Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 January 2012- 19 March 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and EC guidelines and according to the principles of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
(1995)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Clear colourless/slightly yellow, sticky resin
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature protected from light
-Stability at higher temperatures: Maximum 1 month at 50°C
- General information: Avoid heat, direct sunlight, acid and base

Results and discussion

Water solubility
Water solubility:
g/L
Temp.:
20 °C
Details on results:
Preliminary test:
The content of test substance dissolved in the water sample was 7.98 mg/l after a first centrifugation step and 8.13 mg/l after a second centrifugation step. The response in the blank expressed as test substance concentration was 2.38 mg/l after a first centrifugation step and 3.92 mg/l after a second centrifugation step.

Main study:
After 72 hours of stirring, the test substance in the mixture at a loading rate of 5 mg/l had completely dissolved. All other mixtures contained undissolved material. Based on this visual observation, water solubility was expected to be <10 mg/l. The results for the samples at loading rates of 5, 10, 100 and 1000 mg/l taken at 24, 48 and 72 hours after centrifugation are given in the table below. The concentrations in the test samples were corrected for the mean response in the blank water mixture.

Any other information on results incl. tables

Table: Water solubility results

 

Loading rate

 

[mg TS/l]

Stirring time

[hours]

Analysed
concentration

[mg C/l]

Analysed
concentration

[mg TS/l]

Analysed
concentration corrected1
[mg TS/l]

Mean analysed concentration
[mg TS/l]

pH

 

 

 

 

 

 

 

0

72

0.744

1.13

 

 

 

 

72

0.567

0.861

 

 

 

 

72

0.480

0.729

 

 

 

 

 

 

 

 

 

 

5

24

0.707

1.07

0.166

0.7

7.2

 

48

0.907

1.38

0.470

 

7.2

 

72

1.60

2.42

1.52

 

7.3

 

 

 

 

 

 

 

10

24

1.52

2.31

1.40

1.6

7.3

 

48

1.04

1.58

0.670

 

7.3

 

72

2.43

3.68

2.78

 

7.2

 

 

 

 

 

 

 

100

24

5.44

8.24

7.34

8.0

7.1

 

48

6.57

9.97

9.06

 

7.1

 

72

5.64

8.56

7.65

 

7.1

 

 

 

 

 

 

 

1000

24

12.3

18.7

17.8

66.2

7.2

 

48

37.6

57.1

56.2

 

7.2

 

72

82.8

126

125

 

7.1

 

 

 

 

 

 

 

1            Corrected for the mean of the blanks.

TS          Test substance.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L) < 10 mg/L
The water solubility of the test substance at 20°C and pH 7.1-7.3 is < 10 mg/L.