Registration Dossier
Registration Dossier
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EC number: 926-126-4 | CAS number: -
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:
- 14 November 2016 to 18 January 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Remarks:
- modified
- Key result
- Conc. based on:
- test mat.
- Incubation duration:
- 24 h
- Temp.:
- 20 °C
- pH:
- >= 8 - <= 8.8
- Remarks on result:
- other: miscible in all proportions
- Conclusions:
- The test item was determined to be miscible with water in all proportions at 20.0 ± 0.5 °C.
- Executive summary:
GUIDELINE
The determination was carried out by visual assessment, using a modified flask method designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.
RESULTS
The test item was determined to be miscible with water in all proportions at 20.0 ± 0.5 °C.
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 October 2016 to 15 November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Remarks:
- modified
- Key result
- Conc. based on:
- test mat.
- Incubation duration:
- 72 h
- Temp.:
- 20 °C
- pH:
- >= 10.8 - <= 11.3
- Remarks on result:
- other: miscible in all proportions
- Executive summary:
GUIDELINE
The determination was carried out by visual assessment, using a modified flask method designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.
RESULTS
The test item was determined to be miscible with water in all proportions at 20.0 ± 0.5 °C.
Referenceopen allclose all
TABLE 10 – SAMPLE CONCENTRATIONS, OBSERVATIONS AND SOLUTION pH
Sample |
Concentration (% w/w) |
Observations |
Solution pH |
1 |
5.1 |
Clear, colourless, single phase liquid with no visible excess, undissolved test item |
8.0 |
2 |
25.0 |
Clear, slightly straw coloured, single-phase liquid with no visible excess, undissolved test item |
8.3 |
3 |
50.1 |
Clear, straw coloured, single phase liquid with no visible excess, undissolved test item |
8.5 |
4 |
74.7 |
Clear, straw coloured, single phase liquid with no visible excess, undissolved test item |
8.7 |
5 |
94.9 |
Clear, straw coloured, single phase liquid with no visible excess, undissolved test item |
8.8 |
Overall result: Miscible in all proportions at 20.0 ± 0.5 °C
TABLE 2 – SAMPLE CONCENTRATIONS, OBSERVATIONS AND SOLUTION pH
Sample |
Concentration (% w/w) |
Observations |
Solution pH |
1 |
5.2 |
Clear, colourless, single-phase liquid with no visible excess, undissolved test item |
10.8 |
2 |
25.1 |
Clear, colourless, single-phase liquid with no visible excess, undissolved test item |
11.0 |
3 |
49.7 |
Clear, colourless, single-phase liquid with no visible excess, undissolved test item |
11.2 |
4 |
74.5 |
Clear, colourless, single-phase liquid with no visible excess, undissolved test item |
11.3 |
5 |
94.9 |
Clear, colourless, single-phase liquid with no visible excess, undissolved test item |
11.3 |
Overall result: Miscible in all proportions at 20.0 ± 0.5 °C
Description of key information
The research material and the product as manufactured were determined to be miscible in all proportions at 20.0 ± 0.5 °C by visual assessment using a modified flask method (OECD 105 and EU Method A.6).
Key value for chemical safety assessment
Additional information
GUIDELINE
The determinations were carried out by visual assessment, using a modified flask method designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.
RESULTS
The research material and the product as manufactured were determined to be miscible with water in all proportions at 20.0 ± 0.5 °C.
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