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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
Endpoint summary
Administrative data
Description of key information
NOAEL is > 84 mg EDTA-FeNa/kg bw/day for rats after 31/61 days of exposure via the food.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- In the key study the NOAEL >= 84 mg EDTA-FeNa/kg bw/day. Several studies are available for various chelates. 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
There are no repeated dose studies available for the dermal and inhalation route.
In the key study in which rats were administered EDTA-FeNa via the food (Appel et al., 2001), no toxicologically significant effects were observed. It can be concluded from this study that the NOAEL is > 84 mg/kg bw/day. In the study by Yeung et al (2005) rats received EDTA-FeNa at a level of 1200 mg Fe per kg diet for up to 39 days. Taking into account a consumption of ca. 25 g per day, and a mean weight of ca. 250 g during the study, rats received 30 mg Fe per day or 120 mg Fe per kg bw per day. This would correspond to: 421/56 x 120 = 900 mg EDTA-FeNa.3H2O per kg bw/day. At this level no changes in growth rate were seen. Therefore, the NOAEL, also of EDTA-Fe(OH)K2 most probably is much higher than 84 mg/kg bw day.
Other studies with various other metal chelates showed higher NOAELS as they were tested at higher levels.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Key study and several supporting studies available
Justification for classification or non-classification
As the NOAEL most probably is in excess of 100 mg/kg bw, no classification is needed.
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