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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:
February 03rd to 08th, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
adopted 27 July 1995
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Water solubility:
< 0.2 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
7
Details on results:
PRELIMINARY TEST
Preliminary result indicated that the test item had a solubility of less than 10^-2 g/l in milli-Q water. The actual solubility was confirmation by column elution method.

MAIN TEST
The solubility of in Milli-Q water was below limit of detection level, i.e. 0.20 mg/l.

VALIDATION OF ANALYRICAL METHOD
Specificity
Specificity meets the acceptance criterion for test item as the interference obtained for diluent was 6.18 % and diluent spiked with water was 5.84 % which is < 20.0% of the sample response at LOQ.

Limit of Detection (LOD) and Limit of Quantification (LOQ)
The LOD was determined at 0.20 mg/l concentration based on S/N ≈ 3/1 and LOQ was determined at 1.02 mg/l concentration based on S/N ≥ 10/1 for test item.

Linearity
Linearity meets the acceptance criterion for test item as the correlation coefficient obtained was 0.9999 to 1.0000 which is >0.99.

Accuracy (% Recovery) and Precision (% RSD)
Recovery for test item meets the acceptance criterion as the % recovery obtained was 92.13 % for LOQ (1.00 mg/l) and 89.65 % for 10 LOQ (10.03 mg/l) which is within the range 80 % to 120 % of the nominal concentration.
Precision meets the acceptance criterion as the % RSD for test item obtained was 0.22 % for LOQ (1.00 mg/l) and 0.25 % for 10 LOQ (10.03 mg/l) which is ≤ 15.0 %.

SOLUBILITY OF TEST ITEM IN MILLI-Q WATER - DEFINITIVE TEST-FLOW RATE 25 ml/HOUR

 Sample Code pH Dilution Factor Conc. Obtained (mg/l) Mean Conc. Obtained (mg/l)
Sample R1 25 ml/h 7.0 2.00 - -
Sample R2 25 ml/h 7.0 2.00 -
Sample R3 25 ml/h 7.0 2.00 -
Sample R4 25 ml/h 7.0 2.00 -
Sample R5 25 ml/h 7.0 2.00 -
Sample R6 25 ml/h 7.0 2.00 - -
Sample R7 25 ml/h 7.0 2.00 -
Sample R8 25 ml/h 7.0 2.00 -
Sample R9 25 ml/h 7.0 2.00 -
Sample R10 25 ml/h 7.0 2.00 -

SOLUBILITY OF TEST ITEM IN MILLI-Q WATER - DEFINITIVE TEST-FLOW RATE 12.5 ml/HOUR

 Sample Code pH Dilution Factor Conc. Obtained (mg/l) Mean Conc. Obtained (mg/l)
Sample R1 12.5 ml/h 7.0 2.00 - -
Sample R2 12.5 ml/h 7.0 2.00 -
Sample R3 12.5 ml/h 7.0 2.00 -
Sample R4 12.5 ml/h 7.0 2.00 -
Sample R5 12.5 ml/h 7.0 2.00 -
Sample R6 12.5 ml/h 7.0 2.00 - -
Sample R7 12.5 ml/h 7.0 2.00 -
Sample R8 12.5 ml/h 7.0 2.00 -
Sample R9 12.5 ml/h 7.0 2.00 -
Sample R10 12.5 ml/h 7.0 2.00 -
Conclusions:
< 0.20 mg/l at 20 °C at pH 7.0
Executive summary:

The water solubility of test item was determined as per OECD guideline 105 and Guidelines OPPTS 830.7840. On the basis of the preliminary test outcomes, the test item solubility was expected to be less than 10-2 g/l in milli-Q water. Therefore, the definitive test was performed in milli-Q water under laboratory condition at 20.0 °C by column elution method. The samples were analyzed for test item concentration by HPLC-UV. The HPLC-UV analytical method was validated in accordance with SANCO/3029/99, rev 4.0 dated 11/07/00. The validation parameters such as specificity, linearity, accuracy and precision were verified during validation. Method validation parameters evaluated for test item meets the acceptance criteria.

The solubility of test item in milli-Q water was determined as below limit of detection level 0.20 mg/l at 20.0 °C and pH 7.0.

Conclusion

< 0.20 mg/l at 20 °C at pH 7.0

Description of key information

< 0.20 mg/l at 20 °C at pH 7.0

Key value for chemical safety assessment

Additional information

OECD 105 - column elution method