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Registration Dossier
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EC number: 485-140-4 | CAS number: 515815-48-2
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 January 2006 - 3 March 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and in accordance with several internationally established guidelines (OECD, EEC, EPA guidelines, see below).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Reference substance name:
- -
- EC Number:
- 485-140-4
- EC Name:
- -
- Cas Number:
- 515815-48-2
- Molecular formula:
- C33 H30 N4 O2 x HCl
- IUPAC Name:
- 4’-(2-Propyl-4-methyl-6-(1-methylbenzimidazolyl-2-yl)-benzimidazol-1-ylmethyl)biphenyl-2-carbonsäure Hydrochlorid
- Details on test material:
- - Name of test material (as cited in study report): BIBR 277 CL
- Molecular formula (if other than submission substance): C33H30N4O2*HCl
- Molecular weight (if other than submission substance): 514.6 + 36.5 g/mol
- Structural formula attached as image file (if other than submission substance): see reference substance
- Physical state: solid; sligh grey
- Analytical purity: 99.8 %
- Purity test date: 17. october 2005
- Lot/batch No.: 9
- Expiration date of the lot/batch: april 2006
- Storage condition of test material: at room temperature, dark and dry
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- 108 mg/L
- Temp.:
- 20 °C
- pH:
- 2.9
Any other information on results incl. tables
Table 4 Results of the determination of water solubility of BIBR 277 CL
| Measured concentration after 24 hours (mg/L) | pH | Measured concentration after 48 hours (mg/L) | pH | Measured concentration after 72 hours (mg/L) | pH | Solubility of the test item (mg/L) |
| 96 | 2.89 | 112 | 2.90 | 99 | 2.91 | 108 +-24 |
| 100 | 2.90 | 111 | 2.90 | 113 | 2.90 | |
| 98 | 2.91 | 126 | 2.90 | 121 | 2.91 | |
| Mean: 98 +-5 | 2.90 | Mean: 116 +-20 | 2.90 | Mean: 111 +-28 | 2.91 | RSD%=9 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): moderately soluble (100-1000 mg/L)
A water solubility of 108 mg/L at 20°C was determined in a reliable study conducted according to an appropriate OECD test protocol.
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