Safety and toxicological evaluation of a novel niacin-bound chromium (III) complex

Michael Shara, Taharat Yasmin, Anthony Kincaid, Aimee L. Limpach, Jason C. Bartz, Karrie A. Brenneman, Archana Chatterjee, Manashi Bagchi, Sidney J. Stohs, Debasis Bagchi

Research output: Contribution to journalArticle

46 Citations (Scopus)

Abstract

Chromium is an essential trace element required for normal protein, fat and carbohydrate metabolism. It also helps in energy production and increasing lean body mass. Niacin-bound chromium (NBC) is a unique form of bioavailable chromium that promotes healthy lipid profile. This study was focused on determining the broad spectrum safety of NBC. Acute oral, acute dermal, primary dermal irritation and primary eye irritation toxicities of NBC were evaluated. Ames bacterial reverse mutation assay, mouse lymphoma test and a dose-dependent 90-day subchronic toxicity were also conducted. In safety studies, the acute oral LD50 of NBC was found to be greater then 5000 mg/kg in both male and female Sprague-Dawley rats. No changes in body weight or adverse effects were observed following necropsy. The acute dermal LD50 of NBC was found to be >2000 mg/kg. The primary skin irritation test was conducted with NBC on New Zealand Albino rabbits. NBC was classified as slightly irritating. The primary eye irritation test was conducted with NBC on rabbits. NBC was classified as practically non-irritating to the eye. NBC did not induce mutagenic effects in the bacterial reverse mutation test in five Salmonella typhimurium strains (TA1535, TA98, TA100, TA97a and TA102), either with or without metabolic activation. Similarly, NBC did not induce mutagenic effects in the mammalian cell gene mutation test in L5178Y mouse lymphoma cells TK (+/-), either with or without metabolic activation. A dose-dependent 90-day subchronic toxicity study demonstrated no significant changes in selected organ weights individually and as percentages of body and brain weights. NBC supplementation did not cause changes in hepatic lipid peroxidation or DNA fragmentation after 30, 60 or 90 days of treatment. Hematology, clinical chemistry and histopathological evaluations did not show any adverse effects in all organs tested. Taken together, the above results indicate a broad spectrum of safety for NBC.

Original languageEnglish
Pages (from-to)2161-2183
Number of pages23
JournalJournal of Inorganic Biochemistry
Volume99
Issue number11
DOIs
StatePublished - Nov 2005

Fingerprint

Niacin
Chromium
Toxicology
Safety
Toxicity
Lethal Dose 50
Skin
Mutation
Lymphoma
Chemical activation
Rabbits
Lipids
Clinical Chemistry
Body Weight Changes
Salmonella
Organ Size
Carbohydrate Metabolism
Trace Elements
DNA Fragmentation
Hematology

All Science Journal Classification (ASJC) codes

  • Biochemistry
  • Inorganic Chemistry

Cite this

Safety and toxicological evaluation of a novel niacin-bound chromium (III) complex. / Shara, Michael; Yasmin, Taharat; Kincaid, Anthony; Limpach, Aimee L.; Bartz, Jason C.; Brenneman, Karrie A.; Chatterjee, Archana; Bagchi, Manashi; Stohs, Sidney J.; Bagchi, Debasis.

In: Journal of Inorganic Biochemistry, Vol. 99, No. 11, 11.2005, p. 2161-2183.

Research output: Contribution to journalArticle

Shara, M, Yasmin, T, Kincaid, A, Limpach, AL, Bartz, JC, Brenneman, KA, Chatterjee, A, Bagchi, M, Stohs, SJ & Bagchi, D 2005, 'Safety and toxicological evaluation of a novel niacin-bound chromium (III) complex', Journal of Inorganic Biochemistry, vol. 99, no. 11, pp. 2161-2183. https://doi.org/10.1016/j.jinorgbio.2005.07.017
Shara, Michael ; Yasmin, Taharat ; Kincaid, Anthony ; Limpach, Aimee L. ; Bartz, Jason C. ; Brenneman, Karrie A. ; Chatterjee, Archana ; Bagchi, Manashi ; Stohs, Sidney J. ; Bagchi, Debasis. / Safety and toxicological evaluation of a novel niacin-bound chromium (III) complex. In: Journal of Inorganic Biochemistry. 2005 ; Vol. 99, No. 11. pp. 2161-2183.
@article{811e4dfdfddc4b4888ff1f7adce4d34c,
title = "Safety and toxicological evaluation of a novel niacin-bound chromium (III) complex",
abstract = "Chromium is an essential trace element required for normal protein, fat and carbohydrate metabolism. It also helps in energy production and increasing lean body mass. Niacin-bound chromium (NBC) is a unique form of bioavailable chromium that promotes healthy lipid profile. This study was focused on determining the broad spectrum safety of NBC. Acute oral, acute dermal, primary dermal irritation and primary eye irritation toxicities of NBC were evaluated. Ames bacterial reverse mutation assay, mouse lymphoma test and a dose-dependent 90-day subchronic toxicity were also conducted. In safety studies, the acute oral LD50 of NBC was found to be greater then 5000 mg/kg in both male and female Sprague-Dawley rats. No changes in body weight or adverse effects were observed following necropsy. The acute dermal LD50 of NBC was found to be >2000 mg/kg. The primary skin irritation test was conducted with NBC on New Zealand Albino rabbits. NBC was classified as slightly irritating. The primary eye irritation test was conducted with NBC on rabbits. NBC was classified as practically non-irritating to the eye. NBC did not induce mutagenic effects in the bacterial reverse mutation test in five Salmonella typhimurium strains (TA1535, TA98, TA100, TA97a and TA102), either with or without metabolic activation. Similarly, NBC did not induce mutagenic effects in the mammalian cell gene mutation test in L5178Y mouse lymphoma cells TK (+/-), either with or without metabolic activation. A dose-dependent 90-day subchronic toxicity study demonstrated no significant changes in selected organ weights individually and as percentages of body and brain weights. NBC supplementation did not cause changes in hepatic lipid peroxidation or DNA fragmentation after 30, 60 or 90 days of treatment. Hematology, clinical chemistry and histopathological evaluations did not show any adverse effects in all organs tested. Taken together, the above results indicate a broad spectrum of safety for NBC.",
author = "Michael Shara and Taharat Yasmin and Anthony Kincaid and Limpach, {Aimee L.} and Bartz, {Jason C.} and Brenneman, {Karrie A.} and Archana Chatterjee and Manashi Bagchi and Stohs, {Sidney J.} and Debasis Bagchi",
year = "2005",
month = "11",
doi = "10.1016/j.jinorgbio.2005.07.017",
language = "English",
volume = "99",
pages = "2161--2183",
journal = "Journal of Inorganic Biochemistry",
issn = "0162-0134",
publisher = "Elsevier Inc.",
number = "11",

}

TY - JOUR

T1 - Safety and toxicological evaluation of a novel niacin-bound chromium (III) complex

AU - Shara, Michael

AU - Yasmin, Taharat

AU - Kincaid, Anthony

AU - Limpach, Aimee L.

AU - Bartz, Jason C.

AU - Brenneman, Karrie A.

AU - Chatterjee, Archana

AU - Bagchi, Manashi

AU - Stohs, Sidney J.

AU - Bagchi, Debasis

PY - 2005/11

Y1 - 2005/11

N2 - Chromium is an essential trace element required for normal protein, fat and carbohydrate metabolism. It also helps in energy production and increasing lean body mass. Niacin-bound chromium (NBC) is a unique form of bioavailable chromium that promotes healthy lipid profile. This study was focused on determining the broad spectrum safety of NBC. Acute oral, acute dermal, primary dermal irritation and primary eye irritation toxicities of NBC were evaluated. Ames bacterial reverse mutation assay, mouse lymphoma test and a dose-dependent 90-day subchronic toxicity were also conducted. In safety studies, the acute oral LD50 of NBC was found to be greater then 5000 mg/kg in both male and female Sprague-Dawley rats. No changes in body weight or adverse effects were observed following necropsy. The acute dermal LD50 of NBC was found to be >2000 mg/kg. The primary skin irritation test was conducted with NBC on New Zealand Albino rabbits. NBC was classified as slightly irritating. The primary eye irritation test was conducted with NBC on rabbits. NBC was classified as practically non-irritating to the eye. NBC did not induce mutagenic effects in the bacterial reverse mutation test in five Salmonella typhimurium strains (TA1535, TA98, TA100, TA97a and TA102), either with or without metabolic activation. Similarly, NBC did not induce mutagenic effects in the mammalian cell gene mutation test in L5178Y mouse lymphoma cells TK (+/-), either with or without metabolic activation. A dose-dependent 90-day subchronic toxicity study demonstrated no significant changes in selected organ weights individually and as percentages of body and brain weights. NBC supplementation did not cause changes in hepatic lipid peroxidation or DNA fragmentation after 30, 60 or 90 days of treatment. Hematology, clinical chemistry and histopathological evaluations did not show any adverse effects in all organs tested. Taken together, the above results indicate a broad spectrum of safety for NBC.

AB - Chromium is an essential trace element required for normal protein, fat and carbohydrate metabolism. It also helps in energy production and increasing lean body mass. Niacin-bound chromium (NBC) is a unique form of bioavailable chromium that promotes healthy lipid profile. This study was focused on determining the broad spectrum safety of NBC. Acute oral, acute dermal, primary dermal irritation and primary eye irritation toxicities of NBC were evaluated. Ames bacterial reverse mutation assay, mouse lymphoma test and a dose-dependent 90-day subchronic toxicity were also conducted. In safety studies, the acute oral LD50 of NBC was found to be greater then 5000 mg/kg in both male and female Sprague-Dawley rats. No changes in body weight or adverse effects were observed following necropsy. The acute dermal LD50 of NBC was found to be >2000 mg/kg. The primary skin irritation test was conducted with NBC on New Zealand Albino rabbits. NBC was classified as slightly irritating. The primary eye irritation test was conducted with NBC on rabbits. NBC was classified as practically non-irritating to the eye. NBC did not induce mutagenic effects in the bacterial reverse mutation test in five Salmonella typhimurium strains (TA1535, TA98, TA100, TA97a and TA102), either with or without metabolic activation. Similarly, NBC did not induce mutagenic effects in the mammalian cell gene mutation test in L5178Y mouse lymphoma cells TK (+/-), either with or without metabolic activation. A dose-dependent 90-day subchronic toxicity study demonstrated no significant changes in selected organ weights individually and as percentages of body and brain weights. NBC supplementation did not cause changes in hepatic lipid peroxidation or DNA fragmentation after 30, 60 or 90 days of treatment. Hematology, clinical chemistry and histopathological evaluations did not show any adverse effects in all organs tested. Taken together, the above results indicate a broad spectrum of safety for NBC.

UR - http://www.scopus.com/inward/record.url?scp=27644576997&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=27644576997&partnerID=8YFLogxK

U2 - 10.1016/j.jinorgbio.2005.07.017

DO - 10.1016/j.jinorgbio.2005.07.017

M3 - Article

VL - 99

SP - 2161

EP - 2183

JO - Journal of Inorganic Biochemistry

JF - Journal of Inorganic Biochemistry

SN - 0162-0134

IS - 11

ER -