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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:
Study Initiation Date: 23 Jun 2016 Study Completion Date: 21 Nov 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
adopted 1995
GLP compliance:
yes (incl. certificate)
Remarks:
Swiss Federal Office of Public Health, Bern, Switzerland
Type of method:
column elution method
Test material information:
Composition 1
Key result
Water solubility:
0.055 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
200 mg/L
Incubation duration:
ca. 7 - ca. 12 h
Temp.:
20 °C
pH:
> 7.67 - < 7.8
Details on results:
RESULTS AND DISCUSSION
The determination of the water solubility of 10-HSA was performed according to the OECD Guideline for the Testing of Chemicals, No. 105: Water Solubility, using the column elution method. The water solubility at 20°C was found to be 0.055 ± 0.008 mg/L.

The results of the measurements are given in Table 1.

According to the test guideline five consecutive samples should not differ in concentration by more than 30 % and the mean values obtained from two tests with different flows should not differ by more than 30 %. These criteria were fulfilled and therefore, the study is valid.

The R² fits of the calibration curves used were 0.9924 and 0.9943. This reflects the linearity of the analytical system within the calibration range of 0.0359 – 0.115 mg test item /L.


Table 1     Results for Determination of Water Solubility

 

Experiment Number Flow Rate pH Measured Concentration  Mean ± Std. Dev. Relative Standard Deviation 
  [mL/min]   [mg/L] [mg/L] [%]
1 0.69 7.80 0.0601    
    7.76 0.0513    
    7.67 0.0524 0.051 ± 0.006 12
    7.67 0.0483    
    7.71 0.0434    
2 0.35 7.75 0.0517    
    7.69 0.0718    
    7.74 0.0523 0.060 ± 0.008 14
    7.71 0.0638    
    7.69 0.0580    
      Overall Mean: 0.055 ± 0.008 -
Conclusions:
In this study the water solubility of the test item 10-HSA was determined using the column elution method. The value was found to be 0.055 ± 0.008 mg/L at 20°C.
Executive summary:

This study was conducted to determine the water solubility of 10 HSA according to OECD Guideline 105.

Based on the estimated value (0.3315 mg/L) by QSAR calculation (EPI suite, WSKOW 1.41), the column elution method was used.

Under the conditions of the study , the water solubility of the test material was 0.055 ± 0.008 mg/L.

Description of key information

Water solubility is 0.055 mg/L (20 C), using column elution method (OECD 105).

Key value for chemical safety assessment

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

Additional information