  
pp. 1-17
Author(s):  
Robin A. Reddeman ◽  
Róbert Glávits ◽  
John R. Endres ◽  
Timothy S. Murbach ◽  
Gábor Hirka ◽  
...  
Keyword(s):  
Micronucleus Test ◽  
Germanium Dioxide ◽  
Oral Toxicity ◽  
Toxicological Evaluation ◽  
Toxicological Studies ◽  
Adverse Effect Level ◽  
Dose Oral ◽  
Chromosomal Aberration Test

A battery of OECD- and GLP-compliant toxicological studies was performed to assess the safety of a highly purified germanium sesquioxide, an organic form of the naturally occurring, nonessential trace element germanium. Germanium dioxide and germanium lactate citrate (inorganic germaniums) have been shown to induce renal toxicity, whereas germanium sesquioxide (an organic germanium) has been shown to have a more favorable safety profile. However, past toxicity studies on germanium sesquioxide compounds have not clearly stated the purity of the tested compounds. In the studies reported herein, there was no evidence of mutagenicity in a bacterial reverse mutation test or an in vitro mammalian chromosomal aberration test. There was no genotoxic activity observed in an in vivo mammalian micronucleus test at concentrations up to the limit dose of 2000 mg/kg bw/day. In a 90-day repeated-dose oral toxicity study in Han:WIST rats conducted at doses of 0, 500, 1000, and 2000 mg/kg bw/day by gavage, there were no mortalities, treatment-related adverse effects, or target organs identified. The no-observed-adverse-effect-level (NOAEL) was determined to be 2000 mg/kg bw/day.

scholarly journals An Evaluation of the Genotoxicity and Subchronic Oral Toxicity of Synthetic Curcumin

2018 ◽  
Vol 2018 ◽  
pp. 1-27 ◽  
Author(s):  
Sreenivasa Rao Damarla ◽  
Rajesh Komma ◽  
Upendra Bhatnagar ◽  
Navin Rajesh ◽  
Sadik Mohmad Abdulhamid Mulla
Keyword(s):  
Micronucleus Test ◽  
Repeated Dose ◽  
Oral Toxicity ◽  
Split Dose ◽  
Toxicological Studies ◽  
Adverse Effect Level ◽  
Dose Oral ◽  
Chromosomal Aberration Test

A battery of toxicological studies was conducted in accordance with international guidelines to investigate the genotoxicity and repeated-dose oral toxicity in rats of synthetic curcumin (VEAMIN 99, >99% purity). There was no evidence of mutagenicity in a bacterial reverse mutation test, whereas an in vitro mammalian chromosomal aberration test was positive for induction of chromosomal aberrations which is in line with results reported for natural curcumin. There was no evidence of genotoxicity in an in vivo mammalian micronucleus test. Synthetic curcumin did not cause mortality or toxic effects in a 90-day repeated-dose oral toxicity study at daily doses of 250, 500, or 1000 mg/kg body weight (bw)/day (administered by gavage in a split dose). The no observed adverse effect level (NOAEL) determined from the 90-day study was 1000 mg/kg bw/day for both male and female Wistar rats.

scholarly journals A Toxicological Assessment of Creatyl-l-Leucine

2018 ◽  
Vol 37 (2) ◽  
pp. 171-187 ◽  
Author(s):  
Robin A. Reddeman ◽  
Róbert Glávits ◽  
John R. Endres ◽  
Timothy S. Murbach ◽  
Gábor Hirka ◽  
...  
Keyword(s):  
Micronucleus Test ◽  
Female Rats ◽  
Repeated Dose ◽  
Oral Toxicity ◽  
Synthetic Compound ◽  
Male And Female Rats ◽  
Toxicological Studies ◽  
Dose Oral

A battery of toxicological studies was conducted to investigate the genotoxicity and repeated-dose oral toxicity of creatyl-l-leucine, a synthetic compound, in rats in accordance with internationally accepted guidelines. There was no evidence of mutagenicity in a bacterial reverse mutation test and in an in vitro mammalian chromosomal aberration test. There was no genotoxic activity observed in an in vivo mammalian micronucleus test at concentrations up to the limit dose of 2,000 mg/kg bw/d. Creatyl-l-leucine did not cause mortality or toxic effects in Hsd.Han Wistar rats in a 90-day repeated-dose oral (gavage) toxicity study at doses of 1,250, 2,500, and 5,000 mg/kg bw/d. The no observed adverse effect level from the 90-day study was determined to be 5,000 mg/kg bw/d, the highest dose tested, for both male and female rats.

scholarly journals A Toxicological Evaluation of Methylliberine (Dynamine®)

2019 ◽  
Vol 2019 ◽  
pp. 1-25
Author(s):  
Timothy S. Murbach ◽  
Róbert Glávits ◽  
John R. Endres ◽  
Amy E. Clewell ◽  
Gábor Hirka ◽  
...  
Keyword(s):  
Body Weight ◽  
Micronucleus Test ◽  
Recovery Period ◽  
High Dose ◽  
Clinical Effects ◽  
Oral Toxicity ◽  
Food Ingredient ◽  
Toxicological Evaluation ◽  
Potential Health

Methylliberine (CAS 51168-26-4), a methoxiuric acid, is a caffeine metabolite present at low levels in various Coffea plants; however, very little has been published regarding this compound and we could find no toxicological data in the public domain. Therefore, we undertook the toxicological investigation of a pure, synthetic form of methylliberine in order to evaluate its potential health hazards as a food ingredient. A (1) bacterial reverse mutation test, (2) in vitro mammalian chromosomal aberration test, (3) in vivo mammalian micronucleus test, and (4) 90-day repeated-dose oral toxicity study in rats with a 28-day recovery period were conducted. No in vitro mutagenic or clastogenic activity was observed in the presence or absence of metabolic activation up to the maximum OECD recommended test concentrations. No genotoxicity was observed in the mammalian micronucleus study up to the highest dose tested of 700 mg/kg bw. In the 90-day study, methylliberine was administered to Han:WIST rats at doses of 0, 75, 112, 150, 187, and 225 mg/kg bw/day. No mortality or morbidity was observed and no toxicologically relevant clinical effects or effects on clinical pathology parameters were observed. In male animals, test item-related effects on body weight and sexual organs, which were not reversible after a 28-day recovery period without treatment, were observed in the high-dose group. Body weight development was also slightly and reversibly depressed in the 187 mg/kg bw/day male group. No toxicological effects were observed in females. The NOAEL for females was determined to be 225 mg/kg bw/day, the highest dose tested, while the NOAEL for males was determined to be 150 mg/kg bw/day. Future studies are encouraged to corroborate the safety, and assess efficacy, of methylliberine in humans.

scholarly journals A Toxicological Evaluation of a Standardized Hydrogenated Extract of Curcumin (CuroWhite™)

2018 ◽  
Vol 2018 ◽  
pp. 1-16 ◽  
Author(s):  
Alastimmanahalli Narasimhiah Ravikumar ◽  
Joby Jacob ◽  
Sreeraj Gopi ◽  
Tumkur Subbarao Jagannath
Keyword(s):  
Test Item ◽  
Micronucleus Test ◽  
Repeated Dose ◽  
High Dose ◽  
Sprague Dawley ◽  
Oral Toxicity ◽  
Toxicological Evaluation ◽  
Chromosomal Aberration Test

A series of toxicological investigations were conducted in order to evaluate the genotoxic potential and repeated-dose oral toxicity of CuroWhite, a proprietary extract of curcumin that has been hydrogenated and standardized to not less than 25% hydrogenated curcuminoid content. All tests were conducted in general accordance with internationally accepted standards. The test item was not mutagenic in the bacterial reverse mutation test or in vitro mammalian chromosomal aberration test, and no in vivo genotoxic activity was observed in rat bone marrow in the micronucleus test. A 90-day repeated-dose study was conducted in male and female Sprague-Dawley rats. Two mortalities occurred in the main and satellite high-dose groups and were determined due to gavage error. No organ specific or other toxic effects of the test item were observed up to the maximum dose of 800 mg/kg bw/day, administered by gavage. NOAEL was, therefore, estimated as 800 mg/kg bw/day.

scholarly journals Toxicological Evaluation of a Mixture of Astragalus membranaceus and Panax notoginseng Root Extracts (InnoSlim®)

2019 ◽  
Vol 2019 ◽  
pp. 1-14 ◽  
Author(s):  
Timothy S. Murbach ◽  
Róbert Glávits ◽  
John R. Endres ◽  
Gábor Hirka ◽  
Adél Vértesi ◽  
...  
Keyword(s):  
Micronucleus Test ◽  
Panax Notoginseng ◽  
Astragalus Membranaceus ◽  
Human Consumption ◽  
Oral Toxicity ◽  
Toxicological Evaluation ◽  
Root Extracts ◽  
Dose Oral ◽  
History Of

Astragalus spp. and Panax spp. have a long history of traditional human use. A blend, InnoSlim®, of highly purified and fractionated root extracts from Astragalus membranaceus and Panax notoginseng has now been developed for human consumption; however, the unique constituent content of this blend has not been specifically evaluated with respect to safety. Therefore, the toxicological potential of the blend was formally investigated in a series of studies—genetic toxicity was evaluated in a bacterial reverse mutation test followed by an in vivo mammalian micronucleus test, and general toxicity was evaluated in a 28-day repeated-dose oral toxicity study in rats. No evidence of mutagenicity was observed in the bacterial tester strains used, and no evidence of in vivo chromosomal damage resulting in increased frequency of micronucleated cells was observed in male Crl:NMRI BR mice. No mortality or toxic effects were observed, and no target organs were identified, in male and female Han:WIST rats exposed to 0, 400, 800, or 1200 mg/kg bw/day of the blend by gavage for 28 consecutive days. The highest dose—1200 mg/kg bw/day—was determined to be the NOAEL. Based on these results, extrapolation towards a safe human consumption level can be explored.

scholarly journals Stabilized rice bran extract: Acute and 28-day repeated dose oral toxicity with in vitro mutagenicity and genotoxicity study

2015 ◽  
Vol 9 (44) ◽  
pp. 1037-1050
Author(s):  
El Askary Hisham ◽  
B Zickri Maha ◽  
M Helal Amr ◽  
A Heikal Ola ◽  
L Fiebich Bernd ◽  
...  
Keyword(s):  
Rice Bran ◽  
Repeated Dose ◽  
Oral Toxicity ◽  
Rice Bran Extract ◽  
Dose Oral

scholarly journals A Toxicological Evaluation of Mango Leaf Extract (Mangifera indica) Containing 60% Mangiferin

2019 ◽  
Vol 2019 ◽  
pp. 1-14 ◽  
Author(s):  
Robin A. Reddeman ◽  
Róbert Glávits ◽  
John R. Endres ◽  
Amy E. Clewell ◽  
Gábor Hirka ◽  
...  
Keyword(s):  
Leaf Extract ◽  
Micronucleus Test ◽  
Mangifera Indica ◽  
Female Rats ◽  
Oral Toxicity ◽  
Toxicological Evaluation ◽  
Male And Female Rats ◽  
Toxicological Studies

A battery of OECD- and GLP-compliant toxicological studies was performed on mango leaf extract (Mangifera indica) containing 60% mangiferin (MLE). No evidence of genotoxicity was found in a bacterial reverse mutation test (Ames). While evidence of clastogenic activity was noted in an in vitro chromosomal aberration test, an in vivo mammalian micronucleus test showed no findings up to the limit dose (2000 mg/kg bw). A 90-day repeated dose oral toxicity study was conducted in rats using doses of 0 (vehicle control), 500, 1000, and 2000 mg/kg bw/day. Based on the lack of mortality or toxic effects in the 90-day study, the NOAEL for MLE in Han:Wist male and female rats was determined to be 2000 mg/kg bw/day, the highest dose tested.

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