Registration Dossier

Administrative data

Endpoint:
density
Remarks:
density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental Starting Date: 08 August 2012 Experimental Completion Date: 23 August 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Deviations:
no
GLP compliance:
yes
Type of method:
pycnometer method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identification: BMS-528233-01
Description: White powder
BMS Batch Number: 2C80150N
Vendor Batch Number LTBB2S1005
Structure: Please see Attachment 1 of this Summary
Molecular Formula: C17H27NO5
Molecular Weight: 325.41
Purity: >100 %
Expiry Date: 31 January 2015
Storage Conditions: Room temperature, in the dark

Results and discussion

Density
Type:
density
Density:
1 240 kg/m³
Temp.:
21.5 °C

Any other information on results incl. tables

Results

Calibration

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

 

Table 3.2

 

Determination

p1

p2

p3

p4

Reference Cell Volume (cm3)

Sample Cell Volume (cm3)

1

17.013

6.442

17.024

8.439

90.690

148.818

2

17.025

6.454

17.023

8.438

91.154

149.301

3

17.083

6.475

17.014

8.435

91.044

149.157

 


 

Sample

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

 

Table 3.3

 

Determination

Test

p1

p2

Volume (cm3)

Density

(kg/m3)

Mean Density (kg/m3)

1

A

17.020

7.346

29.3

1.24 x 103

1.24 x 103

B

17.004

7.338

29.3

1.24 x 103

C

17.003

7.335

29.2

1.24 x 103

2

A

16.977

7.496

34.0

1.23 x 103

1.24 x 103

B

17.036

7.522

34.0

1.23 x 103

C

16.966

7.487

33.9

1.24 x 103

 

Temperature:              21.5 ± 0.5 ºC
Mean density:            1.24 x 103 kg/m3

Applicant's summary and conclusion

Conclusions:
Please see Conclusion below in the Executive Summary Section.
Executive summary:

The determination was carried out using a gas comparison pycnometer, designed to be compatible with Method A3 Relative Density of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 109 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.

        

Conclusion

The density of the test item has been determined to be 1.24 x 103kg/m3at 21.5 ± 0.5 °C.