Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 230-256-0 | CAS number: 6990-06-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Principles of method if other than guideline:
- The solubility was determined by shaking excess of the investigated compounds with the aqueous solutions for 24 hours in a temperature-controlled cabin at 25±2°C. The experiment was performed in duplicate. The solutions were then centrifuged. The upper liquid was transferred to a clean reaction tube and centrifuged again. The concentrations of the solutions were determined by reversed phase HPLC with UV detection against a standard curve.
- GLP compliance:
- not specified
- Type of method:
- flask method
- Specific details on test material used for the study:
- Fusidic acid, hemihydrate, micronized, Batch No. V 6391
Citrate-phosphate buffer pH 2.0, pH 4.0, pH 5.5, pH 7.4 and pH 8.0. - Key result
- Water solubility:
- 0.6 other: µg/mL
- Conc. based on:
- other:
- Remarks:
- Hemihydrate micronized Batch no. V 6391
- Incubation duration:
- 24 h
- Temp.:
- 25 °C
- pH:
- 2
- Key result
- Water solubility:
- 0.8 other: µg/mL
- Conc. based on:
- other:
- Remarks:
- Hemihydrate micronized Batch no. V 6391
- Incubation duration:
- 24 h
- Temp.:
- 25 °C
- pH:
- 4
- Key result
- Water solubility:
- 8.1 other: µg/mL
- Conc. based on:
- other:
- Remarks:
- Hemihydrate micronized Batch no. V 6391
- Incubation duration:
- 24 h
- Temp.:
- 25 °C
- pH:
- 5.5
- Key result
- Water solubility:
- 525 other: µg/mL
- Conc. based on:
- other: Hemihydrate micronized Batch no. V 6391
- Incubation duration:
- 24 h
- Temp.:
- 25 °C
- pH:
- 7.4
- Key result
- Water solubility:
- 1 738 other: µg/mL
- Conc. based on:
- other: Hemihydrate micronized Batch no. V 6391
- Incubation duration:
- 24 h
- Temp.:
- 25 °C
- pH:
- 8
- Details on results:
- The solubility is increasing with pH as expected, i.e., fusidic acid is a carboxylic acid with a pKa value of 4.91. At pH 2 and 4, the solubility is low and at the same level 0.6-0.8 µg/mL. At pH 5.5, the solubility is 8.1 µg/mL, 525 µg/mL at pH 7.4 and 1738 µg/mL at pH 8.0.
- Conclusions:
- The water solubility of fusidic acid is increasing with pH. Fusidic acid is a carboxylic acid with a pKa value of 4.91. At pH 2 and 4, the solubility is low and at the same level 0.6-0.8 µg/mL. At pH 5.5, the solubility is 8.1 µg/mL, 525 µg/mL at pH 7.4 and 1738 µg/mL at pH 8.0.
- Executive summary:
The water solubility of fusidic acid was determined by shaking excess of the investigated compounds with the aqueous solutions for 24 hours in a temperature-controlled cabin at 25±2°C. The experiment was performed in duplicate.
The solubility is increasing with pH as expected, i.e., fusidic acid is a carboxylic acid with a pKa value of 4.91. At pH 2 and 4, the solubility is low and at the same level. .
Solubility of Fusidic acid, hemihydrate in aqueous solution at 25±2°C
pH 2.0
µg/mL
pH 4.0
µg/mL
pH 5.5
µg/mL
pH 7.4
µg/mL
pH 8.0
µg/mL
Hemihydrate, micronized
Batch No. V 6391
0.6
0.8
8.1
525
1738
Reference
Solubility of Fusidic acid, hemihydrate in aqueous solution at 25±2°C
pH 2.0 µg/mL |
pH 4.0 µg/mL |
pH 5.5 µg/mL |
pH 7.4 µg/mL |
pH 8.0 µg/mL |
|
Hemihydrate, micronized Batch No. V 6391 |
0.6 |
0.8 |
8.1 |
525 |
1738 |
Description of key information
The water solubility of fusidic acid was determined by use of a shaking flask method in aqueous solutions for 24 hours in a temperature-controlled cabin at 25±2°C.
The solubility is increasing with pH, i.e., fusidic acid is a carboxylic acid with a pKa value of 4.91. At pH 2 and 4, the solubility is low and at the same level 0.6-0.8 µg/mL. At pH 5.5, the solubility is 8.1 µg/mL, 525 µg/mL at pH 7.4 and 1738 µg/mL at pH 8.0.
Key value for chemical safety assessment
- Water solubility:
- 525 mg/L
- at the temperature of:
- 25 °C
Additional information
Water solubility given for pH 7.4. The solubility is increasing with increasing pH.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.