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Physical & Chemical properties

Stability in organic solvents and identity of relevant degradation products

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Reference
Endpoint:
stability in organic solvents and identity of relevant degradation products
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-03-05 to 1998-12-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
restriction due to limited details provided in the study report about analytical conditions used for the chromatographic analysis.
Qualifier:
no guideline available
Principles of method if other than guideline:
The stability of the test material as a solution in arachis oil ( the vehicle used in 90-day repeated dose oral toxicity study) was determined by HPLC. Chromatograms of the test substance in the vehicle were compared after 14 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:
yes
Test substance stable:
yes
Transformation products:
no

Table 1: Stability of test material formulations

Nominal concentration (mg/mL)

Concentration found initially (mg/mL)

Concentration found after storage for 14 days

mg/mL

Expressed as % of initial

25

22.1

21.1

96

250

235

219

93

500

508

468

92

Conclusions:
The test substance is stable as a solution in arachis oil for 14 days. Arachis oil is suitable for use as a vehicle in the 90-day repeated dose oral toxicity study.
Executive summary:

The stability of the test substance in arachis oil, used as the vehicle in a 90-day repeated dose oral toxicity study, was determined by comparing the chromatograms of the test substance stored in this vehicle at concentrations of 25, 250 and 500 mg/mL on day 0 and on day 14. The post-storage mean concentrations were 92-96% of the initial concentration after 14 days.

Description of key information

The test substance was determined to be stable in arachis oil for 14 days (procedures associated with OECD 408).

Additional information

The stability of the test substance in arachis oil, used as the vehicle in a 90-day repeated dose oral toxicity study, was determined by comparing the chromatograms of the test substance stored in this vehicle at concentrations of 25, 250 and 500 mg/mL on day 0 and on day 14. The post-storage mean concentrations were 92-96% of the initial concentration after 14 days.