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EC number: 239-802-2 | CAS number: 15708-41-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- other: review
- Adequacy of study:
- supporting study
- Study period:
- not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety Assessment of Iron EDTA [Sodium Iron (Fe3+) Ethylenediaminetetraacetic Acid]: Summary of Toxicological, Fortification and Exposure Data
- Author:
- Heimbach, J., Rieth, S., Mohamedshah, F., Slesinski, R., Samuel-fernando, P., Sheehan, T., Dickmann, R., Borzelleca, J.
- Year:
- 2 000
- Bibliographic source:
- Food and Chemical Toxicology 38 99-111
Materials and methods
Test material
- Reference substance name:
- Fe(III)EDTA
- IUPAC Name:
- Fe(III)EDTA
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Executive summary:
Iron EDTA [sodium iron (Fe3+) ethylenediaminetetraacetic acid (EDTA)], shown to have a significant beneficial effect on iron status by increasing iron bioavailability in human diets, has been proposed for use as a fortificant in certain grain-based products including breakfast cereals and cereal bars. This paper presents an assessment of the safety of iron EDTA for its intended uses in these products. Iron EDTA, like other EDTA metal complexes, dissociates in the gastrointestinal tract to form iron, which is bioavailable, and an EDTA salt; absorption of the metal ion and EDTA are independent. Because of this dissociation, consideration of information on EDTA compounds other than iron EDTA is relevant to this safety assessment. EDTA compounds are poorly absorbed in the gastrointestinal tract and do not undergo significant metabolic conversion. They have a low degree of acute oral toxicity. EDTA compounds are not reproductive or developmental toxicants when fed with a nutrient-sufficient diet or minimal diets supplemented with zinc. In chronic toxicity studies, diets containing as much as 5% EDTA were without adverse effects. EDTA compounds were not carcinogenic in experimental animal bioassays and are not directly genotoxic. This lack of significant toxicity is consistent with a history of safe use of other EDTA compounds (CaNa2EDTA and Na2EDTA) approved by the FDA for use as direct food additives. An upper-bound estimated daily intake (EDI) of EDTA from iron EDTA (1.15 mg/kg bw/day for thepopulation) is less than half the acceptable daily intake (ADI) for EDTA of 2.5 mg/kg bw/day established by JECFA. The data collected and published over the past 20 to 30 years demonstrate that iron EDTA is safe and effective for iron fortification of food products and meets the standard of ``reasonable certainty of no harm''. Based on the published record, iron EDTA may be regarded as generally recognized as safe (GRAS) for the intended food uses and maximum use levels.
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