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Physical & Chemical properties

Water solubility

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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 September - 17 December 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline 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:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as stated in study reports): JNJ-4508530-AAA (T002707)
- Physical state: solid (powder)
- Appearance: white, beige powder
Specific details on test material used for the study:
Batch n°: I15BB0573
Analytical purity: > 97.0%
Expiration date: 08 February 2017
Storage condition: at room temperature

Results and discussion

Water solubility
Key result
Water solubility:
ca. 2.26 g/L
Conc. based on:
test mat. (dissolved fraction)
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 10.3 - <= 10.5
Details on results:
Preliminary test
The content of test item dissolved in the water sample was 2.11 g/L.

Main test
The results for the samples taken at 24, 48 and 72 hours are given in the table in the next section. The maximum difference (MD) of the concentrations determined in the 24, 48 and 72 hour test samples was ≤ 15%. Based on this, the water solubility of the test item is given as the mean value of the analysed concentrations.
Small responses at the retention time of the test item were detected in the chromatograms of the pretreated sample from the blank water mixture. It was considered to derive from carry-over in the analytical system since similar responses were found in the analytical blanks.

Any other information on results incl. tables

The results for the samples taken at 24, 48 and 72 hours are given in the table underneath.

 Stirring time (hours) Analysed concentration (g/L)   Mean (g/L)  Maximum Difference (MD) (%)  pH
 24  2.22 2.26  7.5  10.3
 48  2.19      10.5
 72  2.37      10.4

Applicant's summary and conclusion

Conclusions:
The flask method was applied for the determination of the water solubility of JNJ-4508530-AAA (T002707).
The water solubility of the test item at 20°C was 2.26 g/L.
The pH of the aqueous samples was 10.3 – 10.5.