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Registration Dossier
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EC number: 250-830-4 | CAS number: 31837-42-0
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- according to company guideline, but limitied documentation
- Principles of method if other than guideline:
- UV-Vis analysis of test substance solutions in DMSO and in 1,2-propylene glycol after stirring for 72 hours at room temperature
- Test substance stable:
- yes
- Conclusions:
- The test substance is more than 72 hours stable and homogeneous in DMSO and in 1,2-propylene glycol at room temperature.
- Endpoint:
- stability in organic solvents and identity of relevant degradation products
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The stability of a substance in organic solvents is a question of the chemical structure rather than a question of particle size. Whether any chemical reaction might take place is determined by the functional groups present in the molecule. It has been shown, that the nanoform is stable and read-across to the bulk form is reasonably justified.
- Reason / purpose for cross-reference:
- read-across source
- Test substance stable:
- yes
- Conclusions:
- At room temperature, the test substance is stable and homogeneous for more than 72 hours in DMSO (0.1 and 50 mg/mL) and in1,2 -propylene glycol (0.1 and 50 mg/mL).
Referenceopen allclose all
The test substance is more than 72 hours stable and homogeneous in DMSO and in 1,2-propylene glycol at room temperature.
Description of key information
The test substance is more than 72 hours stable and homogeneous in DMSO and in 1,2.propylene glycol at room temperature.
Additional information
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