Ferrous Lactate

SRP: The most favorable course of action is to use an alternative chemical product with less inherent propensity for occupational exposure or environmental contamination. Recycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air quality; potential migration in soil or water; effects on animal, aquatic, and plant life; and conformance with environmental and public health regulations.

SRP: The scientific literature for the use of contact lenses in industry is conflicting. The benefit or detrimental effects of wearing contact lenses depend not only upon the substance, but also on factors including the form of the substance, characteristics and duration of the exposure, the uses of other eye protection equipment, and the hygiene of the lenses. However, there may be individual substances whose irritating or corrosive properties are such that the wearing of contact lenses would be harmful to the eye. In those specific cases, contact lenses should not be worn. In any event, the usual eye protection equipment should be worn even when contact lenses are in place.

All ... /iron/ preparations should be kept in child-proof bottles. /Iron preparations/

/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Eosinophilic gastroenterocolitis with peripheral eosinophilia was induced in rats fed a diet containing 2.5% or 5.0% iron lactate for 3 months. Additional findings consistent with iron overload were also observed. Microscopically, the lesions consisted of eosinophilic infiltrations in the mucosa and submucosa along the whole length of the gastrointestinal tracts, increased surface area of the gastric mucosal propria covered with mucous cells, and increased apoptotic bodies in the gastric glandular neck of rats in the 2.5% and 5.0% groups. An increased number of intraepithelial globule leukocytes in the gastric and intestinal lamina propria was also observed in the 5.0% group. Globule leukocytes in the gastric mucosa contained obviously enlarged granules in their cytoplasm in these rats. The granules of the globule leukocytes were positive for rat mast cell protease II, suggesting the mastocyte origin of these cells. Although severe infiltration of eosinophils and globule leukocytes suggested a type-1 hypersensitivity reaction, other features such as an increasing vascular permeability were not detected. Serum IgE levels in the 5.0% and control groups were <3 ng/mL. Final body weights of male and female rats of the 5.0% group were suppressed to 70% and 90%, respectively, of those of the control rats, whereas food consumption was comparable to that of the control group. The morphologic characteristics of the gastrointestinal lesions and peripheral eosinophilia induced in rats fed iron lactate were very similar to those in some cases of eosinophilic gastroenterocolitis in humans and other animals.

/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Osteopenia was induced in rats fed a diet containing 50,000 ppm (5%) iron lactate for 2 or 4 weeks. Blood chemistry, urinalysis, and bone histomorphometry of the proximal tibial metaphysis were performed. Urinary pyridinoline and deoxypyridinoline and the osteoclast number per bone surface were selected for the measurement of dynamic resorption. The osteoclast surface, eroded surface, and osteoblast surface increased at both ends of the exposure periods, and bone resorption and formation both increased. The bone volume, trabecular thickness, and trabecular number decreased, and the secondary spongiosa of proximal metaphysis showed a marked bone loss. However, no mineralization defect was observed. At the end of the 2-week exposure period, biomarkers of osteoclasts and osteoblasts had increased the most, and the osteoblast surface, osteoclast surface, and osteoclast number per bone surface increased with prolonged exposure. The pathological changes of the bone lesion in iron lactate-overloaded rats were similar to those in rats of the osteoporotic model, because they consisted of changes reflecting the increase of bone resorption and formation without an osteomalacic change. However, the decline of serum parathyroid hormone (PTH) levels was different from that of the osteoporosis model rat.

/LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity/ The synergistic effects of iron overload and ethanol on the liver of mice were studied over a period of 46 weeks. The determination of several parameters (iron, calcium, magnesium, alpha-hydroxyproline, lipid peroxidation, hepatomegalic and splenomegalic indexes) showed that ferrous and ferric lactates provoke an increase of calcium in the liver, higher than that of ethanol in the control animals. The relationship between liver calcium homeostasis modification and the increase of collagen and lipid peroxidation is discussed. Histological examinations showed differences in the tissular characteristics especially when iron and ethanol were given together.

/GENOTOXICITY/ A number of ferrous and ferric salts have been tested for mutagenicity using the following organisms. Saccharomyces cerevisiae strain D-4, Salmonella typhimurium strains. TA-1535, TA-1537, and TA-1538 with and without activation. Plate tests as well as suspension tests were run with the Salmonella strains. Ferrous lactate... /was/ inactive in all the systems used.

...There is concern that the individual with metabolic defects that impair the ability to regulate iron absorption will be at risk from excessive exposure to iron, primarily as a result of acceleration of accumulation of iron in the body and an earlier onset of clinical symptoms of the disease. /Iron salts/

Basic treatment: Establish a patent airway. Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if necessary. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for shock and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with normal saline during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 ml/kg up to 200 ml of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool. /Iron and related compounds/

Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious. Monitor cardiac rhythm and treat arrhythmias if necessary ... . Start an IV with lactated Ringer's /SRP: "To keep open", minimal flow rate/. Watch for signs of fluid overload. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Iron and related compounds/

Maintain an open airway and assist ventilation if necessary. Treat shock caused by hemorrhagic gastrointestinitis aggressively with intravenous crystalloid fluids, and replace blood if needed. Patients are often markedly hypovolemic owing to gastrointestinal losses and third spacing of fluids into the intestinal wall and interstitial space. Treat coma, seizures, and metabolic acidosis if they occur. For seriously intoxicated victims (eg, shock, severe acidosis, and/or serum iron > 500-600 mcg/dL) administer deferoxamine. Monitor the urine for the urine for the characteristic orange or pink deferoxamine-iron complex. Therapy may be stopped when the urine returns to normal or when the serum iron level decreases to the normal range. Prolonged deferoxamine has been associated with adult respiratory distress syndrome and Yersinia sepsis.

Activated charcoal is not effective. Ipecac is not recommended, because it can aggravate iron-induced gastrointestinal irritation and interfere with whole bowel irrigation. Consider gastric lavage if product was a liquid formulation or tablets were chewed. Do-not use phosphate-containing solutions for lavage; these may result in life-threatening hypernatremia, hyperphosphatemia, and hypocalcemia. Bicarbonate and deferoxamine lavage are of doubtful efficacy. Deferoxamine lavage is not effective and may enhance iron absorption. Whole-bowel irrigation is very effective for ingested tablets and may be considered first-line treatment, especially if large numbers of tablets are visible on plain abdominal x-ray. Massive ingestions may lead to concretions or bezoars. Repeated or prolonged whole-bowel irrigation may remove tablets. Endoscopy or surgical gastrotomy is rarely required.

Hemodialysis and hemoperfusion are not effective for removing iron but may be necessary to remove iron-deferoxamine complex in patients with renal failure. Exchange transfusion is occasionally used for massive pediatric ingestions but is of questionable efficacy.

LD50 Mouse oral 137 +/- 30 mg/kg

LD50 Rabbit sc 578 mg/kg /Trihydrate/

LD50 Rabbit iv 287 mg/kg /Trihydrate/

LD50 Mouse oral 147 mg/kg

Certification of this color additive when used for coloring ripe olives is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act.

Substance added directly to human food affirmed as generally recognized as safe (GRAS).

Ferrous lactate used as a nutrient and/or dietary supplement in animal drugs, feeds, and related products is generally recognized as safe when used in accordance with good manufacturing or feeding practice.