Registration Dossier

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:
2006
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

Constituent 1
Chemical structure
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

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.