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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 932-833-9 | CAS number: -
- 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
No data are available for the acute toxicity of the reaction mass of ammonium iron (III) citrate and ammonium sulfate.
The key study for acute oral toxicity is read across from ferric chloride, which reports an LD50 value equivalent to 440 mg Fe/kg bw in a reliable study conducted according to an appropriate protocol (Hosking 1970). Based on the known composition of the reaction mass of ammonium iron (III) citrate and ammonium sulfate of 12.1% ferric ion and 0.1% ferrous ion, the LD50 for the reaction mass of ammonium iron (III) citrate and ammonium sulfate is calculated to be 3600 mg/kg, based on the available read across data.
The data for acute inhalation and acute dermal toxicity are waived.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 600 mg/kg bw
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
A supporting study on the acute oral and dermal toxicity of ammonium sulfate is also included, reporting LD50values of >2000 mg/kg bw in mice and rats for both acute oral and dermal toxicity (Yamanaka, 1990), which further supports the lack of acute toxicity of the registered substance.
The acute inhalation and acute dermal toxicity endpoints are waived based on a weight-of-evidence approach rather than proposing to conduct further, new experimental animal tests to fulfil the Annex requirements. The ubiquitous nature of iron and citrate in the environment and the fact that iron and citrate play important roles in biological processes, with their homeostasis being under strict control make further testing counterintuitive. The ferric citrate complexation is known to be thermodynamically stable, and given penetration through the lung, systemic toxicity would be unlikely due to the ubiquitous nature of ferric citrate in circulation. Furthermore, the exposure profile of the registered substance comprises the obligatory use of full respiratory protection for loading / charging operations. Similarly, penetration through the skin is unlikely. Due to the ubiquitous nature of the constituents of the registered substance and the intrinsic mechanisms in place for the regulation of citrate and iron homeostasis, further testing would be unjustified. Additional information on basis of read across approach and justification for data waiving is given in an expert report (Peter Fisk Associates, 2012) attached in Section 13 of the IUCLID dossier.
Justification for classification or non-classification
Based on the available information and the ubiquitous nature of the consituent ions of the registered substance, no classification is proposed for acute toxicity of the reaction mass of ammonium iron (III) citrate and ammonium sulfate in accordance with current regulation (EC 1272/2008).
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.