Registration Dossier

Administrative data

Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 3 March 2009 and 27 March 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Recently conducted GLP compliant study using the most recent test methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

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
Details on test material:
- Name of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:

Results and discussion

Vapour pressure
Temp.:
25 °C
Vapour pressure:
> 0 kPa

Any other information on results incl. tables

Run 1

Temperature (°C)

Temperature (K)

Reciprocal Temperature (K-1)

Mass Difference

(μg)

Mass Difference

(kg)

Vapour Pressure

(Pa)

Log10Vp

156

429.15

0.002330188

2.98

2.980E-09

0.004137003

-2.383314115

157

430.15

0.002324770

1.02

1.020E-09

0.001416021

-2.848930207

158

431.15

0.002319378

2.43

2.430E-09

0.003373463

-2.471924105

159

432.15

0.002314011

-0.55

-5.500E-10

-

-

160

433.15

0.002308669

2.12

2.120E-09

0.002943103

-2.531194518

161

434.15

0.002303351

4.16

4.160E-09

0.005775146

-2.238437048

162

435.15

0.002298058

1.81

1.810E-09

0.002512744

-2.599851804

163

436.15

0.002292789

8.24

8.240E-09

0.011439231

-1 941603167

164

437.15

0.002287544

6.67

6.670E-09

0.009259669

-2.033404545

165

438.15

0.002282323

4.24

4.240E-09

0.005886206

-2.230164522

166

439.15

0.002277126

2.83

2.830E-09

0.003928765

-2.405743943

No statistical analysis is given due to the nature of the plot. Graph of Run 1 is attached.

Run 2

Temperature

(oC)

Temperature

(K)

Reciprocal Temperature

(K-1)

Mass Difference

(μg)

Mass Difference

(kg)

Vapour Pressure (Pa)

Log10Vp

156

429.15

0.002330188

-0.78

-7.800E-10

-

-

157

430.15

0.002324770

-0.39

-3.900E-10

-

-

158

431.15

0.002319378

1.18

1.180E-10

0.001638142

-2.785648371

159

432.15

0.002314011

0.78

7.800E-10

0.001082840

-2.965435776

160

433.15

0.002308669

0.39

3.900E-10

0.000541420

-3.266465772

161

434.15

0.002303351

0.31

3.100E-10

0.000430359

-3.366168585

162

435.15

0.002298058

0.55

5.500E-10

0.000763541

-3.117167689

163

436.15

0.002293789

0.63

6.300E-10

0.000874601

-3.058189829

164

437.15

0.002287544

-0.71

-7.100E-10

-

-

165

438.15

0.002282323

1.02

1.020E-09

0.001416021

-2.848930207

165

439.15

0.002277126

1.02

1.020E-09

0.001416021

-2.848930207

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

Graph of Run 2 is attached.

Run 3

 

Temperature

(°C)

Temperature

(K)

Reciprocal Temperature (K-1)

Mass Difference

(μg)

Mass Difference

(kg)

Vapour Pressure

(Pa)

Log10Vp

156

429.15

0.002330188

0.86

8.600E-10

0.001193900

-2.923031927

157

430.15

0.002324770

-0.06

-8.000E-11

-

-

158

431.15

0.002319378

-0.08

-8.000E-11

-

-

159

432.15

0.002314011

-0.47

-4.700E-10

-

-

160

433.15

0.002308669

1.33

1.330E-09

0.001846381

-2.733678738

161

434.15

0.002303351

0.55

5.500E-10

0.000763541

-3.117167689

162

435.15

0.002298058

1.96

1.960E-09

0.002720982

-2.565274307

163

436.15

0.002232789

1.88

1.880E-09

0.002609922

-2.583372529

164

437.15

0.002287544

-0.63

-6.300E-10

-

-

165

438.15

0.002282323

-0.71

-7.100E-10

-

-

166

439.15

0.002277126

0.71

7.100E-10

0.000985662

-3.006272030

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

Graph of Run 3 is attached.

Run 4

 

Temperature

(°C)

Temperature

(K)

Reciprocal Temperature

(K-1)

Mass Difference

(μg)

Mass Difference

(kg)

Vapour Pressure (Pa)

Log10Vp

156

429.15

0.002330188

1.81

1.810E-09

0.002512744

-2.599851804

157

430.15

0.002324770

0.71

7.100E-10

0.000985562

-3.006272030

156

431.15

0.002319378

0.16

1.600E-10

0.000222121

-3.653410396

159

432.15

0.002314011

-0.16

-1.600E-10

-

-

160

433.15

0.002305669

0.78

7.800E-10

0.001082840

-2.965435776

161

434.15

0.002303351

0.86

8.600E-10

0.001193900

-2.923031927

162

435.15

0.002298058

0.47

4.700E-10

0.000652480

-3.185432521

163

436.15

0.002292789

2.51

2.510E-09

0.003484523

-2.457856657

164

437.15

0.002287544

-0.16

-1.600E-10

-

-

165

438.15

0.002282323

0.78

7.800E-10

0.001082840

-2.965435776

166

439.15

0.002277126

1.10

1.100E-09

0.001527082

-2.816137694

 

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

Graph of Run 4 is attached.

Applicant's summary and conclusion

Conclusions:
The vapour pressure of the test material has been determined to be less than 9.0E-9 Pa at 25°C
Executive summary:

The vapour pressure has been assessed using a vapour pressure balance according to EU method A4 in compliance with GLP.

The temperature of the sample was controlled electronically. The mass and temperature readings were recorded automatically into a computer file and recorded over four seperate runs all resulting in extremely low balance readings. Based on the results of Run 4 the vapour pressure was determined to be 9.0E-9 Pa at 25oC