Registration Dossier
Registration Dossier
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EC number: 700-867-1 | CAS number: -
Water solubility
Administrative data
Link to relevant study record(s)
- 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 for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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.
Referenceopen allclose all
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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