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PubMed | AIBMR Life Science Inc., HG&H Pharmaceuticals Pty Ltd. and Toxi Coop Zrt.
Type: | Journal: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association | Year: 2014

A well-characterized standardized hydroethanolic extract of a traditionally recognized mak (mild) variety of Sceletium tortuosum, a South African plant with a long history of traditional ingestion, is marketed under the trade name Zembrin() as an ingredient for use in functional foods and dietary supplements. It is standardized to contain 0.35-0.45% total alkaloids (mesembrenone and mesembrenol 60%, and mesembrine <20%). A 14-day repeated oral toxicity study was conducted at 0, 250, 750, 2500, and 5000mg/kg bw/day. A 90-day subchronic repeated oral toxicity study was conducted at 0, 100, 300, 450, and 600mg/kg bw/day. Because S.tortuosum has a long history of human use for relieving stress and calming, a functional observation battery, including spontaneous locomotor activity measured using LabMaster ActiMot light-beam frames system, was employed. Several parameters, such as locomotion, rearing behavior, spatial parameters, and turning behavior were investigated in the final week of the study. No mortality or treatment-related adverse effects were observed in male or female Crl:(WI)BR Wistar rats in the 14- or 90-day studies. In the 14- and 90-day studies, the NOAELs were concluded as 5000 and 600mg/kg bw/d, respectively, the highest dose groups tested.


Murbach T.S.,AIBMR Life Science Inc. | Hirka G.,Toxi Coop Zrt | Szakonyine I.P.,Toxi Coop Zrt | Gericke N.,HG and H Pharmaceuticals Pty Ltd | Endres J.R.,AIBMR Life Science Inc.
Food and Chemical Toxicology | Year: 2014

A well-characterized standardized hydroethanolic extract of a traditionally recognized mak (mild) variety of Sceletium tortuosum, a South African plant with a long history of traditional ingestion, is marketed under the trade name Zembrin® as an ingredient for use in functional foods and dietary supplements. It is standardized to contain 0.35-0.45% total alkaloids (mesembrenone and mesembrenol ≥60%, and mesembrine <20%). A 14-day repeated oral toxicity study was conducted at 0, 250, 750, 2500, and 5000 mg/kg bw/day. A 90-day subchronic repeated oral toxicity study was conducted at 0, 100, 300, 450, and 600 mg/kg bw/day. Because S.tortuosum has a long history of human use for relieving stress and calming, a functional observation battery, including spontaneous locomotor activity measured using LabMaster ActiMot light-beam frames system, was employed. Several parameters, such as locomotion, rearing behavior, spatial parameters, and turning behavior were investigated in the final week of the study. No mortality or treatment-related adverse effects were observed in male or female Crl:(WI)BR Wistar rats in the 14- or 90-day studies. In the 14- and 90-day studies, the NOAELs were concluded as 5000 and 600 mg/kg bw/d, respectively, the highest dose groups tested. © 2014 The Authors.Published by Elsevier Ltd.


Clewell A.,AIBMR Life Science Inc. | Hirka G.,Toxi Coop Zrt. | Glavits R.,Toxi Coop Zrt. | Palmer P.A.,AIBMR Life Science Inc. | And 4 more authors.
Journal of Toxicology | Year: 2016

A 90-day repeated-dose oral toxicological evaluation was conducted according to GLP and OECD guidelines on the methylurate purine alkaloid theacrine, which is found naturally in certain plants. Four groups of Hsd.Brl.Han Wistar rats (ten/sex/group) were administered theacrine by gavage doses of 0 (vehicle only), 180, 300, and 375 mg/kg bw/day. Two females and one male in the 300 and 375 mg/kg bw/day groups, respectively, died during the study. Histological examination revealed centrilobular hepatocellular necrosis as the probable cause of death. In 375 mg/kg bw/day males, slight reductions in body weight development, food consumption, and feed efficiency, decreased weight of the testes and epididymides and decreased intensity of spermatogenesis in the testes, lack or decreased amount of mature spermatozoa in the epididymides, and decreased amount of prostatic secretions were detected at the end of the three months. At 300 mg/kg bw/day, slight decreases in the weights of the testes and epididymides, along with decreased intensity of spermatogenesis in the testes, and lack or decreased amount of mature spermatozoa in the epididymides were detected in male animals. The NOAEL was considered to be 180 mg/kg bw/day, as at this dose there were no toxicologically relevant treatment-related findings in male or female animals. © 2016 Amy Clewell et al.


Murbach T.S.,AIBMR Life Science Inc. | Beres E.,Toxi Coop Zrt. | Vertesi A.,Toxi Coop Zrt. | Glavits R.,Toxi Coop Zrt. | And 4 more authors.
Food and Chemical Toxicology | Year: 2015

A battery of toxicological studies was conducted in accordance with internationally accepted standards to investigate the genotoxicity and repeated-dose oral toxicity of Fernblock®, a commercial aqueous extraction of the leaves of the tropical fern Polypodium leucotomos used for its oral and topical photoprotective properties. No evidence of mutagenicity was observed in a bacterial reverse mutation test or in vitro mammalian chromosomal aberration test nor was any genotoxic activity observed in an in vivo mouse micronucleus test. Two repeated-dose oral toxicity studies were conducted in male and female Wistar rats. In the first study, no mortality or toxic effects were observed and no target organs were identified at doses administered for 14 days by gavage up to the maximum dose of 5000 mg/kg bw/day. Based on these results, a 90-day study was conducted at 0, 300, 600, and 1200 mg/kg bw/day. No mortality or treatment-related adverse effects were observed and no target organs were identified. The NOAEL from the 90-day study was determined to be 1200 mg/kg bw/day, the highest dose tested. © 2015 The Authors.


PubMed | AIBMR Life Science Inc. and Toxi Coop Zrt.
Type: | Journal: Journal of toxicology | Year: 2016

A 90-day repeated-dose oral toxicological evaluation was conducted according to GLP and OECD guidelines on the methylurate purine alkaloid theacrine, which is found naturally in certain plants. Four groups of Hsd.Brl.Han Wistar rats (ten/sex/group) were administered theacrine by gavage doses of 0 (vehicle only), 180, 300, and 375mg/kgbw/day. Two females and one male in the 300 and 375mg/kgbw/day groups, respectively, died during the study. Histological examination revealed centrilobular hepatocellular necrosis as the probable cause of death. In 375mg/kgbw/day males, slight reductions in body weight development, food consumption, and feed efficiency, decreased weight of the testes and epididymides and decreased intensity of spermatogenesis in the testes, lack or decreased amount of mature spermatozoa in the epididymides, and decreased amount of prostatic secretions were detected at the end of the three months. At 300mg/kgbw/day, slight decreases in the weights of the testes and epididymides, along with decreased intensity of spermatogenesis in the testes, and lack or decreased amount of mature spermatozoa in the epididymides were detected in male animals. The NOAEL was considered to be 180mg/kgbw/day, as at this dose there were no toxicologically relevant treatment-related findings in male or female animals.


PubMed | AIBMR Life Science Inc. and Toxi Coop Zrt.
Type: | Journal: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association | Year: 2015

A battery of toxicological studies was conducted in accordance with internationally accepted standards to investigate the genotoxicity and repeated-dose oral toxicity of Fernblock(), a commercial aqueous extraction of the leaves of the tropical fern Polypodium leucotomos used for its oral and topical photoprotective properties. No evidence of mutagenicity was observed in a bacterial reverse mutation test or invitro mammalian chromosomal aberration test nor was any genotoxic activity observed in an invivo mouse micronucleus test. Two repeated-dose oral toxicity studies were conducted in male and female Wistar rats. In the first study, no mortality or toxic effects were observed and no target organs were identified at doses administered for 14 days by gavage up to the maximum dose of 5000mg/kg bw/day. Based on these results, a 90-day study was conducted at 0, 300, 600, and 1200mg/kg bw/day. No mortality or treatment-related adverse effects were observed and no target organs were identified. The NOAEL from the 90-day study was determined to be 1200mg/kg bw/day, the highest dose tested.


PubMed | AIBMR Life Science Inc. and Toxi Coop Zrt
Type: Journal Article | Journal: International journal of toxicology | Year: 2016

Morus alba L. (white mulberry) leaves are one of the oldest recognized traditional Chinese medicines. More recently, M alba leaves and their constituents, particularly iminosugars (or azasugars), have garnered attention for their ability to maintain normal blood glucose concentrations, an effect identified in both animal studies and human clinical trials. Reducose (Phynova Group Limited) is a commercial water-soluble extract of M alba leaves standardized to 5% 1-deoxynojirimycin (DNJ), an iminosugar with -glucosidase inhibition properties. Although there is an extensive history of consumption of M alba leaves by humans and animals worldwide, suggesting that the leaves and their extracts have a relatively good safety profile, we are unaware of safety assessments on an extract containing a higher amount of DNJ than that occurs naturally. The current 28-day repeated dose oral toxicity study in rats, conducted according to Organisation for Economic Co-operation and Development guidelines, was carried out to assess the safety of Reducose. Male and female Hsd.Han Wistar rats (4 groups of 10 animals/sex) were administered Reducose via gavage at doses of 0, 1,000, 2,000 and 4,000 mg/kg body weight (bw)/d. No treatment-related mortality or adverse effects (per clinical observations, body weight/weight gain, food consumption, ophthalmoscopy, clinical pathology, gross pathology, organ weights, or histopathology) were observed, and no target organs were identified. The no observed adverse effect level was determined to be 4,000 mg/kg bw/d for both male and female rats, the highest dose tested.

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