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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-449-4 | CAS number: 60-00-4
- 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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Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- The Metabolism of 14C Labeled Ethylenediaminetetraacetic Acid in Human Beings
- Author:
- Foreman & Trujillo
- Year:
- 1 954
- Bibliographic source:
- J. Lab. and Clin. Med. 43; 566-571 (1954)
Materials and methods
- Endpoint addressed:
- basic toxicokinetics
- dermal absorption
- 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
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION
- Specific activity (of the radialabelled form): 2.5 x 10^7 d/min
Method
- Ethical approval:
- not specified
- Details on study design:
- - 3 young healthy adult male were used in each application group
- Details on exposure:
- INTRAVENOUS ADMINISTRATION
- Dose preparation:
2.2 mg of 14C-CaNa2EDTA was mixed with 2 g of unlabelled CaNa2EDTA in a total of 10.5 mL water
- Application:
injections were given over a 2-3 min period
- Sample taking:
blood samples: up to 6 h regularly exact time points not stated; urine: over a 24 h period as voided until radioactivity had fallen below detection levels; in one case spinal fluid
- Additional measurements:
blood pressure and electrocardiogram tracings were made every 15 min, starting 1/2 h before the administration and continuing for 1 h after
INTRAMUSCULAR ADMINISTRATION
- Dose preparation:
2.2 mg of 14C-CaNa2EDTA was mixed with 2 g of unlabelled CaNa2EDTA and 2 mL of a 1% procaine solution, all made up to 10 mL with water
- Application:
Injections were made into the buttocks, 5 mL each side
- Sample taking:
blood samples: up to 6 h regularly exact time points not stated ; urine: over a 24 h period as voided until radioactivity had fallen below detection levels
ORAL ADMINISTRATION
- Dose preparation:
1.5 mg of 14C-labelled CaNa2EDTA was dissolved in 1/2 mL water given in a gelatin capsule
- Sample taking:
Urine and feces were collected for the study (sample takings not specified); blood was collected in the first study only
SKIN ABSORPTION
- Dose preparation:
2 mg 14C-labelled CaNa2EDTA and 1 g unlabelled CaNa2EDTA were prepared in a thin paste of Aquaphor. In one study Na salt of EDTA was used instead of Ca salt.
-Application:
The past was spread over an area of 100 cm2 on a sheet of thin latex and taped firmly to the lateral chest wall. It was kept there for 24 h
-Sample taking:
Urine samples were taken
Results and discussion
- Results:
- INTRAVENOUS ADMINISTRATION
- Recovery in urine: 98.1 ± 4.6 %
- 50 % was excreted within 1 h, 90 % within 7 h
- Half-life blood clearance: 1 h 5 min
-Activity in spinal fluid 1 h after injection: 1/20 of the plasma
INTRAMUSCULAR ADMINISTRATION
- Recovery in urine: 98.8 ± 1.6 %
- 50% was excreted within 2.5 h, 90% within 7 h
- Half-life blood clearance: 1.5 h
ORAL ADMINISTRATION
- TS is poorly absorbed
- no TS could be detected in the blood
- 91 ± 2 % are excreted via feaces, 4.2 ± 2 % via urine
- TS is excreted within 72 h
SKIN ABSORPTION
- The maximum activity detected in urine was 0.001 %
Any other information on results incl. tables
- The study indicates that CaNa2EDTA passes through the body unchanged and is excreted via the kidney by both glomerular filtration and tubular excretion.
- The turnover time from the blood is approximately 1 h after iv administration.
- It is poorly absorbed from the GI-tract
- It does not penetrate the skin
Applicant's summary and conclusion
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.
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