Registration Dossier
Registration Dossier
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EC number: 430-550-0 | CAS number: 1671-49-4
Storage stability and reactivity towards container material
Administrative data
Link to relevant study record(s)
- Endpoint:
- storage stability and reactivity towards container material
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted under GLP.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 46
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 113
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- accelerated testing
- Specific details on test material used for the study:
- TEST CONDITIONS
- Study duration: 14d
- Temperature: 54±2°C
- Humidity: no data
- Sampling times: at 14d
ANALYTICAL METHODS
- Analytical method used: GLC with internal standard and comparison of impurity profile - Results:
- CHANGE IN ACTIVE INGREDIENTS (Internal standard analysis)
- Results: Initial content: 100.0%; Content at 14 days: 100.6%
CHANGE IN IMPURITY PROFILE
- Results: No significant change in the impurity profile. - Transformation products:
- no
- Conclusions:
- No significant changes in content of the substance, nor in the impurity profile, were observed.
Reference
At least 2 years shelf life, based on stability test at 54°C for 14 days.
Description of key information
At least 2 years shelf life.
Additional information
No significant changes in content of the substance, nor in the impurity profile, were observed at the end of the 14 day test period at 54 °C. The substance is considered to be stable under normal storage conditions.
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