Registration Dossier

Administrative data

Endpoint:
Henry's law constant
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 2, 2014 - October 9, 2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study with acceptable method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The Henry's Law constant of HFP Kinetic Dimer was determined by the ratio of gas-phase concentration over aqueous phase concentration for a given test system vessel at equilibrium conditions and at ambient temperature and pressure.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hexafluoropropylene (HFP) Kinetic Dimer
- Substance type: Single component substance
- Physical state: Clear, colorless liquid

Results and discussion

Henry's Law constant H
Key result
H:
5 690
Temp.:
22 °C
Atm. press.:
760 mm Hg
Remarks on result:
other: %RSD = 18. Average Log HLC = 3.8, %RSD = 2.5%.

Any other information on results incl. tables

Table 1: Summary of Henry’s Law Constant (HLC) forHFP Kinetic Dimer

Ratio

(Headspace: Aqueous)

Replicate

 

Time point 1

(Four days)

 

Time point 2

(Five days)

 

Time point 3

(Six days)

70 %

Headspace

1

7120

6800

4860

2

4960

6380

3460

Average

6040

6590

4160

%RPD

36(1)

6.4

34(1)

50 %

Headspace

1

5710

6370

6250

2

6760

7940

3770

Average

6240

7150

5010

%RPD

17

22

49(1)

30 %

Headspace

1

5160

6240

4650

2

5680

6480

5920

Average

5420

6360

5290

%RPD

9.7

3.8

24

Intra-Time Point Average

% RSD

5900

15

6700

9.5

4820

23

Overall Average

%RSD

5690

18

 

(1) Calculated values of HLC did not meet the targeted precision of <25% for intra-vial replicates.

Table 2: Summary of Log (HLC) forHFP Kinetic Dimer

 

Ratio

(Headspace: Aqueous)

Replicate

 

Time point 1

(Four days)

 

Time point 2

(Five days)

 

Time point 3

(Six days)

70 %

Headspace

1

3.9

3.8

3.7

2

3.7

3.8

3.5

Average

3.8

3.8

3.6

%RPD

4.1

0.73

4.1

50 %

Headspace

1

3.8

3.8

3.8

2

3.8

3.8

3.6

Average

3.8

3.8

3.7

%RPD

1.9

2.5

5.9

30 %

Headspace

1

3.7

3.8

3.7

2

3.8

3.8

3.8

Average

3.7

3.8

3.7

%RPD

1.1

0.43

2.8

Intra-Day Average

% RSD

3.8

1.7

3.8

1.0

3.7

2.8

Overall Average

%RSD

3.8

2.5

 

 

Applicant's summary and conclusion

Conclusions:
The Henry's Law constant (HLC) for HFP Kinetic Dimer was determined based on measured concentrations in the gas-phase and aqueous-phase. Under an average study temperature of 22°C, the average HLC was 5690, the average log HLC was 3.8.
Executive summary:

 The Henry's Law constant of HFP Kinetic Dimer was determined by the ratio of gas-phase concentration over aqueous-phase concentration.

Duplicate test vessels were filled with water and dosed with HFP Kinetic Dimer gas at three headspace:water ratios (70%, 50% and 30%). The vials were incubated for 4, 5, and 6 days at ambient temperature. Both the headspace and the water phase for each vial were sampled and analyzed in duplicates using gas chromatography/mass spectrometry (GC/MS). The average measured gas phase and water phase concentrations were used to calculate Henry's Law constant for HFP Kinetic Dimer for each test vessel. Under the conditions of this study (average temperature of 22°C), overall average HLC for HFP Kinetic Dimer is 5690 (%RSD = 18), the overall average log HLC was 3.8 (% RSD= 2.5). The dimensionless HLC can be converted to 1.40E+07 Pa·m³/mol (138 atm·m³/mole).

This study was conducted under GLP compliance with accepted method. However, there were seveal samples that had high %RPD. Therefore, it is considered reliable with restrictions.