Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 918-984-3 | 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:
- 2009-09-21 to 2010-03-18
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- yes
- Remarks:
- For the preliminary test at pH 4, 6 and 7, 1g of the test item was weighed instead of 0.1g.
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- yes
- Remarks:
- For the preliminary test at pH 4, 6 and 7, 1g of the test item was weighed instead of 0.1g.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Water solubility:
- ca. 395 g/L
- Temp.:
- 25 °C
- pH:
- 6.2
- Details on results:
- The pH of the solution has no significant effect on the solubility.
The test item contains 30.3% of dry material, the solubility of the test item, based on the dry material content is: 120g (dry material)/L in deionized water (pH 6.2) at 25°C. - Conclusions:
- Interpretation of results (migrated information): moderately soluble (100-1000 mg/L)
the solubility of the PROTEOL APL is: 395g/L in deionized water (pH 6.2) at 25°C. - Executive summary:
Objective of The Study
This study consisted in the determination of the solubility of one batch of the test item in water.
Summary of Results
The solubility of the test item in water is:
395 g/L in deionized water (pH 6.2) at 25 °CThe pH of the solution has no significant effect on the solubility.
The test item contains 30.3 % of dry material, the solubility of the test item, based on the dry material content is
120 g (dry material)/L in deionized water (pH 6.2) at 25 °C
Reference
Results
1 - Preliminary test
Test temperature : 23.5°C
Date : 21.09.2009 Solvent used : purified water, pH 6
| Amount test item weighed (g) | 1.00 | ||||||
| Volume of water added (ml) | 0.1 | 0.5 | 1 | 2 | 10 | 50 | 100 |
| Solubility (yes/no) | yes | ||||||
Date : 21.09.2009 Solvent used : Buffer solution, pH 4
| Amount test item weighed (g) | 1.06 | ||||||
| Volume of water added (ml) | 0.1 | 0.5 | 1 | 2 | 10 | 50 | 100 |
| Solubility (yes/no) | yes | ||||||
Date : 21.09.2009 Solvent used : Buffer solution, pH 7
| Amount test item weighed (g) | 1.02 | ||||||
| Volume of water added (ml) | 0.1 | 0.5 | 1 | 2 | 10 | 50 | 100 |
| Solubility (yes/no) | yes | ||||||
Date : 21.09.2009 Solvent used : Buffer solution, pH 9
| Amount test item weighed (g) | 0.98 | ||||||
| Volume of water added (ml) | 0.1 | 0.5 | 1 | 2 | 10 | 50 | 100 |
| Solubility (yes/no) | yes | ||||||
Estimation of the solubility:
| pH | 4 | 7 | 9 | H2O |
| Approximative solubility (g/L) | > 10 000 | > 10 000 | > 10 000 | > 10 000 |
pH (H2O) = 6.0
Thus, from these preliminary tests, the solubility of the test item is more than 10 000 g/L. The confirmation test will be performed with the flask method.
These data show that the pH has no significant effect on the solubility.
2 - Confirmation tests
The final test is performed with purified water ( pH 6.2)
An amount of 5.5 g of the test item, corresponding to approximately 2 times the amount estimated during the preliminary tests, is mixed with 10 mL of water (3 separate test solutions are prepared). The mixture is submitted to ultrasonication to ease solubilisation. The tests solutions are then incubated at 30 °C. One tube is withdrawn after 24 hours, 48 hours and 72 hours and equilibrated at the test temperature 25°C for 24 hours.
After this equilibration time, an aliquot of the test solution is taken and diluted with water and the amount of test item is determined through HPLC analysis.
Results are summarised in the table below:
| Solvent: Purified water (pH 6.2) | |
| Presaturation time | Solubility(g/L) |
| 24 hours | 201.7 |
| 48 hours | 395.4 |
| 72 hours | 200.3 |
Between 24 hours and 48 hours presaturation time, the solubility of the test item is increasing. After 72 hours presaturation time, the measured solubility has decreased again. This may be due to a degradation of the test item.
Taking these observations into account, the solubility of the test item is given as the maximum solubility recorded during the testing period.
Description of key information
Key value for chemical safety assessment
- Water solubility:
- 395 g/L
- at the temperature of:
- 25 °C
Additional information
the solubility of the PROTEOL APL is: 395g/L in deionized water (pH 6.2) at 25°C according OECD 105 -Flask method.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
