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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Key result
Water solubility:
0.105 mg/L
Temp.:
20 °C
pH:
>= 6.8 - <= 7.3
Details on results:
The preliminary estimate of water solubility was 0.0986 mg/L. The definitive test indicated the water solubility of of the test material is 0.105 ng/L (mean of two measurements).

Results of HPLC-MS analyses are given in Table 3. Chromatograms obtained for the water soluble portion of the test material are shown in the attached Figure 3.

Table 3. Results of Water Solubility Testing

Replicate

Test Material (g)

mL Water

Shaking Time

(30 0C)

Equilibration Time at 20 0C

pH

Water Solubility (mg/L)

1

0.02

500

24

24

6.8 – 7.3

0.114

2

0.02

500

48

24

 0.209*

3

0.02

500

72

24

 0.0967

*Replicate 2 was excluded from calculations of mean. All undissolved material was not removed from supernatant by centrifuging prior to analysis by HPLC-MS

Mean water solubility: 0.105 mg/L

Validation: The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0.5 - 5.0 mg/L. The detector response gave an R2 value of 0.997.

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of the test material is 0.105 mg/L at 20 C
Executive summary:

The water solubility of the test material was determined by the shake flask method according to EU Method A.6. After shaking and equilibration, the test samples were centrifuged leaving a clear supernatant on which HPLC-MS analyses were performed to quantify the water-soluble portion of the test substance. Results of analyses indicated the water solubility of the test material is 0.105 mg/L at 20 deg. C.

The shake flask method was determined to be the more appropriate method for determination of water solubility over the column elution method. Experience has shown that the test material coats the glass bead of columns causing them to adhere together to form a plug within the column preventing water circulation.

Description of key information

The water solubility of the test material  is 0.105 mg/L at 20 C.

Key value for chemical safety assessment

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

Additional information