Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 16 February to 03 May 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
other: Reference to the validated analytical method used for quantification of the water samples.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
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 (incl. certificate)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Appearance: Brown coloured, brittle solid
- Storage condition of test material: At room temperature
- Chemical name: Zinc modified rosinate, hydrogenated zinc rosinate
- CAS No.: 68425-02-5

Results and discussion

Water solubilityopen allclose all
Water solubility:
4.73 mg/L
Temp.:
20 °C
pH:
6.7
Remarks on result:
other: Flowrate 24 mL/h. Mean of 10 samples. CV= 5.4%.
Water solubility:
3.69 mg/L
Temp.:
20 °C
pH:
6.7
Remarks on result:
other: Flowrate 12 mL/h. Mean of 10 samples. CV= 9.3%.
Key result
Water solubility:
<= 4.2 mg/L
Temp.:
20 °C
pH:
6.7
Remarks on result:
other: see 'Details on results'
Details on results:
The coefficient of variation (CV) (n=10) was ≤ 30% at both flow rates. It demonstrated that the system was in equilibrium at all flow rates. As the maximum difference on the mean values at both flow rates was ≤ 30% (i.e. 25%), the mean was calculated: 4.2 mg/L. As undissolved particles were detected in the eluates from the column loaded with test item, this value should be considered as a maximum value for the water solubility. The water solubility of the substance was therefore concluded to be ≤ 4.2 mg/L.

Any other information on results incl. tables

In the samples from the blank column, small responses were detected at the retention time of the test item. The maximum contribution to the sample of the test item containing column with the lowest concentration was 0.039% and 0.13% for the flow rate of 24 mL/hour and 12 mL/hour respectively. In view of the very small maximum contribution, there was no impact on the study.

Applicant's summary and conclusion

Conclusions:
The water solubility at 20°C was determined to be ≤ 4.2 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. The pH of the aqueous samples was 6.7. Quantification was performed by UPLC-MS. The water solubility at 20°C was determined to be ≤ 4.2 mg/L.