Registration Dossier
Registration Dossier
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EC number: 618-312-6 | CAS number: 898566-17-1
Stability in organic solvents and identity of relevant degradation products
Administrative data
Link to relevant study record(s)
- Endpoint:
- stability in organic solvents and identity of relevant degradation products
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 October 2015 - 21 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- To determine the stability of formulations of the test item in propylene glycol over a large concentration range, trial formulations were prepared in vehicle at 1 mg/mL (low) and 200 mg/mL (high) and analysed according to a validated analytical method.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch: M14KB4863
Stable under storage conditions until 10 November 2017 (retest date)
Storage conditions: at room temperature - Test substance stable:
- yes
- Transformation products:
- no
- Remarks:
- not specified since analysed concentrations were in agreement with nominal concentrations
- Conclusions:
- Formulations of T003063 in propylene glycol at 1 mg/mL (low) and 200 mg/mL (high) were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours.
Reference
The concentrations analysed in the formulations at 1 mg/mL (low) and 200 mg/mL (high) were in agreement with target concentrations. Mean accuracies should be between 85 and 115% and were 85% in the low dose group and 107% in the high dose group.
Analysis of the formulations at 1 mg/mL (low) and 200 mg/mL (high) after storage yielded a relative difference of <= 10% (-3.9% in the low dose group and -1.8% in the high dose group). Based on this, the formulations were found to be stable during storage at room temperature under normal laboratory light conditions for at least 6 h.
Description of key information
Formulations of T003063 in propylene glycol at 1 mg/mL (low) and 200 mg/mL (high) were stable when stored at room temperature under normal laboratory light conditions for at least 6 hours, as determined by Brekelmans (2016) in a GLP study (Klimisch 1).
Additional information
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