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EC number: 231-545-4 | CAS number: 7631-86-9
- 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
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- transformation / dissolution of metals and inorganic metal compounds
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan. 8 - Feb. 14, 2019 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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:
- 2001
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Name High Surface Precipitated SiO2
Batch no. F7SCF01
Appearance white powder
Composition SiO2; Na2SO4
CAS No. 7631-86-9 (112926-00-8)
EC-No. 231-545-4 - Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- 990.5 µg/L
- Element analysed:
- Si
- Loading of aqueous phase:
- 1 000 µg/L
- Incubation duration:
- 28 d
- Test conditions:
- 20.6 - 21.9 °C, ph 8.5
- Remarks on result:
- other: mean value of days 4 – 28
- Conclusions:
- 990.5 µg/L (c. 99%) of the test Item were dissolved in pH 8.5 buffer solution at 20.6 – 21.9 °C (1 mg/L nominal load, mean value of days 4 – 28).
- Executive summary:
This study was performed in order to determine the transformation and/or dissolution of High Surface Precipitated SiO2 via measurement of Silicon (Si) per ICP-OES in aqueous media.
- Endpoint:
- transformation / dissolution of metals and inorganic metal compounds
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 14, 2019 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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:
- 2001
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- nano particular colloidal silica dispersed in water
CAS No. 7631-86-9
EC-No. 231-545-4
pH 8.5 – 9.2 in dispersion - Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- 557.8 µg/L
- Element analysed:
- Si
- Loading of aqueous phase:
- 1 000 µg/L
- Incubation duration:
- 28 d
- Test conditions:
- 21 - 22 °C, ph 8.5
- Remarks on result:
- other: mean value of days 7 – 28
- Conclusions:
- 990.5 µg/L (c. 99%) of the test Item were dissolved in pH 8.5 buffer solution at 20.6 – 21.9 °C (1 mg/L nominal load, mean value of days 4 – 28).
- Executive summary:
This study was performed in order to determine the transformation and/or dissolution of High Surface Precipitated SiO2 via measurement of Silicon (Si) per ICP-OES in aqueous media.
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.09.2016-04.10.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Name: AEROSIL® OX 50 (UB 862812)
Batch no.: 155111045
Appearance: white powder
Composition: Silicon dioxide, chemically prepared
CAS No.: 112945-52-5
EINECS-No.: 231-545-4
Molecular formula: SiO2
Molecular weight: 60.1 g/mol
Purity: > 99.8% (ISO 3262-20)
Homogeneity: homogeneous
Production date: 10. Nov. 2015
Expiry date: 09. Nov. 2017
Specific surface area: 44 m2/g
Storage: Room Temperature (20 ± 5°C) - Key result
- Water solubility:
- >= 111.7 - <= 124 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- >= 1 - <= 8 d
- Temp.:
- 20 °C
- pH:
- 5
- Details on results:
- At the plateau, the concentration of the test item AEROSIL® OX 50 (UB 862812) using
ICP-OES was calculated based on the measured Silicon concentrations in flasks 1A-C
(mean, 6 – 8 d) and 2 – 4 and the Silicon content in the test item as 111.7 ± 1.7 mg/L.
Additionally, the concentration of Silicon in the filtrated solutions (flasks 1C and flasks 2 –
4) was determined using photometry for comparison of the results with the first measurement
via ICP-OES. The mean concentration of the test item AEROSIL® OX 50 (UB
862812) in the four replicates was 124.0 ± 1.7 mg/L.
The determination of the solubility of the test item in water using two different methods
(ICP-OES and photometry) showed similar results. The solubility of the test item was stated
as
117.9 ± 6.7 mg/L at 20.0 ± 0.5 °C
(mean value of two methods ± standard deviation of eight individual values (six vessels),
nominal concentration 50 g/L) - Conclusions:
- The determination of the solubility of the test item in water using two different methods
(ICP-OES and photometry) showed similar results. The water solubility of the test item was
stated as 117.9 ± 6.7 mg/L (mean value of two methods). - Executive summary:
The solubility of the test item AEROSIL® OX 50 (UB 862812) in water was determined by
measurement of the Silicon concentration in the filtrated test solutions using two different
methods, ICP-OES and photometry. Potentially available undissolved particles in the filtrated
test item solutions were measured using Tyndall device.
The solubility of the test item was provided by the sponsor to be > 10 mg/L and therefore
the preliminary test described in the guideline was not performed. Following the guideline,
the flask method was used for the determination of the solubility of the test item in water.
In the main test, 50 g/L test item in water were used for the test. Six individual flasks
(flasks 1A - 1C and 2 – 4) were prepared. Five vessels (blank, flasks 1C (for the sampling
point 72 h) and 2 – 4) were set onto the shaking apparatus immediately. After 24 ± 2
hours, flask 1B (for the sampling point 48 h) and after further 24 ± 2 hours, flask 1A (for the
sampling point 24 h) were set on the shaker and all flasks were shaken for further 24 ± 2
hours at room temperature (20.0 ± 0.5 °C). Then, flasks 1A - 1C were taken from the
shaker, samples were taken, membrane filtrated and analysed for Silicon via ICP-OES on
day 3 (flasks 1A, 1B, 1C). Because of an upward tendency in the three values on day 3 the
test was prolonged. Due to a difference of less than 15 % in the concentrations on days 7
and 8 and no upward tendency in the last three values, the test was finished.
No Tyndall effect (i.e. a laser beam was not scattered when transmitted through the liquid)
could be observed indicating that no colloidal dispersed particles were present.
All measurements using Tyndall device lay below LOD of the method (< 2 mg/L particle
concentration).
At the plateau, the concentration of the test item AEROSIL® OX 50 (UB 862812) using
ICP-OES was calculated based on the measured Silicon concentrations in flasks 1A-C
(mean, 6 – 8 d) and 2 – 4 and the Silicon content in the test item as 111.7 ± 1.7 mg/L.
Additionally, the concentration of Silicon in the filtrated solutions (flasks 1C and flasks 2 –
4) was determined using photometry for comparison of the results with the first measurement
via ICP-OES. The mean concentration of the test item AEROSIL® OX 50 (UB
862812) in the four replicates was 124.0 ± 1.7 mg/L.
The determination of the solubility of the test item in water using two different methods
(ICP-OES and photometry) showed similar results. The solubility of the test item was stated
as
117.9 ± 6.7 mg/L at 20.0 ± 0.5 °C
= 1.179 ± 0.067 * 10-1 kg/m3 (SI units)
(mean value of two methods ± standard deviation of eight individual values (six vessels),
nominal concentration 50 g/L)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12.01.2016-11.02.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Name: AEROSIL® 200 Pharma
Lot nos.: 155070414 (15121707G), 155101214 (15121708G), 155120414 (15121709G), 155120514 (15121710G), 155120614 (15121711G)
Appearance: white powder
Composition: Silicon dioxide, chemically prepared
Purity 99.0-100.5% (acc. Ph.Eur., USP/NF; JP)
Homogeneity: homogeneous
Expiry dates: 03. Jul. 2017 (15121707G) 11. Oct. 2017 (15121708G), 03. Dec. 2017 (15121709G), 04. Dec. 2017 (15121710G), 05. Dec. 2017 (15121711G)
Specific surface area: 202 m2/g (15121707G), 210 m2/g (15121708G), 203 m2/g (15121709G), 208 m2/g (15121710G), 206 m2/g (15121711G)
Storage: Room Temperature (20 ± 5°C)
CAS No. 112945-52-5
Molecular formula: SiO2
Molecular weight: 60 g/mol - Key result
- Water solubility:
- >= 193.5 - <= 209.3 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- >= 1 - <= 4 d
- Temp.:
- 20 °C
- pH:
- >= 5 - <= 6
- Details on results:
- The determination of the solubility of the test items in water using two different methods
(ICP-OES and photometry) showed similar results. The total mean of the water solubility of the test items was
stated as 201.6 ± 5.3 mg/L (total mean value of two methods and five lots). - Conclusions:
- The determination of the solubility of the test items in water using two different methods
(ICP-OES and photometry) showed similar results. The total mean of the water solubility of the test items was
stated as 201.6 ± 5.3 mg/L (mean value of two methods). - Executive summary:
The solubility of AEROSIL® 200 Pharma (5 lots) in water was determined by
measurement of the Silicon concentrations in filtrated test solutions with the nominal concentration
50 g/L. The content of Silicon in the test item was calculated from the molecular
formula as 46.75 %.
Two different analytical methods were used for the determination of Silicon in the test item
solutions. The measurements from the flasks 1A-C and 2 – 4 were used in the calculation
of the mean. Potentially available undissolved particles in the filtrated test item solutions
were measured using Tyndall device.
Using ICP-OES, the water solubility of the test item lay in the range of 193.5 – 209.3 mg/L
(all lots). Additionally, the concentration of Silicon in the filtrated solutions (flasks 1C, 2 – 4)
was determined via photometry. The concentration of the test item was calculated based
on the measured Silicon concentrations and the Silicon content in the test item (46.75 %)
and lay in the range of 195.3 – 208.1 mg/L (five lots).
Mean of all lots was stated as 201.6 ± 5.3 mg/L (relative standard deviation 2.6 %).
Therefore, determination of the solubility of the test item in water using two different methods
(ICP-OES and photometry) showed similar results for each lot.
The filtrated solutions of the test items 15121707G, 15121708G and 15121709G were
measured via Tyndall device after storage of the solutions for approx. 3 weeks in the
fridge. The other samples (15121710G and 15121711G) were stored at room temperature
and filtrated before measurement. All measurements using Tyndall device lay below the
LOD of the method (< 3 mg/L particle concentration).
No observations arousing doubts concerning the accuracy of the results and the validity of
the study were made.
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08.03.2018 - 18.05.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Designation in Test Facility: 17121903G
Date of Receipt: 20. Dec. 2017
Condition at Receipt: room temperature, in proper conditions
Name: CAB-O-SIL® high BET Untreated Fumed Silica
Batch no.: 4418650A-1
Other Designation: 17122001M
Appearance: white powder
Composition: 100% synthetic amorphous silica
CAS No.: 112945-52-5 (pyrogenic); 7631-86-9 (generic)
EINECS-No.: 231-545-4
Molecular formula: SiO2
Molecular weight: 60.074 g/mol
Homogeneity: homogeneous
Production date: 19. Sep. 2017
Expiry date: Shelflife is 24 months from production date
Storage: Room Temperature (20 ± 5°C); Keep away from humidity;
Keep away from volatile chemicals - Key result
- Water solubility:
- >= 225.8 - <= 239.4 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- > 1 - < 3 d
- Temp.:
- 20 °C
- pH:
- >= 6 - <= 7
- Remarks on result:
- other: Main Test 1
- Key result
- Water solubility:
- >= 216 - <= 237 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- >= 1 - <= 3 d
- Temp.:
- 20 °C
- pH:
- 4.08 - 4.18
- Remarks on result:
- other: Main Test 2
- Details on results:
- The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results.
The solubility of the test item in the main test 1 was stated as:
232.6 ± 6.8 mg/L at 20.0 °C
= 232.6 ± 6.8 * 10-3 kg/m3 (SI units).
The solubility of the test item in the main test 2 was stated as:
226.5 ± 10.5 mg/L at 20.0 ± 0.5 °C
= 226.5 ± 10.5 * 10-3 kg/m3 (SI units).
The recovery rate of the test item in the main test 2 in comparison to the main test 1 was
97.4 %. - Conclusions:
- The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results.
The solubility of the test item in the main test 1 was stated as:
232.6 ± 6.8 mg/L at 20.0 °C
= 232.6 ± 6.8 * 10-3 kg/m3 (SI units).
The solubility of the test item in the main test 2 was stated as:
226.5 ± 10.5 mg/L at 20.0 ± 0.5 °C
= 226.5 ± 10.5 * 10-3 kg/m3 (SI units).
The recovery rate of the test item in the main test 2 in comparison to the main test 1 was
97.4 %. - Executive summary:
The solubility of the test item CAB-O-SIL® high BET Untreated Fumed Silica in water was
determined by measurement of the Silicon concentration in the filtrated test solutions using
two different methods, ICP-OES and photometry. Potentially available undissolved particles
in the filtrated test item solutions were measured using Tyndall device. The concentration
of the test item was calculated from the silicon content of 46.75 % (100 % purity of the
test item).
The preliminary test which is described in the guideline was not performed as the solubility
of the test item was performed analogous to all silica samples. Therefore, the flask method
was used.
The main test was performed two times (in March and May 2018) for characterization purposes
(request by sponsor).
In both main tests, 50 g/L test item in water were used for the test. Six individual flasks
(flasks 1A - 1C and 2 – 4) were prepared. Five vessels (blank, flasks 1C (for the sampling
point 72 h) and 2 – 4) were set onto the shaking apparatus immediately. After 24 ± 2
hours, flask 1B (for the sampling point 48 h) and after further 24 ± 2 hours, flask 1A (for the
sampling point 24 h) were set on the shaker and all flasks were shaken for further 24 ± 2
hours at room temperature. Then, flasks 1A - 1C were taken from the shaker, tempered at
20.0 ± 0.5 °C, samples were taken, membrane filtrated and analysed for Silicon via ICPOES
on day 3 (flasks 1A, 1B, 1C). Due to a difference of less than 15 % in the concentrations
on days 2 and 3 and no upward tendency, both tests were finished on day 3. Therefore,
on the same day 3, flasks 2 – 4 were sampled and analysed for Silicon in the same
fashion.
No Tyndall effect (i.e. a laser beam was not scattered when transmitted through the liquid)
could be observed indicating that no colloidal dispersed particles were present.
All measurements using Tyndall device lay below LOD of the method (< 3 mg/L particle
concentration).
The solubility of the test item in the main test 1 was stated as:
232.6 ± 6.8 mg/L at 20.0 °C
= 232.6 ± 6.8 * 10-3 kg/m3 (SI units).
The solubility of the test item in the main test 2 was stated as:
226.5 ± 10.5 mg/L at 20.0 ± 0.5 °C
= 226.5 ± 10.5 * 10-3 kg/m3 (SI units).
The recovery rate of the test item in the main test 2 in comparison to the main test 1 was
97.4 %.
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan. 28 - Feb. 8, 2019 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 2014
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- DAVISIL XWP1500A
- Key result
- Water solubility:
- >= 82 - <= 90.4 mg/L
- Loading of aqueous phase:
- 50 g/L
- Incubation duration:
- 11 d
- Temp.:
- 20 °C
- pH:
- >= 6 - <= 7.26
- Details on results:
- At the plateau, the concentration of the test item DAVISIL XWP1500A 90-130μ using ICP-OES was calculated based on the measured Silicon concentrations in flasks 1A-C (8 – 11 d) and 2 – 4 and the Silicon content in the test item was determined as 83.5 ± 1.0 mg/L.
Additionally, on day 11, the concentration of Silicon in the filtrated solutions (flasks 1C and flasks 2 – 4) was determined using photometry for comparison of the results with the first measurement via ICP-OES. The mean concentration of the test item DAVISIL XWP1500A 90-130μ in the four replicates was 90.9 ± 5.0 mg/L.
The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results. The solubility of the test item was stated as 87.2 ± 5.2 mg/L at 20.0 ± 0.5 °C = 8.72 ± 0.52* 10^-2 kg/m3 (SI units) (mean value of two methods ± standard deviation of eight individual values (six vessels), nominal concentration 50 g/L). - Conclusions:
- The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results. The water solubility of the test item was stated as 87.2 ± 5.2 mg/L (mean value of two methods).
- Executive summary:
The solubility of DAVISIL XWP1500A 90-130μ in water was determined by measurement of the Silicon concentrations in filtrated test solutions with the nominal concentration 50 g/L.
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.09.2017-29.09.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Designation in Test Facility: 17071805G
Date of Receipt: 18. Jul. 2017
Condition at Receipt: Room temperature, in proper conditions
Name: WACKER HDK® T30
Batch no.: VK78834
Appearance: white powder
Composition: pure silica
CAS No.: 112945-52-5
Molecular formula: SiO2
Purity: 99.8%
Homogeneity: homogeneous
Expiry date: at least end of 2018
Specific surface area: 290 m2/g
Storage: Room Temperature (20 ± 5°C), keep away from humidity - Key result
- Water solubility:
- >= 217.1 - <= 228.5 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- >= 1 - <= 3 d
- Temp.:
- 20.5 °C
- pH:
- >= 3.58 - <= 6
- Details on results:
- The determination of the solubility of the test item in water using two different methods
(ICP-OES and photometry) showed very similar results. The solubility of the test item was
stated as 222.8 ± 5.7 mg/L at 20.5 °C - Conclusions:
- The determination of the solubility of the test item in water using two different methods
(ICP-OES and photometry) showed very similar results. The water solubility of the test
item was stated as 222.8 ± 5.7mg/L (mean value of two methods). - Executive summary:
The solubility of the test item WACKER HDK® T30 in water was determined by measurement
of the Silicon concentration in the filtrated test solutions using two different methods,
ICP-OES and photometry. Potentially available undissolved particles in the filtrated test
item solutions were measured using Tyndall device.
The solubility of the test item was provided by the sponsor to be > 10 mg/L and therefore
the preliminary test described in the guideline was not performed. Following the guideline,
the flask method was used for the determination of the solubility of the test item in water.
In the main test, 50 g/L test item in water were used for the test. Six individual flasks
(flasks 1A – 1C and 2 – 4) were prepared. Five vessels (blank, flasks 1C (for the sampling
point 72 h) and 2 – 4) were set onto the shaking apparatus immediately. After 24 ± 2
hours, flask 1B (for the sampling point 48 h) and after further 24 ± 2 hours, flask 1A (for the
sampling point 24 h) were set on the shaker and all flasks were shaken for further 24 ± 2
hours at room temperature (20.0 ± 0.5 °C). Then, flasks 1A - 1C were taken from the
shaker, samples were taken, membrane filtrated and analysed for Silicon via ICP-OES on
day 3 (flasks 1A, 1B, 1C). Due to a difference of less than 15 % in the concentrations on
days 2 and 3 and no upward tendency in the three values, the test was finished on day 3.
Therefore, on the same day 3, flasks 2 – 4 were sampled and analysed for Silicon in the
same fashion.
No Tyndall effect (i.e. a laser beam was not scattered when transmitted through the liquid)
could be observed indicating that no colloidal dispersed particles were present.
All measurements using Tyndall device lay below LOD of the method (< 3 mg/L particle
concentration).
At the plateau, the concentration of the test item WACKER HDK® T30 using ICP-OES was
calculated based on the measured Silicon concentrations in flasks 1A-C and 2 – 4 and the
Silicon content in the test item as 220.2 ± 7.7 mg/L.
Additionally, on day 3, the concentration of Silicon in the filtrated solutions (flasks 1C and
flasks 2 – 4) was determined using photometry for comparison of the results with the first
measurement via ICP-OES. The mean concentration of the test item WACKER HDK® T30
in the four replicates was 225.4 ± 0.2 mg/L.
The determination of the solubility of the test item in water using two different methods
(ICP-OES and photometry) showed very similar results. The solubility of the test item was
stated as
222.8 ± 5.7 mg/L at 20.5 °C
= 2.228 ± 0.057* 10-1 kg/m3 (SI units)
(mean value of two methods ± standard deviation of eight individual values (six vessels),
nominal concentration 50 g/L)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.12.2014 - 23.03.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Designation in Test Facility: 14111307G
Date of Receipt: 13. Nov. 2014
Condition at Receipt: room temperature, in proper conditions
Name: Perkasil SM 660
Batch no.: 1403257006
Appearance: white powder
Composition: 95-100% SiO2
CAS No.: 7631-86-9
EINECS-No.: 231-545-4
Molecular formula: SiO2
Molecular weight: 60.08 g/mol
Purity: ≥ 95%
Homogeneity: homogeneous
Vapour pressure: 0 hPa at 20 °C
Stability: stable
Solubility: slightly soluble >10 mg/L
Production date: Mar. 2014
Expiry date: Dec. 2018
Storage: not stated
BET surface area: 182 m2/g - Key result
- Water solubility:
- >= 102.5 - <= 113.7 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- > 1 - < 3 d
- Temp.:
- 20 °C
- pH:
- >= 6 - <= 6.93
- Details on results:
- The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results. The solubility of the test item was stated as
108.1 ± 5.6 mg/L at 20.0 ± 0.5 °C
(mean value of two methods ± standard deviation of eight individual values (six vessels), nominal concentration 50 g/L) - Conclusions:
- The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results. The solubility of the test item was stated as
108.1 ± 5.6 mg/L at 20.0 ± 0.5 °C
(mean value of two methods ± standard deviation of eight individual values (six vessels), nominal concentration 50 g/L) - Executive summary:
The solubility of the test item Perkasil SM 660 in water was determined by measurement
of the Silicon concentration in the filtrated test solutions using two different methods, ICPOES
and photometry. Potentially available undissolved particles in the filtrated test item
solutions were measured using Tyndall device.
The solubility of the test item was provided by the sponsor to be > 10 mg/L and therefore
the preliminary study described in the guideline was not performed. Following the guideline,
the flask method was used for the determination of the solubility of the test item in
water.
In the main study, after consultation with the sponsor, 50 g/L test item in water were used
for the test. Six individual flasks (flasks 1A - 1C and 2 – 4) were prepared. Four vessels
(flasks 1C (for the sampling point 72 h) and 2 – 4) were set onto the shaking apparatus
immediately. After 24 ± 2 hours, flask 1B (for the sampling point 48 h) and after further 24
± 2 hours, flask 1A (for the sampling point 24 h) were set on the shaker and all flasks were
shaken for further 24 ± 2 hours at room temperature (20.0 ± 0.5 °C). Then, flasks 1A - 1C
were taken from the shaker, samples were taken, membrane filtrated and analysed for
Silicon via ICP-OES on day 3 (flasks 1A, 1B, 1C). Because of a difference of less than 15
% in the concentrations on days 2 and 3 and no upward tendency, the test was finished on
day 3. Therefore, on the same day 3, flasks 2 – 4 were sampled and analysed for Silicon
in the same fashion. No Tyndall effect (i.e. a laser beam was not scattered when transmitted
through the liquid) could be observed indicating that no colloidal dispersed particles
were present.
For the determination of the filtrated test solutions using Tyndall device three flasks 5 – 7
were prepared with the nominal concentration 50 g/L and the flasks were shaken for 72 ±
2 h. All measurements using Tyndall device lay below LOQ of the method (< 4 mg/L particle
concentration).
At the plateau, the concentration of the test item Perkasil SM 660 using ICP-OES was calculated
based on the measured Silicon concentrations in flasks 1A-C and 2 – 4 and the
Silicon content in the test item as 113.3 ± 0.5 mg/L.
Additionally, on day 3, the concentration of Silicon in the filtrated solutions (flasks 1C and
flasks 2 – 4) was determined using photometry for comparison of the results with the first
measurement via ICP-OES. The mean concentration of the test item Perkasil SM 660 in
the four replicates was 102.9 ± 1.2 mg/L.
Therefore, the determination of the solubility of the test item in water using two different
methods (ICP-OES and photometry) showed similar results. The solubility of the test item
was stated as
108.1 ± 5.6 mg/L at 20.0 ± 0.5 °C
= 1.081 ± 0.056 * 10-1 kg/m3 (SI units)
(mean value of two methods ± standard deviation of eight individual values (six vessels),
nominal concentration 50 g/L)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19.01.2016-16.02.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Designation in Test Facility: 15121713G, 15121714G, 15121715G, 15121716G, 15121717G
Date of Receipt: 17. Dec. 2015
Condition at Receipt: room temperature, in proper conditions
Name: SIPERNAT® 22 S ex WES, Germany
Batch nos.: 195111223 (15121713G), 195120323 (15121714G), 195120523 (15121715G), 195120623 (15121716G), 195120823 (15121717G)
Appearance: white powder
Composition: Silicon dioxide, chemically prepared
Purity: ≥ 97 % (foll. ISO 3262-19)
Homogeneity: homogeneous
Expiry date: 11. Nov. 2017 (15121713G), 02. Dec. 2017 (15121714G), 04. Dec. 2017 (15121715G), 05. Dec. 2017 (15121716G), 07. Dec. 2017 (15121717G)
Specific surface area: 187 m2/g (15121713G), 185 m2/g (15121714G), 184 m2/g (15121715G), 188 m2/g (15121716G), 190 m2/g (15121717G)
Storage: Room temperature: 20 ± 5 °C, keep away from humidity
CAS No.: 112926-00-8, 7631-86-9
Molecular formula: SiO2
Molecular weight: 60 g/mol - Key result
- Water solubility:
- >= 111 - <= 112.8 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- >= 1 - <= 3 d
- Temp.:
- 20 °C
- pH:
- >= 5 - <= 6
- Details on results:
- The determination of the solubility of five batches of the test item in water using two different
methods (ICP-OES and photometry) showed very similar results for each batch. The total mean value of the solubility of the test items was
stated as111.9 ± 0.9 mg/L at 20.0 °C - Conclusions:
- The determination of the solubility of five batches of the test item in water using two different methods (ICP-OES and photometry) showed very similar results for each batch. The total mean value of the solubility of the test items was stated as111.9 ± 0.9 mg/L at 20.0 °C
- Executive summary:
The solubility of the test item SIPERNAT® 22 S ex WES, Germany (five batches) in water
was determined by measurement of the Silicon concentration in the filtrated test solutions
using two different methods, ICP-OES and photometry. The concentration of the test item
was calculated based on the measured Silicon concentrations and the Silicon content in
the test item (45.35 %). Potentially available undissolved particles in the filtrated test item
solutions were measured using Tyndall device.
The solubility of the test item was provided by the sponsor to be > 10 mg/L and therefore
the preliminary test described in the guideline was not performed. Following the guideline,
the flask method was used for the determination of the solubility of the test item in water.
In the main test, after consultation with the sponsor, 50 g/L test item in water were used for
the test. Six individual flasks (flasks 1A - 1C and 2 – 4) were prepared with the same nominal
load. For each batch the same procedure was performed. Five vessels (blank, flasks
1C (for the sampling point 72 h) and 2 – 4) were set onto the shaking apparatus immediately.
After 24 ± 2 hours, flask 1B (for the sampling point 48 h) and after further 24 ± 2
hours, flask 1A (for the sampling point 24 h) were set on the shaker and all flasks were
shaken for further 24 ± 2 hours at room temperature (20.0 ± 0.5 °C). Then, flasks 1A - 1C
were taken from the shaker, samples were taken, membrane filtrated and analysed for
Silicon via ICP-OES on day 3 (flasks 1A, 1B, 1C). Because of a difference of less than
15 % in the concentrations on days 2 and 3 and no upward tendency, the test was finished
on day 3. The final measurement was performed as determination from flasks 2 – 4 in the
same fashion.
Additionally, the test solutions from the flasks 1C and 2 – 4 were measured using photometry
on day 3. The solutions from the flasks 2 – 4 were examined for colloidal particles by
testing the solution using Tyndall device. All measurements using Tyndall device lay below
LOD of the method (< 3 mg/L particle concentration).
The determination of the solubility of five batches of the test item in water using two different
methods (ICP-OES and photometry) showed very similar results for each batch. The total mean value of the solubility of the test items was
stated as111.9 ± 0.9 mg/L at 20.0 °C
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.11.2012 - 30.11.2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Designation in Test Facility: 12101103G
Date of Receipt: 11. Oct. 2012
Condition at Receipt: room temperature, in proper conditions
Name: Sylodent VP5
Batch no.: 1208257029
Appearance: white powder
Composition: SiO2 synthetic amorph
CAS No.: 7631-86-9
EINECS-No.: 231-545-4
Molecular formula: SiO2
Molecular weight: not stated
Purity: ≥ 95% SiO2
Homogeneity: homogeneous material
Solubility: H2O: 01-1 g/L; EtOH; acetone; CH3CN; DMSO: not stated
Production date: 08. Aug. 2012
Expiry date: 08. Aug. 2014
Storage: room temperature
Stability: H2O: 96 h; EtOH; acetone; CH3CN; DMSO: not stated - Key result
- Water solubility:
- >= 102.3 - <= 114.3 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- > 1 - < 3 d
- Temp.:
- 20 °C
- pH:
- >= 6 - <= 6.58
- Details on results:
- The determination of the solubility of the test item in water using two different methods (AAS and photometry) showed identical results. Allmeasurements were used for calculation of water solubility of the test item. The solubility of the test item was stated as
108.3 ± 6.0 mg/L at 20.0 ± 0.3 °C
(mean value of two methods ± standard deviation of nine individual measurements (five vessels), nominal concentration 50 g/L) - Conclusions:
- The determination of the solubility of the test item in water using two different methods (AAS and photometry) showed identical results. Allmeasurements were used for calculation of water solubility of the test item. The solubility of the test item was stated as
108.3 ± 6.0 mg/L at 20.0 ± 0.3 °C
(mean value of two methods ± standard deviation of nine individual measurements (five vessels), nominal concentration 50 g/L) - Executive summary:
The solubility of the test item Sylodent VP5 in water was determined by measuring of Silicium concentration in the filtrated test solutions using two different methods, AAS
and photometry.
The solubility of the test item was provided by the sponsor to be > 10 mg/L and therefore the preliminary study described in the guideline was not performed. According to the guideline, the flask method was used for the determination of the solubility of the test item in water.
In the main study, 50 g/L test item in water were used for the test. Six individual flasks (flasks 1A - 1C and 2 – 4) were prepared. Four vessels (flasks 1C (for the sampling point 72 h) and 2 – 4) were set onto the shaking apparatus immediately. After 24 ± 2 hours, flask 1B (for the sampling point 48 h) and after further 24 ± 2 hours, flask 1A (for the sampling point 24 h) were set on the shaker and all flasks were shaken for further 24 ± 2 hours at room temperature (20.0 ± 0.5 °C). Then, flasks 1A - 1C
were taken from the shaker and stored at 20.0 ± 0.5 °C. Samples were taken, membrane filtrated and analysed for Silicium via AAS. No difference above 15 % and no rising tendency in the Silicium concentration of the solutions were determined between sampling dates 2 and 3, indicating that the maximum concentration of the test item had been reached. Therefore, on the same day 3, flasks 2 – 4 were sampled and analysed for Silicium in the same fashion. No Tyndall effect (i.e. a laser beam was not scattered when transmitted through the liquid) could be observed indicating that no colloidal dispersed particles were present.
At the plateau, the concentration of the test item Sylodent VP5 was calculated based on the measured Silicium concentrations in flasks 1B-C and 2 – 4 and the Silicium
content in the test item as 104.1 ± 4.6 mg/L. Additionally, on day 3, the concentration of Silicium in the filtrated solutions (flasks 1C and flasks 2 – 4) was determined using photometry for comparison of the results with the first measurement via AAS. The mean concentration of the test item Sylodent VP5 in the four replicates was 113.5 ± 1.0 mg/L.
Therefore, the determination of the solubility of the test item in water using two different methods (AAS and photometry) showed identical results. The solubility of the test item was stated as
The determination of the solubility of the test item in water using two different methods (AAS and photometry) showed identical results. Allmeasurements were used for calculation of water solubility of the test item. The solubility of the test item was stated as
108.3 ± 6.0 mg/L at 20.0 ± 0.3 °C
= 1.083 ± 0.060 * 10-1kg/m3 (SI units)
(mean value of two methods ± standard deviation of nine individual measurements (five vessels), nominal concentration 50 g/L)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.11.2014 - 24.03.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Designation in Test Facility: 14111305G
Date of Receipt: 13. Nov. 2014
Condition at Receipt: room temperature, in proper conditions
Name: Syloid 244 FP
Batch no.: 1000222580
Appearance: white powder
Composition: 95-100% SiO2
CAS No.: 7631-86-9
EINECS-No.: 231-545-4
Molecular formula: SiO2
Molecular weight: 60.08 g/mol
Purity: ≥ 95%
Homogeneity: homogeneous
Vapour pressure: 0 hPa at 20 °C
Stability: stable
Solubility: slightly soluble >10 mg/L
Production date: Mar. 2012
Expiry date: Dec. 2018
Storage: not stated
BET surface area: 349 m2/g - Key result
- Water solubility:
- >= 95.4 - <= 100.8 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- > 1 - < 4 d
- Temp.:
- 20 °C
- pH:
- >= 1.16 - <= 7.62
- Details on results:
- The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results. The solubility of the test item was stated as
98.1 ± 2.7 mg/L at 20.0 ± 0.5 °C
(mean value of two methods ± standard deviation of ten individual values (five vessels), nominal concentration 50 g/L) - Conclusions:
- The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results. The solubility of the test item was stated as
98.1 ± 2.7 mg/L at 20.0 ± 0.5 °C
(mean value of two methods ± standard deviation of ten individual values (five vessels), nominal concentration 50 g/L) - Executive summary:
The solubility of the test item Syloid 244 FP in water was determined by measurement of
the Silicon concentration in the filtrated test solutions using two different methods, ICPOES
and photometry. Potentially available undissolved particles in the filtrated test item
solutions were measured using Tyndall device.
The solubility of the test item was provided by the sponsor to be > 10 mg/L and therefore
the preliminary study described in the guideline was not performed. Following the guideline,
the flask method was used for the determination of the solubility of the test item in
water.
In the main study, 50 g/L test item in water were used for the test. Six individual flasks
(flasks 1A - 1C and 2 – 4) were prepared. Four vessels (flasks 1C (for the sampling point
72 h) and 2 – 4) were set onto the shaking apparatus immediately. After 24 ± 2 hours,
flask 1B (for the sampling point 48 h) and after further 24 ± 2 hours, flask 1A (for the sampling
point 24 h) were set on the shaker and all flasks were shaken for further 24 ± 2 hours
at room temperature (20.0 ± 0.5 °C). Then, flasks 1A - 1C were taken from the shaker,
samples were taken, membrane filtrated and analysed for Silicon via ICP-OES on day 3
(flasks 1A, 1B, 1C). Due to the upward tendency in the flasks 1A – C, the flask 1C was
additionally measured on the following day 4. Because of a difference of less than 15 % in
the concentrations on days 3 and 4 and no upward tendency, the test was finished on day
4. Therefore, on the same day 4, flasks 2 – 4 were sampled and analysed for Silicon in the
same fashion. No Tyndall effect (i.e. a laser beam was not scattered when transmitted
through the liquid) could be observed indicating that no colloidal dispersed particles were
present.
For the determination of the filtrated test solutions using Tyndall device three flasks 5 – 7
were prepared with the nominal concentration 50 g/L and the flasks were shaken for 96 ±
2 h. All measurements using Tyndall device lay below LOQ of the method (< 4 mg/L particle
concentration).
At the plateau, the concentration of the test item Syloid 244 FP using ICP-OES was calculated
based on the measured Silicon concentrations in flasks 1B-C and 2 – 4 and the Silicon
content in the test item as 96.4 ± 1.0 mg/L. The measurement from the flask 1A was
not used in the calculation of the mean, as equilibration was not reached on day 1.
Additionally, on day 4, the concentration of Silicon in the filtrated solutions (flasks 1C and
flasks 2 – 4) was determined using photometry for comparison of the results with the first
measurement via ICP-OES. The mean concentration of the test item Syloid 244 FP in the
four replicates was 100.6 ± 2.4 mg/L.
Therefore, the determination of the solubility of the test item in water using two different
methods (ICP-OES and photometry) showed similar results. The solubility of the test item
was stated as
98.1 ± 2.7 mg/L at 20.0 ± 0.5 °C
= 0.981 ± 0.027 * 10-1 kg/m3 (SI units)
(mean value of two methods ± standard deviation of ten individual values (five vessels),
nominal concentration 50 g/L)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.12.2014 - 20.03.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Designation in Test Facility: 14111306G
Date of Receipt: 13. Nov. 2014
Condition at Receipt: room temperature, in proper conditions
Name: Syloid 74 C
Batch no.: 1000240283
Appearance: white powder
Composition: 95-100% SiO2
CAS No.: 7631-86-9
EINECS-No.: 231-545-4
Molecular formula: SiO2
Molecular weight: 60.08 g/mol
Purity: ≥ 95%
Homogeneity: homogeneous
Vapour pressure: 0 hPa at 20 °C
Stability: stable
Solubility: slightly soluble >10 mg/L
Production date: Mar. 2013
Expiry date: Dec. 2018
Storage: not stated
BET surface area: 377 m2/g - Key result
- Water solubility:
- >= 102.4 - <= 109.6 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- > 1 - < 3 d
- Temp.:
- 20 °C
- pH:
- >= 6 - <= 6.97
- Details on results:
- The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results. The solubility of the test item was stated as
106.0 ± 3.6 mg/L at 20.0 ± 0.5 °C
(mean value of two methods ± standard deviation of eight individual values (five vessels), nominal concentration 50 g/L) - Conclusions:
- The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results. The solubility of the test item was stated as
106.0 ± 3.6 mg/L at 20.0 ± 0.5 °C
(mean value of two methods ± standard deviation of eight individual values (five vessels), nominal concentration 50 g/L) - Executive summary:
The solubility of the test item Syloid 74 C in water was determined by measurement of the Silicon concentration in the filtrated test solutions using two different methods, ICP-OES and photometry. Potentially available undissolved particles in the filtrated test item solutions were measured using Tyndall device.
The solubility of the test item was provided by the sponsor to be > 10 mg/L and therefore the preliminary study described in the guideline was not performed. Following the guideline, the flask method was used for the determination of the solubility of the test item in water.
In the main study, after consultation with the sponsor, 50 g/L test item in water were used for the test. Six individual flasks (flasks 1A - 1C and 2 – 4) were prepared. Four vessels (flasks 1C (for the sampling point 72 h) and 2 – 4) were set onto the shaking apparatus immediately. After 24 ± 2 hours, flask 1B (for the sampling point 48 h) and after further 24 ± 2 hours, flask 1A (for the sampling point 24 h) were set on the shaker and all flasks were shaken for further 24 ± 2 hours at room temperature (20.0 ± 0.5 °C). Then, flasks 1A - 1C were taken from the shaker, samples were taken, membrane filtrated and analysed for
Silicon via ICP-OES on day 3 (flasks 1A, 1B, 1C). Because of a difference of less than 15 % in the concentrations on days 2 and 3 and no upward tendency, the test was finished on day 3. Therefore, on the same day 3, flasks 2 – 4 were sampled and analysed for Silicon in the same fashion. No Tyndall effect (i.e. a laser beam was not scattered when transmitted through the liquid) could be observed indicating that no colloidal dispersed particles were present.
For the determination of the filtrated test solutions using Tyndall device three flasks 5 – 7 were prepared with the nominal concentration 50 g/L and the flasks were shaken for 72 ± 2 h. All measurements using Tyndall device lay below LOQ of the method (< 4 mg/L particle concentration).
At the plateau, the concentration of the test item Syloid 74 C using ICP-OES was calculated based on the measured Silicon concentrations in flasks 1B-C and 2 – 4 and the Silicon content in the test item as 103.0 ± 0.5 mg/L. The measurement from the flask 1A was stated as outlier and was not used in the calculation of the mean. Additionally, on day 3, the concentration of Silicon in the filtrated solutions (flasks 1C and flasks 2 – 4) was determined using photometry for comparison of the results with the first measurement via ICP-OES. The mean concentration of the test item Syloid 74 C in the four replicates was 109.0 ± 2.6 mg/L.
Therefore, the determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results. The solubility of the test item was stated as 106.0 ± 3.6 mg/L at 20.0 ± 0.5 °C = 1.06 ± 0.036 * 10-1 kg/m3 (SI units)
(mean value of two methods ± standard deviation of eight individual values (five vessels), nominal concentration 50 g/L)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.11.2014 - 19.03.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Designation in Test Facility: 14111304G
Date of Receipt: 13. Nov. 2014
Condition at Receipt: room temperature, in proper conditions
Name: Syloid Al - 1 FP
Batch no.: 1000265654
Appearance: white powder
Composition: 95-100% SiO2
CAS No.: 7631-86-9
EINECS-No.: 231-545-4
Molecular formula: SiO2
Molecular weight: 60.08 g/mol
Purity: ≥ 95%
Homogeneity: homogeneous
Vapour pressure: 0 hPa at 20 °C
Stability: stable
Solubility: slightly soluble >10 mg/L
Production date: Sep. 2014
Expiry date: Dec. 2018
Storage: not stated
BET surface area: 781 m2/g - Key result
- Water solubility:
- >= 139.5 - <= 146.3 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- > 1 - < 3 d
- Temp.:
- 20 °C
- pH:
- >= 5.73 - <= 6
- Details on results:
- The determination of the solubility of the test item in water using two different
methods (ICP-OES and photometry) showed similar results. The solubility of the test item
was stated as
142.9 ± 3.4 mg/L at 20.0 ± 0.5 °C
(mean value of two methods ± standard deviation of nine individual values (five vessels),
nominal concentration 50 g/L) - Conclusions:
- The determination of the solubility of the test item in water using two different
methods (ICP-OES and photometry) showed similar results. The solubility of the test item
was stated as
142.9 ± 3.4 mg/L at 20.0 ± 0.5 °C
(mean value of two methods ± standard deviation of nine individual values (five vessels),
nominal concentration 50 g/L) - Executive summary:
The solubility of the test item Syloid Al - 1 FP in water was determined by measurement of
the Silicon concentration in the filtrated test solutions using two different methods, ICPOES
and photometry. Potentially available undissolved particles in the filtrated test item
solutions were measured using Tyndall device.
The solubility of the test item was provided by the sponsor to be > 10 mg/L and therefore
the preliminary study described in the guideline was not performed. Following the guideline,
the flask method was used for the determination of the solubility of the test item in
water.
In the main study, 50 g/L test item in water were used for the test. Six individual flasks
(flasks 1A - 1C and 2 – 4) were prepared. Four vessels (flasks 1C (for the sampling point
72 h) and 2 – 4) were set onto the shaking apparatus immediately. After 24 ± 2 hours,
flask 1B (for the sampling point 48 h) and after further 24 ± 2 hours, flask 1A (for the sampling
point 24 h) were set on the shaker and all flasks were shaken for further 24 ± 2 hours
at room temperature (20.0 ± 0.5 °C). Then, flasks 1A - 1C were taken from the shaker,
samples were taken, membrane filtrated and analysed for Silicon via ICP-OES on day 3
(flasks 1A, 1B, 1C). Because of a difference of less than 15 % in the concentrations on
days 2 and 3 and no upward tendency, the test was finished on day 3. Therefore, on the
same day 3, flasks 2 – 4 were sampled and analysed for Silicon in the same fashion.
No Tyndall effect (i.e. a laser beam was not scattered when transmitted through the liquid)
could be observed indicating that no colloidal dispersed particles were present.
For the determination of the filtrated test solutions using Tyndall device three flasks 5 – 7
were prepared with the nominal concentration 50 g/L and the flasks were shaken for 72 ±
2 h. All measurements using Tyndall device lay below LOQ of the method (< 4 mg/L particle
concentration).
At the plateau, the concentration of the test item Syloid Al - 1 FP using ICP-OES was calculated
based on the measured Silicon concentrations in flasks 1B-C and 2 – 4 and the
Silicon content in the test item as 140.2 ± 1.6 mg/L. The measurement from the flask 1A
was stated as outlier (Grubbs outlier test).
Additionally, on day 3, the concentration of Silicon in the filtrated solutions (flasks 1C and
flasks 2 – 4) was determined using photometry for comparison of the results with the first
measurement via ICP-OES. The mean concentration of the test item Syloid Al - 1 FP in the
four replicates was 146.2 ± 0.8 mg/L.
Therefore, the determination of the solubility of the test item in water using two different
methods (ICP-OES and photometry) showed similar results. The solubility of the test item
was stated as
142.9 ± 3.4 mg/L at 20.0 ± 0.5 °C
= 1.429 ± 0.034 * 10-1 kg/m3 (SI units)
(mean value of two methods ± standard deviation of nine individual values (five vessels),
nominal concentration 50 g/L)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.11.2014 - 18.03.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Designation in Test Facility: 14111303G
Date of Receipt: 13. Nov. 2014
Condition at Receipt: room temperature, in proper conditions
Name: Syloid MX 107
Batch no.: 1405280021
Appearance: white powder
Composition: 95-100% SiO2
CAS No.: 7631-86-9
EINECS-No.: 231-545-4
Molecular formula: SiO2
Molecular weight: 60.08 g/mol
Purity: ≥ 95%
Homogeneity: homogeneous
Vapour pressure: 0 hPa at 20 °C
Stability: stable
Solubility: slightly soluble >10 mg/L
Production date: May 2014
Expiry date: Dec. 2018
BET surface area: 749 m2/g - Key result
- Water solubility:
- >= 131 - <= 139.9 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- > 1 - < 3 d
- Temp.:
- 20 °C
- pH:
- >= 6 - <= 6.71
- Details on results:
- The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results. The solubility of the test item was stated as
135.4 ± 4.4 mg/L at 20.0 ± 0.5 °C
(mean value of two methods ± standard deviation of ten individual values (six vessels), nominal concentration 50 g/L) - Conclusions:
- The determination of the solubility of the test item in water using two different methods (ICP-OES and photometry) showed similar results. The solubility of the test item was stated as
135.4 ± 4.4 mg/L at 20.0 ± 0.5 °C
(mean value of two methods ± standard deviation of ten individual values (six vessels), nominal concentration 50 g/L) - Executive summary:
The solubility of the test item Syloid MX 107 in water was determined by measurement of
the Silicon concentration in the filtrated test solutions using two different methods, ICPOES
and photometry. Potentially available undissolved particles in the filtrated test item
solutions were measured using Tyndall device.
The solubility of the test item was provided by the sponsor to be > 10 mg/L and therefore,
the preliminary study described in the guideline was not performed. Following the guideline,
the flask method was used for the determination of the solubility of the test item in
water.
In the main study, after consultation with the sponsor, 50 g/L test item in water were used
for the test. Six individual flasks (flasks 1A - 1C and 2 – 4) were prepared. Four vessels
(flasks 1C (for the sampling point 72 h) and 2 – 4) were set onto the shaking apparatus
immediately. After 24 ± 2 hours, flask 1B (for the sampling point 48 h) and after further
24 ± 2 hours, flask 1A (for the sampling point 24 h) were set on the shaker and all flasks
were shaken for further 24 ± 2 hours at room temperature (20.0 ± 0.5 °C). Then, flasks 1A
- 1C were taken from the shaker, samples were taken, membrane filtrated and analysed
for Silicon via ICP-OES on day 3 (flasks 1A, 1B, 1C). Because of a difference of less than
15 % in the concentrations on days 2 and 3 and no upward tendency, the test was finished
on day 3. Therefore, on the same day 3, flasks 2 – 4 were sampled and analysed for Silicon
in the same fashion. No Tyndall effect (i.e. a laser beam was not scattered when
transmitted through the liquid) could be observed indicating that no colloidal dispersed particles
were present.
For the determination of the filtrated test solutions using Tyndall device three flasks 5 – 7
were prepared with the nominal concentration 50 g/L and the flasks were shaken for 72 ±
2 h. All measurements using Tyndall device lay below LOQ of the method (< 4 mg/L particle
concentration).
At the plateau, the concentration of the test item Syloid MX 107 using ICP-OES was calculated
based on the measured Silicon concentrations in flasks 1A-C and 2 – 4 and the Silicon
content in the test item as 133.0 ± 2.5 mg/L.
Additionally, on day 3, the concentration of Silicon in the filtrated solutions (flasks 1C and
flasks 2 – 4) was determined using photometry for comparison of the results with the first
measurement via ICP-OES. The mean concentration of the test item Syloid MX 107 in the
four replicates was 138.9 ± 4.4 mg/L.
Therefore, the determination of the solubility of the test item in water using two different
methods (ICP-OES and photometry) showed similar results. The solubility of the test item
was stated as
135.4 ± 4.4 mg/L at 20.0 ± 0.5 °C
= 1.354 ± 0.044 * 10-1 kg/m3 (SI units)
(mean value of two methods ± standard deviation of ten individual values (six vessels),
nominal concentration 50 g/L)
Referenceopen allclose all
The determined values of the dissolution test are presented in attached table 3.2-a together with the measured concentrations in each flask plotted versus time.
No linear dependency of measured concentrations on time was observed. On day 4, the plateau was considered as reached as the difference between the measured concentrations on day 4 and day 28 was lower than 15 %. As no linear dependency of measured concentrations on time was observed, the first order model was used for the determination of kinetic. The linear dependency of “ln (A / (A – Ct))” on time was observed after 2 h – 1 d only. The first order constant “k” was calculated as 1.64 1/d (mean value of the flasks 3 – 5) with the RSD of 8.7%
The conditions RSD < 10 % (within-vessel) and < 20 % (between-vessel) were fulfilled at each sampling point in all flasks. Therefore, the mean value from the flasks 3 – 5 (1 mg/L nominal load, mean value of days 4 – 28) was stated as the result of the study: 990.5 µg/L Test Item at 20.6 – 21.9 °C.
The test item was completely dissolved in pH 8.5 buffer solution (99 % dissolved part of the nominal load 1000 µg/L).
The determined values of the dissolution test are presented in attached table 3.2-a together with the measured concentrations in each flask plotted versus time.
No linear dependency of measured concentrations on time was observed. On day 4, the plateau was considered as reached as the difference between the measured concentrations on day 4 and day 28 was lower than 15 %. As no linear dependency of measured concentrations on time was observed, the first order model was used for the determination of kinetic. The linear dependency of “ln (A / (A – Ct))” on time was observed after 2 h – 1 d only. The first order constant “k” was calculated as 1.64 1/d (mean value of the flasks 3 – 5) with the RSD of 8.7%
The conditions RSD < 10 % (within-vessel) and < 20 % (between-vessel) were fulfilled at each sampling point in all flasks. Therefore, the mean value from the flasks 3 – 5 (1 mg/L nominal load, mean value of days 4 – 28) was stated as the result of the study: 990.5 µg/L Test Item at 20.6 – 21.9 °C.
The test item was completely dissolved in pH 8.5 buffer solution (99 % dissolved part of the nominal load 1000 µg/L).
117.9 ± 6.7 mg/L at 20.0 ± 0.5 °C
= 1.179 ± 0.067 * 10-1 kg/m3 (SI units)
232.6 ± 6.8 mg/L at 20.0 °C
= 232.6 ± 6.8 * 10-3 kg/m3 (SI units).
226.5 ± 10.5 mg/L at 20.0 ± 0.5 °C
= 226.5 ± 10.5 * 10-3 kg/m3 (SI units).
222.8 ± 5.7 mg/L at 20.5 °C
= 2.228 ± 0.057* 10-1 kg/m3 (SI units)
108.1 ± 5.6 mg/L at 20.0 ± 0.5 °C
= 1.081 ± 0.056 * 10-1 kg/m3 (SI units)
108.3 ± 6.0 mg/L at 20.0 ± 0.3 °C
= 1.083 ± 0.060 * 10-1 kg/m3 (SI units)
98.1 ± 2.7 mg/L at 20.0 ± 0.5 °C
= 0.981 ± 0.027 * 10-1 kg/m3 (SI units)
106.0 ± 3.6 mg/L at 20.0 ± 0.5 °C
= 1.06 ± 0.036 * 10-1 kg/m3 (SI units)
142.9 ± 3.4 mg/L at 20.0 ± 0.5 °C
= 1.429 ± 0.034 * 10-1 kg/m3 (SI units)
135.4 ± 4.4 mg/L at 20.0 ± 0.5 °C
= 1.354 ± 0.044 * 10-1 kg/m3 (SI units)
Description of key information
Water solubility of all non surface-treated SAS types (silica gel, colloidal, precipitated and pyrogenic SAS) is in the range of 100 mg/L or higher.
Applying a modified method to accomplish sufficient material wetting, all hydrophobic SAS products analyzed (surface treated pyrogenic SAS only) exhibit a solubility between 100 and 160 mg/L in 10 % ethanol/water. It is expected, that other SAS products not tested so far will fit into that range. Thus, we conclude that the solubility of hydrophobic SAS (surface-treated SAS) products does not differ from the results of hydrophilic SAS (non-surface-treated SAS).
Key value for chemical safety assessment
Additional information
See also in IUCLID section 13 attached "Expert statement on Water solubility"
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