Registration Dossier

Administrative data

Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Modern study peformed under GLP and using the recommended method, EU method A.4.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.4 (Vapour Pressure)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of method:
gas saturation method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
The test material received from F. Hoffmann-La Roche Ltd was a white solid powder from lot no. 25927 with a purity of 99.8%.

Results and discussion

Vapour pressureopen allclose all
Temp.:
25 °C
Vapour pressure:
0.001 Pa
Temp.:
35 °C
Vapour pressure:
0.004 Pa
Temp.:
40 °C
Vapour pressure:
0.01 Pa

Any other information on results incl. tables

The test was carried out at 25 ⁰C and 35 ⁰C in four replicates for each temperature at a flow rate of 10 mL/min. During the preliminary test the vapour pressure was determined at four flow rates at 40 ⁰C. The results are presented in the table below;

Temp (⁰C)

Replicate

Flow Rate (mL/min)

Duration (h)

Gas Volume (m3)

Mass PTH-decahydroamide (g x 10-6)

Vapour Pressure (Pa)

25

1

10

116

0.0696

9.929

1.482 x 10-3

25

2

10

116

0.0696

10.380

1.550 x 10-3

25

3

10

116

0.0696

11.226

1.676 x 10-3

25

4

10

116

0.0696

7.798

1.165 x 10-3

 

 

 

 

 

Average

1.468 x 10-3

35

1

10

54

0.0324

11.665

3.868 x 10-3

35

2

10

54

0.0324

12.403

4.113 x 10-3

35

3

10

54

0.0324

11.867

3.935 x 10-3

35

4

10

54

0.0324

11.642

3.860 x 10-3

 

 

 

 

 

Average

3.944 x 10-3

40

1

5

-

0.151

171.755

12.402 x 10-3

40

2

10

-

0.302

301.545

10.886 x 10-3

40

3

20

-

0.605

382.855

6.911 x 10-3

40

4

25

-

0.756

636.380

9.190 x 10-3

 

 

 

 

 

Average

9.847 x 10-3

Applicant's summary and conclusion

Conclusions:
The vapour pressure of PTH-decahydroamide (Ro 31 -9373/000) was determined to be 1.468 x 10(-3) Pa at 25 ⁰C,
3.944 x 10(-3) Pa at 35 ⁰C and 9.847 x 10(-3) Pa at 40 ⁰C.
Executive summary:

The vapour pressure of PTH-decahydroamide (Ro 31 -9373/000) was determined using EC directive 92/69/EEC, A.4 (1992).

The vapour pressure of PTH-decahydroamide (Ro 31 -9373/000) was determined to be 1.468 x 10-3Pa at 25 ⁰C,

3.944 x 10-3Pa at 35 ⁰C and 9.847 x 10-3Pa at 40 ⁰C.