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EC number: 239-802-2 | CAS number: 15708-41-5
- 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
Endpoint summary
Administrative data
Description of key information
NOAEL is > 84 mg/kg bw/day for rats after 31/61 days of exposure via the food.
Key value for chemical safety assessment
Additional information
There are no repeated dose studies available for the dermal and inhalation route.
The key study in which rats were administered NaFeEDTA 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 corresponds 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 most probably is much higher than 84 mg/kg bw day.
In two other oral repeated dose studies where NaFeEDTA was administered via the food (Sichuan Station, 1993; Su et al., 1999), the NOAEL was determined to be at least 640 and 250 mg/kg bw/day, respectively. However these studies were given a reliability rating of 4 (not assignable), since the only available information consisted of short inofficial English translations of the unpublished reports that were submitted to the WHO and that did not contain many details about conduct or results. The studies did not at all appear to have been conducted according to current standards. The concentrations of test material in the diet were not analytically confirmed. Also in the Su et al. study (1999), the effects observed in the lungs and intestines of high-dose rats may have been indicative of an underlying illness that may have exaggerated the effects of ferric sodium EDTA in this study.
Justification for classification or non-classification
As the NOAEL most probably is in excess of 100 mg/kg bw, no classification is needed.
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.
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