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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:
2001-06-18 to 2002-03-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to other study
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)
Remarks:
The Federal Office of Public Health, the Swiss Agency for the Environment, Forests and Landscape and the Intercantonal Office for the Control of Medicines with respect to the compliance with the Swiss legislation on Good Laboratory Practice
Type of method:
flask method
Remarks:
HPLC analysis
Specific details on test material used for the study:
- Batch n°: RT002102G4A311
- Analytical purity: 99.4%
- Expiration date: 25 March 2002
- Storage condition: at room temperature
Key result
Water solubility:
36.4 g/L
Temp.:
20 °C
pH:
2.33 - 2.45
Details on results:
The water solubility of T002102 at 20.0 deg C was determined to be 36.4 g/L (standard deviation ± 1.1 g/L).
Conclusions:
The water solubility of T002102 at 20.0 deg C was determined to be 36.4 g/L (standard deviation ± 1.1 g/L) and thus considered very soluble (> 10000 mg/L).
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
no data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Insufficient documentation for an assessment of reliability.
GLP compliance:
not specified
Water solubility:
38 g/L
Temp.:
20 °C
pH:
3.7
Conclusions:
The water solubility of the test item was determined to be 38 g/L at 20°C and pH 3.7.

Description of key information

A K1 GLP study was performed according to the OECD guideline 105 and EU Method A.6 (flask method). The water solubility was determined to be 36.4 g/L at 20°C (RCC, 2002). 

Key value for chemical safety assessment

Water solubility:
36.4 g/L
at the temperature of:
20 °C

Additional information

The study of RCC (2002) according to the OECD guideline 105 and EU Method A.6 (flask method), concluded that the water solubility of T002102 at 20.0 °C was 36.4 g/L (standard deviation ± 1.1 g/L), with a pH comprised in the range of 2.33 - 2.45. This study is considered reliable (Klimisch 1) and assigned as key study for this endpoint.

Another study performed by J&J PRD determined the water solubility of T002102 to be 38 g/L at 20°C and pH 3.7. As the information was insufficient to determine the relability of the study, a K4 reliability score has been assigned to this supporting study.