Registration Dossier

Administrative data

Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Jul - 15 Aug 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.4 (Vapour Pressure)
Version / remarks:
adopted in 2008
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 104 (Vapour Pressure Curve)
Version / remarks:
adopted in 2006
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Department of Health, London, UK
Type of method:
effusion method: vapour pressure balance

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Storage conditions: room temperature in the dark

Results and discussion

Vapour pressure
Key result
Temp.:
ca. 25 °C
Vapour pressure:
ca. 0 hPa
Remarks on result:
other:
Remarks:
estimated from vapour pressure curve
Transition / decomposition
Key result
Transition / decomposition:
no
Remarks:
The test item did not change in appearance under the conditions used in the determination

Any other information on results incl. tables

Results

Recorded temperatures, mass differences and the resulting calculated values of vapor pressure are shown in the following tables.

Run 7

Table 1 – Vapor Pressure Data

Temperature [°C]

Temperature [K]

Reciprocal Temperature [K-1]

Mass Difference [μg]

Mass Difference [kg]

Vapor Pressure [Pa]

Log10Vp

20

293.15

0.003411223

1.99

1.990E-09

0.002762630

-2.558677302

21

294.15

0.003399626

2.44

2.440E-09

0.003387345

-2.470140552

22

295.15

0.003388108

3.14

3.140E-09

0.004359124

-2.360600731

23

296.15

0.003376667

2.23

2.230E-09

0.003095811

-2.509225516

24

297.15

0.003365304

2.15

2.150E-09

0.002984751

-2.525091919

25

298.15

0.003354016

2.52

2.520E-09

0.003498406

-2.456129838

26

299.15

0.003342805

3.15

3.150E-09

0.004373007

-2.359219825

27

300.15

0.003331667

3.63

3.630E-09

0.005039370

-2.297623754

28

301.15

0.003320604

3.90

3.900E-09

0.005414199

-2.266465772

29

302.15

0.003309614

3.69

3.690E-09

0.005122665

-2.290504013

30

303.15

0.003298697

3.80

3.800E-09

0.005275374

-2.277746782

 

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

 

Run 8

Table 2 – Vapor Pressure Data

Temperature [°C]

Temperature [K]

Reciprocal Temperature [K-1]

Mass Difference [μg]

Mass Difference [kg]

Vapor Pressure [Pa]

Log10Vp

20

293.15

0.003411223

1.47

1.470E-09

0.002040737

-2.690213044

21

294.15

0.003399626

1.74

1.740E-09

0.002415566

-2.616981130

22

295.15

0.003388108

1.01

1.010E-09

0.001402139

-2.853209005

23

296.15

0.003376667

2.41

2.410E-09

0.003345697

-2.475513336

24

297.15

0.003365304

2.41

2.410E-09

0.003345697

-2.475513336

25

298.15

0.003354016

2.30

2.300E-09

0.003192989

-2.495802543

26

299.15

0.003342805

2.40

2.400E-09

0.003331815

-2.477319137

27

300.15

0.003331667

2.92

2.920E-09

0.004053708

-2.392147527

28

301.15

0.003320604

2.90

2.900E-09

0.004025943

-2.395132381

29

302.15

0.003309614

2.74

2.740E-09

0.003803822

-2.419779816

30

303.15

0.003298697

2.83

2.830E-09

0.003928765

-2.405743943

 

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

 

Run 9

Table 3 – Vapor Pressure Data

Temperature [°C]

Temperature [K]

Reciprocal Temperature [K-1]

Mass Difference [μg]

Mass Difference [kg]

Vapor Pressure [Pa]

Log10Vp

20

293.15

0.003411223

1.78

1.780E-09

0.002471096

-2.607110376

21

294.15

0.003399626

1.57

1.570E-09

0.002179562

-2.661630726

22

295.15

0.003388108

1.19

1.190E-09

0.001652025

-2.781983417

23

296.15

0.003376667

1.06

1.060E-09

0.001471552

-2.832224513

24

297.15

0.003365304

1.81

1.810E-09

0.002512744

-2.599851804

25

298.15

0.003354016

2.08

2.080E-09

0.002887573

-2.539467044

26

299.15

0.003342805

2.69

2.690E-09

0.003734409

-2.427778099

27

300.15

0.003331667

2.50

2.500E-09

0.003470640

-2.459590370

28

301.15

0.003320604

2.04

2.040E-09

0.002832043

-2.547900211

29

302.15

0.003309614

2.06

2.060E-09

0.002859808

-2.543663158

30

303.15

0.003298697

2.03

2.030E-09

0.002818160

-2.550034341

 

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

 

Run 10

Table 4 – Vapor Pressure Data

Temperature [°C]

Temperature [K]

Reciprocal Temperature [K-1]

Mass Difference [μg]

Mass Difference [kg]

Vapor Pressure [Pa]

Log10Vp

20

293.15

0.003411223

1.84

1.840E-09

0.002554391

-2.592712556

21

294.15

0.003399626

1.58

1.580E-09

0.002193445

-2.658873292

22

295.15

0.003388108

2.37

2.370E-09

0.003290167

-2.482782033

23

296.15

0.003376667

1.29

1.290E-09

0.001790850

-2.746940668

24

297.15

0.003365304

1.41

1.410E-09

0.001957441

-2.708311266

25

298.15

0.003354016

1.49

1.490E-09

0.002068502

-2.684344110

26

299.15

0.003342805

1.33

1.330E-09

0.001846381

-2.733678738

27

300.15

0.003331667

1.86

1.860E-09

0.002582157

-2.588017435

28

301.15

0.003320604

2.12

2.120E-09

0.002943103

-2.531194518

29

302.15

0.003309614

1.66

1.660E-09

0.002304505

-2.637422291

30

303.15

0.003298697

1.77

1.770E-09

0.002457213

-2.609557112

 

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

 

Discussion

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

The results may represent rounded-off values obtained by calculations based on the exact raw data.

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 vapor pressure at 25 °C.

Run 10 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 22 °C (295 K) was chosen because this is the data point which gives the highest estimated vapor 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 vapor pressure on a wide range of samples using the vapor pressure balance method. Extrapolation to 25 °C gave a vapor pressure of 3.70E-03 Pa which has been taken as a maximum for this material.

Conclusion

The vapor pressure of the test item has been determined to be less than 3.7E-03 Pa at 25 °C.

Applicant's summary and conclusion