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Diss Factsheets
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EC number: 931-219-8 | 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: in house methodology developed in conjunction with other fibre manufacturers, in house testing facility is not a GLP accredited laboratory
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Type of study / information:
- simulated bio-solubility testing to assess how easily fibres will be broken down in the fluids of the lung and macrophages
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- a flow test where fibres are continuously exposed to a simulated body fluid at 37°C for 3 weeks. Soluble species in the fibres dissolve out into the fluid and these can be measured in the solution. Knowing the surface area, mass and flow rate used, the dissolution rate of the fibre can be calculated.
- GLP compliance:
- no
Test material
- Reference substance name:
- silicon(4+) dialuminium(3+) dipotassium hexaoxidandiide
- EC Number:
- 931-219-8
- Molecular formula:
- SinO(3n-1)2(n-1) polymeric anions ionically bonded to Al3+ and K2+ cations
- IUPAC Name:
- silicon(4+) dialuminium(3+) dipotassium hexaoxidandiide
- Test material form:
- solid: fibres
- Details on test material:
- - Name of test material (as cited in study report): Superwool XT
- Substance type: Inorganic
Constituent 1
Results and discussion
Any other information on results incl. tables
The following fibre chemistries have been tested many times in Morgan. These reflect both past, existing and future commercial fibres. The first 4 compositions belong to the AES family (REACH registration 01-2119457644-32-0000) and Superwool XT is the new Potassium Alumino Silicate fibre
The average dissolution rates measured are shown in the table below;
Fibre |
Dissolution rate (ng/cm2hr) |
Standard deviation |
Number of tests |
Superwool 607 (Plus) |
290 |
115 |
35 |
Superwool 607Max |
285 |
90 |
23 |
Superwool 612 |
100 |
40 |
32 |
Superwool 607 HT |
110 |
30 |
30 |
Superwool XT |
485 |
110 |
6 |
Rockwool HT |
270 |
60 |
7 |
Superwool 607, 607 Max, 612 and 607 HT were all tested using pH 7.4 solution, as the AES chemistry is most sensitive to this pH. All of these fibres have been submitted to testing under Note Q conditions and have passed according to the EU protocol requirement(3).
Superwool XT is more sensitive to the pH 4.7 solution and so it was tested in this pH. Rockwool HT is another vitreous fibre which is sensitive to pH 4.7 and which has passed the Note Q bio-persistence testing. The solubility for this fibre has therefore also been included as a control to illustrate that solubility at either pH is a valid assessment of bio-persistence.
Generally fibres with dissolution rates >100ng/cm2hr are expected to pass the IT clearance test(3). This appears to be valid regardless of the solution used. It is also seen that fibres with higher dissolution rates also have lower bio-persistence. However this is not always the case as weaker fibres will need lower dissolution rates and stronger fibres will need higher dissolution rates.
Fibres that have not passed the Note Q testing generally have dissolution rates that are <25ng/cm2hr.
It is also clear that the chemical species in the fibres can change dramatically but do not change the underlying premise that high dissolution rate generally results in an IT half-life that is <40 days as required by the Note Q protocol.
Applicant's summary and conclusion
- Conclusions:
- These solubility tests demonstrate that high dissolution rates (>100ng/cm2hr) result in fibres that pass the Note Q IT clearance test. The fibre chemistry basis can be highly different from fibre to fibre provided the species dissolve at either pH 7.4 or 4.5.
Reference 1 reports that vitreous fibres are characterised in the lung by their bio-persistence and not by any direct chemical toxicity. Bio-persistence is strongly related to Bio-solubility as described in this report. The AES family of fibres, Potassium Alumino Silicates and Rockwool HT all display similar levels of bio-solubility when measured in the same laboratory test.
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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