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Physical & Chemical properties

Water solubility

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Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 December 2016 - 07 July 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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
Specific details on test material used for the study:
- Batch n°: M16FB2273
- Analytical purity: 101.7%
- Expiration date: 12 September 2017
- Storage condition: at room temperature
Key result
Water solubility:
< 0.02 mg/L
Conc. based on:
test mat. (dissolved fraction)
Remarks:
No test item was detected at flow rate of 12 and 24 mL/h. The analysed concentrations are therefore reported to be below the limit of detection of the analytical method (0.02 mg/L)
Loading of aqueous phase:
52 other: mg
Incubation duration:
2 h
Temp.:
20 °C
pH:
>= 8 - <= 8.3
Details on results:
Main test
No test item was detected at flow rate of 12 and 24 mL/h. The analysed concentrations are therefore reported to be below the LOD of the analytical method (i.e. < 0.020 mg/L).
To demonstrate proper preparation of the carrier material, an aliquot of the carrier material was analyzed. The test item was detected in this solution and therefore demonstrated that the test item was used for the preparation of the carrier material.

The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.

The analytical method was re-validated for different preparation of accuracy samples. The mean accuracy at each concentration level fell below the criterion 70.00-110.00 (results are archived in the raw data). The results were accepted and no correction was made since the water solubility is reported < limit of detection
Conclusions:
The column elution method was applied for the determination of the water solubility of JNJ-42808389-AAA (T003421).
The water solubility of the test item at 20°C was <0.020 mg/L.
The pH of the aqueous samples was 8.0 and 8.3.
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
19 May 2009 - 28 May 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not performed in accordance with the respective test guidelines. No GLP compliance.
Qualifier:
no guideline followed
GLP compliance:
no
Type of method:
other: visually
Water solubility:
< 0.01 other: g/100 mL
Temp.:
20 °C
pH:
8.3
Conclusions:
The water solubility of T003421 was determined visually. The results show a water solubility of < 0.01 g/100 mL at 20 °C and pH 8.3.
The results of the test can be considered reliable with restriction.

Description of key information

The water solubility of T003421 was determined in a GLP study performed according to the OECD Guideline 105, EU Method A.6 and EPA OPPTS 830.7840 (K1, Ciric, 2017) and was reported to be <0.020 mg/L at 20°C and at pH 8.0 - 8.3.

Key value for chemical safety assessment

Additional information

In a supporting study performed at Anabiotec (K2, Vercruysse, 2009) the water solubility of T003421 was determined visually as <0.01 g/100 mL at 20°C and pH 8.3.