Registration Dossier
Registration Dossier
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EC number: 946-061-5 | CAS number: -
Stability in organic solvents and identity of relevant degradation products
Administrative data
- Endpoint:
- stability in organic solvents and identity of relevant degradation products
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the stability of the substance is not considered to be critical
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- solubility in organic solvents / fat solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Internationally accepted guideline was followed, all parameters are described in depth and in accordance with guideline. RSS is categorised with reliability 2 because it wasn't conducted under GLP conditions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EU Method A.6 (Water Solubility)
- Deviations:
- yes
- Remarks:
- solvent used was 1-octanol instead of water
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 105 "Water Solubility", July 27, 1995.
- Deviations:
- yes
- Remarks:
- solvent used was 1-octanol instead of water
- Principles of method if other than guideline:
- The 1-octanol solubility was tested as per the method given in Council Regulation (EC) No 440/2008 of 30 may 2008. Method A.6 “Water Solubility. Flask Method”, replacing water as solvent for 1-octanol.
- GLP compliance:
- yes (incl. QA statement)
- Medium:
- n-octanol
- Solubility:
- > 796 g/L
- Temp.:
- 25 °C
- Remarks on result:
- other: solubility in n-octanol could not be determined because tested substance and octanol are fully miscible
- Test substance stable:
- not determined
- Conclusions:
- Exact solubility of the tested substance in n-octanol could not be determined because both are fully miscible. The solubility of the tested substance in n-octanol at 25°C is determined as higher than 796g/l
- Executive summary:
The solubility of the tested substance in 1-octanol was tested according to Council Regulation (EC) No 440/2008 of 30 may 2008. Method A.6 “Water Solubility. Flask Method” replacing water as solvent for 1 -octanol.
After stirring the test substance with n-octanol at a nominal concentration of 7.96 g/l at 26.6 ± 1.7°C for 65 hours, the substance and n -octanol resulted fully miscible. Therefore an exact solubility of the tested substance in n-octanol could not be determined. The solubility of the tested substance in n-octanol at 25°C is determined as higher than 796g/l.
After the stirring period, the test sample was clear and no undissolved test substance was observed.
From this, it was concluded that the n-octanol solubility of Akypo RO 20 VG at 25°C was > 796g/l.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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