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Diss Factsheets
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EC number: 239-407-5 | CAS number: 15375-84-5
- 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
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- short-term repeated dose toxicity: other route
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Old study, pre-GLP and pre-guideline. Sufficient details available for evaluation.
Data source
Reference
- Reference Type:
- publication
- Title:
- Hydropic degeneration of the rat kidney after administration of Na2[Ca-EDTA] and Na3[Ca-DTPA]
- Author:
- Weber KM
- Year:
- 1 970
- Bibliographic source:
- Virchows Arch. Abt. B Zellpathol. 5, 39-59
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Examination of kidney effects following repeated ip or sc injections
- 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:
- other: aqueous solutions
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Heiligenberg Inbred strains
- Sex:
- male
Administration / exposure
- Route of administration:
- other: intraperitoneal or subcutaneous
- Vehicle:
- physiological saline
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Daily injections or every 3rd day
- Frequency of treatment:
- Variable up to 32 times
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1, 2, 4 and 8 mmol/kg bw/day (1st study), 2.5 mmol/kg bw/day (2nd study)
- No. of animals per sex per dose:
- 5 (in total 782 test animals and 245 control animals used)
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 4 other: mmol/kg bw/day
- Based on:
- test mat.
- Sex:
- male
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
The lesions induced in the kidneys of the rat by 1, 2, 4 and 8 mmol Na2[Ca-EDTA]/kg bw/day were compared with those induced by Na3[Ca-DTPA]. The following results were obtained: 1. The well-known renal alterations caused by chelates include more than a hydropic degeneration of the proximal convoluted tubule. Iysosomes probably partake in the development of that degeneration. 2. The degeneration of the epithelium of the proximal tubules, typical of the action of EDTA doses <8 mmol, cannot be considered as important in causing death. 3. None of the renal effects as seen histologically - such as alteration of the straight portion of the proximal tubules (typical of the action of DTPA doses >1 mmol and of 8mmol EDTA, alteration of glomeruli, distal tubules, and collecting ducts, tubulorhexis, hyaline casts and others - can be correlated directly with mortality. It is questionable whether the kidney is the critical organ in chelate toxicity. 4. This conclusion is corroborated by studying the effects of chelate as they develop. In the pertinent experiment the kidney as well as duodenum, liver, and adrenal cortex were studied 48 and 72 hr, after the injection of 2.5 mmol/kg of chelates. The results showed that the lesions of the straight portion of the proximal tubules, typical of the action of DTPA, became
manifest after a latent period but in general regenerate quickly.
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