Registration Dossier

Administrative data

Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 December 2004 to 23 May 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in 2005 according to EU and OECD Method and in accordance with GLP. The study material is well characterized.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 104 (Vapour Pressure Curve)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.4 (Vapour Pressure)
Deviations:
no
GLP compliance:
yes
Type of method:
effusion method: by loss of weight or by trapping vaporisate
Remarks:
modified Knudsen Effusion apparatus

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Off-white powder; stored at room temperature; received at testing laboratory on 06-10-2004.

Results and discussion

Vapour pressure
Remarks on result:
other: too low to be determined by this method-the theoretical lower detection limit of the Knudsen Effusion apparatus is 1 x 10-4 Pa.
Transition / decomposition
Transition / decomposition:
no

Any other information on results incl. tables

Examination of the DSC thermograms indicated that a maximum test temperature of 170°C would be practical in the vapour pressure tests in order to ensure that the samples remained solid.

Preliminary tests showed that no significant weight changes were evident, or that the calculated results were consistent. the following "definitive" testing was performed. After 140 minutes at 170°C, a small weight loss was recorded, most likely due to the

evaporation of associated volatile impurities. However, when the samples continued to be held isothermally at 170°C, no further significant weight losses were recorded. The weight losses were too small to determine a value for the vapour pressure. The theoretical lower detection limit of the Knudsen Effusion apparatus is 1 x 10-4 Pa.

 Weight Changes during the Vapour Pressure Test for BMS 528233-01

Run number

Date

Time

Temperature (°C)

Test 5 mass (mg)

Test 6 mass

(mg)

1*

19/5/05

11:10

170

53.540

54.675

19/5/05

13:30

170

53.533

54.657

2

19/5/05

13:35

170

53.533

54.657

20/5/05

08:43

170

53.535

54.659

3

20/5/05

08:48

170

53.535

54.659

23/5/05 

08:45

170

53.534

54.658

* - Initial loss of mass is most likely due to loss of associated volatile

A sample was subjected to DSC analysis on completion of the test, to determine if any physical change had occurred during the test. The DSC thermogram showed no significant changes to the thermograms produced in the melting and boiling point determinations, suggesting no physical change had occurred.

Applicant's summary and conclusion

Conclusions:
The vapour pressure of BMS 528233-01 was too low to be accurately determined by the Knudsen Effusion apparatus. There was no significant weight loss from the test substance at 170°C, the maximum temperature that could be used in the test. The theoretical lower detection limit of the Knudsen Effusion apparatus is 1 x 10-4 Pa.
Executive summary:

The vapour pressure of BMS 528233-01 was too low to be accurately determined by the Knudsen Effusion apparatus. There was no significant weight loss from the test substance at 170°C, the maximum temperature that could be used in the test. The theoretical lower detection limit of the Knudsen Effusion apparatus is 1 x 10-4 Pa.