Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 1st September to 10th October 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC, A6 (flask method)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
ca. 196 000 mg/L
Temp.:
20 °C
pH:
ca. 6.5

Any other information on results incl. tables

Results of the preliminary estimate indicated that the water solubility was in the range 10.3 to 19.8% w/w.

Definitive test

The results of the definitive test for the water solubility are shown in the following table.

 Sample Number  Observations  Concentration % w/w  pH
 1  Single phase opaque black solution  9.79  6.6
 2  Single phase opaque black solution  15.2  6.5
 3  Single phase opaque black solution 16.7  6.3
 4  Single phase opaque black solution, increased viscosity  19.6  6.5
 5  Viscous mainly opaque black semi-sold liquid  21.6  *
 6  Opaque black semi-sold mixture  25.1  *

The standard A6 method was not applicable to this test material as it was not possible to prepare samples at 5 times the saturation level, as recommended in the guideline.

No analysis could be performed due to the high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.

At 9.79% w/w the substance formed an opaque black solution. The viscosity of the solution increased at higher concentrations, until at 25.1% a semi-solid opaque black was observed.

The water solubility of the test material was determined to be in the range 19.6 to 21.6% w/w of solution at 20.0 +/- 0.5°C.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
The water solubility of the test material has been determined to be in the range 19.6 to 2 1.6% w/w at 20.0 +/- 0.5°C.
Executive summary:

Introduction:

test was conducted according to 92/69/EEC,EC method A6 (flask method)

Results and conclusions:

The water solubility of the test material has been determined to be in the range 19.6 to 2 1.6% w/w at 20.0 +/- 0.5°C.