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:
OECD Guideline 109 (Density of Liquids and Solids)
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
Qualifier:
according to
Guideline:
other: CIPAC MT 3.2
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: 2016110462

Results and discussion

Density
Type:
relative density
Density:
0.984 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 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

31.6020

81.4763

31.5889

33.8590

81.4335

49.8743

0.9853

B

31.3322

79.9240

31.3397

33.3997

79.8968

48.5918

0.9817

Mean value :

0.9835

Delta % :

0.37%

Specific gravity (pure number) :

0.9853

Relative density (pure number) :

0.9835

Applicant's summary and conclusion

Conclusions:
Relative density of Dehydrocholic acid is 0.9835 at 20.09°C.