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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 March 2016 - 24 November 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Specific details on test material used for the study:
- Batch n°: I15FB3131
- Analytical purity: 100% (Based on base titration assay)
- Expiration date: 11 June 2017
- Storage condition: at room temperature

Key result
Water solubility:
3.35 g/L
Conc. based on:
test mat. (dissolved fraction)
Remarks:
concentration analysed after centrifugation
Loading of aqueous phase:
17.7 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 6.4 - <= 6.9
Details on results:
Preliminary test
The content of test item dissolved in the water sample was 3.23, 3.32, 3.39 and 3.83 g/L after 1, 3, 6 and 72h of stirring.

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.
No test item was detected in the pretreated sample from the blank water mixture.

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  3.18 3.35   8.7  6.9
 48  3.47      6.4
 72  3.39      6.7
Conclusions:
The flask method was applied for the determination of the water solubility of JNJ-119379-AAA (T001141).
The water solubility of the test item at 20°C was 3.35 g/L.
The pH of the aqueous samples was 6.4 – 6.9.

Description of key information

The water solubility of T001141 was determined in a GLP study performed according to the OECD Guideline 105, EU Method A.6 and EPA OPPTS 830.7840 (Klimisch 1, Reingruber, 2017) using the flask method and was determined to be 3.35 g/L at 20°C and pH 6.4 - 6.9.

Key value for chemical safety assessment

Water solubility:
3.35 g/L
at the temperature of:
20 °C

Additional information