Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 February 2016 - 06 July 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

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 cited in study reports): JNJ-17299412-AAA (T001599)
- Physical state: solid (powder)
- Appearance: white powder
Specific details on test material used for the study:
- Batch n°: I15HB2951
- Analytical purity: 100.2% (Based on base titration assay)
- Expiration date: 09 August 2017
- Storage condition: at room temperature

Results and discussion

Water solubility
Key result
Water solubility:
0.013 g/L
Conc. based on:
test mat. (dissolved fraction)
Loading of aqueous phase:
0.127 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 6.9 - <= 7
Remarks on result:
other: Mean of 24 and 72h measurements
Details on results:
Preliminary test
The content of test item dissolved in the water sample was 0.0207 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 48-hour measurement was significantly higher than the 24- and 72-hour measurements (maximum difference (MD) > 15%). Based on this, the water solubility of the test item was given as the mean value of the 24- and 72-hour measurements. No test item was detected in the pretreated sample from the blank water mixture. Its pH value was 6.3.

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  0.0121          0.0127  9.0       7.0
 48  0.0168  6.9
 72  0.0132  6.9

Applicant's summary and conclusion

Conclusions:
The flask method was applied for the determination of the water solubility of JNJ-17299412-AAA (T001599).
The water solubility of the test item at 20°C was 0.0127 g/L.
The pH of the aqueous samples was 6.9 – 7.0.