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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From November 20 to December 07, 2007
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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
UK GLP Compliance Programme (inspected on August 21, 2007/ signed on October 15, 2007)
Type of method:
flask method
Key result
Water solubility:
13.7 g/L
Loading of aqueous phase:
50 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
4
Details on results:
Linearity range: 0 to 202 mg/L (r=0.999)

Preliminary test: The preliminary estimate of water solubility was 19.2 g/L
Definitive test: Mean concentration: 13.7 g/L at 20.0 ± 0.5°C; Range: 13.1-14.2 g/L

Table 4.8/1: Water solubility results

 

Sample number

Time shaken at ca. 30 °C (hours)

Time equilibrated at 20 °C (hours)

Concentration (g/L)

Solution pH

1

24

24

14.2

4.0

2

48

24

13.9

4.0

3

72

24

13.1

4.0

 

Mean concentration: 13.7 g/L at 20.0 ± 0.5°C; Range: 13.1-14.2 g/L

Executive summary:

The water solubility of the test substance was measured under GLP according OECD 105 guideline, flask method. Three measurements were performed at 24, 48 and 72 h, with duplicate analysis. Equilibrium was found to be reached from 24h, and the mean result was retained.

The water solubility of the test substance is 13.7 g/L at 20 ± 0.5 °C and pH 4.0.

Description of key information

Very soluble, dissolves rapidly (<=24h), pH of saturated solution: 4.0

Key value for chemical safety assessment

Water solubility:
13.7 g/L
at the temperature of:
20 °C

Additional information

A fully reliable experimental study, conducted according to a recognized OECD method and under GLP, is available. It is considered as a key study, and the result is retained as key value for purpose of CSA.