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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:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Study was carried out according to generally valid and internationally accepted testing guidelines and under GLP. The substance is considered to be adequately characterised. Therefore full validation applies.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
Cited as Directive 92/69/EEC, A.6
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Key result
Water solubility:
ca. 717 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
1 000 g/L
Incubation duration:
>= 48 - <= 96 h
Temp.:
20 °C
pH:
> 4.49 - < 4.58
Remarks on result:
other:
Remarks:
Mean value of 6 determinations (3 replicates and 2 dilutions for each of them) between 627 and 789 g/L (RSD = 9%)
Water solubility:
ca. 736 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
1 000 g/L
Incubation duration:
>= 48 - <= 96 h
Temp.:
20 °C
pH:
> 4.74 - < 4.82
Remarks on result:
other:
Remarks:
Mean value of 6 determinations (3 replicates and 2 dilutions for each of them) between 663 and 874 g/L (RSD = 11%)
Water solubility:
ca. 696 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
1 000 g/L
Incubation duration:
>= 48 - <= 96 h
Temp.:
20 °C
pH:
> 8.64 - < 8.7
Remarks on result:
other:
Remarks:
Mean value of 6 determinations (3 replicates and 2 dilutions for each of them) between 650 and 735 g/L (RSD = 4%)
The test was performed at 20.0 +/- 0.5  C, in vessels protected from light.

Conclusion:In Milli-Q water, 717 +/- 65 g/L with a precision of 9 % and measured pH ranged from 4.49 to 4.58
In buffer pH 6, 736 +/- 79 g/L with a precision of 11 % and measured pH ranged from 4.74 to 4.82
In buffer pH 9, 696 +/- 31 g/L with a precision of 4 % and measured pH ranged from 8.64 to 8.70.

No statistical difference was found in the stability of the test item, when tested in pH's from 4.49 to 8.70

Conclusions:
The water solubility of test item was found to be between 696 g/L and 736 g/L at 20°C for pH's ranging from 4.49 to 8.70.
A mean value of 717 g/L, corresponding to the water solubility of test item obtained in Milli-Q water, was considered as key data.
Executive summary:

The water solubility of test item was determined acccording to EU method A.6 based on the flask method and under GLP.

A mean value of 717 g/L at 20°C, corresponding to the water solubility of test item obtained in Milli-Q water, was considered as key data.

Description of key information

A fully reliable experimental study, conducted according to a recognized EC method and under GLP, is available. It is considered as a key study.

Water solubility of test item : 696-736 g/L at 20°C for pH 4.49 to 8.70.

A mean value of 717 g/L, corresponding to the water solubility of test item obtained in Milli-Q water, was considered as key data.

Key value for chemical safety assessment

Water solubility:
717 000 mg/L
at the temperature of:
20 °C

Additional information

A fully reliable experimental study, conducted according to a recognized EC method and under GLP, is available.

The water solubility of test item was found to be between 696 g/L and 736 g/L at 20°C for pH's ranging from 4.49 to 8.70.

A mean value of 717 g/L, corresponding to the water solubility of test item obtained in Milli-Q water, was considered as key data.