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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
No guideline for this endpoint is available. 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 peanut oil ( the vehicle used in 28-day repeated dose oral toxicity study) was determined by HPLC. Chromatograms of the test substance in the vehicle were compared after at least 4 days and 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:
yes
Test substance stable:
yes
Transformation products:
no

Processed samples were stored at room temperature for a minimum of 3 days before being re-analyzed to assess test item stability. The mean 3-day post-storage values ranged from 102% to 124% of the pre-storage values.

Formulations prepared at target concentrations of 20 and 200 mg/mL were analyzed on the day of preparation. Aliquots of the formulations were stored refrigerated for at least 4 days or 10 days and analyzed to assess test item stability. The mean post-storage concentration ranged from 95.4% to 116% of pre-storage values.

Formulations prepared at target test item concentrations of 50 and 200 mg/mL met the protocol-specified acceptance criteria for stability following 5 days of frozen (approximately -20°C) storage.

Conclusions:
The test substance is stable as a solution in peanut oil for 10 days. Peanut oil is suitable for use as a vehicle in the 28-day repeated dose oral toxicity study.
Executive summary:

The stability of the test substance in peanut oil, used as the vehicle in a 28-day repeated dose oral toxicity study, was determined by comparing the chromatograms of the test substance stored in this vehicle at concentrations of 20 and 200 mg/L over a 10 -day storage period. The post-storage mean concentrations were 95.4% to 116% of the corresponding time-zero values.

Description of key information

The test substance is stable as a solution in peanut oil for 10 days.

Additional information

The stability of the test substance in peanut oil, used as the vehicle in a 28-day repeated dose oral toxicity study, was determined by comparing the chromatograms of the test substance stored in this vehicle at concentrations of 20 and 200 mg/L over a 10 -day storage period. The post-storage mean concentrations were 95.4% to 116% of the corresponding time-zero values.