Soybean oil, oligomerized

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01/10/2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study according to international guideline (OECD guideline 105) under GLP. No deviations from guideline reported.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Principles of method if other than guideline:

Not relevant

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Key result

Water solubility:

< 0.115 mg/L

Temp.:

20 °C

pH:

>= 4.9 - <= 5

Details on results:

The mean peak area and concentration of each standard were plotted on a calibration curve and the sample concentration interpolated from the curve. The concentration was then corrected for dilution factor (0.01). This automated by the chromatographic software.

The preliminary estimate of the water solubility was less than or equal to 8.77 x 10-5 g/L at 20.0 ± 0.5°C.

Recovery of analysis of the sample procedure was assessed and proved adequate for the test.
At a nominal concentration of 0.25 mg/L, a mean percentage recovery of 95.0 % was obtained (range 90.4 to 97.4 %). Concentrations have not been corrected for recovery of analysis.

For detailed results, see attached file "Results.docx".

The peak in the chromatography at the approximately 2 minutes was not used in the calculations or considered one of the main components of the test item. This peak, although significant in size in the samples, was not significant in the standards. It was considered to be a minor water soluble component or impurity in the test item. The main components of the test item were, as expected highly retained and required a gradient to 100% tetrahydrofuran to elute them.

 

The result for the standard matrix blank was subtracted from the duplicate sample results. The highest corrected result of the duplicates was used as a limit value for the individual sample results. The overall water solubility result was taken from the highest sample result to be a worst case scenario. The blank result was subtracted because a significant proportion of the sample peak area was attributed to the baseline profile being integrated. With no distinct test item peak in the chromatography of the samples to be integrated, an accurate and quantifiable result was not possible. Therefore, the overall result was taken as a limit value based on the lowest standard (11.5 mg/L) which gave a definitive peak for the test item and then taking the concentration factor (100) of the recovery procedure into account to represent a sample concentration of 1.15 x 10^-4mg/L. Also, below the lowest standard the calibration curve will become increasing inaccurate.

Conclusions:

Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of soybean oil, polymerized is < 0.115 mg/l at 20ºC.

Executive summary:

The water solubility of soybean oil, polymerized was determined according to OECD guideline 105 using the flask method under GLP> The water solubility was found to be < 0.115 mg/l at 20ºC.

Description of key information

The water solubility of soybean oil, polymerized  was found to be < 0.115 mg/l at 20ºC.

Key value for chemical safety assessment

Water solubility:

0.115 mg/L

at the temperature of:

20 °C

Additional information

The water solubility of soybean oil, polymerized was determined according to OECD guideline 105 using the flask method under GLP> The water solubility was found to be < 0.115 mg/l at 20ºC.