Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The experimental apparatus consisted of a 8 mL screw top vial with a Teflon®. -lined cap which was suspended over a stir-plate. The vial was physically isolated from the stir-plate to remove the possibility of heat transfer from the motor to the vial and its contents. Approximately 2mL of DCTFPX was added to the vial followed by the addition of approximately 2mL of deionized, distilled water. A small stir bar was added and the vial sealed. Stirring was initiated and the experiment continued for 24 hours. After 24 hours, an aliquot was removed from each layer for testing.

The sample of the water layer was directly injected into a gas chromatograph and analyzed under the conditions given below.

- Instrument: Hewlett-Packard HP 5890 gas chromatograph equipped with a Hewlett-Packard 7673 autosampler, a split/splitless injection port, flame ionization detector, electronic pressure programming and an HP 3365 Chemsracion.
- Column: 30m x 0.25 mm i.d. alfa-DEX 120 fused silica capillary column having a 0.25 micron film thickness. (Supelco, Bellefonte, PA)
- Oven Program: 40°C for 3 minutes, then 8°C/minute to 240°C and hold for 12 minutes.
- Injection: Split mode, 60:1 split ratio, 1.0 microL injection volume (10 microL, syringe), Injector block maintained at 250°C.
- Detector: Flame ionization detector operated under standard flow conditions. Detector block maintained at 260°C.
- Carrier Gas: Helium at 1.0 mL/minute (11.6 psig head pressure).

The method had been calibrated with standards prepared from in-house material. A stock solution was prepared by weighing approximately 0.1 gram of analyte into a 10 milliliter volumetric flask and diluting to final volume with acetone. This solution was then serially diluted to provide a range of analyte concentrations. These solutions were analyzed to provide a working calibration curve for each analyte of interest. The calibration curve was found to linear (correlation constant > 0.9990) over the range of concentrations tested.

CALCULATIONS:
The chromatograms were processed by the HP 3365 Chemstation to produce raw areas for the peaks observed. These peak areas were used to yield both qualitative and quantitative results. The areas generated were calibrated by analyzing solutions of known composition, yielding response factors for each compound of interest (given as weight/area count). These factors were then used to calculate the weight % of these compounds in the samples.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
0.68 other: micrograms/milliliter
Temp.:
25 °C

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)