Registration Dossier

Administrative data

Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29/07/2008-03/09/2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 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 relevant results.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.4 (Vapour Pressure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)).
Type of method:
effusion method: vapour pressure balance

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
See section 1.2

Results and discussion

Vapour pressure
Temp.:
25 °C
Vapour pressure:
< 0.001 Pa
Remarks on result:
other: No transition or decomposition was stated in the study report.

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 25ºC.

Copies of the study results are included in the atachments section.

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 63ºC (336.15 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 deg C gave a vapour pressure of 7.945 x 10-4 Pa which has been taken as a maximum for this material.

The test material did not change in appearance under the conditions used in the determination.

Applicant's summary and conclusion

Conclusions:
The vapour pressure of the test material has been determined to be less than 8.0 x 10-4 Pa at 25ºC under the conditions of the test.
Executive summary:

The vapour pressure was determined using a vapour pressure balance with measurements being made at several temperatures and linear regression analysis used to calculate the vapour pressure at 25°C.  Testing was conducted using Method A4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The vapour pressure of the test material has been determined to be less than 8.0 x 10-4 Pa at 25ºC under the conditions of the test.