Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06-22 August 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

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
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 report): JNJ-16169374-AAC (T002113)
- Physical state: solid (powder)
- Appearance: off-white powder
Specific details on test material used for the study:
- Batch n°: RT002113G3A231
- Analytical purity: 92.9%
- Expiration date: 01 December 2001
- Storage condition: at room temperature

Results and discussion

Water solubility
Key result
Water solubility:
207.9 g/L
Conc. based on:
test mat. (dissolved fraction)
Loading of aqueous phase:
400 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
Remarks on result:
other: standard deviation +/-9.7g/L
Details on results:
The water solubility was not corrected for the purity of the test item.

Any other information on results incl. tables

 Sample No.  Shaking time at 30°C Concentration analysed (mg/L)  Concentration calculated (g/L) 
 1 72  84.16  210.40 
 2   81.57  203.92 
 3 48  78.89  197.24 
 4   79.29  198.21 
 5 24  87.23  218.08 
 6   87.77  219.42 

From these results a rounded value of 207.88 g/L was calculated . Standard deviation +/- 9.65 g/L

The measured results differed by less than 15%. Therefore, the study is considered to be valid.

Applicant's summary and conclusion

Conclusions:
The water solubility of T002113 was determined by the flask method to be 207.9 g/L at 20°C +/- 0.5°C. T002113 is very soluble.