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Stability in organic solvents and identity of relevant degradation products

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Reference
Endpoint:
stability in organic solvents and identity of relevant degradation products
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 21 September 2011 and 22 November 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviation from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Reference:
Composition 0
Qualifier:
no guideline followed
Principles of method if other than guideline:
The feasibility of performing the stability in organic solvent test was conducted by assessment of the solubility of the test item in organic solvent.
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Test substance stable:
not determined
Transformation products:
not measured

Results

The flasks were visually examined for the presence of test item by observation of the Tyndall beam effect.

Sample Number

Observation

Concentration

1

Tyndall beam effect observed indicating the presence of excess undissolved test item.

1.05

2

Tyndall beam effect observed indicating the presence of excess undissolved test item

1.05

The solubility of the test item was determined to be less than 1.05 mg/l in both xylene and ethanol; therefore it was not possible to perform stability in organic solvent testing.

Conclusions:
The solubility of the test item was determined to be less than 1.05 mg/l in both xylene and ethanol; therefore it was not possible to perform stability in organic solvent testing.
Executive summary:

In an assessment of the feasibility of the test, the solubility of the test item was determined visually in xylene and ethanol, using a flask method. The solubility of the test item was determined to be less than 1.05 mg/l in both xylene and ethanol; therefore it was not possible to perform stability in organic solvent testing.

Description of key information

The solubility of the test item was determined to be less than 1.05 mg/l in both xylene and ethanol; therefore it was not possible to perform stability in organic solvent testing.

Additional information

In an assessment of the feasibility of the test, the solubility of the test item was determined visually in xylene and ethanol, using a flask method. The solubility of the test item was determined to be less than 1.05 mg/l in both xylene and ethanol; therefore it was not possible to perform stability in organic solvent testing.