Registration Dossier
Registration Dossier
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Reactions mass of N-{2-[(4-bromo-6-substituted-2-alkyl-1,3-dioxo-2,3-dihydro-1H-isoindol-5-yl)diazenyl]-[alkyl(2-methoxyalkyl)amino]phenyl}acetamide) and N-{2-[(4-bromo-6-substiuted-2-alkyl-1,3-dioxo-2,3-dihydro-1H-isoindol-5-yl)diazenyl]-[alkyl(2-hydroxy-3-phenoxypropyl)amino]phenyl}acetamide
EC number: - | CAS number: -
Water solubility
Administrative data
Link to relevant study record(s)
Description of key information
Determination of the water solubility of FAT 41044/A TE using the flask method.
Key value for chemical safety assessment
- Water solubility:
- 0 g/L
- at the temperature of:
- 20 °C
Additional information
The determination was carried out using the flask method, designed to be compatible with Method A6 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.
The test system consists of purified (reverse osmosis) water.
Discussion
The preliminary water solubility test results indicated that the column elution method should have been performed (since the solubility was determined to be less than 1 x 10-2g/L). However, due to a) the somewhat complex nature of the test item and b) the extraction procedure requiring an excessive volume of sample solution, it was considered that the flask method would be the more appropriate method in this instance.
Due to lack of final solution volume for Sample 3, it was necessary to use 150 mL (in duplicate) for that sample. However, upon review, it was considered that the effect of this requirement on the results for Sample 3 would be negligible.
As a result of the extreme variability in the sample results, it was considered more appropriate to report the water solubility as less than or equal to the highest concentration value found during the test, to represent a worst case scenario for risk assessment.
Based on the linearity results, the limit of quantification was considered to be approximately 0.10 mg/L in the vial, and therefore, approximately 1.0 x 10-3mg/L in the sample solutions. Thus, as Sample 3 replicates A and B both indicated “none detected”, the concentration of test item in these replicates was considered to be less than 1.0 x 10-6g/L.
Conclusion
The water solubility of the test item has been determined to be less than or equal to 2.13 x 10-5 g/L of solution at 20.0 ± 0.5 °C
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