Registration Dossier

Physical & Chemical properties

Water solubility

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26-Nov 2015 to 04-Dec-2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. certificate)
Remarks:
Staatliches Gewerbeaufsichtsamt Hildeshelm
Type of method:
flask method
Key result
Water solubility:
2.57 g/L
Temp.:
20 °C
pH:
4

Results

 

Preliminary Test (non GLP)

The determined solubility in double distilled water was in the range of 2.016 - 4.032 g/L. For the application dose for the definitive study, approx. 20 g/L was used (approximately five times the maximum solubility result).

 

Main test

 

Water solubility results at 20 °C

Pre-incubation time

Replicate No.

Concentration1) (g/L)

Mean

24 h

1

2.56

2.54

2

2.51

48 h

1

2.58

2.59

2

2.60

72 h

1

2.56

2.57

2

2.58

Mean (24 – 72 h)

SD

2.57

Deviation (%) (24 – 72)2)

CV (%)

2.0

 

1) Mean value of double injections, dilution factor of 200 and exact weighs taken into account

2) Calculated according to the formula:

Deviation (%) = 100 x (max value - min value) / min value

SD Standard deviation

CV Coefficient of variation

 

No significant signal was determined for the control sample.

Validity Criteria

The study was performed based on OECD Guideline 105 for Testing of Chemicals (1995) and Council Regulation (EC) No. 260/2014, Method A.6. The validity criteria were fulfilled:

 

-       The concentration measured did not differ by more than 15 %.

-       Temperatures were kept constant within ± 0.5 °C.

 

Conclusions:
A water solubility value of 2.57 g/L (at 20 °C, pH 4.0) was determined for the test substance according to E.U. Method A.6.

Description of key information

Water solubility: 2.57 g/L at 20 °C, pH =4.0 (EU Method A.6., flask method)

Key value for chemical safety assessment

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

Additional information

A water solubility value of 2.57 g/L (at 20 °C, pH 4.0) was determined for the test substance according to E.U. Method A.6.