Registration Dossier

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:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No specific guideline for this endpoint are available. The study was performed under GLP conditions by an analytical method (GC) which was validated with respect to linearity of instrument response and recovery of test material.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The stability of test material in Arachis Oil BP (vehicle used in a Reproduction /Developmental Toxicity Screening ) was determined by GC (gas chromatography). The analytical method was evaluated for linearity of GC detector response and % recovery from column.

Chromatograms of the test substance in Arachis Oil BP were compared immediately after preparation and then again after storage at ambient conditions. 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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Test substance stable:
yes
Transformation products:
not specified

Any other information on results incl. tables

GC results show the formulations to be stable in Arachis Oil for at least four hours. Table 3 gives a comparison of the iniial concentration and the concentration of test material after 4 hours

Table 3: Stability of test material in Arachis Oil BP after 4 hours

Nominal (mg/mL)

Initial Concentration (mg/mL)

Concentration After 4 Hours

mg/mL

as % of initial concentraton)

3.75

3.85

4.06

105

37.5

35.9

36.1

104

125

121

127

107

Applicant's summary and conclusion

Conclusions:
Results show the formulations to be stable for at least four hours. Formulations were therefore prepared daily and stored at approximately +4ºC in the dark, under nitrogen, over silica gel until use within 4 hours.
Executive summary:

The stability of test material in Arachis Oil BP (the vehicle used in Reproduction/Developmental Toxicity Screening ) was determined by GC (gas chromatography). A comparison of the peak area responses showed solutions of the test material in Arachis Oil BP were stable for at least four hours. Formulations were therefore prepared daily and stored at approximately +4ºC in the dark, under nitrogen, over silica gel until use within 4 hours.