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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23-Aug-2006 (animal arrival) to 8-Sep- 2006 (necropsy).
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted in accordance with the principles mentioned in the CPMP/SWP/1042/99 guideline “Note for guidance on repeated dose toxicity".
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: CPMP/SWP/1042/99 guideline
- GLP compliance:
- no
- Test type:
- other: 1 week dose-finding study
Test material
- Reference substance name:
- Fusidic acid
- EC Number:
- 230-256-0
- EC Name:
- Fusidic acid
- Cas Number:
- 6990-06-3
- Molecular formula:
- C31H48O6
- IUPAC Name:
- 2-[(1Z,2S,3aS,3bS,5aS,6S,7R,9aS,9bS,10R,11aR)-2-(acetyloxy)-7,10-dihydroxy-3a,3b,6,9a-tetramethyl-hexadecahydro-1H-cyclopenta[a]phenanthren-1-ylidene]-6-methylhept-5-enoic acid
- Test material form:
- solid: crystalline
- Details on test material:
- Details are given for each individual study
Constituent 1
- Specific details on test material used for the study:
- Batch no. 06 265 151 used in oral suspension for group 2, 100 mg/mL
Batch no. 06 268 150 used in oral suspension for group 3, 200 mg/mL
No CoA available as the study is a non-GLP dose-finding study.
Test animals
- Species:
- mouse
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- Fusidic acid is tested in the following vehicle: Methylcellulose 15 cps 10 mg Polysorbate 80 4 mg Water purified ad 1 mL containing methylcellulose and polysorbate 80.
- Doses:
- Two mice were treated orally by gavage daily for 7 days with 1000 mg/kg of fusidic acid.
Another two mice were treated likewise with 2000 mg/kg of fusidic acid
The dose volume was 10 ml of suspension/kg/day. - Control animals:
- no
- Details on study design:
- 2 concentrations (1000 mg/kg bw. and 2000 mg/kg bw.)
2 mice per concentration tested
Duration: 1 week - Statistics:
- No statistical calculations were made in this study as no control group of animals were used
Results and discussion
- Preliminary study:
- This study is a preliminary study for dose level setting for a 2 week study.
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- 7 days
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- No clinical findings were observed
- Body weight:
- Only a transient and minor weight loss was observed in the beginning of the treatment period in one mouse receiving 2000 mg/kg/day of fusidic acid. However, on the last days of the treatment period this effect was not so pronounced,
suggesting an adaptation to the treatment.
Any other information on results incl. tables
A dose level of up to 2000 mg/kg/day of fusidic acid given orally by gavage for 7 days were well tolerated in mice in this study
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A dose level of up to 2000 mg/kg/day of fusidic acid given orally by gavage for 7 days were well tolerated in mice in this study. Based on the results from this study, an LD50 > 2000 mg/kg bw/d could be established.
- Executive summary:
Two mice were treated orally by gavage daily for 7 days with 1000 mg/kg of fusidic acid. Another two mice were treated likewise with 2000 mg/kg of fusidic acid
The dose volume was 10 ml of suspension/kg/day. A dose level of up to 2000 mg/kg/day of fusidic acid given orally by gavage for 7 days were well tolerated in mice in this study. Based on the results from this study, an LD50 > 2000 mg/kg bw/d could be established.
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.