Accrufer: which tox species, and why?

“Twenty-eight-day repeat dose oral administration toxicity studies were conducted in dogs with initial ferric maltol doses of 0, 250, 500, and 1000 mg/kg.”

“Twenty-eight-day repeat dose oral administration toxicity studies were conducted in dogs with initial ferric maltol doses of 0, 250, 500, and 1000 mg/kg.”

“These include 6-month studies in mice (Report 79029) and rats (Report 79031) at doses of 0, 100, 200 or 400 mg/kg/day by dietary administration, and a 3-month study in dogs (Report 79032) at doses of 0, 100, 200 or 300 mg/kg/day by administration of capsules.”

“Embryo-fetal development studies have not been conducted with ferric maltol. Embryo-fetal development studies have been conducted in mice and rats treated with ferrous sulfate and ferric sodium pyrophosphate.”

“Maltol The carcinogenic potential of maltol has been evaluated in long-term animal toxicity studies in two species: CD-1 mice and Sprague-Dawley rats. Maltol was not carcinogenic in a 18-month study in mice at doses up to 400 mg/kg (approximately 5.6 times the human daily dose).”

“Carcinogenicity studies have not been conducted with ferric maltol. Ferric maltol was mutagenic in vitro in bacterial reverse mutation (Ames) assays.”