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Physical & Chemical properties

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

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.

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.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion