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EC number: 309-304-0 | CAS number: 100208-97-7
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-02-07 to 2018-03-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Deviations:
- no
- Principles of method if other than guideline:
- The solubility of the test item is below 0.01 g/L, so the column elution method should be applied according to the guideline. However, column elution method is not feasible with this test item, because coating of the support material is not possible due to the low solubility of the test item in any solvent. Therefore, the flask method was applied.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Reference substance name:
- 2-Naphthalenesulfonic acid, 5(or 8)-amino-, reaction products with 4-aminophenol and sodium sulfide (Na2(Sx))
- EC Number:
- 309-304-0
- EC Name:
- 2-Naphthalenesulfonic acid, 5(or 8)-amino-, reaction products with 4-aminophenol and sodium sulfide (Na2(Sx))
- Cas Number:
- 100208-97-7
- Molecular formula:
- not applicable
- IUPAC Name:
- 2-Naphthalenesulfonic acid, 5(or 8)-amino-, reaction products with 4-aminophenol and sodium sulfide (Na2(Sx))
- Test material form:
- solid: particulate/powder
- Details on test material:
- Test Item: Leuco Sulfur Blue 15
Appearance: Dark, near black powder
Constituent 1
Results and discussion
Water solubilityopen allclose all
- Key result
- Water solubility:
- >= 1.36 - <= 5.2 mg/L
- Conc. based on:
- act. ingr.
- Incubation duration:
- 24 h
- Temp.:
- 20 °C
- pH:
- >= 2.97 - <= 2.99
- Key result
- Water solubility:
- >= 3.17 - <= 5.1 mg/L
- Conc. based on:
- act. ingr.
- Incubation duration:
- 48 h
- Temp.:
- 20 °C
- pH:
- > 2.92 - <= 3
- Key result
- Water solubility:
- 4.1 mg/L
- Conc. based on:
- act. ingr.
- Incubation duration:
- 72 h
- Temp.:
- 20 °C
- pH:
- >= 2.89 - <= 2.99
- Details on results:
- The measured concentrations were contant within +/- 15% and thus within the range required by the guidelines.
Any other information on results incl. tables
Table 1: Results of the determination of the test item concentrations
| Sampling time | Measured concentration of the test item [mg/L] | Measured pH | |
| Test vessels | Mean with the 95% confidence intervals | ||
| After 24 hours | 3.44 3.85 4.46 |
3.92 ± 1.28 | 2.97 2.99 3.00 |
| After 48 hours | 3.70 4.45 4.27 |
4.14 ± 0.97 | 2.98 2.95 3.00 |
| After 72 hours | 4.48 3.98 * |
4.23 | 2.89 2.91 2.99 |
| Solubility of the test item (mg/L) | 4.08 ± 0.33 |
4.1 ± 0.4 |
|
RSD% |
10 |
4 |
|
Ultra-pure water |
< LOQ |
6.73 |
|
* outlier data
Applicant's summary and conclusion
- Conclusions:
- The water solubility of the test item was assessed according to OECD Guideline 105, EU Method A.6 and US EPA OPPTS 830.7840 under GLP conditions. The water solubility of the test item was determined to be 4.1 ± 0.4 mg/L (95% confidence interval) at 20 °C +/- 1 °C using the shake-flask method.
- Executive summary:
The water solubility of the test item was assessed according to OECD Guideline 105, EU Method A.6 and US EPA OPPTS 830.7840 under GLP conditions. The solubility of the test item is below 10 E-2 g/L, so the column elution method should be applied according to the guideline. However, column elution method is not feasible with this test item, because coating of the support material is not possible due to the low solubility of the test item in any solvent. Therefore, the shake-flask method was applied. In result, the water solubility of the test item was determined to be 4.1 ± 0.4 mg/L (95% confidence interval) at 20 °C +/- 1 °C.
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