Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 268-018-3 | CAS number: 67989-88-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited documentation.
Data source
Reference
- Reference Type:
- publication
- Title:
- The metabolism of 14C-labeled ethylenediamine tetraacetic acid in the rat
- Author:
- Foreman H, Vier M, Magee M
- Year:
- 1 953
- Bibliographic source:
- J Biol Chem 203, 1045-1053
Materials and methods
- Objective of study:
- absorption
- excretion
- metabolism
- toxicokinetics
- Principles of method if other than guideline:
- Metabolism studies were conducted in rat. First distribution and balance studies were carried out with male animals. The animals were housed individually in metabolism cages for the separate collection of expired CO2, urine and feces. In a second series of experiments detailed studies on blood and urine were conducted on female animals. Studies were made after intraperitoneal, intravenous, intramuscular, and oral administration (intubation).
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium calcium edetate
- EC Number:
- 200-529-9
- EC Name:
- Sodium calcium edetate
- Cas Number:
- 62-33-9
- Molecular formula:
- C10H12CaN2O8.2Na
- IUPAC Name:
- calcium disodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
- Details on test material:
- - no further data available
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200 - 250 g
Administration / exposure
- Route of administration:
- other: ip, iv, im and oral (gavage)
- Vehicle:
- water
- Duration and frequency of treatment / exposure:
- single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50 mg/kg bw
(additionally one study was performed using 250 mg/kg bw for ip application)
- No. of animals per sex per dose / concentration:
- no data
- Control animals:
- no
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Oral studies:
2-18% (most of the values were in the range of 2-4%) - Details on distribution in tissues:
- - no organ retained more than 0.5% of the dose
- Details on excretion:
- ORAL
- 2-18% of the dose was excreted in the urine
- 80-95% of the dose was excreted via feces within 24 h
- less than 0.1% of the dose was exhaled as CO2
PARENTERAL ADMINISTRATION
- 95 - 98% of the dose appeared in the urine within 6 h (iv: 96.09%; ip: 98.67%; im: 95.35%)
- less than 0.1% of the dose was exhaled as CO2
- the dose size 250 mg/kg bw vs 50 mg/kg bw had no effect on the excretion kinetics
(see table 1)
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- half-life 1st: 32 min (half-live urine; im application)
- Toxicokinetic parameters:
- half-life 1st: 31 min (half-live urine; iv application)
- Toxicokinetic parameters:
- half-life 1st: 35 min (half-live urine; ip application)
- Toxicokinetic parameters:
- half-life 1st: no data (half-live urine; oral)
Metabolite characterisation studies
- Details on metabolites:
- Chromatography provided evidence that EDTA is not metabolized but passes the body unchanged.
Any other information on results incl. tables
While the half-life determine in urine was 31 to 35 min after parenteral application, a 50% drop of activity in plasma took 35- 50 min.
Table 1: Distribution of 14C activity following administration of Ca C14 -EDTA to rats
time after ip administration | oral administration | |||
Tissue sample | 1.5 h | 6 h | 24 h | 24 h |
Urine | 85.2 | 95.7 | 94.6 | 10.3 |
Feces | 0.5 | 2.0 | 3.6 | 88.3 |
Expired CO2 | 0.05 | 0.08 | ||
Skin | 2.3 | 0.8 | 0.3 | 0.16 |
Kidney | 1.4 | 0.3 | 0.3 | 0.04 |
GI tract | 0.2 | 0.2 | 0.7 | 0.45 |
Liver | 0.5 | 0.2 | 0.05 | 0.18 |
Skeleton | 0.3 | 0.1 | 0.08 | |
Muscle | 0.1 | 0.3 | 0.36 | |
Blood | 1.7 | 0.1 | 0.01 | 0.04 |
Remains | 8.1 | 0.03 | 0.01 | 0.03 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)