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Diss Factsheets

Physical & Chemical properties

Water solubility

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2014-10-24 to 2015-01-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
712 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
0.7 mg/L
Temp.:
20 °C
pH:
6.1

Preliminary Test (non-GLP)

The determined solubility was in the range of 0.11 – 0.141 g/L. The sample was checked negative for Tyndall-effects at 0.11 g/L. For the application dose of the definitive study, 0.7 g/L, as approx. the fivefold of the solubility result, was used.

Method Validation

The LOQ was defined corresponding to the study requirements and set to 2 mg/L with a dilution factor of 10, corresponding to a concentration of 0.2 mg/L in the final samples at 1 x LOQ.

Water Solubility Results

Preincubation time

Replicate No.

Test Item Concentration1 [mg/L]

Mean Concentration [mg/L]

24 h

1

681

688

2

695

48 h

1

759

760

2

760

72 h

1

687

689

2

691

Mean (24 – 72 h)

 

712

Deviation [%]2

11

1 Mean value of two injections

2 Calculated according to Deviation [%] = (100 x (max value – min value)) / min value

Conclusions:
The solubility of the test item was determined to be 712 mg/L (pH 6.1) at 20 ± 0.5 °C.
Executive summary:

The water solubility of the test item was determined according to OECD guideline 105 (1995) and Council Regulation (EC) No. 440/2008, Method A.6. The solubility of the test item was determined using the flask method at 20 ± 0.5 °C with preincubation at 30 ± 0.5 °C. The analytical method (HPLC-UV/DAD, test item as 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 712 mg/L (20 °C, pH 6.1).

Description of key information

The solubility of the test item was determined to be 712 mg/L (pH 6.1) at 20 ± 0.5 °C.

Key value for chemical safety assessment

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

Additional information

The water solubility of the test item was determined according to OECD guideline 105 (1995) and Council Regulation (EC) No. 440/2008, Method A.6. The solubility of the test item was determined using the flask method at 20 ± 0.5 °C with preincubation at 30 ± 0.5 °C. The analytical method (HPLC-UV/DAD, test item as 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 712 mg/L (20 °C, pH 6.1).