Registration Dossier
Registration Dossier
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EC number: 606-883-4 | CAS number: 219921-94-5
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 January - 26 May 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 105) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7860 (Water Solubility Generator Column Method)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Reference substance name:
- (S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid
- EC Number:
- 606-883-4
- Cas Number:
- 219921-94-5
- Molecular formula:
- C16-H26-N2 x C7-H11-N-O5
- IUPAC Name:
- (S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): AGEE 623 Glutaminate; L-Glutamic acid, N-acteyl, compd. with (S)-alpha-(2-methylpropyl)-2-(1-piperidinyl)-benzene
- Molecular formula (if other than submission substance): C16H26N2 * C7H11NO5
- Molecular weight (if other than submission substance): 435.57 (246.4 + 189.17)
- Structural formula attached as image file (if other than submission substance): see reference substance
- Physical state: solid white powder
- Analytical purity: 100% (4% of (R)-(-)-enantiomer)
- Purity test date: 5 June 1998
- Lot/batch No.: T29725
- Expiration date of the lot/batch: 31 December 1999
- Stability under test conditions: pure: see expiry date
- Storage condition of test material: in original container, at room temperature, in the dark
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- 23 g/L
- Temp.:
- 20 °C
- pH:
- ca. 4
Any other information on results incl. tables
Results of the water solubility of AGEE 623 Glutaminate
| Sample no. | Shaking time at 30°C [hours] | Initial weight [g] | pH measured | concentration of the test substance found [mg/L] | calculated saturation mass concentration [g/L] |
| 1 | 72 | 10 | 4.3 | 23.3 | 23.0 +/- 0.2 SD |
| 2 | 10 | 4.2 | 22.8 | ||
| 3 | 48 | 10 | 4.2 | 22.9 | |
| 4 | 10 | 4.2 | 22.9 | ||
| 5 | 24 | 10 | 4.1 | 23.2 | |
| 6 | 10 | 4.1 | 23.0 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): very soluble (> 10000 mg/L)
In conclusion, the water solubility of AGEE 623 Glutaminate was determined to be 23.0 g/L +- 0.2 g/L std at 20°C +- 0.5°C.
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