Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5856864 | Regulatory Toxicology and Pharmacology | 2014 | 15 Pages |
Abstract
The potential use of pyrroloquinoline quinone disodium salt (BioPQQâ¢), as a supplemental food ingredient, was evaluated in a range of oral toxicity studies in rats including an acute study, a 14-day preliminary and a 28-day repeated-dose study, and a 13-week subchronic study. The median lethal dose of BioPQQ⢠was shown to be 1000-2000 mg/kg body weight (bw) in male and 500-1000 mg/kg bw in female rats. In the 14-day study, high doses of BioPQQ⢠resulted in increases in relative kidney weights with associated histopathology in female rats only, while a follow-up 28-day study in female animals resulted in increases in urinary protein and crystals. These findings were reversible, and resolved during the recovery period. In the 13-week study, a number of clinical chemistry findings and histopathological changes were noted, which were deemed to be of no toxicological significance, as the levels were within the historical control range, were not dose-dependent, occurred at a similar frequency in control groups, or only occurred in the control group. Based on these findings, a no-observed-adverse-effect level of 100 mg/kg bw/day was determined for BioPQQ⢠in rats, the highest dose tested in the 13-week study.
Keywords
OECDEDTA-2KGLPNOAELγ-GTPMCVMCHCPQQMCHi.p.ALTRBCWBCAPTTLD50γ-glutamyl transpeptidaseASTAspartate aminotransferaseAlanine aminotransferaseALPAlkaline phosphataseethylenediamine tetraacetic acidGood Laboratory PracticeAcuteMean corpuscular volumeBUNintraperitonealRelative humidityactivated partial thromboplastin timeprothrombin timeSubchronicOrganization for Economic Co-operation and DevelopmentSodiumRenal toxicityInorganic phosphorusmean corpuscular hemoglobinmedian lethal doseMean corpuscular hemoglobin concentrationblood urea nitrogenno-observed-adverse-effect levelbody weightPotassiumPyrroloquinoline quinoneChlorideCalciumwhite blood cellred blood cell
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Authors
Masahiko Nakano, Hisaaki Takahashi, Seiko Koura, Catherine Chung, Shahrzad Tafazoli, Ashley Roberts,