Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: CIPAC method MT 3.2
Qualifier:
according to
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
GLP compliance:
yes
Type of method:
pycnometer method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Specific details on test material used for the study:
Batch number: 2015030121

Results and discussion

Density
Type:
relative density
Density:
0.99 other: dimensionless
Temp.:
20.09 °C

Any other information on results incl. tables

Results

 

Data in the tables are rounded values taken from Excel spreadsheets which will be archived together with the raw data. The use of Excel spreadsheets for calculations produces more accurate endpoints. These endpoints may slightly differ from the values derived by replacing the rounded values in the formulae given in the methods section.

 

Data and results for the water equivalent (WE) and for the liquid equivalent (LE) (testitemsaturated solution) are reported in Table 1.

Data and results for the density calculation at 20.09°C (rounded value 20.2°C), as temperature measurement recorded by the Evisense SensorLabguard thermometer placed in the thermostatic oven, are reported below.

 

 

Table1 Density

 

Determination

W1

(g)

W2

(g)

W3

(g)

W4

(g)

W5

(g)

WE

(g)

Density

(g/mL)

A

31.5920

81.4763

31.5843

33.0772

81.4560

49.8843

0.9898

B

24.7992

77.0812

24.7997

26.1204

77.0719

52.2820

0.9908

Mean value :

0.9903

Delta % :

0.10%

Specific gravity (pure number) :

0.9921

Relative density (pure number) :

0.9903

 


 

Applicant's summary and conclusion

Conclusions:
Relative density of Desoxycholic acid is 0.9903 at 20.09°C.