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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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Remarks:
- Interperitoneal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
- Principles of method if other than guideline:
- Sprague-Dawley rats 5 of each sex placed in cages.
NMRI mice 5 of each sex placed in cages.
Animals were identified, mice by ear tags and rats by ear notching.
Test substance suspended in water for injection with methocel and administrated orally 0.5 ml in mice and 1.0 ml in rats. And 1 ml intraperitoneally.
Clinically observations were performed after 0,5, 1, 1,5 and 2 hours and hereafter daily.
Time of death was recorded and the following observations were made:
Skin and fur
Eyes
Mucous membrane
Respiration
Circulatory system
Diarrhoea
Salivation
Behaviour
Tremors
Convoulsion
Weight loss
Lethargy longevity
Coma longevity
After 14 days animals were killed and autopsied and histological examinations performed - GLP compliance:
- no
- Limit test:
- yes
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 830517
Assay 99.9%
Related substances <0.1%
Water 1.7%
Test animals
- Species:
- other: Both rats and mice were tested
- Strain:
- Sprague-Dawley
- Remarks:
- mice: NMRI strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rat: Pathogen free Sprague-Dawley (mol: SPRD (Syn. Sprague-Dawley)), 90-110 g obtained from Møllegaard Breeding Center Ltd. Ejby Denmark - kept in microlon cages with 5 of one sex in each cage.
Mice: 19-22 g supplied from LEO Pharma A/S breeding laboratory and kept in microlon cages with 5 of one sex in each cage.
Conventional conditions, room temperature 17-23 °C, relative humidity 30-40%
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Remarks:
- injected with 0.25% w/v methocel
- Details on exposure:
- Intraperitoneal administration was 1 ml.
- Doses:
- Rats: 2000; 3000; 4000 and 5000 mg/kg bw
Mice: 3000; 4000 and 5000 mg/kg bw - No. of animals per sex per dose:
- 5 males and 5 female were used per dose level
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 900 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Mice
- 95% CL:
- > 3 111 - < 4 440
- Remarks on result:
- other: intraperitoneal
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 550 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Rats
- 95% CL:
- > 2 554 - < 4 934
- Remarks on result:
- other: Intraperitoneal
- Mortality:
- Observed mortality:
Rats: 2000 mg/kg - no mortality; 3000 mg/kg - 4 of 10 animals; 4000 mg/kg 6 of 10 animals; 5000 mg/kg 7 of 10 animals
Mice: 3000 mg/kg 3 of 10 animals; 4000 mg/kg 5 of 10 animals; 5000 mg/kg 9 of 10 animals
- Clinical signs:
- Reduced spontaneous activity. After 2-3 hours following exposure, intraperitoneally treated mice exhibited reduced spontaneous activity. From here onwards no abnormal behaviour. Interperitoneally treated rats exhibited reduced spontaneous activity up to 24 hours. From here onwards no abnormal behaviour.
- Body weight:
- Depression in bodyweight
- Gross pathology:
- Minor hemorrhages in the small intestines and ascites were observed in animals dying within 48 hours. Residues of the test preparation were seen on the surface of the liver, intestine and other organs within the peritoneal cavity in animals exposed to the high dose of fusidic acid.
Applicant's summary and conclusion
- Conclusions:
- Acute toxicity of fusidic acid was determined for intraperitoneal administration to mice and rats. LD50 values were determined to be > 3900 mg/kg bw (3111-4440) for mice and > 3550 mg/kg bw (2554-4934) for rats.
- Executive summary:
In an acute toxicity study, Fusidic acid was dosed by intraperitoneal administation to mice (3000 -5000 mg/kg bw) and rats (2000 -5000 mg/kg bw). The following results were obtained: LD50 > 3900 mg/kg bw (3111-4440) for mice and > 3550 mg/kg bw (2554-4934) for rats. Depression in body weight was observed after the intraperitoneal administration of fusidic acid. Reduced spontaneous activity was noted in mice after 2 -3 hours and up to 24 hours in rats. From here onwards no abnormal behaviour. Minor hemorrhages in the small intestines and ascites were observed. In the high dose animals, residues of the test preparation were seen on the surface of the liver, intestine and other organs within the peritoneal cavity.
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