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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016 -01 -25 to 2016 -01 -29
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:
2.15 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
10 g/L
Incubation duration:
24 - 72 h
Temp.:
20 °C
pH:
6.8
Remarks on result:
other: mean
Details on results:
Please see the results details under the section "Any other information on results" section

1. Preliminary test (non-GLP):

The determination solubility in double distilled water was in the range of 1.32 - 2.11 g/L. For the application dose for the definitive study, 10 g/L, as ca. the fivefold of the maximum solubility result, was used.

2. Method validation:

- Detection limits: LOD = 0.1 mg/L

- System quantification limit: 1 mg/L (= 10 x LOD)

- Linearity: linear response in the range of nominal 1 - 100 mg/L with r2 > 0.992

- Limit of quantification: LOQ = 2 mg/L

- Accuracy: mean recovery rates of 101% at 1 x LOQ and 102% at 10 x LOQ

- Precision: coefficient of determination <= 2.2%

- Specificity: identity of test item signals demonstrated by automatic comparisson of sample peaks against spectra obtained from standard peaks.

- Check of Tyndall-Effect: negative in all replicates and at all time points

3. Water solubility results;

Water solubility has been measured at 20°C:

Preincubation time Replicate No. Test substance
Concentration (g/L)* Mean
24 h 1 2.17 2.16
2 2.16
48h 1 2.16 2.16
2 2.16
72h 1 2.11 2.14
2 2.17
Mean (24-72h)   2.15
Deviation (%) (24-72h)** 1.1

* Mean value of double injection, dilution factor of 40 and exact weights taken into account

** Calculated according to formula deviation [%]= 100x(max value-min value) / min value

Validity Criteria:

Repeatability: The concentration measured in at least the samples with the two longest incubation times (48 and 72h) should not differ by more than 15%.

Temperatures: Temperatures should be kept constant within +- 0.5°C

Conclusions:
The solubility of the test item was determined at 20 +- 0.5°C to be 2.15 g/L (pH 6.8). The test item can be considered as soluble.
Executive summary:

The water solubility of the test substance was determined according to OECD test guideline 105 (1995) and Council Regulation (EC) No. 260/2014, Method A.6.

The solubility of the test substance was determined using the flask method at 20 +- 0.5 °C with pre-incubation at 30 +- 0.5°C.

The water solubility of the test substance was determined to be 2.15 g/L (20°C, pH 6.8).

Description of key information

The water solubility of the test substance was determined to be 2.15 g/L (20 °C, pH 6.8).

Key value for chemical safety assessment

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

Additional information

The water solubility of the test substance was determined according to OECD test guideline 105 (1995) and Council Regulation (EC) No. 260/2014, Method A.6.

The solubility of the test substance was determined using the flask method at 20 +/- 0.5 °C with pre-incubation at 30 +/- 0.5 °C.

The water solubility of the test substance was determined to be 2.15 g/L (20 °C, pH 6.8).