Registration Dossier
Registration Dossier
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EC number: 215-947-7 | CAS number: 1458-18-0
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 February 2013 - 03 May 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- (1995)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- column elution method
Test material
- Reference substance name:
- Methyl 3-amino-5,6-dichloropyrazine-2-carboxylate
- EC Number:
- 215-947-7
- EC Name:
- Methyl 3-amino-5,6-dichloropyrazine-2-carboxylate
- Cas Number:
- 1458-18-0
- Molecular formula:
- C6H5Cl2N3O2
- IUPAC Name:
- methyl 3-amino-5,6-dichloropyrazine-2-carboxylate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Identification: Amiloride Compound 7
Molecular formula: C6H5Cl2N3O2
Molecular weight: 222.03
CAS Number:1458-18-0
Description: Tan powder
Batch: 206-2
Purity/Composition: 99.7 area%
Test substance storage: In refrigerator (2-8°C) protected from light, desiccated
Stability under storage conditions: Stable
Expiry date: 11 May 2014 (Retest date)
Constituent 1
Results and discussion
Water solubilityopen allclose all
- Water solubility:
- 6.48 mg/L
- Temp.:
- 20 °C
- pH:
- 7.9
- Remarks on result:
- other: Flowrate 24 ml/h. Mean of 10 samples. CV= 0.62%.
- Water solubility:
- 6.34 mg/L
- Temp.:
- 20 °C
- pH:
- 7.7
- Remarks on result:
- other: Flowrate 12 ml/h. Mean of 10 samples. CV= 0.99%.
- Details on results:
- The coefficient of variation (n= 10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates. The maximum difference on the mean values at both flow rates was ≤ 30% (2.1% was calculated). The water solubility of the substance is given as the mean value of these measurements: 6.41 mg/L.
Any other information on results incl. tables
No test substance was detected in the samples from the blank column.
Applicant's summary and conclusion
- Conclusions:
- The water solubility of Amiloride Compound 7 at 20°C was determined to be 6.41 mg/L using the column elution method (in accordance with EC A.6, OECD 105 and OPPTS 830.7840 and in compliance with GLP). The pH was 7.7-7.9 and would be considered slightly soluble (0.1-100 mg/L)
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