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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 824-774-1 | CAS number: 148124-40-7
- 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
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Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not peformed according to guideline or GLP. No data on test substance composition or purity.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Iron Absorption by Humans and Swine from Fe(lll)-EDTA. Further Studies
- Author:
- Candela E, Camacho MV, Martinez Torres C, Perdomo J, Mazzarri G, Acurero G, Layrisse M
- Year:
- 1 984
- Bibliographic source:
- J Nutr 114(12): 2204-2211.
Materials and methods
- Objective of study:
- other: aboroption and excretion
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium feredetate
- EC Number:
- 239-802-2
- EC Name:
- Sodium feredetate
- Cas Number:
- 15708-41-5
- Molecular formula:
- C10H12N2O8FeNa
- IUPAC Name:
- Sodium; 2-[2-(bis(carboxylatomethyl)amino)ethyl-(carboxylatomethyl)amino]acetate; iron(+3) cation
- Details on test material:
- Fe(III)-EDTA
No further details.
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- pig
- Strain:
- other: Yorkshire-Hampshire
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: capsule
- Vehicle:
- unchanged (no vehicle)
- Duration and frequency of treatment / exposure:
- single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
36 mg
- No. of animals per sex per dose / concentration:
- 16 males
- Control animals:
- no
Results and discussion
- Preliminary studies:
- Not applicable
Main ADME results
- Type:
- other: absorption and excretion
- Results:
- see table
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The examination of the absorption of the 14C-labeled EDTA complex reveals that about 5% is absorbed by the mucosa from the pylorus up to 9 m of the jejunum, trans ferred very slowly from the mucosa to the plasma, and then eliminated by the kidney.
About 5% of the 55Fe is split from the EDTA complex in the lumen of the gut, absorbed mainly by the mucosa of the stomach (pylorus) and the upper jejunum, then transferred to plasma transferrin and finally incorporated into hemoglobin.
- Details on excretion:
- Approximately 5.4% of the administered dose is excereted in the urine. About 80% of the 14C administered is found in the soluble fraction of the feces and 20% in the precipitate.
Only a small proportion of the iron ab sorbed is excreted by the kidney. The 55Fe activity found in the soluble and insoluble fractions of stool apparently indicate that a large proportion of the iron (about 92% of the dose adminis tered) is split from EDTA, and precipitated as an insoluble compound, then eliminated via the feces.
Only a small proportion of the iron administered (about 3%) remains soluble, possibly still bound to EDTA. These data only show the distribution of soluble and insoluble iron in stool, that is, at the last stage of digestion.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
This study showed that 14C labelled NaFe(III)EDTA is poorly ( ± 5%) and slowly absorbed to the plasma and excreted by the kidney within 48 hours.
The rest of the 14C was excreted in the feces, about 80% in a soluble form and 20% in the insoluble fraction. - Executive summary:
Studies on iron absorption from Na59Fe-EDTA in humans have shown that only a small proportion of the iron absorbed is excreted by the kidney, less than 1% of the dose administered. The pathway of Na55Fe-[2-14C]EDTA absorption and excretion when administered orally was studied in swine. A certain proportion (about 5% ) of the55Fe is split from the EDTA complex in the lumen of the gut, absorbed mainly from the pylorus and upper jejunum, transferred to plasma transferring and then incorporated into the circulating hemoglobin. A small proportion of the iron absorbed, less than 1% of the dose administered, is excreted by the kidney, to a degree similar to that excreted by humans. The rest of the iron is eliminated in the feces; about 3% in a soluble form possibly still bound to EDTA and the greater part, about 92%, in an insoluble form. About 5% of the14C is absorbed almost uniformly along the pyloric duodenal and jejunal mucosa, then transferred slowly to the plasma and excreted by the kidney within 48 hours. The rest of the14C was excreted in the feces, about 80% in a soluble form and 20% in the insoluble fraction.
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