A 90‐day preclinical toxicological evaluation in rats of a highly purified and concentrated mulberry leaf extract

Mulberry (genus Morus) leaves have long been used as a human food, especially in Asia, and animal feed. More recently, mulberry leaf extracts have been introduced as a convenient way to consume mulberry for non‐nutritional functional effects. Reducose® 5% is an Morus alba leaf extract that has been...

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Vydáno v:	Journal of applied toxicology Ročník 44; číslo 10; s. 1504 - 1517
Hlavní autoři:	Murbach, Timothy S., Glávits, Róbert, Endres, John R., Hirka, Gábor, Pasics Szakonyiné, Ilona
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	England Wiley Subscription Services, Inc 01.10.2024
Témata:	1-Deoxynojirimycin - analogs & derivatives 1-Deoxynojirimycin - toxicity 1‐deoxynojirimycin 90‐day study Administration, Oral Animal feed Animals Body weight Body Weight - drug effects DNJ Dose-Response Relationship, Drug Feeds Female Global marketing Histopathology Leaves Male Morus - chemistry Morus alba mulberry leaf extract, MLE No-Observed-Adverse-Effect Level NOAEL OECD 408 Organ Size - drug effects Pathology Piperidine Plant extracts Plant Extracts - toxicity Plant Leaves - chemistry Rats Rats, Wistar Reducose Side effects Toxicity Toxicity testing Toxicity Tests, Subchronic Toxicology toxicity DNJ 90‐day study NOAEL mulberry leaf extract, MLE 1‐deoxynojirimycin Reducose Morus alba OECD 408
ISSN:	0260-437X, 1099-1263, 1099-1263
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Abstract	Mulberry (genus Morus) leaves have long been used as a human food, especially in Asia, and animal feed. More recently, mulberry leaf extracts have been introduced as a convenient way to consume mulberry for non‐nutritional functional effects. Reducose® 5% is an Morus alba leaf extract that has been highly purified and standardized to a content of 5 ± 0.5% 1‐deoxynojirimycin, a naturally present polyhydroxylated piperidine alkaloid analog of D‐glucose. This extract has previously been evaluated in acute and subacute (28‐day) oral toxicity studies in which no adverse effects of the test item were observed in mice or rats, respectively. Due to continued and growing interest in the extract in multinational markets, we have now further investigated potential toxic effects in subchronic (90‐day) oral toxicity study in male and female Han:WIST rats. The test item was administered at doses of 850, 1700, and 2550 mg/kg bw/day, and did not cause adverse effects in clinical signs, body weight development, clinical pathology, gross pathology, or histopathology in comparison to the vehicle‐control group. The no‐observed‐adverse‐effect‐level was determined to be 2550 mg/kg bw/day. These results add to the existing body of both preclinical and clinical work relevant to the safety of the extract and of interest to regulators in various global markets. In recent times, extracts of mulberry leaves, which have long been consumed as food, have gained popularity. We have conducted a 90‐day oral toxicity study in rats of a purified Morus alba leaf extract standardized to contain 5 ± 0.5% 1‐deoxynojirimycin to add to past acute and subacute toxicological evaluations. No adverse effects were observed, and no target organs were identified following administration of 0 (vehicle control), 850, 1700, and 2550 mg/kg bw/day. The NOAEL was determined as 2550 mg/kg bw/day.
AbstractList	Mulberry (genus Morus) leaves have long been used as a human food, especially in Asia, and animal feed. More recently, mulberry leaf extracts have been introduced as a convenient way to consume mulberry for non-nutritional functional effects. Reducose® 5% is an Morus alba leaf extract that has been highly purified and standardized to a content of 5 ± 0.5% 1-deoxynojirimycin, a naturally present polyhydroxylated piperidine alkaloid analog of D-glucose. This extract has previously been evaluated in acute and subacute (28-day) oral toxicity studies in which no adverse effects of the test item were observed in mice or rats, respectively. Due to continued and growing interest in the extract in multinational markets, we have now further investigated potential toxic effects in subchronic (90-day) oral toxicity study in male and female Han:WIST rats. The test item was administered at doses of 850, 1700, and 2550 mg/kg bw/day, and did not cause adverse effects in clinical signs, body weight development, clinical pathology, gross pathology, or histopathology in comparison to the vehicle-control group. The no-observed-adverse-effect-level was determined to be 2550 mg/kg bw/day. These results add to the existing body of both preclinical and clinical work relevant to the safety of the extract and of interest to regulators in various global markets. Mulberry (genus Morus ) leaves have long been used as a human food, especially in Asia, and animal feed. More recently, mulberry leaf extracts have been introduced as a convenient way to consume mulberry for non‐nutritional functional effects. Reducose® 5% is an Morus alba leaf extract that has been highly purified and standardized to a content of 5 ± 0.5% 1‐deoxynojirimycin, a naturally present polyhydroxylated piperidine alkaloid analog of D‐glucose. This extract has previously been evaluated in acute and subacute (28‐day) oral toxicity studies in which no adverse effects of the test item were observed in mice or rats, respectively. Due to continued and growing interest in the extract in multinational markets, we have now further investigated potential toxic effects in subchronic (90‐day) oral toxicity study in male and female Han:WIST rats. The test item was administered at doses of 850, 1700, and 2550 mg/kg bw/day, and did not cause adverse effects in clinical signs, body weight development, clinical pathology, gross pathology, or histopathology in comparison to the vehicle‐control group. The no‐observed‐adverse‐effect‐level was determined to be 2550 mg/kg bw/day. These results add to the existing body of both preclinical and clinical work relevant to the safety of the extract and of interest to regulators in various global markets. In recent times, extracts of mulberry leaves, which have long been consumed as food, have gained popularity. We have conducted a 90‐day oral toxicity study in rats of a purified Morus alba leaf extract standardized to contain 5 ± 0.5% 1‐deoxynojirimycin to add to past acute and subacute toxicological evaluations. No adverse effects were observed, and no target organs were identified following administration of 0 (vehicle control), 850, 1700, and 2550 mg/kg bw/day. The NOAEL was determined as 2550 mg/kg bw/day. Mulberry (genus Morus) leaves have long been used as a human food, especially in Asia, and animal feed. More recently, mulberry leaf extracts have been introduced as a convenient way to consume mulberry for non-nutritional functional effects. Reducose® 5% is an Morus alba leaf extract that has been highly purified and standardized to a content of 5 ± 0.5% 1-deoxynojirimycin, a naturally present polyhydroxylated piperidine alkaloid analog of D-glucose. This extract has previously been evaluated in acute and subacute (28-day) oral toxicity studies in which no adverse effects of the test item were observed in mice or rats, respectively. Due to continued and growing interest in the extract in multinational markets, we have now further investigated potential toxic effects in subchronic (90-day) oral toxicity study in male and female Han:WIST rats. The test item was administered at doses of 850, 1700, and 2550 mg/kg bw/day, and did not cause adverse effects in clinical signs, body weight development, clinical pathology, gross pathology, or histopathology in comparison to the vehicle-control group. The no-observed-adverse-effect-level was determined to be 2550 mg/kg bw/day. These results add to the existing body of both preclinical and clinical work relevant to the safety of the extract and of interest to regulators in various global markets.Mulberry (genus Morus) leaves have long been used as a human food, especially in Asia, and animal feed. More recently, mulberry leaf extracts have been introduced as a convenient way to consume mulberry for non-nutritional functional effects. Reducose® 5% is an Morus alba leaf extract that has been highly purified and standardized to a content of 5 ± 0.5% 1-deoxynojirimycin, a naturally present polyhydroxylated piperidine alkaloid analog of D-glucose. This extract has previously been evaluated in acute and subacute (28-day) oral toxicity studies in which no adverse effects of the test item were observed in mice or rats, respectively. Due to continued and growing interest in the extract in multinational markets, we have now further investigated potential toxic effects in subchronic (90-day) oral toxicity study in male and female Han:WIST rats. The test item was administered at doses of 850, 1700, and 2550 mg/kg bw/day, and did not cause adverse effects in clinical signs, body weight development, clinical pathology, gross pathology, or histopathology in comparison to the vehicle-control group. The no-observed-adverse-effect-level was determined to be 2550 mg/kg bw/day. These results add to the existing body of both preclinical and clinical work relevant to the safety of the extract and of interest to regulators in various global markets.
Author	Hirka, Gábor Pasics Szakonyiné, Ilona Murbach, Timothy S. Endres, John R. Glávits, Róbert
Author_xml	– sequence: 1 givenname: Timothy S. orcidid: 0000-0002-7658-858X surname: Murbach fullname: Murbach, Timothy S. email: tim@aibmr.com organization: AIBMR Life Sciences, Inc – sequence: 2 givenname: Róbert surname: Glávits fullname: Glávits, Róbert organization: Toxi‐Coop Zrt – sequence: 3 givenname: John R. surname: Endres fullname: Endres, John R. organization: AIBMR Life Sciences, Inc – sequence: 4 givenname: Gábor surname: Hirka fullname: Hirka, Gábor organization: Toxi‐Coop Zrt – sequence: 5 givenname: Ilona surname: Pasics Szakonyiné fullname: Pasics Szakonyiné, Ilona organization: Toxi‐Coop Zrt
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Snippet	Mulberry (genus Morus) leaves have long been used as a human food, especially in Asia, and animal feed. More recently, mulberry leaf extracts have been... Mulberry (genus Morus ) leaves have long been used as a human food, especially in Asia, and animal feed. More recently, mulberry leaf extracts have been...
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SubjectTerms	1-Deoxynojirimycin - analogs & derivatives 1-Deoxynojirimycin - toxicity 1‐deoxynojirimycin 90‐day study Administration, Oral Animal feed Animals Body weight Body Weight - drug effects DNJ Dose-Response Relationship, Drug Feeds Female Global marketing Histopathology Leaves Male Morus - chemistry Morus alba mulberry leaf extract, MLE No-Observed-Adverse-Effect Level NOAEL OECD 408 Organ Size - drug effects Pathology Piperidine Plant extracts Plant Extracts - toxicity Plant Leaves - chemistry Rats Rats, Wistar Reducose Side effects Toxicity Toxicity testing Toxicity Tests, Subchronic Toxicology
Title	A 90‐day preclinical toxicological evaluation in rats of a highly purified and concentrated mulberry leaf extract
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