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EC number: 940-884-3 | 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
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Starting Date: 21 July 2015. Experimental Completion Date: 11 November 2015.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- Principles of method if other than guideline:
- Solubility in Simulated Alveolar Lung Fluid determined using a procedure based on the flask shake method
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 150324
- Expiration date of the lot/batch: 24 March 2016 - Water solubility:
- 544 mg/L
- Temp.:
- 37 °C
- pH:
- 12.71
- Remarks on result:
- other: Total Concentration of test item determined at 72 hours
- Conclusions:
- The solubility of the test item in simulated alveolar lung fluid monitored by ICP-MS analysis of the elements specified was determined in accordance with OECD Guideline 105 at 37.0 ± 0.5 °C. The total concentration (g/L) of test item determined after 72-hours at 37.0 ± 0.5°C was 544mg/L (0.544 g/L).
- Executive summary:
GUIDELINE
The solubility of the test item in simulated Alveolar Lung fluid was determined using a procedure based on the flask method, Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.
METHOD
The solubility of the test item in simulated alveolar lung fluid was determined by ICP-MS for the following; magnesium aluminium, silicon, phosphorus, potassium, calcium, titanium, vanadium, chromium, manganese, iron, strontium, zirconium. Organic carbon was determined by total organic carbon.
RESULTS
0.544g/L of solution at 37 ± 0.5°C. Further information on the individual ions can be found in Table 3.24 (attached)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Starting Date: 21 July 2015. Experimental Completion Date: 11 November 2015.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 150324
- Expiration date of the lot/batch: 24 March 2016 - Water solubility:
- 3.42 g/L
- Temp.:
- 37 °C
- pH:
- >= 1.4 - <= 1.42
- Remarks on result:
- other: Solubility of test item in simulated gastric fluid at 1 hour
- Water solubility:
- 3.52 g/L
- Temp.:
- 37 °C
- pH:
- >= 1.35 - <= 1.43
- Remarks on result:
- other: Solubility of test item in simulated gastric fluid at 2 hour
- Water solubility:
- 3.61 g/L
- Temp.:
- 37 °C
- pH:
- >= 1.24 - <= 1.3
- Remarks on result:
- other: Solubility of test item in simulated gastric fluid at 5 hour
- Water solubility:
- 3.69 g/L
- Temp.:
- 37 °C
- pH:
- >= 1.33 - <= 1.37
- Remarks on result:
- other: Solubility of test item in simulated gastric fluid at 24 hour
- Water solubility:
- 3.7 g/L
- Temp.:
- 37 °C
- pH:
- >= 1.24 - <= 1.28
- Remarks on result:
- other: Solubility of test item in simulated gastric fluid at 72 hour
- Details on results:
- - Carbon analysis results
The limit of quantification for TOC analysis is 1 mg/L. Therefore since all test solutions were less than 1 mg/L, the total carbon content of the test solutions corrected for a dilution factor of 100 is reported as less than 100 mg/L. - Conclusions:
- The solubility of the test item in simulated gastic fluid monitored by ICP-MS analysis of the elements specfied was determined in accordance with OECD Guideline 105 at 37.0±1°C. The results are summarised below:
Sample Time Point Total Test Item Concentration (g/L)
1 Hr 3.42
2 Hr 3.52
5 Hr 3.61
24-Hr 3.69
72-Hr 3.70 - Executive summary:
GUIDELINE
The solubility of the test item in simulated gastric fluid was determined using a procedure based on the flask method, Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.
METHOD
The solubility of the test item in simulated gastic fluid was determined by ICP-MS for the following elements; sodium, magnesium, aluminium, silicon, phosphorus, potassium, calcium, titanium, vanadium, chromium, manganese, iron, strontium and zirconium. Carbon was determined by total organic carbon (TOC)
RESULTS
Sample Time Point Total Test Item Concentration (g/L)
1 Hr 3.42
2 Hr 3.52
5 Hr 3.61
24-Hr 3.69
72-Hr 3.70
Referenceopen allclose all
- The mean instrument response for the standard, blank and sample solutions are shown in Tables 3.19 and 3.20 attached
- The calibration curves for the elements monitored are presented in Figures 3.18 -3.39 attached
- The mean concentration (mg/L) of each element in the sample blank and sample solutions are shown in Table 3.21 attached
- The results for total carbon and inorganic carbon analysed by TOC are shown in Table 3.22 attached
RESULTS SUMMARY
The mean concentration of individual elements corrected for the mean blank for each time point
Element (Mass) |
Mean Concentration Corrected for Matrix Blank (mg/L) |
Magnesium |
Not quantifiable |
Aluminium |
0.183 |
Silicon |
0.292 |
Phosphorus |
Not quantifiable |
Potassium |
17.7 |
Calcium |
529 |
Titanium |
Not quantifiable |
Vanadium |
0.006 |
Chromium |
Not quantifiable |
Manganese |
Not detected |
Iron |
Not detected |
Strontium |
1.21 |
Zirconium |
Not quantifiable |
Carbon |
Not quantifiable |
The total concentration (g/L) of test item determined after 72 hours at 37.0 ± 0.5 °C was 544 mg/L (0.544 g/L).
DISCUSSION
The pH of the solutions increased from 7.2 to 12.7 over the duration of the test. This was due to the basic nature of the test item and it was not considered appropriate or within the scope of the test to adjust the pH after addition of the test item to the test media.
Calibration curves for the analytes, Al, Si, Ti, V, Cr, Mn, Fe, Sr, and Zr (Figures 3.18 to 3.35) are presented as full range and limited range. The limited range was used for quantification whereas the full range is for information purposes only.
Results for Mg, P, Ti, Cr, Zr and C have been reported as “not quantifiable” where the concentration of the analyte in the simulated alveolar lung fluid blank was greater than the concentration of the analyte in the sample solution. This may have been due to pH effects on the solubility of certain species since the blank media was approximately neutral whereas the test solutions were alkaline.
Sodium was not determined due to the large excess of sodium present in the simulated alveolar lung fluid matrix.
Accuracy/recovery analysis was conducted for the following analytes; Al, Si, Ti, V, Cr, Mn, Fe, Sr, and Zr. This was performed at a nominal concentration of 1 mg/L in simulated alveolar lung fluid matrix. The results were acceptable with recoveries in the range of 99.0 to 111 %, with the exception of zirconium (34.2 %). The zirconium content of the sample solutions was found to be less than the limit of detection and so this was considered not to have a significant effect on the overall result.
ICP-MS Analysis Results
- Mean instrument response for the standard, blanks and sample solutions are shown in Table 3.7 attached
- Typical Calibration plots for the elements are shown in Figures 3.3 to 3.16 attached
- Mean concentration of each element in the sample blank and sample solutions is shown in Table 3.8 attached
- Mean concentration of each element corrected for the mean blank for each time point is shown in Table 3.9 attached
- Results for total carbon and inorganic carbon analysed by TOC are shown in Table 3.10 attached
- Total test item solubility is shown in Figure 3.17 attached
Discussion
The pH of each sample solution did not exceed the pH specified in the guidelines.
Description of key information
The solubility of the test item in simulated gastic fluid monitored by ICP-MS analysis of the elements specified was determined in accordance with OECD Guideline 105 at 37.0±1°C. The results are summarised below:
Shaking time at 37 °C |
Total Test Item Concentration (g/L) |
1-Hr |
3.42 |
2-Hr |
3.52 |
5-Hr |
3.61 |
24-Hr |
3.69 |
72-Hr |
3.70 |
Furthermore, the solubility of the test item in simulated alveolar lung fluid monitored by ICP-MS analysis of the elements specified was determined in accordance with OECD Guideline 105 at 37.0 ± 0.5 °C. The total concentration (g/L) of test item determined after 72-hours at 37.0 ± 0.5°C was 544mg/L (0.544 g/L).
The transformation/dissolution of the test material in aqueous media has been determined using a procedure designed to be compatible with Annex 10, Guidance on Transformation/Dissolution of Metals and Metal Compounds in Aqueous Media, OECD Environment, Health and Safety Publications, Series on Testing and Assessment, No.29, Environment Directorate, Organisation for Economic Co-operation and Development, 23 July 2001. The concentrations of dissolved test item constituent observed in the main test (7-day short term and 28-day long term) are shown in the following table:
Main Test, pH 8.5 - Concentration (mg/L)
Short Term (7 Day) Long Term (28-Day)
Analyte Loading Rate 100 mg/L Loading Rate 10 mg/L Loading Rate 1 mg/L Loading Rate 1 mg/L
Al 0.58 3.47 x 10E-2 ND 1.20 x 1-E-3
Si 2.80 0.200 ND 7.59 X 10E-2
Ti ND ND ND ND
V 4.52 x 10E-3 4.02 x 10E-4 ND 6.83 x 10E-5
Cr ND ND ND ND
Mn 1.09 x 10E-2 2.49 x 10E-3 ND 3.50 x 10E-4
Fe ND ND ND ND
Sr 5.19 x 10E-3 ND ND 2.70 x 10-4
Zr ND ND ND ND
Key value for chemical safety assessment
Additional information
No additional information.
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