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Physical & Chemical properties

Stability in organic solvents and identity of relevant degradation products

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stability in organic solvents and identity of relevant degradation products
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 October 2005 - 7 September 2006
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Restriction because the stability data in organic solvent is reported in a repeat dose toxicity study report.
no guideline available
Principles of method if other than guideline:
The stability of the test material as a solution in corn oil (the vehicle used in a repeated dose oral toxicity study, OECD 421) was determined by GC (gas chromatography). Chromatograms of the test substance in the vehicle were compared after 10 days of storage to a chromatogram of the test material in the vehicle immediately after preparation. Chromatograms were compared both qualitatively (by retention times of eluted peaks) and quantitatively on the basis of peak areas. Results of the analysis are used as the basis for determining if the test material is stable in the vehicle for the duration of study.
GLP compliance:
Test substance stable:
Transformation products:

Results indicated that the test substance is stable in corn oil over the 10 day storage period. Chromatograms are attached as Figure 1.

Table 1: Stability of Test Material in corn oil


10 mg/mL

35 mg/mL

120 mg/mL

Mean Concentration (mg/mL)








RSD (%)




Mean % of Target





The test substance is stable as a solution in corn oil for 10 days. The corn oil is suitable for use as a vehicle in the repeated dose oral toxicity study (OECD 421).
Executive summary:

This report provides a detailed description of a transfer validation using gas chromatography with flame ionization detection for the determination of thiophene, 3-(decyloxy) tetrahydro-1, 1-dioxide (thiophene), in corn oil formulations. Test article stability in processed samples (10 and 11 days of storage at room temperature) were assessed.

In this study, test article stability in formulations stored at room temperature for 10 days was evaluated and met the WIL SOP requirement for stability, i.e., the post-storage mean analyte concentration was not less than 90% of the time-zero concentration.

Description of key information

The substance was determined to be stable in corn oil for 10 days; stability determined with GC analysis in a repeat-dose toxicity study; Knapp (2006)

Additional information

In a GLP repeat-dose toxicity study, the substance was determined to be stale in corn oil for 10 days by Gas Chromatography.