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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:
10 November 2015 - 23 February 2016
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:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): JNJ-38940642-AAA (T003010)
- Physical state: solid
- Appearance: white powder
Specific details on test material used for the study:
- Batch N°: I15AB0298
- Analytical purity: 99.7%
- Expiry date: 22 January 2017
- Storage condition: at room temperature

Results and discussion

Water solubility
Key result
Water solubility:
>= 1 - <= 2 mg/L
Conc. based on:
test mat. (dissolved fraction)
Remarks:
concentration analysed after filtration
Loading of aqueous phase:
54.4 other: mg
Incubation duration:
ca. 24 h
Temp.:
20 °C
pH:
7.6
Remarks on result:
other: Water solubility could not be determined with higher accuracy due to adsorption of test material to filter material.
Details on results:
The results for the samples taken at flow rates of 12 mL/h and 24 mL/h are given in the table in the next section.
The coefficient of variation (CV) (n = 10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates.
The maximum difference (MD) on the mean values of the samples at both flow rates was ≤ 30%. Based on this, the water solubility of the test item is given as the mean value of these measurements.
The turbidity of the eluates from test item loaded columns was > 0.2 NTU. According to this, undissolved particles were detected in the eluates. The turbidity of the eluates from the blank column was < 0.2 NTU. Undissolved material from the eluates from test item loaded columns was obviously linked to the test item. It was therefore decided to filter the eluate. Checking the filtration method a decrease of 38% was observed comparing the concentration of the twice-filtered sample to what was found after one filtration. Such a decrease could have been due to adsorption of the test item to the filter material. In order to acknowledge possible underestimation of the mean water solubility due to adsorption to the filter material, the recovery after filtration is taken into account and the water solubility is reported as 1 – 2 mg/L.

Any other information on results incl. tables

The results for the samples taken at flow rates of 12 mL/h and 24 mL/h are given in the table underneath.

Flow rate (mL/h)  

Sanple no.

 

           Analysed concentration

 pH  

Individual (mg/L)

Mean (mg/L)

Coefficient of Variation (CV) (%)

Mean of concentrations obtained at both flow rates Maximum Difference (MD) (%) 
24   

1

2

3

4

5

6

7

8

9

10

1.56*

0.982

1.13

1.25

1.04

1.16

1.08

1.05

1.25

1.21

1.17   14  1.18     2.3     7.6
 12

1

2

3

4

5

0.698

1.47

1.35

1.34

1.13 

 1.20  25  7.6

*This sample was used checking the filtration procedure. After an additional filtration step, a concentration of 1.05 mg/L was observed. This corresponded to a decrease of 38%.

Applicant's summary and conclusion

Conclusions:
The column elution method was applied for the determination of the water solubility of JNJ-38940642-AAA (T003010).
The water solubility of the test item at 20°C was 1-2 mg/L. Adsorption to filter material prohibited a determination with higher accuracy.
The pH of the aqueous samples was 7.6.