Registration Dossier
Registration Dossier
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EC number: 272-712-1 | CAS number: 68909-77-3 The residuum from the reaction of diethylene glycol and ammonia. It consists predominantly of morpholine-based derivatives such as [(aminoethoxy)ethyl]morpholine, [(hydroxyethoxy)ethyl]morpholine, 3-morpholinone, and 4,4'-(oxydi-2,1-ethanediyl)bis[morpholine].
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:
- 2010-09-30 - 2010-11-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- yes
- Remarks:
- total misciblity performed by visual assessment
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Sponsor's identification: Amine C8
Description: dark brown liquid
Batch number: T7-271109
Date received: 21 September 2010
Expiry date: 31 December 2011
Storage conditions: room temperature in the dark - Key result
- Temp.:
- 20 °C
- pH:
- >= 10.3 - <= 11.5
- Remarks on result:
- completely miscible
- Details on results:
- Please see section Remarks on results including tables and figures.
- Conclusions:
- The test item has been determined to be miscible with water in all proportions at 20.0 ± 0.5°C.
- Executive summary:
The test item was found to be miscible with water in all proportions at 20.0 ± 0.5°C, using a procedure based on the flask method, designed to be compatible with Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008.
Reference
Results
Preliminary test
The test item was found to be miscible in water at nominal concentrations of 5, 10, 20, 50 and 95 % w/w.
Definitive test
The concentration (% w/w) of test item in the sample solutions and observations are shown in the following table:
Sample Number |
Concentration |
Observation |
Solution pH |
1 |
5.04 |
Clear orange solution with no excess test item observed. |
10.3 |
2 |
49.9 |
Clear brown solution with no excess test item observed. |
10.7 |
3 |
94.4 |
Clear dark brown solution with no excess test item observed. |
11.5 |
The viscosity of the solutions was observed to increase with increasing concentration.
Description of key information
The test substance was found to be miscible with water in all proportions at 20.0 ± 0.5°C, using a procedure based on the flask method, designed to be compatible with EC test method A.6, under GLP conditions (Butler and White, 2010).
Key value for chemical safety assessment
- Water solubility:
- 100 g/L
- at the temperature of:
- 20 °C
Additional information
The substance is concluded to be miscible with water. For the CSA, it is proposed to use a bounded value of 100 g/L for the water solubility. The pH of the 1:1 ratio (water:test item) was measured to be 10.7.
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