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EC number: 238-372-3 | CAS number: 14402-88-1
- 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
Endpoint summary
Administrative data
Description of key information
Several repeated oral toxicity studies were available for EDTA-CaNa2; results of these studies were compared with studies with other metal chelates and with EDTA (see below). One repeated inhalation toxicity study was avalaible for DTPA-CaNa3, another, Ca-containing chelate. Several ip and iv studies were also available showing various effects but mostly on kidneys. However, as workers and consumers are not exposed via these non-physiological routes these studies are not further taken into account.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The 2-year NOAEL in a rat study with EDTA-CaNa2 was >= 250 mg/kg bw. Other long term oral toxicity studies with other metal chelates or with EDTA showed comparable results.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- A repeated 12-day inhalation toxicity with another chelate (Ca-DTPA) at levels up to 1.18 mg/L induced only a mild, focal and reversible pulmonary histiocytosis in the rat.
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A 2 -year oral toxicity study in rats with EDTA-CaNa2 revealed no toxicity up to and including 250 mg/kg bw. No toxicity was seen up to and including 338 mg/kg in a 1 -year oral study in dogs. Short-term studies with EDTA-CaNa2 in rats revelead a NOAEL of >= 3636 mg/kg (31 -day study) or a LOAEL of 2750 mg/kg bw (1 -month study). A 61 -day study with another metal chelate (EDTA-FeNa) revealed a NOAEL of >= 84 mg/kg bw in rats (higest dose tested), whereas a 14 -week study in rats with EDTA-MnNa2 resulted in a NOAEL of 500 mg/kg bw. Chronic studies with EDTA-Na3H revealed a NOAEL of >= 500 mg/kg bw in rats, and >= 938 mg/kg bw in mice. Finally, a 13 -week study with EDTA-Na2H2 resulted in a NOAEL of >= 500 mg/kg bw. These results together show that EDTA-CaNa2 like other EDTA's is of low toxicity following repeated oral exposure. The NOAEL observed in the 2 -year study in rats, which was at least 250 mg/kg bw, may therefore be higher. It is not expected that repeated inhalation exposure to EDTA-CaNa2 would result in harmful effects based on the results of a 12 -day exposure study with DTPA-CaNa3 in which a NOAEL of 420 mg/m3 was observed. Futher, because EDTA-CaNa2 is not irritating to the skin, local dermal effects are not expected and because the absorption via the skin is expected to be very low (EU RAR, 2004), no systemic toxicity is expected following dermal exposure.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Several studies available for metal EDTA chelates (see read across document in section 13)
Justification for classification or non-classification
Based on the results indicated above and based on rread across document (see section 13) no classification is needed for EDTA-MgNa2 following repeated exposure.
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