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Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 30-October 19, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
adopted July 27, 1995
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4,5,5,6,6,7,7,8,8,9,9,9-tridecafluorononyl methacrylate
EC Number:
812-877-4
Cas Number:
1228350-17-1
Molecular formula:
C13 H11 F13 O2
IUPAC Name:
4,4,5,5,6,6,7,7,8,8,9,9,9-tridecafluorononyl methacrylate
Test material form:
liquid
Details on test material:
Test Item name Fluowet PMA600
Batch No. DH213/16
Appearance transparent to brownish liquid
Purity 99.4 %
Expiry date 01 June 2017
Storage room temperature, protected from light
Specific details on test material used for the study:
Test Item name Fluowet PMA600
Batch No. DH213/16
Appearance transparent to brownish liquid
Purity 99.4 %
Expiry date 01 June 2017
Storage room temperature, protected from light

Results and discussion

Water solubility
Key result
Water solubility:
0.076 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
518 mg/L
Incubation duration:
2 h
Temp.:
20 °C
pH:
> 6.66 - < 6.68

Any other information on results incl. tables

Results of the determination of Fluowet PMA600 concentrations

Analytical occasion / Time Period hours

Flow rate (mL/hour)

Measured concentration ofFluowet PMA600(mg/L)

Column 1.

Column 2.

October 04, 2016

20; 22

~ 25

Before the saturation range

October 07, 2016

88

90

92

94

0.103

0.047

0.099

0.104

 pH = 6.66

pH = 6.67

pH = 6.67

pH = 6.68

0.100

0.060

0.076

0083

pH = 6.67

pH = 6.68

pH = 6.67

pH = 6.67

October 09, 2016

142

144.5

147

0.099

0.101

0.088

pH = 6.67

pH = 6.67

pH = 6.68

-*

0.091

0.075

pH = 6.66

pH = 6.67

pH = 6.67

Mean

0.091

pH = 6.67

0.081

pH = 6.67

Mean of the Column 1 and Column 2 with95% confidence interval

0.087 ± 0.011

RSD %

21

Analytical occasion / Time Period hours

Flow rate (mL/hour)

Measured concentration ofFluowet PMA600(mg/L)

Column 1.

Column 2.

October 10, 201

2.5, 4.5, 10.5

~ 15

Before the saturation range

October 11, 2016

26.5

28.5

34

0.080

0.056

-*

pH = 6.68

pH = 6.70

pH = 6.70

0.065

0.078

0.064

pH = 6.66

pH = 6.67

pH = 6.67

October 12, 2016

53

55.5

57.5

61

0.079

0.069

0.063

0.080

pH = 6.80

pH = 6.80

pH = 6.78

pH = 6.80

0.073

0.054

0.093

0.078

pH = 6.82

pH = 6.84

pH = 6.88

pH = 6.88

October 13, 2016

75

81

83.5

0.078

0.060

0.045

pH = 6.82

pH = 6.78

pH = 6.80

0.073

0.061

0.053

pH = 6.90

pH =6.86

pH = 6.88

Mean

0.068

pH = 6.77

0.069

pH = 6.81

Mean of the Column 1 and Column 2 with95% confidence interval

0.069 ± 0.006

RSD %

18

Mean all with 95% confidence interval

0.076 ±0.006

RSD %

22 

-*   Excluded because of a technical error

Applicant's summary and conclusion

Conclusions:
In conclusion the water solubility of Fluowet PMA600 was determined to be 0.076  0.006 mg/L (95% confidence interval) at 20 °C ± 1 °C using the column elution method for the performance.
Executive summary:

The purpose of this study was to determine the solubility of the test item in water at 20±1 °C.

The method is based on the elution of the test substance with water from a micro-column which is charged with an inert support material coated with an excess of test substance. The water solubility is determined when the mass concentration of the eluate is constant. This is shown by a concentration plateau as a function of time.

Results of the test and measured concentrations of Fluowet PMA600 on the two parallel columns using two different flow rates. The measured concentrations are constant within ± 30 % and thus within the range required by the guidelines.

The water solubility of Fluowet PMA600 was determined to be 0.076 ± 0.006 mg/L (95% confidence interval)  at± 1 °C using the column elution method for the performance.