Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 4 March 2009 and 29 May 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Recently conducted GLP compliant study using the most recent test methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
GLP compliance:
yes (incl. certificate)
Type of method:
pycnometer method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:

Results and discussion

Density
Type:
relative density
Density:
137 g/cm³
Temp.:
21 °C

Any other information on results incl. tables

Calibration

The pressure readings (P1 and P2) and the calculated volume for the calibration ball are shown in the table below

Determination  P1  P2 Volume (cm3)  Certified volume (cm3) 
17.468  8.642  56.3  56.6 
17.397  8.607  56.3  56.6 

Sample

The pressure readings, calculated volumes and density values obtained for the test material are shown in the following table

 Determination P1   P2 Volume (cm3)  Density (kg/cm3) 
17.083  6.991  17.928  1360 
17.153  7.054  19.010  1380 

Applicant's summary and conclusion

Conclusions:
The relative density of the test material has been determined to be 1.37 g/cm3 at 21 ± 0.5oC
Executive summary:

The relative density has been assessed using a gas comparison pycnometer according to EU method A3 in compliance with GLP. Using a calibrated pycnometer, the relative pressure in comparison with the known volume of the sample cell was recorded in duplicate. An average relative density of the substance calculated to be 1.37g/cm3 at 21± 0.5oC