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Physical & Chemical properties

Density

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Reference
Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study was conducted according to an internationally recognised method. Test substance is adequately characterised. Therefore full validation applies.
Qualifier:
according to
Guideline:
other: Method 01/2008: 20205 of the europeen pharmacopea
Version / remarks:
2008
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
Version / remarks:
2008
Deviations:
no
GLP compliance:
no
Type of method:
oscillating densitimeter
Key result
Type:
relative density
Density:
0.904 other: unitless
Temp.:
20 °C

Results

The results of the relative density measurements are given in the following table.

Parameter

Temperature (°C)

Value

Deviation

Relative density: determination 1

20

0.904

0.001

Relative density: determination 2

20

0.904

0.001

Discussion

No deviations from the guideline were stated. The two determinations show no variations. No additional measurements were performed for confirmatory purposes.

Conclusions:
The mean relative density of the test item was measured as D20/20 = 0,904 ± 0,001.
Less dense than water.
Executive summary:

The density of the test substance was measured according to EU A3 guideline, using oscillating density meter. After calibration, two determinations were performed and the mean value was retained.

The relative density of the test item was measured as D20/20= 0,904 ± 0,001.

Description of key information

The mean relative density of the test item was D20/20 = 0,904 ± 0,001.

Less dense than water.

Key value for chemical safety assessment

Relative density at 20C:
0.904

Additional information

A fully reliable experimental study, conducted according to EU A3 guideline, using oscillating density meter, is available. It is considered as a key study, and the result is retained as key data.