Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 Jun - 28 Jun 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The water solubility was determined based on total organic carbon (TOC) measurements.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
adopted in 1995
Deviations:
yes
Remarks:
The water solubility was determined based on total organic carbon (TOC) measurements.
GLP compliance:
yes (incl. certificate)
Remarks:
LUBW Landesanstalt für Umwelt, Messungen un Naturschutz Baden-Württemberg, Karlsruhe, Germany
Type of method:
flask method
Remarks:
The water solubility was determined based on total organic carbon (TOC) measurements.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
326 mg/L
Temp.:
20 °C
pH:
ca. 4.44

Any other information on results incl. tables

Table 3 – Preliminary test results (first test)

Test item [mg]

 

Total volume of ultra-pure water [mL]

Time of shaking [min]

remarks

Approx.. solubility [g/L]

100.8

0.1

10

Not completely dissolved

< 1008

0.5

10

Not completely dissolved

< 201.6

1

10

Not completely dissolved

< 100.8

2

10

Not completely dissolved

< 50.4

10

10

Not completely dissolved

< 10.1

100

10

Not completely dissolved

< 1.0

105

16 hours

Not completely dissolved

< 1.0

Table 4 – Preliminary test results (second test)

Test item [mg]

 

Total volume of ultra-pure water [mL]

Time of shaking [min]

remarks

Approx.. solubility [mg/L]

39

100

20

Not completely dissolved

< 390

200

20

Not completely dissolved

< 195

300

20

Not completely dissolved

< 130

400

20

Not completely dissolved

< 97.5

500

20

Not completely dissolved

< 178

1000

16 hours

dissolved

39 - 78

Table 5 – TOC Results

Sample code

TOC [mg/L]

S16-03664 PTFE Blank

< 0.3

S16-0364 Flask 1 T120

S16-0364 Flask 1 T144

S16-0364 Flask 1 T168

164

173

181

Mean

Standard deviation [mg/L]

Relative standard deviation [%]

173 mg/L TOC

9

5.2

S16-0364 Flask 2 T120

S16-0364 Flask 2 T144

S16-0364 Flask 2 T168

167

174

177

Mean

Standard deviation [mg/L]

Relative standard deviation [%]

173 mg/L TOC

5

2.9

Mean Flask 1 and Flask 2

Deviation mean Flask 1 and mean Flask 2

173 mg/L TOC

0%

S16-03662 test item-Bulk material

TOC [%]

53.0

 

Test item concentration calculation:

C(test item in sample) in mg/L

TOC(sample) in mg/L

TOC(test item) in %

 

C(test item in sample) = [TOC(sample) / TOC(test item)] *100% = [173 mg/L / 53.0%] * 100% = 326 mg/L

 

Results display the required reproducibility (relative standard deviation is < 15%, deviation between the means of Flask 1 and Flask 2 is < 15%).

The water solubility of the test item was determined to be 326 mg/L in ultra-pure water at a temperature of 20 ± 0.5 °C at a pH 4.44.

Applicant's summary and conclusion