Registration Dossier

Administrative data

Endpoint:
density
Remarks:
density
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: European guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2003-02-13
Type of method:
air comparison pycnometer (for solids)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Description: cream coloured solid
Batch nimber: 00171300
Received: 2003-30-01
storage conditions: room temperature, in the dark

Results and discussion

Density
Type:
density
Density:
ca. 1.12
Temp.:
19 °C

Applicant's summary and conclusion

Conclusions:
The relative density of the test material has been determined to be 1.12 at 19.0 +/- 0.5 °C
Executive summary:

Relative density of the test item has been detemined at 1.12 (19 +/- 5°C), using a gas comparaison pyvnometer, method A3 of comission directive 92/69/EEC. This study complies with the GLP.

Testing was carried out using a quantachrome MVP-2 gas comparaison pycnometer.

A satinless steel ball of known volume was used to calibrate the instrument prior to measurement of the test smple.

For the test sample, two assay was done.

1st assay: d= 1.1221

2nd assay: d=1.1161

Conclusion :

The relative density of the test material has been determined to be 1.12 at 19.0 +/- 0.5 °C