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Physical & Chemical properties

Stability in organic solvents and identity of relevant degradation products

Administrative data

Endpoint:
stability in organic solvents and identity of relevant degradation products
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 June 2009 - 15 July 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No guideline available for this endpoint. The study was performed under GLP conditions by an analytical method (HPLC) which was validated with respect to linearity of instrument response.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
The stability of the test material as a solution in Arachis Oil BP ( the vehicle used in a repeated dose oral toxicity study) was determined by HPLC. Chromatograms of the test substance in Arachis Oil BP were compared after 21 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 were used as the basis for determining the stability of the test material in the vehicle for the duration of the study.
GLP compliance:
yes (incl. certificate)
Remarks:
Issued by: The Department of Health of the Government of the United Kingdom Inspection date: 19 August 2008

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Test substance stable:
yes
Transformation products:
no

Any other information on results incl. tables

The stability of the test material was determined by comparing peak areas obtained for freshly prepared solutions to solutions stored for 21 days at 4 0C in the dark. Data is summarized in Table 3. Example chromatograms of a standard and the test material at 250 mg/mL are attached as Figure 2.

Table 3:  Stability of Test Material After 21 Days

Nominal Concentration (mg/mL)

Initial Concentration Found – Day 0

(mg/mL)

Concentration Found – Day 21

mg/mL

% of initial

3.75

3.69

3.79

103

250

257

261

101

 

Applicant's summary and conclusion

Conclusions:
The test material is stable for at least 21 days as a solution in Arachis oil BP.
Executive summary:

Arachis oil BP is a vehicle used for a repeated dose oral toxicity range-finding study. The stability of the test material in Arachis oil BP was determined by comparing the chromatograms of freshly prepared solutions of the test material in the oil to oil solutions stored for 21 days. Data obtained from the analysis showed the test substance is stable in Arachis oil BP for at least 21 days. Concentrations of the test material after 21 days storage in the oil were 101 - 103 % of the initial concentration.