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Diss Factsheets
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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 information was available on the irritation potential of the reaction mass of ammonium iron (III) citrate and ammonium sulfate. The key information is therefore read across from trisodium citrate and iron sulfate. The key studies, for both skin and eye irritation of trisodium citrate were conducted according to current OECD guideline and in compliance with GLP, and they found the substance not irritating (Roche, 1995a, 1995b).
In the key study (Clouzeau, 1994), iron sulfate was irritating to the skin of two of three New Zealand white rabbits, and it is concluded that the substance is irritating to the skin. In the case of eye irritation, a reliable study (Johnson, 2003) suggest that a weak solution is not irritating. However, based on the weight of evidence across the iron salts category, it is concluded that this substance may be irritating to the eyes.
Key value for chemical safety assessment
Additional information
Reliable data on skin and eye irritation were available for trisodium citrate and iron sulfate, which were used to fill the irritation endpoints for reaction mass of ammonium iron (III) citrate and ammonium sulfate. The original studies were considered reliability 1. Read across to the registered substance is considered scientifically justified and is reliability 2.
Both the registered substance and the read across substance (trisodium citrate) contain citrate ions, and the read across substance has been selected based on the analogy of trisodium citrate to the registered substance in that the counterpart ion is bound to citrate. Sodium citrate will dissociate freely, whereas ferric citrate will not and it therefore represents the worst case scenario of potential irritation from citric acid.
The data read across from iron sulfate presents results with irritant effects on the skin (Clouzeau 1994) but not the eye (Johnson 2003). Based on the evidence across the iron salts category (OECD SIAR 2008) and an approach weighing on the side of caution, the reaction mass of iron ammonium (III) citrate and ammonium sulfate is belived to have the potential to have irritant effects on the skin and eye.
The other non-citrate chemical species that are part of the registered substance are ammonium and ammonium sulfate for which no data are included in the present data set, however a disseminated REACH dossier for ammonium sulfate is available via the ECHA website which includes confidential company data as key studies for the irritation endpoints. For skin irritation, slight erythema is reported in rabbits after a 24 hour occlusive exposure to the test material which was fully reversible within 8 days. For eye irritation, a single instillation of undiluted test material into the eyes of rabbits resulted in slight redness at 24 hours with no detectable effects by day 8. Both studies conclude ammonium sulfate to be not irritating. The ammonium and ammonium sulfate are therefore not expected to contribute to the irritation potential of the registered substance.
OECD SIAR 2008. SIDS Initial Assessment Report for SIAM 24, Paris, 2007. Chemical Category: Iron Salts. Sponsor Country: Finland. Industry sponsor/consortium: CEFIC Incopa Iron Salts Group. July 2007, published online 2008.
Effect level: empty Endpoint conclusion: Adverse effect observed
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Based on the potential of ferric salts to cause irritation it is proposed that the reaction mass of iron ammonium (III) citrate and ammonium sulfate is labelled according to regulation 1272/2008 as 'Category 2: Irritant' for eyes and skin, and hence 'H315: Causes skin irritation'
and 'H319: Causes serious eye irritation'.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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