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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
Materials and methods
- Principles of method if other than guideline:
- Fusidin suspended in saccharose solution was administrated to rats six days weekly in doses of 400 mg/kg bw for 5 months.
Growth as well as haemoglobin percentage and count of red and white cells were observed and compared to control animals. - GLP compliance:
- no
- Limit test:
- no
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:
- No details on the test material.
Test animals
- Species:
- rat
- Strain:
- other: Local LEO strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 35 females and 35 males (weight: 110-120 g at the beginning of the test) of which 10 females and 10 males were control animals.
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- oral sugar solution
- Vehicle:
- other: saccharose solution
- Details on oral exposure:
- Six days weekly in doses of 400 mg/kg body weight
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 5 months
- Frequency of treatment:
- Perorally on six days weekly
Doses / concentrations
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- Remarks:
- Dose was given six days weekly
- No. of animals per sex per dose:
- 25
- Control animals:
- yes
- Details on study design:
- Control animals were given sugar solution without fusidin.
- Positive control:
- not included
Examinations
- Observations and examinations performed and frequency:
- Weekly weighings; Monthly blood examinations; including haemoglobin percentage and red and white blood cell counts
- Sacrifice and pathology:
- At the end of the test, all animals were sacrified and macroscopic inspections performed. Historical slides were prepared from lung, heart, spleen, lever, kidney, stomach and intestine.
- Statistics:
- No effects observed, no statistics reported
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Macroscopic examination revealed nothing abnormal.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Analysis of blod samples showed average values within normal compared to the control group.
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histological slides were prepared from lung, heart, spleen, liver, kidney, stomach and intestine. No pathological changes were found.
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 400 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- haematology
- histopathology: non-neoplastic
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Organ:
- erythrocyte development
- heart
- intestine
- kidney
- leucocyte development
- liver
- lungs
- spleen
- stomach
Any other information on results incl. tables
No effects on the growth was observed. Body weight within normal range compared to the control group.
Blood samples: average values within normal compared to the control group.
By macroscopic inspection, nothing abnormal was found.
No pathological changes were observed.
Applicant's summary and conclusion
- Conclusions:
- The subchronic toxicity of fusidin acid from oral administration was evaluated rats at doses of 400 mg/kg bw/day, given six days weekly for 5 months. No toxic effects were observed and no effects on the growth. Analysis of blood samples showed average values within normal compared to the control group and no pathological changes were found. Based on these observations, a NOAEL of 400 mg/kg bw/d could be established.
- Executive summary:
In a 5 months oral toxicity study in rats, fusidic acid was suspended in a saccharose solution and administered orally by gavage to one group of 25 male + 25 female rats of the local LEO strain. Daily doses of 400 mg/kg bw were administered six days a week for 5 months. A control group of 10 male + 10 female rats was treated with the sugar solution. No haematological changes and no untoward manifestations of toxicity were apparent throughout the test period. No gross pathological changes were detected. Microscopic examination of lung, heart, spleen, liver, kidney, stomach and intestine did not disclose any morphological alterations that could be attributed to the drug. Based on these observations, a NOAEL of 400 mg/kg bw/d could be established.
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