Registration Dossier

Physical & Chemical properties

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:
2014
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

Constituent 1
Chemical structure
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
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.