Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 February - 22 March 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:
other: Visual observation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: powder
- Appearance: white powder
Specific details on test material used for the study:
- Batch n°: M16HD2757
- Analytical purity: 95.1% (determined by GC assay)
- Expiration date: 04 July 2018
- Storage condition: at room temperature

Results and discussion

Water solubility
Key result
Water solubility:
> 1 000 g/L
Conc. based on:
test mat. (dissolved fraction)
Incubation duration:
1.2 h
Temp.:
19.7 °C
pH:
2.4
Details on results:
After the stirring period, the test sample was clear and no undissolved test item was observed. Therefore, it was concluded that the water solubility of JNJ-63756992-AAC (T003680) at 20°C is > 1 x 10³ g/L.

The pH of the aqueous sample was 2.4.

Applicant's summary and conclusion

Conclusions:
The water solubility of the test item at 20°C was determined to be > 1 x 10³ g/L.
The pH of the aqueous sample was 2.4.