Registration Dossier

Administrative data

Endpoint:
surface tension
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because water solubility is below 1 mg/L at 20°C
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 January 2016 - 06 June 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to other study
Remarks:
validated analytical method used for quantification of the water samples
Reference:
Composition 0
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2014
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method
Test material information:
Composition 1
Water solubility:
0.657 mg/L
Temp.:
20 °C
pH:
6.2
Remarks on result:
other: Flowrate 24 mL/h. Mean of 10 samples. CV= 11%.
Water solubility:
0.715 mg/L
Temp.:
20 °C
pH:
6.3
Remarks on result:
other: Flowrate 12 mL/h. Mean of 10 samples. CV= 3.6%.
Key result
Water solubility:
0.686 mg/L
Temp.:
20 °C
pH:
>= 6.2 - <= 6.3
Remarks on result:
other: mean value (maximum difference= 8.5%)
Details on results:
The coefficient of variation (CV) (n=10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates.

The maximum difference on the mean values at both flow rates was ≤ 30%. The water solubility of the substance is given as the mean value of these measurements: 0.686 mg/L.

Small responses at the retention time of the test item were found in the samples from the blank column at both flow rates. This was probably caused by carry-over since a higher response was found in the analytical blank.The maximum contribution to the samples at a flow rate of 24 mL/h was 0.2% and 0.5 % to the samples at a flow rate of 12 mL/h. It was considered that it has no significant effect on the results of the test samples.

Conclusions:
The water solubility at 20°C was determined to be 0.686 mg/L.
Executive summary:

The water solubility of the substance was determined using the column elution method in a GLP study according to EC A.6, OECD 105 and OPPTS 830.7840.

Quantification was performed by UPLC-MS/MS. The water solubility at 20°C was determined to be 0.686 mg/L. The pH of the aqueous samples was 6.2 -6.3.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion