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EC number: 238-953-1 | CAS number: 14882-18-9
- 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:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 January 2010 to 1 February 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with EU and OECD guidelines and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- yes
- Remarks:
- See below
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- yes
- Remarks:
- See below
- Principles of method if other than guideline:
- Deviations from the Guideline: Deionised water was used for the determination of the solubility in water of Bismuth sub¬salicylate, instead of doubly distilled water, as validation showed, that usage of deionised water was acceptable for the determination of the solubility in water of Bismuth compounds. Additionally, commercially available doubly distilled water may have a TOC of up to 5 ppm.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Water solubility:
- >= 0.19 - <= 22.83 mg/L
- Temp.:
- 20 °C
- Remarks on result:
- other: Standard deviation of all samples was 8.9 mg/L
- Details on results:
- Most replicates showed poor correspondence. Standard deviation of all samples (flask method) was 8.90 mg/L, corresponding to a relative standard deviation of 96.7 %. The concentration of Bismuth subsalicylate in water lay in the range of 0.19 - 22.83 mg/L. During equilibration, the concentration of Bi in flask 1 had been well reproducible. Therefore, flasks 2-6 were sampled on day 4 and measured, but the values showed large variations. The repetition of sampling and measurement on day 7 gave as large variations, and only moderate correspondence to the measurements on day 4. Dependency of solubility on pH was not observed.
In comparison standard deviation of all samples (column elution method) was 0.954 mg/L, corresponding to a relative standard deviation of 4.2 %. Therefore the mean at the plateau was 22.97 ± 0.954 mg/L.
Accuracy measurements via standard addition showed a correlation of 0.997, indicating that no matrix effects were present.
A defined value for the water solubility of Bismuth subsalicylate cannot be stated. The test item doesn't show reproducible dissolution in deionised water (flask method), although the influence of oxygen was minimised by working under inert gas (Argon).
No observations arousing doubts concerning the accuracy of the results and the validity of the study were made. - Conclusions:
- Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
Using the flask method, the concentration of Bismuth subsalicylate in water (all samples) lay in the range of 0.19 - 22.83 mg/L at 20 ± 0.5 °C with a mean at the plateau 9.20 ±8.90 mg/L at 20 ± 0.5 °C (mean value ± standard deviation of six individual vessels). - Executive summary:
After two pre-tests (pre-test according guideline and column elution method), the water solubility of bismuth subsalicylate was estimated to be > 10 mg/L. Therefore, the flask method was employed. For the flask method, different amounts of the test item were weighed into each of six individual vessels, water was added to achieve concentrations ranging from 800 - 1200 mg/L, and the vessels were shaken at 19.1 - 21.7 °C.
On the days 1, 2, 3 and 4, vessel 1 was taken from the shaking apparatus and stored at 20 ± 0.5 °C for equilibration. Samples were withdrawn, filtrated and analysed using AAS as shaking of the test vessels was continued.
No differences above 15% in the concentration of the solution could be determined between the sampling dates 3 and 4, supporting the hypothesis, that the maximum concentration of the test item had been reached. Therefore, on day 4, vessels 2-6 were sampled and analysed in the same fashion. Because of high deviation of flasks 2-6 from flask 1, measurements of flasks 2 - 6 on day 7 was repeated and showed incomparable values.
Using the flask method, the concentration of Bismuth subsalicylate in water (all samples) lay in the range of 0.19 - 22.83 mg/L at 20 ± 0.5 °C with a mean at the plateau 9.20 ±8.90 mg/L at 20 ± 0.5 °C (mean value ± standard deviation of six individual vessels).
In comparison, the concentration of Bismuth subsalicylate in water (all samples) with the column elution method had reached: 22.97 ± 0.954 mg/L at 21.2 ± 0.4 °C.
Reference
Measurements during Equilibration Flask Method
The data which was acquired during equilibration is presented in the following table:
Day |
Flask |
Temperature in °C |
pH |
Dilution factor |
Bi Concentration (diluted sample) in mg/L |
Difference to previous sample % |
Concentration test item in mg/L |
1 |
1 |
20.0 |
6 |
10.1 |
1.133 |
- |
19.83 |
2 |
1 |
20.0 |
5 |
10.1 |
1.304 |
15.1 |
22.83 |
3 |
1 |
20.0 |
6 |
10.1 |
1.062 |
-18.6 |
18.59 |
4 |
1 |
20.0 |
6 |
10.1 |
0.999 |
-5.9 |
17.48 |
pH was measured using pH paper.
The concentrations of the test item were calculated from the measured Bi concentrations and the content of Bi in the test item (57.715%).
After the analysis of the sample of day 4, the plateau was considered as reached.
Measurements at Plateau Flask Method
The following table gives the values which were measured at the plateau:
Flask |
2 |
3 |
4 |
5 |
6 |
pH |
4.036 |
4.040 |
4.410 |
4.708 |
4.236 |
First Measurement (day 4) |
|||||
Concentration Bi in mg/L (diluted sample) |
0.904 |
0.477 |
0.011 (< LOQ) |
0.033 (< LOQ) |
1.189 |
Dilution factor |
10.1 |
10.1 |
10.1 |
10.1 |
10.1 |
Concentration Bi in mg/L (original sample) |
9.13 |
4.81 |
0.11 |
0.33 |
12.01 |
Concentration test item in mg/L |
15.82 |
8.34 |
0.19 |
0.58 |
20.81 |
Second Measurement (day 7) |
|||||
Concentration Bi in mg/L (diluted sample) repetition |
0.400 |
0.168 |
0.055 |
0.045 |
0.058 |
Dilution factor |
10.1 |
10.1 |
10.1 |
10.1 |
10.1 |
Concentration Bi in mg/L (original sample) repetition |
4.04 |
1.70 |
0.56 |
0.46 |
0.59 |
Concentration test item in mg/L (repetition) |
7.00 |
2.95 |
0.96 |
0.79 |
1.02 |
The measurements of the days 1 - 7 (Flask 1) were included in the calculation of the mean and presented in the following table:
Day |
Flask |
Mean Conc. (mg/L) |
Total Mean (mg/L) |
Total Stand. Dev. |
1 |
1 |
19.83 |
9.20 |
8.90 (96.7 %) |
2 |
1 |
22.83 |
||
3 |
1 |
18.59 |
||
4 |
1 |
17.48 |
||
4 |
2 |
15.82 |
||
4 |
3 |
8.34 |
||
4 |
4 |
0.19 |
||
4 |
5 |
0.58 |
||
4 |
6 |
20.81 |
||
7 |
2 |
7.00 |
||
7 |
3 |
2.95 |
||
7 |
4 |
0.96 |
||
7 |
5 |
0.79 |
||
7 |
6 |
1.02 |
The concentration of Bismuth subsalicylate in water lay in the range of 0.19 and 22.83 mg/L.
Measurements of the Test Item Column Elution Method
The analytical determinations were made using the collected aqueous fractions. The change in volume was taken into account when calculating the concentration in the original samples.
The analytical determinations which were performed are presented in the following tables: Measurements at flow rate 24.88 ml/h:Sample # |
Concentration Bi mg/L |
Dilution factor |
Factor |
Concentration Bismuth subsalicylate mg/L |
pH |
1 |
1.148 |
10.162 |
0.57715 |
20.22 |
6 |
2 |
1.330 |
10.190 |
0.57715 |
23.48 |
6 |
3 |
1.343 |
10.174 |
0.57715 |
23.67 |
6 |
4 |
1.323 |
10.186 |
0.57715 |
23.36 |
6 |
5 |
1.310 |
10.165 |
0.57715 |
23.07 |
6 |
6 |
1.334 |
10.193 |
0.57715 |
23.57 |
6 |
Sample # |
Concentration Bi mg/L |
Dilution factor |
Factor |
Concentration Bismuth subsalicylate mg/L |
pH |
7 |
1.330 |
10.208 |
0.57715 |
23.517 |
6 |
8 |
1.333 |
10.200 |
0.57715 |
23.551 |
6 |
9 |
1.300 |
10.203 |
0.57715 |
22.988 |
6 |
10 |
1.283 |
10.203 |
0.57715 |
22.684 |
6 |
11 |
1.267 |
10.182 |
0.57715 |
22.355 |
6 |
12 |
1.312 |
10.208 |
0.57715 |
23.205 |
6 |
Results Column Elution Method
The measurements of both flow rates were included in the calculation of the mean since the differences between the measured concentrations lay below 30%.
Flow Rate |
Mean Concentration (mg/L) |
Standard Deviation |
Total Mean (mg/L) |
Total Standard Deviation. |
24.88 |
22.89 |
1.328 |
22.97 |
0.954 (4.2 %) |
12.26 |
23.05 |
0.472 |
Mean at the plateau is 22.97 ± 0.954 mg/L
Description of key information
The water solubility of bismuth subsalicylate ranges from 0.19 to 22.83 mg/L (mean = 9.2 mg/L) at 20 ± 0.5 °C.
Key value for chemical safety assessment
- Water solubility:
- 9.2 mg/L
- at the temperature of:
- 20 °C
Additional information
A study was conducted to determine the water solubility of bismuth subsalicylate in accordance with OECD Guideline 105 and EU Method A.6.
Using the flask method, the concentration of bismuth subsalicylate in water (all samples) lay in the range of 0.19 - 22.83 mg/L at 20 ± 0.5 °C with a mean at the plateau 9.20 ±8.90 mg/L at 20 ± 0.5 °C (mean value ± standard deviation of six individual vessels).
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