Registration Dossier

Administrative data

Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 May 2011 - 16 May 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP 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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.4 (Vapour Pressure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
effusion method: vapour pressure balance

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Vapour pressure
Temp.:
25 °C
Vapour pressure:
< 0 Pa
Remarks on result:
other: The test item did not change in appearance under the conditions used in the determination.

Any other information on results incl. tables

No statistical analyses were performed because the balance readings were too low and variable for a line of best fit to have any meaning. instead it was considered more appropriate to impose a regression slope on a chosen data point to provide an estimate of the maximum value for the vapour pressure at 25 °C.

Run 5 was chosen because the sample had been under vacuum for the longest period prior to this run and so degassing would have been the most complete. The reading at 105 °C (378.15 K) was chosen because this is the data point which gives the highest estimated vapour pressure at any given temperature when a slope of -1500 K is imposed upon it.

The value of -1500 K is an in-house value and is the shallowest slope observed whilst determining the vapour pressure on a wide range of samples using the vapour pressure balance method. Extrapolation to 25 °C gave a vapour pressure of 4.298 x 10-4 Pa which has been taken as a maximum for this material.

Applicant's summary and conclusion

Conclusions:
The vapour pressure of the test item has been determined to be less than 4.3 x 10^-4 Pa at 25 °C.
Executive summary:

The vapour pressure of the test item has been determined to be less than 4.3 x 10-4 Pa at 25 °C. Testing was conducted using a procedure designed to be compatible with Method A4 Vapour Pressure of Commission Regulation (EC) No 440/2008 of 30 May 2008.