Registration Dossier
Registration Dossier
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EC number: 246-119-3 | CAS number: 24280-93-1
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 27 - June 11, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study, conducted according to internationally accepted technical guidelines and in compliance with GLP in recognized contract research organization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- 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
- Type of method:
- flask method
Test material
- Reference substance name:
- Mycophenolic acid
- EC Number:
- 246-119-3
- EC Name:
- Mycophenolic acid
- Cas Number:
- 24280-93-1
- Molecular formula:
- C17H20O6
- IUPAC Name:
- 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoic acid
- Reference substance name:
- 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methylhex-4-enoic acid
- EC Number:
- 207-595-8
- EC Name:
- 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methylhex-4-enoic acid
- Cas Number:
- 483-60-3
- Molecular formula:
- C17H20O6
- IUPAC Name:
- 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoic acid
- Details on test material:
- - Name of test material (as cited in study report): MYCOPHENOLIC ACID
- Appearance: White powder (wrongly specified in the report as 'Batch'; cf. Notox Project 265152 - Primary Skin Irritation / Corrosion in Rabbit)
- Expiration date of the lot/batch: 01 November 2000
- Storage conditions: In refrigerator in the dark
- Stability under storage conditions: Stable
Constituent 1
Constituent 2
Results and discussion
Water solubility
- Water solubility:
- 24.8 mg/L
- Temp.:
- 19.5 °C
- pH:
- 5.3
- Details on results:
- The 24-, 48- and 72- hour measurements were in agreement. Therefore, the water solubility of MYCOPHENOLlC ACID was calculated as the mean value of all measurements.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
- Executive summary:
The water solubility of Mycophenolic Acid was determined in accordance with OECD Guideline 105 and the corresponding EC Guideline. The study was performed in compliance with GLP. The flask method was applied. Reliability grade 1 was assigned. The water solubility at 19.5 °C was 24.8 mg/L.
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