TAFA400™ treatments have been shown to be non-toxic. There have been numerous toxicity studies undertaken on the Triamino™ and Triamino Fulvate™ molecules. Characterization of local and systemic toxicities from topically applied TAFA400™ compounds to full-thickness dermal wounds was assessed in rats. No abnormal clinical observations, significant differences in serum chemistry or hematology parameters, or abnormalities on gross necropsy were noted in any of the animals.
Systemic toxicity of TAFA400™ compounds were also assessed by injection in mice. No mortality or evidence of any systemic toxicity was observed in any of the animals receiving any level of dosing of TAFA400™ compounds.
TAFA400™ compounds were administered by the oral route to rats to permit absorption and characterize any inherent toxicities of the product. No mortality, clinical signs, or abnormalities on gross necropsy were noted in any animals exposed to TAFA400™ compounds in any levels of oral dosing.
TAFA400™ compounds were administered to rats by inhalation to determine the acute inhalation toxicity potential. No mortality or abnormalities on gross necropsy were noted in any animals exposed to TAFA400™ compounds by inhalation.
When applied topically to intact dermis or open full-thickness dermal wounds, in the conjunctival sac, orally, by inhalation, or by injection, TAFA400™ compounds have shown no product related adverse effects with results showing a similar toxicity profile as saline.