Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 Jul - 16 Aug 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
Version / remarks:
adopted in 2008
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Version / remarks:
adopted in 2012
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Department of Health, London, UK
Type of method:
air comparison pycnometer (for solids)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Storage conditions: room temperature in the dark

Results and discussion

Density
Key result
Type:
relative density
Density:
ca. 1.47 other: dimensionless
Temp.:
20 °C

Any other information on results incl. tables

Calibration

The pressure readings and the calculated volume for the reference and sample cells are shown in the following table.

Table 2

Determination

P1

[psig]

P2

[psig]

P3

[psig]

P4

[psig]

Reference

Cell Volume

[cm3]

Sample

Cell

Volume

[cm3]

1

17.242

6.527

17.302

8.572

90.754

148.986

2

17.286

6.546

17.171

8.517

90.551

148.566

3

17.183

6.506

17.497

8.673

90.684

148.822

 

Mean reference cell volume: 90.663 cm3

Mean sample cell volume: 148.792 cm3

As the reference cell volume and sample cell volume were within the defined tolerance (90.953 ± 1.0 cm3 and 149.225 ± 1.0 cm3  for the reference and sample cell volumes respectively) the gas comparison pycnometer was therefore considered acceptable for use.

 

Sample

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

 

Table 3

Determination

Test

P1(sample)

[psig]

P2(sample)

[psig]

Volume [cm3]

Density

[kg/m3]

Mean

Density

[kg/m3]

1

A

17.193

7.022

17.471

1.476E03

1.469E03

B

17.348

7.090

17.618

1.464E03

C

17.165

7.014

17.579

1.467E03

2

A

17.275

7.046

17.172

1.486E03

1.470E03

B

17.261

7.050

17.478

1.460E03

C

17.267

7.051

17.432

1.464E03

 

Mean density: 1.47E03 kg/m3

Relative density: 1.47

Temperature: 20.0 ± 1.0 °C             

 

Discussion

Duplicate determinations were performed to ensure a reproducibility of less than ± 20 kg/m3 was obtained.

Conclusion

The density of the test item has been determined to be 1.47E03 kg/m3 at 20.0 ± 1.0 °C;

relative density: 1.47.

Applicant's summary and conclusion