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EC number: 603-073-2 | CAS number: 12549-23-4
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: A paper-based toxicokinetics assessment by a qualified toxicologist based on summaries of studies on the substance and literature.
- Adequacy of study:
- key study
- Study period:
- 26.08.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- In accordance with Annex VIII (point 8.8) of Regulation (EC) No 1907/2006 (REACH), a paper-based toxicokinetics assessment has been conducted by a qualified toxicologist based on summaries of studies on the substance and literature. The assessment of the likely toxicokinetic behaviour of the substance is provided to the extent that can be derived from the relevant available information at the time of the assessment. The assessment is based on the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, November 2014).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- Principles of method if other than guideline:
- The assessment is based on the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, November 2014). In accordance with Annex VIII (point 8.8) of Regulation (EC) No 1907/2006 (REACH), a paper-based toxicokinetics assessment has been conducted for the substance by a qualified toxicologist.
- GLP compliance:
- no
Test material
- Reference substance name:
- λ²-cobalt(2+) potassium hexacyanoirondiuide
- EC Number:
- 603-073-2
- Cas Number:
- 12549-23-4
- Molecular formula:
- K2[CoFe(CN)6]
- IUPAC Name:
- λ²-cobalt(2+) potassium hexacyanoirondiuide
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
- Details on test material:
- - Substance type: commercial product (pure active substance)
- Physical state: Solid powder
- Storage condition of test material: Ambient temperature, humidity and pressure. Stored in sealed containers in darkness.
- Stability under test conditions: Stable
- Purity: ca 100 %
- Particle size distribution: 1.05% <100μm
- Crystal structure: Face-centered cubic structure
- Density: 2.21 x 10^3 kg/m3
- pH value: the substance has a neutral pH value in an aqueous solution
Constituent 1
Results and discussion
Any other information on results incl. tables
Toxicokinetic behaviour
The substance is a black/brown granular solid and the molecular weight is 349 g/mol. The substance has low solubility in water. The substance has a low vapour pressure value (calculated as <1.2x 10^-9 Pa at 25°C), is not highly flammable and does not have explosive or oxidising properties. It is therefore considered to be of low volatility. The percentage of the test item having an inhalable particle size of less than 100 μm was determined to be 1.05%. The test item has been considered to be essentially non-inhalable.
The available repeated dose reproductive OECD 422 screening study (oral route) showed toxicologically significant treatment-related effects. The oral administration of the substance to rats by gavage, at dose levels of 30, 100 and 300 mg/kg bw/day resulted in the premature termination or early death of all females around the time of parturition at 300 mg/kg bw/day. One female given 100 mg/kg bw/day was also found dead shortly after completing parturition. These deaths were considered to be treatment related with histopathological changes in the gastrointestinal tract considered to the be primary cause along with secondary changes to the liver, adrenals and lympho-reticular system at the point of parturition when the intrinsic stress on these females was notably increased. The surviving animals of either sex treated with 100 mg/kg bw/day and males given 300 mg/kg bw/day showed adverse changes in hematology profile which were associated with toxicologically significant alterations in the spleen and sternal bone marrow.
The OECD 422 study therefore showed evidence of absorption of the substance. The acute toxicity studies via oral and dermal routes showed no signs of systemic toxicity. The substance is not classified as a skin sensitiser, skin irritant or eye irritant. The substance gave negative results in three appropriate in vitro genotoxicity studies in either the presence or absence of an auxiliary metabolising system.
Absorption
Results of the repeated dose reproductive OECD 422 screening study (oral route) showed evidence to support the gastric absorption of the test item. The molecular size of the substance may also allow absorption through passive diffusion. This would suggest the gastro-intestinal tract may provide a route of absorption, following oral administration, before entering the circulatory system via the blood.
An acute dermal toxicity study showed no signs of systemic toxicity, so did not show evidence to support significant dermal absorption. As the substance is not a skin corrosive or irritant, potential dermal absorption will not be increased by damage to the skin at point of contact.
Inhalation is not considered to be a significant route of exposure based on the low volatility of the substance and particle size.
Distribution
Systemic distribution of the substance is evident from the repeated dose reproductive OECD 422 screening study due to the changes seen in histopathology, organs and hematology.
The substance is of low water soluble so is unlikely to be absorbed unchanged. The substance is not a skin sensitiser (based on results of a LLNA study). This suggests that the substance does not bind to carrier proteins in the circulatory system.
Metabolism
The results of the repeated dose reproduction OECD 422 screening study showed some effects in the liver of rats (e.g. organ weight, hepatocellular atrophy),which can be associated with enhanced metabolism. However, review of the study suggests the hepatic changes observed are not conclusively indicative of hepatic induction but may be associated with other detoxification processes. The effects observed in the liver therefore may suggest there is potential for enhanced metabolism but does not provide strong evidence to support enhanced metabolism.
The results of the genotoxicity assays showed that genotoxicity is neither enhanced or diminished in the presence of the S9 metabolising system.
Excretion
Poorly-water soluble substances are not favourable for urinary excretion and therefore biliary excretion may well be a significant route for this substance.
There is no strong evidence to support enhanced hepatic metabolism, but there may be some potential for this. Therefore, urinary excretion is not expected to be a major route of excretion but cannot be ruled out completely.
Any substance that is not adsorbed from the gut will be excreted in the faeces.
Applicant's summary and conclusion
- Conclusions:
- The available information suggests that absorption of the test substance from the gastrointestinal tract can take place. Dermal absorption is considered unlikely. Based on available evidence once absorbed, the substance would be distributed systemically. Biliary excretion is likely to be the significant route of excretion. Experimental toxicokinetic studies were not available.
- Executive summary:
In accordance with Annex VIII (point 8.8) of Regulation (EC) No 1907/2006 (REACH), a paper-based toxicokinetics assessment was conducted by a qualified toxicologist based on summaries of studies on the substance and literature. The assessment of the likely toxicokinetic behaviour of the substance was provided to the extent that can be derived from the relevant available information at the time of the assessment. Experimental toxicokinetic studies were not available.
The available information suggests that the substance is available for absorption via the oral route but unlikely to be available for absorption via the dermal route. This is supported by the physico-chemical properties of the substance and by available toxicological data. Once absorbed, the substance is likely to be distributed systemically. Biliary excretion is considered to be the significant route of excretion for the substance.
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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