Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 03 June 2016 to 11 November 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to other study

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
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Appearance: white solid
- Storage conditions: in refrigerator (2-8°C) protected from light

Results and discussion

Water solubilityopen allclose all
Water solubility:
10.4 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 2.3 - <= 2.4
Remarks on result:
other: Main study 1 result
Key result
Water solubility:
8.2 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
2.4
Remarks on result:
other: Main study 2 result
Details on results:
Main study 1:
Concentrations analysed after 24, 48 and 72 hours of stirring: 10.7 g/L, 10.6 g/L and 9.96 g/L, resp. Maximum difference meets the criterion of ≤ 15% (i.e. 7.6%). No test substance was detected in the pretreated sample from the blank.

Main study 2:
Concentration analysed after 24, 48 and 72 hours of stirring: 8.12 g/L, 8.20 g/L and 8.29 g/L, resp. Maximum difference meets the criterion of ≤ 15% (i.e. 1.1%). The mean of the three concentrations was reported as the water solubility of the substance. A small peak at the retention time of the test item was detected in the pretreated sample from the blank water mixture. Its maximum contribution is 0.00029% based on peak area corrected for dilution factor.

Applicant's summary and conclusion

Conclusions:
The water solubility at 20°C was determined to be 8.2 g/L.
Executive summary:

The water solubility of the substance was determined using the flask method in a GLP study according to EC A.6, OECD 105 and OPPTS 830.7840. Quantification was performed by UPLC. The pH of the aqueous samples was 2.4. From the measurements obtained after 24, 48 and 72 hours of stirring, the water solubility at 20°C was determined to be 8.2 g/L.