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Diss Factsheets

Physical & Chemical properties

Water solubility

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Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 2, 2009 to November 5, 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Water solubility was estimated based on visual conception
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
Acceptable
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
Acceptable
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
> 846 - < 866 g/L
Temp.:
20 °C
pH:
13.6
Remarks on result:
other: pH was measured if technically feasible

Preliminary test was conducted with various concentration % w/w (40.8, 50.2, 59.9, 70.2, 79.9, 89.0 %).

For all the samples, a slightly hazy colorless solution with a few black particles, no excess substance.

pH was measured at all concentration solubility was found to be >89% w/w at 20±0.5C.

The standard A6 method was not applicable to this test substance due to indeterminable saturation level produced it was not possible to prepare samples at five times the saturation level (recommended in guideline).

 

Conclusions:
Under the study conditions, the water solubility of the test substance was determined to be in the range of 84.6 - 86.6% w/w at 20±0.5⁰C by visual assessment.
Executive summary:

A study was conducted to determine the water solubility of the test substance according to EU method A6 and OECD Guideline 105, in compliacne with GLP. Preliminary study was performed and based on that the concentation for the definitive study was chosen. In definitive study, various concentration in % w/w (80.7, 82.6, 84.6, 86.6, 88.6, 90.7, 92.8, 94.9% w/w) were used. In a preliminary visual experiment, the test substance showed a water solubility >89% w/w. No analysis could be performed due to high solubility producing an unfilterable mixture and thus water solubility was estimated based on visual conception. The 24 h definitive test gave more time to reach concentration equilibrium. Under the study conditions, the water solubility of the test substance was determined to be in the range of 84.6 - 86.6% w/w at 20±0.5⁰C by visual assessment (Fox, 2009).

Endpoint:
water solubility
Type of information:
not specified
Adequacy of study:
key study
Study period:
2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted and well documented study with reliable results but not run according to GLP.
Principles of method if other than guideline:
Method followed unknown, data from technical manual.
GLP compliance:
no
Type of method:
other: No data
Key result
Water solubility:
ca. 83 other: % w/w
Temp.:
20 °C
pH:
>= 10 - <= 11
Conclusions:
Under the study conditions the water solubility of the test substance powder was determined to be 83 % w/w at 20°C.
Executive summary:

A study was conducted to determine the water solubility of the test substance using method from Technical Manual, part A: chemical and physical properties, section A1: chemistry. Under the study conditions the water solubility of the test substance powder was determined to be 83 % w/w at 20°C (Company data, 2008).

Description of key information

Solid form: the water solubility was determined by:

- visual assessment (no analysis could be performed due to high solubility producing an unfilterable mixture)

- method from Technical manual, Part A: chemical and physical properties, section A1: chemistry

Key value for chemical safety assessment

Additional information

Solid form:

- in the range of 84.6 - 86.6% w/w at 20±0.5⁰C (visual assessment)

- 83 % w/w at 20°C (Technical manual)