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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 September 2003 to 11 October 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method
Key result
Water solubility:
< 0.05 mg/L
Conc. based on:
test mat.
Temp.:
25 °C
pH:
>= 6.59 - <= 7.45
Details on results:
The chromatograms obtained with 10 µL injection volumes at 292 nm exhibited an instrument detection limit of 0.05 mg/L based on an instrument detection limit standard at a prepared concetration of 0.05 mg/L. Samples A-1/B-1 to A-5/B-5 did not exhibit absorptions for the test substance. The blank water samples (A and B) did not exhibit absorptions for the test substance.

The Instrument Detection Limit was 0.05 mg/L based on an analyzed standard.

Time (hours)   Sample ID  pH  System A/System B Conc. (mg/L)
 system blank  A/B  7.18/7.43  ND/ND

 45

 A-1/B-1

 6.59/6.87

 ND/ND

 47

 A-2/B-2

 7.15/6.85

 ND/ND

 51

 A-3/B-3

 6.94/7.07

 ND/ND

 93

 A-4/B-4

 7.06/7.45

 ND/ND

 96

 A-5/B-5

 6.82/6.93

 ND/ND

ND - 'None detected'. The test system chromatograms had no observable test substance peak above the instrument detection limit of 0.05 mg/L.

Conclusions:
Interpretation of results: insoluble (< 0.1 mg/L)
Under the conditions of the test, the water solubility of the test substance was less than 0.05 mg/L (based on the analyzed instrument detection limit test substance standard).
Executive summary:

In a GLP compliant water solubility study conducted in line with OECD Guideline 115 and EU Method A.6, the water solubility of butanoic acid, 4-[[4-[7-chloro-6-(1,1-dimethylethyl)-3H-pyrazolo[1,5-b][1,2,4]triazol-2-yl]phenyl]amino]-4-oxo-, tetradecyl ester was determined using the column elution method. The water solubility of the test substance was determined to be less than 0.05 mg/L (based on the analyzed instrument detection limit test substance standard).

Description of key information

Key study:- Isaacs (2004) 'Water solubility-column elution' conducted in line with OECD Guideline 105 and EU Method A.6. The water solubility of the test substance was determined to be <0.05 mg/L

Key value for chemical safety assessment

Additional information

The key study (Isaacs, 2004) was performed in compliance with GLP and to the OECD Guideline 105 and EU Method A.6 with a sufficient level of detail to assess the quality of the presented data. The study was performed to a good standard in line with accepted, standardised guidelines and was assigned a reliability score of 1 using the principles for assessing data quality as set out in Klimisch et al. (1997). The water solubility of the test substance was determined to be <0.05 mg/L (based on the analyzed instrument detection limit test substance standard).