FERRONYL® IRON

Safety & Toxicity Summary
In rats given a LD 90 dose of iron (ISP 1997c), Ferronyl iron treated animals had lower plasma iron after 1
hour and no visibly detected gastrointestinal tract erythema, despite about 100 and 290 times higher
dosages of iron in male and female rats, respectively, than the ferrous sulfate treated animals (Table 9).
This corroborates the previous finding that Ferronyl iron entered the vascular space more slowly than
ferrous ion.
Table 9. The low toxicity of Ferronyl iron results from the controlled release of iron into the blood stream.
Iron Source
Iron Dose
(mg/kg)
Plasma Iron (µg / dl) 1
Hour Post-Dosing
Stomach & Intestine;
Gross Pathological
Examination
FeSO 4
240 (1200 FeSO4) Male;
220 (1100 FeSO4) Female
993 + 638
Erythema
“slight - pronounced”
Ferronyl
23,000 Male;
64,000 Female
438 + 22
No Erythema
“black granular [test]
material”
In a study of young swine (ISP 1998), all of the animals lived, but the physiologic response to a noxious
insult (vomiting and diarrhea) was less severe for the highest dose of Ferronyl iron than the lowest dose
of FeSO 4 (a 750-fold difference in iron content) (Table 10).
Table 10. Despite significantly lower dosages of ferrous sulfate, the reaction to Ferronyl iron in young swine
was significantly less severe than to ferrous sulfate.
Iron Source
Dose of Test Substance
(mg/kg)
Dose of Iron
(mg Fe/kg)
Mortalities Vomiting Diarrhea
FeSO 4 100 20 None Severe Severe
FeSO 4 250 50 None Severe Severe
FeSO 4 500 100 None Severe Severe
Ferronyl 500 500 None None Moderate
Ferronyl 5,000 5,000 None Minimal Moderate
Ferronyl 15,000 15,000 None Minimal Moderate
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