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Water solubility

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Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 - 11 June 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted by a recognised facility in compliance with GLP to a recent regulatory test guideline.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Water solubility:
0.367 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
Remarks on result:
other: pH not specified; assumed neutral as conducted in HPLC-grade reagent water.
Details on results:
The solubility of Reofos 35 in water was determined based upon the mean analytical results of samples analyzed on Days 2 and 3. Overall mean analytical results were 0.331 mg/L + 0.008 (RSD = 2.28%), 0.384 mg/L ± 0.020 (RSD = 5.17%) and 0.387 mg/L ± 0.005 (RSD = 1.22%) mg/L, respectively. The percent change in solubility between the Day 2 and Day 3 samples (using the overall mean values) was 16.0%. Thepercent change in solubility between the Day 3 and Day 4 samples was 0.781%. The water solubility of Reofos 35 was, therefore, determined to be 0.367 mg/L (SD = 0.030, RSD = 8.09%) calculated as the mean analytical result of all subsamples from the Day 2, 3 and 4 sampling intervals.

Solubility of Reofos 35 in HPLC-Grade Reagent Water at 20 °C

Nominal

Sample

Sample

Measured

Mean

% Change

Concentration

Identification

Interval

Concentration

Std. Dev.

Between

(mg/L)

(298C-145-)

(Day)

(mg/L)

RSD

Intervals

100

A-l

2

0.322

x =0.331

 

100

A-2

2

0.334

SD = 0.008

~

100

A-3

2

0.336

RSD = 2.28%

 

100

B-l

3

0.406

x =0.384

 

100

B-2

3

0.367

SD = 0.020

16.0

100

B-3

3

0.380

RSD = 5.17%

 

100

C-l

4

0.389

x =0.387

 

100

C-2

4

0.391

SD = 0.005

0.781

100

C-3

4

0.382

RSD = 1.22%

 

 

 

Mean =

0.367

 

 

 

Standard Deviation =

0.030

 

 

 

 

RSD =

8.09%

 

 

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The mean water solubility for the substance is 0.367 mg/l; the substance is considered slightly soluble.
Executive summary:

The water solubility was assessed using the flask shake method according to the OECD 105 guideline and samples analysed using GC/MS. Completed in triplicate and the mean result evaluated, the mean water solubility for the substance is 0.367 mg/l; the substance is considered slightly soluble.

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7-11 June 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted by a recognised facility in compliance with GLP to a recent regulatory test guideline.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Water solubility:
0.33 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
Remarks on result:
other: pH not specified; assumed neutral as conducted in HPLC-grade reagent water.
Details on results:
The solubility of Reofos 65 in water was determined based upon the mean analytical results of samples analyzed on Days 2 and 3. Overall mean analytical results were 0.355 mg/L ± 0.006 (RSD = 1.70%) and 0.304 mg/L + 0.007 (RSD = 2.38%), respectively. The percent change in solubility between the Day 2 and Day 3 samples (using the overall mean values) was 14.4%. The water solubility of Reofos 65 was, therefore, determined to be 0.330 mg/L (SD=0.028, RSD=8.55%) calculated as the mean analytical result of substances from Day 2 and 3 sampling intervals.

 

Solubility of Reofos 65 in HPLC-Grade Reagent Water at 20 °C

Nominal

Sample

Sample

Measured

Mean

% Change

Concentration

Identification

Interval

Concentration

Std. Dev.

Between

(mg/L)

(298C-145-)

(Day)

(mg/L)

RSD

Intervals

100

A-l

2

0.354

x =0.355

 

100

A-2

2

0.349

SD = 0.006

~

100

A-3

2

0.361

RSD = 1.70%

 

100

B-l

3

0.309

x =0.304

 

100

B-2

3

0.296

SD = 0.007

14.4

100

B-3

3

0.308

RSD = 2.38%

 

 

 

Mean =

0.330

 

 

 

Standard Deviation =

0.0280

 

 

 

 

RSD =

8.55%

 

 

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The mean water solubility for the substance is 0.330 mg/l; the substance is considered slightly soluble.

Executive summary:

The water solubility was assessed using the flask shake method according to the OECD 105 guideline and samples analysed using GC/MS. Completed in triplicate and the mean result evaluated, the mean water solubility for the substance is 0.330 mg/l; the substance is considered slightly soluble.

Description of key information

Water solubility

Key value for chemical safety assessment

Water solubility:
0.33 mg/L
at the temperature of:
20 °C

Additional information

Two GLP compliant studies are available on different runs of the product. These give the water solubility as a range of 0.330 to 0.367 mg/l at 20 °C