Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 April 2009 - 10 August 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Issued by: The Department of Health of the Government of the United Kingdom Inspection date: 19 August 2008
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubilityopen allclose all
Water solubility:
ca. 39.5 mg/L
Temp.:
20 °C
pH:
>= 6.2 - <= 6.5
Remarks on result:
other: at a nominal loading rate of 100 mg/L water
Water solubility:
ca. 137.6 mg/L
Temp.:
20 °C
pH:
6.4
Remarks on result:
other: at a nominal loading rate of 1000 mg/L water
Details on results:
The water solubility of the test material is loading rate dependent. At loading concentrations of 100 and 1,000 mg/L, the water solubility is 39.5 mg/L and 137.6 mg/L, respectively, at 20 degrees C

Any other information on results incl. tables

Table 5: Results of Water Solubility Test

Test No.

Loading Rate (mg/L)

Shaking Time at 300C (hours)

Equilibration Time at 200C (hours)

pH

Water Solubility (mg/L)

Mean (mg/L)

1

103.8

24

24

6.4

* 29.5

39.5

2

100.9

48

24

6.2

38.5

3

100.9

72

24

6.5

40.5

4

1009.8

24

24

6.4

130

137.6

5

1007.1

48

24

6.4

134

6

1018

72

24

6.4

149

* not included in calculation of mean; this sample not fully equilibrated

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: The water solubility is loading rate dependent: 39.6 mg/L (at loading rate of 100 mg/L) and 137.6 mg/L (at loading rate of 1 g/L) at 20 degrees C.
The water solubility of the test material is loading rate dependent.
Executive summary:

The water solubility of the test substance was assessed using a shake flask method performed according to EU Method A.6 guidelines and the recommendations in the ECHA Chapter R.7a: Endpoint specific guidance for complex UVCB substances.

The study was performed at test substance loading rates of 100 mg/L and 1000 mg/L, with quantitation of the water soluble portion by GPC (gel permeation chromatography).  In this study, the solubility of the test material at 20 C was determined to be loading rate dependent: 39.5 mg/L (at loading rate 100 mg/L) and 138 mg/L (at loading rate 1000 mg/L).  

The chemical identity of the water soluble and insoluble components of the test material could not be determined.  The test substance is an incompletely characterized mixture of components (a UVCB). Normal phase chromatography followed by ESI-MS characterization of isolated fractions showed fractions with similar spectral characteristics. The complexity and inability to isolate individual components and the lack of significant diffrences in the spectra of isolated fractions indicates a mixture of components that may be interacting to form complexes that cannot be separated and limits our ability to identify and quantify individual components in the test substance.