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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January 26 to February 8, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method, and under GLP. No deviation affected the quality of the study. The substance is considered to be adequately characterised with its purity. Therefore full validation applies.
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
inspected on September 22, 1999 / signed on January 18, 2000
Type of method:
flask method
Key result
Water solubility:
609 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
860 mg/L
Incubation duration:
24 - 72 h
Temp.:
20 °C
pH:
8.6 - 9.3
Details on results:
The solubility of the test material in water was found to be 609 ± 8 mg/L (RSD = 1%) at 20 ± 2 °C. The resulting saturated solutions were basic (pH 8.6 to 9.3) and whitish.

Preliminary test

This test was performed at 20 °C in vessels protected from light. The pH value of the water used was 9.15.

The preliminary test indicated that the test substance was soluble in water with solubility above 10 mg/L.

On the basis of these results, the final solubility determination was undertaken using the flask method

 

Flask method

The test was performed at 20 ± 2 °C, in vessels protected from light.

The solubility in water was found to be 609 ± 8 mg/L with a precision of 1%.

The water used had a pH value of 9.12. In the three replicate solutions prepared, the pH values were found to be 9.25, 8.88 and 8.59 (replicates 1 to 3).

 

Table 4.8/1: Water solubility of test item (Flask method)

 

Replicate number / Sampling Time

Water solubility (mg/L)

First dilution

Second dilution

Mean (n=2)

Mean (n=6)

3 / T24h

606

596

601

 

2 / T48h

608

616

612

 

1 / T72h

613

617

615

 

 

 

 

 

609

 

 

 

SD

8

 

 

 

RSD %

1

Conclusions:
Interpretation of results (migrated information): moderately soluble (100-1000 mg/L)
Executive summary:

The water solubility of the test substance was measured under GLP according OECD 105/EU A6 guideline, flask method.

Three measurements were performed at 48, 72 and 96 h, analysis were performed with HPLC-UV after suitable calibration, and dilution of the test samples. Equilibrium was achieved and the mean result was retained.

The water solubility of the test substance is 609 ± 8 mg/L (RSD = 1%) at 20 ± 2 °C. The resulting saturated solutions were basic (pH 8.6 to 9.3) and colourless.

Description of key information

Considered as moderately soluble, with equilibrium reached from 24h. pH of saturated solution: ca 9.

Key value for chemical safety assessment

Water solubility:
609 mg/L
at the temperature of:
20 °C

Additional information

A fully reliable experimental study, conducted according to a recognized OECD/EC method and under GLP, is available. Therefore, it is considered as a key study, and the result is retained as key value.