Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: DIN EN ISO 697 'Determination of apparent Density'
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
other: method by measuring the mass of a given volume

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Results and discussion

Density
Key result
Type:
bulk density
Density:
0.399 g/cm³
Remarks on result:
other: Room temperature; arithmetic mean of two measurements

Applicant's summary and conclusion

Conclusions:
The GLP study was performed according to EU method A.3 without deviations and therefore reliability of Klimisch 1 has been assigned. The bulk density has been determined to be 0.399 g/mL.
Executive summary:

The bulk density of 0.399 g/mL of the test substance was determined in a GLP test according to DIN EN ISO 697. The mass of the empty vessel was determined. The funnel of the filling equipment was filled with the substance. The vessel was placed under the funnel and the closing plate was removed. The substance fell down in the vessel. The overlaying substance was removed by a scraper, so that the vessel was completely filled without overlying. The mass of the filled vessel was determined and the mass of the substance inside the vessel was calculated by subtraction of the mass of the empty vessel. The bulk density was calculated by dividing the mass of the substance by the volume of the vessel. The determination was repeated one time.