Registration Dossier
Registration Dossier
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EC number: 695-696-1 | CAS number: 124763-51-5
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:
- from 2020-10-15 to 2020-11-16
- 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:
- yes
- Remarks:
- A procedure based on the preliminary test was carried out instead of the shake-flask test to evaluate the solubility of test Item in water.
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 2014
- Deviations:
- yes
- Remarks:
- A procedure based on the preliminary test was carried out instead of the shake-flask test to evaluate the solubility of test Item in water.
- Principles of method if other than guideline:
- A procedure based on the preliminary test was carried out instead of the shake-flask test to evaluate the solubility of test Item in water. Although, this procedure deviates from the guideline, because of the test Item properties, it is considered scientifically valid.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- other: Procedure based on the preliminary test
- Key result
- Water solubility:
- 575 g/L
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 1 000 g/L
- Temp.:
- 20 °C
- pH:
- ca. 3.2
- Conclusions:
- The water solubility of the test item was determined at 20 °C as 575 g/L with a pH of 3.2.
- Executive summary:
An experimental study was conducted according to OECD 105 and EU Regulation, method A.6 to determine the water solubility of the test item. Because of the test item properties a procedure based on the preliminary test was carried out instead of the shake-flask test to evaluate the water solubility. Therefore, about 2 g of test item was weighed into a tube and 2 mL were added. Subsequently, the concentration was determined by LC/MS/MS. Five replicates were carried out. The water solubility of the test item was determined at 20 °C as 575 g/L with a pH of 3.2.
Reference
Test vessels | Measured concentration of test Item, (g/L) | Measured pH | |
Replicates | Mean | ||
1 | 538 | 565 | 3.22 |
593 | |||
2 | 595 | 570 | 3.20 |
545 | |||
3 | 583 | 576 | 3.21 |
570 | |||
4 | 590 | 586 | 3.20 |
583 | |||
5 | 590 | 575 | 3.24 |
560 | |||
Measured concentration of the test item (g/L): | 575 | - | |
RSD%: | 1 | - | |
Description of key information
The water solubility of the test item was determined at 20 °C as 575 g/L with a pH of 3.2 (reference 4.8-1).
Key value for chemical safety assessment
- Water solubility:
- 575 g/L
- at the temperature of:
- 20 °C
Additional information
An experimental study was conducted according to OECD 105 and EU Regulation, method A.6 to determine the water solubility of the test item. Because of the test item properties a procedure based on the preliminary test was carried out instead of the shake-flask test to evaluate the water solubility. Therefore, about 2 g of test item was weighed into a tube and 2 mL were added. Subsequently, the concentration was determined by LC/MS/MS. Five replicates were carried out. The water solubility of the test item was determined at 20 °C as 575 g/L with a pH of 3.2.
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