Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 February 2018 - 13 April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

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 the test material (as cited in study reports): JNJ-63757109-AAA (T003690)
- Physical state: solid (powder)
- Appearance: white to slightly yellow power
Specific details on test material used for the study:
- Batch n°: I17BD0751
- Analytical purity: 99.9% (titration)
- Expiration date: 24 February 2019

Results and discussion

Water solubility
Key result
Water solubility:
<= 0.159 mg/L
Conc. based on:
test mat. (dissolved fraction)
Loading of aqueous phase:
52 other: mg
Incubation duration:
ca. 12 h
Temp.:
20 °C
pH:
>= 7.6 - <= 8
Details on results:
Preliminary test
The content of test item dissolved in the water sample was 0.0171 mg/L after two centrifugation steps.
Main test
The coefficient of variation (CV) (n = 10) was ≤ 30% at both flow rates. The values, however, showed a decreasing tendency. The second set of the water solubility samples gathered at 24 mL/h was considerably lower than the first.
The results of the chromatographic analysis of the column elution fractions suggest that the test item was flushed off the column. The particle size of the test item was so fine that it was not immobilized on the water solubility column. This might have been caused by dry mixing it with the carrier material. Obtained concentrations were considered to be increased to too high values by the presence of undissolved material. The water solubility of the test item is, therefore, considered to be ≤ 0.159 mg/L.
The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates. The particle size of the test item might have been smaller than what could be detected with the turbidimeter.
No test item was detected in the samples from the blank column.

Any other information on results incl. tables

Results for the samples taken at the flowrate of 24, 12 and 24 mL/hour are given in the table underneath.

 Flow rate [mL/h]  Mean analysed concentration [mg/L]  CV [%]  pH
 24  1.04 3.6  8.0
 12  0.809 6.4  8.0
 24  0.159 1.1  7.6

 

Applicant's summary and conclusion

Conclusions:
The column elution method was applied for the determination of the water solubility of JNJ-63757109-AAA (T003690)
The water solubility of the test item at 20°C was <= 0.159 mg/L.
The pH of the aqueous samples was 7.6 – 8.0.