Registration Dossier
Registration Dossier
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EC number: 604-569-1 | CAS number: 147126-62-3
Storage stability and reactivity towards container material
Administrative data
- Endpoint:
- storage stability and reactivity towards container material
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP test performed
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: internal lab guideline
- Deviations:
- yes
- Principles of method if other than guideline:
- Storage over two years in a climate chamber. The chamber was calibrated and released for the stability studies in June 1997. The unit will be recalibrated yearly. An alarm system is in place.
- GLP compliance:
- no
- Type of method:
- accelerated testing
Test material
- Reference substance name:
- (1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
- EC Number:
- 604-569-1
- Cas Number:
- 147126-62-3
- Molecular formula:
- C14H24O4S
- IUPAC Name:
- (1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- Ongoing study at temperature: 25 °C+- 2 °C, relative humidity: 60 % +- 5 %.
Accelerated temperature stability: 40 °C,relative humidity: 75 %
Results and discussion
- Results:
- Loss on drying decreases during storage, while the purity seems to stay constant - within the accuracy of the GC measurement. Stability testing and under accelerated conditions has been finalised after 6 month with in-spec results. Taking into account the known limitations of the analytical methods, there are not any significant changes in quality detecable during the ongoing stability test period of 24 month, too.
However, under accelerated conditions product colour changes to brownish and generates off-odours, clearly indicating degadation. - Transformation products:
- not measured
- Storage stability / reactivity towards container material:
- other: However, under accelerated conditions product colour changes to brownish and generates off-odours, clearly indicating degadation.
Applicant's summary and conclusion
- Conclusions:
- Loss on drying decreases during storage, while the purity seems to stay constant - within the accuracy of the GC measurement. Stability testing and under accelerated conditions has been finalised after 6 month with in-spec results. Taking into account the known limitations of the analytical methods, there are not any significant changes in quality detecable during the ongoing stability test period of 24 month, too.
However, under accelerated conditions product colour changes to brownish and generates off-odours, clearly indicating degadation.
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