Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 230-794-6 | CAS number: 7321-53-1
- 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
Acute oral toxicity: not classified according to the CLP Regulation (EC) No. 1272/2008
Acute dermal toxicity: not classified according to the CLP Regulation (EC) No. 1272/2008
Acute inhalation toxicity: waived
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute Oral Toxicity
The potential in vitro cytotoxicity of the test item has been evaluated on Balb/c 3T3 cells. Cell cultures were treated with different concentrations of the test item. At the end of treatment time, measurement of neutral red uptake was performed to assess cytotoxicity and cell layers were examined in order to evaluate changes in cell morphology. Test item solutions were prepared using Ethanol.
A preliminary range-finder experiment was undertaken in order to select appropriate dose levels for the Main Assay. Based on the results obtained in a preliminary solubility trial, the test item was assayed at a maximum dose level of 250 µg/mL and at a wide range of lower dose levels: 25.0, 2.50, 0.250, 0.0250, 0.00250, 0.000250 and 0.0000250 µg/mL.
Reduction of the cell layer and change in cell morphology were noted at 250 µg/mL, where slight reduction in neutral red uptake was also observed. However, at this concentration precipitation of the test item was seen.
Since cytotoxicity should be evaluated at dose levels without visible precipitate, the Main Assay was performed using the following concentrations spaced by a factor of 2.5: 125, 50.0, 20.0, 8.00, 3.20, 1.28, 0.512 and 0.205 µg/mL. Precipitation of the test item was observed by the end of treatment at the highest dose level. Slight reduction of cell layer was noted at 50 µg/mL, while reduction of the cell layer and change in cell morphology were noted at 125 µg/mL. At these concentrations mild reduction in neutral red uptake was also observed.
Negative and positive control treatments were included in the Main Assay. Negative control cultures gave acceptable optical density values (0.183 ≤ OD≤ 0.769). Dose related toxicity was observed after treatment with the positive control, with a calculated IC50 value of 45.6 µg/mL, indicating the correct functioning of the assay system.
The test item was not considered to be cytotoxic, under the reported experimental conditions. However, solubility is a limiting factor in achieving sufficient cytotoxicity for the calculation of the IC50 value.
To support this results an evaluation on the information available on different Iron(III) complexes and on the free carboxilic acid has been done.
Based on the data collected starting from this two topics, no hazards have been identified.
Acute Dermal Toxicity
Based on the available information on the acute oral toxicity, no hazard via dermal exposure has been identified.
Acute Inhalation Toxicity
Inhalation exposure to the test item is not likely or expected based on the liquid form of the test item and low vapour pressure, therefore, it was not necessary to perform an acute inhalation toxicity study in order to determine acute toxicity.
Justification for classification or non-classification
The substance is considered exempt from classification for acute oral toxicity according to the CLP Regulation (EC) No. 1272/2008 (Appendix R.7.4–1 of Chapter R.7a: Endpoint Specific Guidance). Detailed documentation for the evaluation of acute oral toxicity using a Weight of Evidence approach is provided in a separate attachment.
The substance is not classified for acute dermal toxicity according to the CLP Regulation (EC) No. 1272/2008.
Further, inhalation exposure to the test item is not likely or expected based on the liquid form of the test item and low vapour pressure, therefore, it was not necessary to perform an acute inhalation toxicity study in order to determine acute toxicity.
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.