Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 Jan 2019 - 05 Mar 2019
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:
2019
Report Date:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2016
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: particulate/powder
Details on test material:
- Appearance: Off-white powder
- Storage condition of test material: In refrigerator protected from light

Results and discussion

Water solubility
Key result
Water solubility:
223 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
335 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 7.2 - <= 7.4
Remarks on result:
other: result is the mean of 48 and 72 h measurements.
Details on results:
The result of the preliminary test after 26 hours of stirring is comparable to the result obtained in the main study after stirring for 24 hours. Saturation factor in the main study is less than 2. This however is accepted since mixtures at higher nominal concentrations than used in the main study cannot be stirred anymore.

- No test item was detected in the pretreated sample from the blank water mixture.
- The 24-hour measurement was considerably lower than the 48- and 72- hour measurements - concentration analysed after 24, 48 and 72 hours of stirring: 176 g/L, 240 g/L and 2073 g/L, resp.
- Maximum difference was > 15% thus the water solubility of the test item was given as the mean value of the 48- and 72-hour measurements.



Applicant's summary and conclusion

Conclusions:
The water solubility of the substance at 20°C was determined to be 223 g/L (flask method).