Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 May - 18 May 2007
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:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Qualifier:
according to guideline
Guideline:
EU Method A.3 (Relative Density)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7300 (Density / Relative Density / Bulk Density)
GLP compliance:
yes (incl. QA statement)
Type of method:
pycnometer 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

Density
Type:
relative density
Density:
1.286
Temp.:
20 °C

Any other information on results incl. tables

   Mass (g)  Volume (cm3)  Density (g/cm3)
Sample 1   0.858  0.668  1.284
Sample 2  0.887  0.690  1.286
 Sample 3  0.870  0.675  1.289
 Sample 4  1.233  0.958  1.287
 Sample 5  1.073  0.835  1.285
 Average density (g/cm3)  1.286      
 Relative density  1.286      
 standard deviation  0.002      
 (95%) Confidence Interval  0.0024      

Applicant's summary and conclusion

Conclusions:
A relative density of 1.286 at 20°C was determined in a reliable study conducted according to an appropriate OECD test method.