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EC number: 215-684-8 | CAS number: 1344-00-9
- 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 information on environmental fate and behaviour
Administrative data
- Endpoint:
- additional information on environmental fate and behaviour
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct. 25, 2021 - Feb. 25, 2022; experimental phase: Oct. 27 - Dec. 20, 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- transformation / dissolution of metals and inorganic metal compounds
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct. 25, 2021 - Feb. 25, 2022; experimental phase: Oct. 27 - Dec. 20, 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Series on Testing and Assessment No. 29 (23-Jul-2001): Guidance document on transformation/dissolution of metals and metal compounds in aqueous media
- Version / remarks:
- Jul. 23, 2001
- Deviations:
- yes
- Remarks:
- mass balance (%) was not performed during the full test for 1 mg/L as the determination was not precise
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Remarks:
- measurement of Silicon and Aluminium per ICP-OES in aqueous media
- Specific details on test material used for the study:
- Name: Sodasil P-95
Batch no.: 937201AS_023301AS
CAS no.: 1344-00-9
Composition Silicic acid, aluminum sodium salt: 100%
Storage: room temperature (20 ± 5 °C)
Expiry date: 30. Jul. 2022
Stability: stable under storage conditions
Appearance: white powder
Purity: 100%
Homogeneity: homogeneous
Production date: 10. Sep. 2019
EC no.: 215-684-8
Molecular formula: nSiO2*mAl2O3*zNa2O
Molecular weight: unknown
Vapour pressure: 13.3 hPa at 1732 °C - Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- 64.7 µg/L
- Element analysed:
- silicon
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 28 d
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- 3.48 µg/L
- Element analysed:
- aluminium
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 28 d
- Details on results:
- In this study, the maximum concentration of total dissolved Si and Al was determined in order to identify compounds of SODASIL P-95 which undergo either dissolution or rapid transformation.
The method validation of Si was performed during the study 21080202G989 and the results were also be used in this study. The method validation for the determination of Al in buffer solutions was performed during this study.
The calibration was performed using the certified Al stock solution (1000 mg/L nominal). All validation conditions for the range of 3 – 50 µg/L Al in pH 8.5 buffer solution were ful-filled except the accuracy in pH 5.5 and pH 7.0 buffer solutions. The accuracy was out-side 70 – 120 % of the nominal values. Therefore, the calibration of Al was additionally performed in each buffer solution.
The correlation coefficient r was > 0.99 and the accuracy values of the calibration stand-ards lay in the demanded ranges 100 ± 15 % and 100 ± 20 % (low concentration) of each calibration.
All accuracy values lay in the demanded range of 70 – 110 % after recalculation of the accuracy in pH 5.5 and pH 7.0 buffer solutions using the corresponding calibration function in the respective buffer. As the values lay outside the range 100 ± 5 %, the mean recovery rates were taken into account in the calculation of Al concentrations in the respective buffer solution. The condition for precision “RSD ≤ 20 % per level” was fulfilled for all media and levels.
During the screening test, the adjustment of pH value in the range of 5.5 ± 0.2 in pH 5.5 buffer solution was not possible as the test item has changed the pH value of the buffer (5.90 – 6.31). The highest concentration of Si was measured in pH 8.5 buffer solution. Therefore, pH 8.5 buffer solution was chosen for the reproducibility test. The concentration of Al was below the LOQ (< 3 µg/L Al).
The reproducibility test was performed with 100 mg/L test item over a period of 24 hours. Five vessels were prepared; each flask was measured in triplicate. A within-vessel variation of max. 10% and a between-vessel variation of max. 20% was demanded. These conditions were fulfilled. The mean concentration of Si in all flasks was stated as 384.0 µg/L Si.
The full test was performed with 1 mg/L nominal load (three replicates) over a period of 28 days with samplings after 2 h, 6 h, 1 d, 4 d, 7 d, 14 d, 21 d and 28 d. Two flasks were prepared as blanks without addition of test item. Dependency of measured concentrations of Si on time was linear during the whole test. The measured concentration of Al was below the LOQ (< 3 µg/L Al) in each flask at each sampling point except on day 28.
Both conditions RSD ≤ 10 % (within-vessel) and ≤ 20 % (between-vessel) were fulfilled for Si in all flasks at each sampling point and Al on day 28 during the full test. On day 1, the within-vessel variation of Si was > 10 % in the flask 3 as one replicate showed the concentration of Si < 10 µg/L.
The following concentrations of Si and Al were stated on day 28:
1 mg/L nominal: 64.7 µg/L Si; 3.48 µg/L Al.
No observations arousing doubts concerning the accuracy of the results and the validity of the study were made. - Conclusions:
- The following concentrations of Si and Al were stated for 1 mg/L nominal load after 28 d:
64.7 µg/L Si,
3.48 µg/L Al
at 20.8 ± 0.8 °C and pH 8.41 ± 0.09. - Executive summary:
This study was performed in order to determine the transformation and/or dissolution of Sodasil P-95 via measurement of Silicon (Si) and Aluminium (Al) per ICP-OES in aqueous media. The full test was performed with 1 mg/L nominal load (three replicates) over a period of 28 days with samplings after 2 h, 6 h, 1 d, 4 d, 7 d, 14 d, 21 d and 28 d. The following concentrations of Si and Al were stated on day 28 with 1 mg/L nominal load: 64.7 µg/L Si and 3.48 µg/L Al.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Series on Testing and Assessment No. 29
- Version / remarks:
- Jul. 23, 2001
- Deviations:
- yes
- Remarks:
- mass balance (%) was not performed during the full test for 1 mg/L as the determination was not precise
- GLP compliance:
- yes (incl. QA statement)
- Type of study / information:
- transformation / dissolution:
- flask method
- measurement of Silicon and Aluminium per ICP-OES in aqueous media
Test material
- Reference substance name:
- Silicic acid, aluminum sodium salt
- EC Number:
- 215-684-8
- EC Name:
- Silicic acid, aluminum sodium salt
- Cas Number:
- 1344-00-9
- Molecular formula:
- nSiO2*mAl2O3*zNa2O n = 2-4; m = 0.12-3.20; z = 0.11-4.5
- IUPAC Name:
- aluminium(3+) sodium bis(oxosilanebis(olate))
- Test material form:
- solid: nanoform, no surface treatment
- Remarks:
- crystalline-free
Constituent 1
- Specific details on test material used for the study:
- Name: Sodasil P-95
Batch no.: 937201AS_023301AS
CAS no.: 1344-00-9
Composition Silicic acid, aluminum sodium salt: 100%
Storage: room temperature (20 ± 5 °C)
Expiry date: 30. Jul. 2022
Stability: stable under storage conditions
Appearance: white powder
Purity: 100%
Homogeneity: homogeneous
Production date: 10. Sep. 2019
EC no.: 215-684-8
Molecular formula: nSiO2*mAl2O3*zNa2O
Molecular weight: unknown
Vapour pressure: 13.3 hPa at 1732 °C
Results and discussion
Any other information on results incl. tables
In this study, the maximum concentration of total dissolved Si and Al was determined in order to identify compounds of SODASIL P-95 which undergo either dissolution or rapid transformation.
The method validation of Si was performed during the study 21080202G989 and the results were also be used in this study. The method validation for the determination of Al in buffer solutions was performed during this study.
The calibration was performed using the certified Al stock solution (1000 mg/L nominal). All validation conditions for the range of 3 – 50 µg/L Al in pH 8.5 buffer solution were ful-filled except the accuracy in pH 5.5 and pH 7.0 buffer solutions. The accuracy was out-side 70 – 120 % of the nominal values. Therefore, the calibration of Al was additionally performed in each buffer solution.
The correlation coefficient r was > 0.99 and the accuracy values of the calibration stand-ards lay in the demanded ranges 100 ± 15 % and 100 ± 20 % (low concentration) of each calibration.
All accuracy values lay in the demanded range of 70 – 110 % after recalculation of the accuracy in pH 5.5 and pH 7.0 buffer solutions using the corresponding calibration function in the respective buffer. As the values lay outside the range 100 ± 5 %, the mean recovery rates were taken into account in the calculation of Al concentrations in the respective buffer solution. The condition for precision “RSD ≤ 20 % per level” was fulfilled for all media and levels.
During the screening test, the adjustment of pH value in the range of 5.5 ± 0.2 in pH 5.5 buffer solution was not possible as the test item has changed the pH value of the buffer (5.90 – 6.31). The highest concentration of Si was measured in pH 8.5 buffer solution. Therefore, pH 8.5 buffer solution was chosen for the reproducibility test. The concentration of Al was below the LOQ (< 3 µg/L Al).
The reproducibility test was performed with 100 mg/L test item over a period of 24 hours. Five vessels were prepared; each flask was measured in triplicate. A within-vessel variation of max. 10% and a between-vessel variation of max. 20% was demanded. These conditions were fulfilled. The mean concentration of Si in all flasks was stated as 384.0 µg/L Si.
The full test was performed with 1 mg/L nominal load (three replicates) over a period of 28 days with samplings after 2 h, 6 h, 1 d, 4 d, 7 d, 14 d, 21 d and 28 d. Two flasks were prepared as blanks without addition of test item. Dependency of measured concentrations of Si on time was linear during the whole test. The measured concentration of Al was below the LOQ (< 3 µg/L Al) in each flask at each sampling point except on day 28.
Both conditions RSD ≤ 10 % (within-vessel) and ≤ 20 % (between-vessel) were fulfilled for Si in all flasks at each sampling point and Al on day 28 during the full test. On day 1, the within-vessel variation of Si was > 10 % in the flask 3 as one replicate showed the concentration of Si < 10 µg/L.
The following concentrations of Si and Al were stated on day 28:
1 mg/L nominal load: 64.7 µg/L Si; 3.48 µg/L Al
No observations arousing doubts concerning the accuracy of the results and the validity of the study were made.
Applicant's summary and conclusion
- Conclusions:
- The following concentrations of Si and Al were stated for 1 mg/L nominal load after 28 d:
64.7 µg/L Si,
3.48 µg/L Al
at 20.8 ± 0.8 °C and pH 8.41 ± 0.09. - Executive summary:
This study was performed in order to determine the transformation and/or dissolution of Sodasil P-95 via measurement of Silicon (Si) and Aluminium (Al) per ICP-OES in aqueous media. The full test was performed with 1 mg/L nominal load (three replicates) over a period of 28 days with samplings after 2 h, 6 h, 1 d, 4 d, 7 d, 14 d, 21 d and 28 d. The following concentrations of Si and Al were stated on day 28 with 1 mg/L nominal load: 64.7 µg/L Si and 3.48 µg/L Al.
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