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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:
Experimental dates: 2017-10-13 to 2017-10-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method, and under GLP. No significant deviation was reported. The test substance is adequately characterised. Therefore full validation applies.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
(1995)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
Regulation (EC) No.440/2008 (as updated by Regulation (EC) No.260/2014)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Inspection June 7th-10th,2016 and July 13th,2016. Signed Jan. 03rd, 2017.
Type of method:
flask method
Key result
Water solubility:
13.2 mg/L
Conc. based on:
test mat. (dissolved fraction)
Loading of aqueous phase:
100 mg/L
Incubation duration:
ca. 24 - ca. 72 h
Temp.:
20 °C
pH:
ca. 6.5
Details on results:
The analytical method was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity:
Linearity
Range: 0.25 – 10 mg/L with r2 = 0.9997 (n=6)
Limit of Quantification = 1 mg/L.
Accuracy
Recovery rates were 98% for the 1 x LOQ (RSD=0.61%, n=5) and 102% for the 10 x LOQ (RSD=0.13%, n=5).
Specificity
Comparison of spectra of sample peaks against spectra obtained from standard peaks verified. Blank values < 30% of the LOQ.

Water solubility results

No Tyndall‑effects were observed for any sample during this study.

Pre-incubation time

Replicate No.

Measured
pH

Water solubility
[mg/L]

Concentration

Mean

24 h

1

6.614

13.2

12.7

2

6.327

12.3

48 h

1

6.443

13.7

13.6

2

6.474

13.4

72 h

1

6.769

14.0

13.4

2

6.394

12.7

Mean (24 - 72 h)

 

6.5 +/- 0.2

 

13.2

Maximum deviation [%]

 

6.5

pH of control: 6.799

Executive summary:

The water solubility of the test item was determined according to OECD 105 / EC A6 guidelines, under GLP, using the flask method, in double distilled water, at 20°C.

Analytical evaluation was performed using HPLC-DAD. The analytical method was validated with satisfactory results regarding linearity, limit of quantification, accuracy, precision and specificity.

Measurements were performed on duplicate samples for each pre-incubation times (24, 48 and 72 h) at 30°C, with duplicate analysis. Equilibrium was considered achieved at first sampling interval, and the mean result was retained.

The water solubility was determined to be 13.2 mg/L (20 °C, pH 6.5)

Description of key information

Slightly soluble, with equilibrium reached at 24h. pH of saturated solution: ca 6.5.

Key value for chemical safety assessment

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

Additional information

A fully reliable experimental study, conducted according to a recognized OECD/EC method and under GLP, is available. It is considered as a key study, and the result is retained as key value.