A 28-Day Repeated Dose Toxicological Study of an Aqueous Extract of Morus Alba L
Autor: | Timothy S. Murbach, Amy E. Clewell, Róbert Glávits, John R. Endres, Philip A. Palmer, Tennille K. Marx, Gábor Hirka, Ilona Pasics |
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Rok vydání: | 2016 |
Předmět: |
Male
0301 basic medicine medicine.medical_specialty No-observed-adverse-effect level Biology Toxicology 03 medical and health sciences 0302 clinical medicine medicine Animals Adverse effect No-Observed-Adverse-Effect Level Traditional medicine Clinical pathology Plant Extracts Moraceae biology.organism_classification Rats Plant Leaves Toxicity Tests Subacute 030104 developmental biology 030220 oncology & carcinogenesis Toxicity Female Histopathology Morus Animal studies medicine.symptom Weight gain |
Zdroj: | International Journal of Toxicology. 35:683-691 |
ISSN: | 1092-874X 1091-5818 |
Popis: | 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 α-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. |
Databáze: | OpenAIRE |
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