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:
25 Sep to 01 Oct 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 Hildesheim
Type of method:
flask method
Key result
Water solubility:
84.3 mg/L
Conc. based on:
test mat.
Incubation duration:
ca. 96 h
Temp.:
20 °C
pH:
5.5

Results

 

Preliminary Test (non GLP)

The determined solubility was in the range of 0.0176 - 0.176 g/L, no Tyndall-effect was observed at 0.0176 g/L. For the application dose of the definitive study, 1 g/L, as a approx, fivefold of the solubility result, was used.

 

Main test

 

Water solubility results at 20 °C

Pre-incubation time

Replicate No.

Concentration1) (g/L)

Mean

48 h

1

88.3

86.6

2

84.9

72 h

1

82.3

81.9

2

81.5

96 h

1

83.6

84.4

2

85.2

Mean (48 – 96 h)

SD

84.3

Deviation (%) (48 – 96)2)

CV (%)

5.7

 

1) Mean values of two injections

2) Calculated according to the formula

SD Standard deviation

CV Coefficient of variation

 

Validity Criteria

The study was performed based on OECD Guideline 105 for Testing of Chemicals (1995) and Council Regulation (EC) No. 440/2008, 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

The solubility of the test item was determined to be 84.3 mg/L (pH 5.5) at 20 ± 0.5 °C.

Conclusions:
A water solubility value of 84.3 mg/L (at 20 °C, pH 5.5) was determined for the test substance according to E.U. Method A.6.
Executive summary:

The study was conducted according to OECD Guideline 105 for Testing of Chemicals (1995) and Council Regulation (EC) No. 260/2014, Method A.6. The solubility of the test item was determined using the flask method at 20±0.5°C with pre-incubation at 30±0.5°C. The analytical method (HPLC-DAD, external standard) for the determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity. The water solubility of the test item was determined to be: 84.3 mg/L (20°C, pH 5.5).

Description of key information

Water solubility: 84.3 mg/L at 20 °C, pH = 5.5 (EU Method A.6., flask method)

Key value for chemical safety assessment

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

Additional information

A study was conducted according to OECD Guideline 105 for Testing of Chemicals (1995) and Council Regulation (EC) No. 260/2014, Method A.6. The solubility of the test item was determined using the flask method at 20±0.5°C with pre-incubation at 30±0.5°C. The analytical method (HPLC-DAD, external standard) for the determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity. The water solubility of the test item was determined to be: 84.3 mg/L (20°C, pH 5.5).