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Administrative data

Endpoint:
surface tension
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because water solubility is below 1 mg/L at 20°C
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 10, 2012 - September 14, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP without restriction.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Water solubility:
295 µg/L
Temp.:
30 °C
Remarks on result:
other: pH was not measured
Details on results:
Water solubility reported as ng/mL.

Triplicate samples were incubated for three time points (1, 2, and 3 days) at approximately 30 °C. Triplicate analysis was performed for each sample at each time point. The average measured solubilities for day 1 was 291 (250 -307) ng/mL; the average measured solubilities for day 2 was 293 (227 - 320) ng/mL; and the average measured solubilities for day 3 was 303 (280 - 320) ng/mL. An overall average value of 295 ng/mL was reported. The average %RSD for days 1, 2 and 3 were 5.7%, 17%, and 3.4%, respectively, Overall %RSD was 10%, meeting the sample precision requirements of ≤ 20% (%RSD).

Table 1. Summary of HFE-7300 Water Solubility in MiIIi-Q Water.

 

 

Day 1

Day 2

Day 3

Sample

Avg. Conc. (ng/mL)

 

%

RSD

Avg. Conc.  (ng/mL)

 

%

RSD

Avg. Conc.  (ng/mL)

 

%

RSD

Vial 1

278

8.5

229

0.81

295

4.4

Vial 2

304

1.0

339

0.20

303

0.47

Vial 3

291

1.5

311

2.5

309

3.2

Intra-day Average

291

5.7

293

17

303

3.4

Overall average

295 ng/mL

Overall %RSD

10

Table 2. Water solubility results of HFE-7300

Day 1 solubility Data (ng/mL)

Samples

Rep 1

Rep 2

Rep 3

Average Conc. (ng/mL)

% RSD

Vial 1

250

294

288

278

8.5

Vial 2

307

302

301

304

1.0

Vial 3

286

293

293

291

1.5

Average

 

 

 

291

 

RSD%

 

 

 

5.7%

 

Day 2 solubility Data

Samples

Rep 1

Rep 2

Rep 3

Average Conc. (ng/mL)

% RSD

Vial 1

229

227

231

229

0.81

Vial 2

339

339

338

339

0.2

Vial 3

306

320

307

311

2.5

Average

 

 

 

293

RSD%

 

 

 

17

Day 3 solubility Data

Samples

Rep 1

Rep 2

Rep 3

Average Conc. (ng/mL)

% RSD

Vial 1

304

280

302

295

4.4

Vial 2

303

302

305

303

0.47

Vial 3

301

306

320

309

3.2

Average

 

 

 

303

RSD%

 

 

 

3.4

Conclusions:
Under conditions of this study, the water solubility of Novec 7300 is 295 ng/mL.
Executive summary:

The solubility of HFE-7300 in Milli-Q water was determined using the Shake Flask method according to OPPTS 830.7840. Triplicate samples were incubated for 1, 2, and 3 days at approximately 30 °C. Samples were equilibrated at room temperature for 24 hours prior to analysis. Concentrations were analyzed in triplicate using a purge and trap gas chromatography/mass spectrometry (GC/MS).

HFE-7300 has a measured water solubility of 295 ng/mL at approximately 30˚C, as an average of day 1,2, and 3 measurements. The overall %RSD was 10%.

This is a guideline study conducted under GLP compliance. The study meets test requirements with no deviation. Therefore, it is considered reliable without restrictions.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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