Registration Dossier

Administrative data

Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 October 2007
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 the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.4 (Vapour Pressure)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 104 (Vapour Pressure Curve)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of inspection: 21 August 2007 Date of Signature: 15 October 2007
Type of method:
effusion method: vapour pressure balance

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Octadecyloxypropyl-N,N,N-trimethylammonium chloride
- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Smiles notation (if other than submission substance): Not applicable
- InChl (if other than submission substance): Not applicable
- Structural formula attached as image file (if other than submission substance): Not applicable
- Substance type: white solid
- Physical state: solid
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: Not reported
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: Exp. I-070518
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): Not applicable
- Specific activity (if radiolabelling): Not applicable
- Locations of the label (if radiolabelling): Not applicable
- Expiration date of radiochemical substance (if radiolabelling): Not applicable
- Stability under test conditions: Not reported.
- Storage condition of test material: room temperature
- Other: Not reported.

Results and discussion

Vapour pressure
Temp.:
25 °C
Vapour pressure:
0.001 Pa

Any other information on results incl. tables

Table

Temperature (ºC)

Temperature (K)

Reciprocal Temperature (K-1)

Mass Difference (µg)

Mass Difference (kg)

Vapour Pressure (Pa)

Log10Vp

29

302.15

0.003309614

1.06

1.060E-09

0.001471552

-2.832224513

30

303.15

0.003298697

0.85

8.500E-10

0.001180018

-2.928111453

31

304.15

0.003287851

1.17

1.170E-09

0.001624260

-2.789344517

32

305.15

0.003277077

1.06

1.060E-09

0.001471552

-2.832224513

33

306.15

0.003266373

1.17

1.170E-09

0.001624260

-2.789344517

34

307.15

0.003255738

1.06

1.060E-09

0.001471552

-2.832224513

35

308.15

0.003245173

0.85

8.500E-10

0.001180018

-2.928111453

36

309.15

0.003234676

1.38

1.380E-09

0.001915794

-2.717651292

37

310.15

0.003224246

1.38

1.380E-09

0.001915794

-2.717651292

38

311.15

0.003213884

1.38

1.380E-09

0.001915794

-2.717651292

39

312.15

0.003203588

1.59

1.590E-09

0.002207327

-2.656133254

No statistical analysis is given due to the nature of the plot.

Discussion

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.

The table below shouws the results of the run chosen for this study. This particular table 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 39ºC (312.15 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 25ºC gave a vapour pressure of 1.313 x 10 -3 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 1.4 x 1.00E-03 Pa at 25ºC.
Executive summary:

Vapour pressure was determined using methods specified in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC) (A4) and OECD Guidelines for Testing of Chemicals (104). The vapour pressure of the test material has been determined to be less than 1.4 x 1.00E-03 Pa at 25ºC.