Vinyl neononanoate

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a U.S.F.D.A. Technical Assessment document under the GLP regulations.

Qualifier:

according to guideline

Guideline:

other: U.S.F.D.A. Environmental Assessment Technical Document 3.01.

Deviations:

not specified

Principles of method if other than guideline:

The primary objective of this study was to determine the aqueous solubility of vinyl neononanoate by producing a saturated aqueous solution and analyzing this solution by purge and trap Gas Chromatography. This was accomplished using a test method which is based on a method initially developed by May et al., modified by DeVoe and finalized by Wasik et al. The study was conducted according to the guidelines set forth in the U.S. _Food and Drug Administration Environmental Assessment Technical Assistance Document 3.01(5) and outlined in ABC Protocol No. FDA-3.01.

GLP compliance:

yes

Type of method:

column elution method

Remarks:

Generator Column Method

Water solubility:

ca. 13.9 µg/L

Temp.:

25 °C

pH:

7

The recovery of the quality control fortification sample analyzed concurrently with water solubility samples during the course of the study was 94.5 %. Values determined for samples were not corrected for quality control recovery.

The water solubility of VeoVa 9 as determined in this study is 13.0 +/-0.9 ug/mL. This is the mean value of nine measurements taken at three distinct flow rates. Each of these nine eluates were collected as three consecutive segments for each flow rate, each of which was analyzed in duplicate by purge and trap GLC.

The precision of the data was measured by calculating the percent relative standard deviation of the triplicate eluates collected at each flow rate. The relative standard deviations determined at the two lower flow rates were 8.0% and 2.7% for the 0.35 and 0.61 mL/min flow rates, respectively, indicating very good precision. The relative standard deviation of the data at the highest flow rate, 0.87 mL/min, was calculated to be 7.9 %. Although these values are somewhat higher than the target value of 5%, the overall results of the study are not compromised by this data. A review of the raw data indicates that a few isolated measurements at higher than anticipated levels are the cause of the high relative standard deviation.

The pH of the elution control water and selected water samples was monitored during the course of the study. No appreciable change in the pH of the system occurred over the course of the study.

There appears to be a slight trend in the water solubility measurements associated with the range of flow rates used in the study. There is a minimal increase in the water measured solubility as the flow rate increases. However, the 95 % confidence interval was calculated from the mean and standard deviation at each flow rate and equilibration was demonstrated by the overlap of these 95% confidence intervals at the three flow rates.

Conclusions:

Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility of VeoVa-9 was determined to be 13.1 ± 0.9 µg/mL.

Executive summary:

The water solubility of VeoVa 9 at 25°C was determined at ABC Laboratories, Inc., using a column generator method on November 11, 1991.

Saturated aqueous samples were generated using a column which contained a solid sand support coated with an excess of VeoVa 9. Millipore® water was then pumped through this column at a low flow rate to allow adequate time for equilibration. Equilibration was demonstrated by determining the solubility at three distinct flow rates of 0.35, 0.61 and 0.87 mL/min. The solubility was then calculated and shown to be independent of flow rate by demonstrating overlap of the 95% confidence intervals. The temperature was held at a constant 25 +/- l.0°C throughout the study by use of a temperature—controlled water bath and a circulating water jacket around the generator column. Samples were collected in three sequential eluents in triplicate at each flow rate. The samples were analyzed in duplicate by direct injection against a VeoVa 9 standard curve on a purge and trap GC system.

The water solubility of VeoVa~9 was determined to be 13.1 +/- 0.9 µg/mL

Description of key information

The water solubility of vinyl neononanoate was determined by a U.S.F.D.A. Generator Column Method with GLC detection.   

Key value for chemical safety assessment

Water solubility:

0.013 mg/L

at the temperature of:

25 °C

Additional information

The water solubility of VeoVa-9 was determined to be 13.1 ± 0.9 µg/mL.