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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
Endpoint summary
Administrative data
Description of key information
Acute toxicity (oral):
- Oral (gavage) administration of fusidic acid or spiked fusidic acid at 2000 mg/kg/day to female mice of the Crl:CD1(ICR) strain for 15 days was well tolerated and fusidic acid and spiked fusidic acid can be considered comparable in terms of their toxicological potential to mice. Based on the results from this study, an LD50 > 2000 mg/kg bw/d could be established.
- 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.
Acute toxicity (dermal):
- In a cutaneous absorption study using 8 rabbits, 1g of 2% triated fusidin in fusidin salve (without lanolin) corresponding to 6.4-10 mg/kg bw was applied to the rabbit skin. 4 rabbits were treated with sodium lauryl sulphate in vaseline (to damage skin) / 4 served as control and were not treated (undamaged skin). 24 h later all animals were treated with fusidin salve (1g) and after 0, 2, 4,6, 8,24 and 48 h blood samples were taken. Absorption was measured in serum samples. This test method is comparable to recognised guideline for acute dermal toxicity testing in terms of application. Based on the results form the cutaneous absorption study using up to 10 mg/kg bw, an LD50 for dermal toxicity can be established to > 10 mg/kg bw.
Acute toxicity (inhalation):
- No data available
Acute toxicity (other routes):
- 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.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting 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
- 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
- Test type:
- other:
- Limit test:
- yes
- Specific details on test material used for the study:
- Batch number: 830517
Assay 99.9%
Related substances <0.1%
Water 1.7% - Species:
- other: Both rat 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: 90-110 g obtained from Møllegaard Breeding Center Ltd. Ejby Denmark
Mice: 19-22 g LEO Pharma A/S breeding laboratory
Room temperature: 19-23 °C
Relative humidity: 30-40%
Animals were labeled; rats ear notching by and mice by ear tags - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Doses:
- 5000 mg/kg bw.
- No. of animals per sex per dose:
- 5 males and 5 female were used per dose level
- Details on study design:
- 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% - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Mice
- Remarks on result:
- other: oral
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Rats
- Remarks on result:
- other: oral
- Mortality:
- No mortality observed
- Clinical signs:
- No effects
- Body weight:
- No effect
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a 2-week study, rats and mice were exposed orally to fusidic acid (5000 mg/kg bw). No mortalities observed. Based on the results form this study, LD50 > 5000 mg/kg bw for both rat and mice can be established.
- Executive summary:
In a 2-week study, rats and mice were exposed orally to fusidic acid (5000 mg/kg bw).
No mortalities observed. There were no effects on body weight and clinical signs, only reduced activity up to 4 hous after exposure was observed but was normal for the rest of the study. Based on the results form this study, LD50 > 5000 mg/kg bw for both rat and mice can be established.
- 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".
- Qualifier:
- according to guideline
- Guideline:
- other: CPMP/SWP/1042/99 guideline
- GLP compliance:
- no
- Test type:
- other: 1 week dose-finding study
- 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. - Species:
- mouse
- Sex:
- not specified
- 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
- Preliminary study:
- This study is a preliminary study for dose level setting for a 2 week study.
- 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. - 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.
Referenceopen allclose all
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 2 key studies available (Klimich score 1)
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Eight male rabbits were shaved on their backs (area = 6*10cm)
4 rabbits were treated with sodium lauryl sulphate in vaseline / 4 served as control and were not treated.
24 h later all animals were treated with fusidin salve (1g) and after 0, 2, 4,6, 8,24 and 48 h blood samples were taken.
Serum was prepared from the blood samples and 1 ml samples mixed with a little water and 10 ml dimilume assed and counted up to 50min. each in Beckman CPM-100 liquid scintillation counter.
Test method is comparable to recognised guideline for acute dermal toxicity testing. - GLP compliance:
- not specified
- Limit test:
- yes
- Specific details on test material used for the study:
- 2% tritiated fusidin in fusidin salve (without lanolin). The salve contained 0.68MCi/g.
Total concentration of fusidic acid in salve was 2%. - Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- weight: 2.55-3.05kg
- Vehicle:
- not specified
- Details on dermal exposure:
- Eight male rabbits were shaved on their backs (area = 6*10cm)
4 rabbits were treated with sodium lauryl sulphate in vaseline (to damage the skin) / 4 served as control (undamaged skin).
24 h later all animals were treated with fusidin salve (1g) - Duration of exposure:
- 24h
- Doses:
- 1g of 2% triated fusidin in fusidin salve (without lanolin) corresponding to 6.4-10 mg/kg bw.
- No. of animals per sex per dose:
- 4 males (only one dose)
- Control animals:
- yes
- Details on study design:
- please refer to section "principels of method if other than guideline"
- Statistics:
- NA
- Key result
- Sex:
- male
- Dose descriptor:
- other:
- Effect level:
- > 10 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: serum levels were measured over time. In exposure groups levels were 3-45 times blank counts. Animals with intact skin had substantially lower levels.
- Mortality:
- No mortality
- Clinical signs:
- NA
- Body weight:
- NA
- Gross pathology:
- NA
- Other findings:
- Serum levels showed no effects from application of fucidin salve on intact skin.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In this cutaneous absorption study using 8 rabbits, 1g of 2% triated fusidin in fusidin salve (without lanolin) corresponding to 6.4 -10 mg/kg bw was applied to the rabbit skin. 4 rabbits were treated with sodium lauryl sulphate in vaseline (to damage skin) / 4 served as control and were not treated (undamaged skin). 24 h later all animals were treated with fusidin salve (1g) and after 0, 2, 4,6, 8,24 and 48 h blood samples were taken. Absorption was measured in serum samples.
This test method is comparable to recognised guideline for acute dermal toxicity testing in terms of application. Bsed on the results form the cutaneous absorption study using up to 10 mg/kg bw, an LD50 for dermal toxicity can be established to > 10 mg/kg bw. - Executive summary:
In this cutaneous absorption study using 8 rabbits, 1g of 2% triated fusidin in fusidin salve (without lanolin) corresponding to 6.4-10 mg/kg bw was applied to the rabbit skin.
Eight male rabbits were shaved on their backs (area = 6*10cm). 4 rabbits were treated with sodium lauryl sulphate in vaseline (to damage skin) / 4 served as control and were not treated (undamaged skin). 24 h later all animals were treated with fusidin salve (1g) and after 0, 2, 4,6, 8,24 and 48 h blood samples were taken. Absorption was measured in serum samples.
This test method is comparable to recognised guideline for acute dermal toxicity testing in terms of application. Bsed on the results form the cutaneous absorption study using up to 10 mg/kg bw, an LD50 for dermal toxicity can be established to > 10 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 mg/kg bw
Additional information
Justification for classification or non-classification
Based on the available data showing low potential for acute toxicity, no classification for acute toxicity is proposed.
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