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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1965
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
- Principles of method if other than guideline:
- Rats:
Pregnant rats were devided into 3 groups of 29-31 animals and exposed from day 3-15 of gestation.
Dosing: 0, 20, 100, 200 mg/kg bw/day (control 59 pregnant rats, reciving water by oral tube)
On day 21 half the animals were killed and examined. Remaining animals were allowed to continue until term.
Endpoints examined: average number of foetus and average weight, average length of pregnancy, average number of young, average weight of young, average no. of mothers with dead foetus, number of dead foetus, number of still-born, no. ofyoung with subcutaneous haematomas at birth, average no. of weanlings, mortality during lactation period,average weight at weaning
Mice:
Pregnant mice were devided into 3 groups of 16-19 animals and exposed from day 6-15 of gestation.
Dosing: 0, 20, 100, 200 mg/kg bw/day (control 23 pregnant mice, reciving water by oral tube)
On day 18 half the animals were killed and examined. Remaining animals were allowed to continue until term.
Endpoints examined: average number of foetus and average weight, average no. of mothers with dead foetus, number of dead foetus, average length of pregnancy, average litter size, average weight, average number of weanlings,mortality during lactation period, average weight at weaning
Rabbits:
Pregnant rabbits were exposed from day 6-18 of gestation.
Dosing: 0, 125 mg/kg bw/day (control 11 pregnant rabbits, reciving placebo tablets)
On day 30 half the animals were killed and examined .Remaining animals were allowed to continue until term.
Endpoints examined: average number of foetus and average weight, average number of young and average weight of young - 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:
- Sodium fusidate
Test animals
- Species:
- other:
- Strain:
- other: albino rats; albino mice, rabbits (Danish white breed)
Administration / exposure
- Route of administration:
- other: Rats and mice: oral drinking water. Rabbits: tablets
- Vehicle:
- not specified
- Details on exposure:
- Rats:
Pregnant rats were devided into 3 groups of 29-31 animals and exposed from day 3-15 of gestation.
Dosing: 0, 20, 100, 200 mg/kg bw/day (control 59 pregnant rats, reciving water by oral tube)
Mice:
Pregnant mice were devided into 3 groups of 16-19 animals and exposed from day 6-15 of gestation.
Dosing: 0, 20, 100, 200 mg/kg bw/day (control 23 pregnant mice, reciving water by oral tube)
Rabbits:
Pregnant rabbits were exposed from day 6-18 of gestation.
Dosing: 0, 125 mg/kg bw/day (control 11 pregnant rabbits, reciving placebo tablets) - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- animals pregnant at initiation of the study
- Duration of treatment / exposure:
- rat: 12d (3-15 of gestation)
mice: 9d (day 6-15 of gestation.)
rabbits: 12d (day 6-18 of gestation) - Frequency of treatment:
- daily dose of either 0, 20, 100 or 200 mg/kg bw.
- Duration of test:
- rat: 21d
mice: 18d
rabbits: 30d
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 20 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- only pregnant females were exposed:
rat: 29-31
mice: 16-19
rabbits: 18 - Control animals:
- yes, concurrent no treatment
- Details on study design:
- please refer to above section: principles of method if other than guideline
Examinations
- Maternal examinations:
- duration of pregnancy (mice and rat)
number of mothers with dead foetuses/ number of dead foetus (mice and rat)
number of mothers with stillborn (rat) - Fetal examinations:
- average number
average weight
subcutaneous haematomas - Statistics:
- NA
- Indices:
- NA
- Historical control data:
- NA
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- not examined
- Body weight and weight changes:
- not examined
- 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:
- not examined
- 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:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Mice: The rather large number of partially absorbed foetuses seen in all groups at autopsy, is probably due to mothers discomfort from the daily oral administration
- Early or late resorptions:
- not examined
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- rat: number of stillborn examined: No effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- Rats: Number of stillborn
Mice, rabbit: Litter size
All: average number of young, distribution male/female - Details on maternal toxic effects:
- no effects
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- rat, mice and rabbit
- Effect level:
- >= 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
Maternal abnormalities
- Abnormalities:
- not examined
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- effects observed, treatment-related
- Description (incidence and severity):
- Rabbit: Litter size was rather low in the fusidin treatment group. Findings might be explained by the fact that intestinal disturbances (loose stool, decreased appetite) were encountered more often among mothers treated with the antibiotic and could be ascribed to an alternation in the intestinal flora.
- Changes in postnatal survival:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Rats: rather high mortality is believed to be caused by manipulative procedures with mother and young
- External malformations:
- not examined
- Skeletal malformations:
- not examined
- Visceral malformations:
- not examined
- Other effects:
- not specified
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- changes in litter size and weights
- changes in postnatal survival
- Remarks on result:
- other: Rats: high ratio of mortality in all groups during gestation and lactation period, not treatment related
Fetal abnormalities
- Abnormalities:
- not examined
Any other information on results incl. tables
Data show that 634 foetuses and young from 89 treated rats do not deviate from 447 foetuses and young from 59 control rats.
Data show that 352 foetuses and young from 52 treated mice do not deviate from 179 foetuses and young from 23 control mice.
Data show that 91 foetuses and young from 18 treated rabbits do not deviate from 86 foetuses and young from 11 control rabbits.
Applicant's summary and conclusion
- Conclusions:
- A prenatal non-GLP developmental toxicity study was performed in pregnant rats, mice and rabbits to examine the possible teratogenic effects of fusidin acid.
No test-item related toxicity and adverse effects observed using dose levels of 0, 20, 100, 200 mg/kg bw/d (rats/mice) or 0, 125 mg/kg bw/d (rabbits). Thus, based on the results of this study using three species (mice/rats/rabbits), the dose level of 200 mg fusidin acid/kg/ bw/d can be considered as the No Observed Adverse Effect Level (NOAEL) for maternel toxicity as well as for developmental effects. - Executive summary:
A prenatal non-GLP developmental toxicity study was performed in pregnant rats, mice and rabbits to examine the possible teratogenic effects of fusidin acid.
Rats and mice were dosed orally with 0, 20, 100, 200 mg/kg bw/d for 12 days (rats, day 3-15 of gestation) or 9 days (mice, day 6-15 of gestation). Rabbits were dosed orally with 0, 125 mg/kg bw/d for 12 days
(day 6-18 of gestation).
No test-item related toxicity and adverse effects observed. Thus, based on the results of this study using three species (mice/rats/rabbits), the dose level of 200 mg fusidin acid/kg/ bw/d can be considered as the No Observed Adverse Effect Level (NOAEL) for maternel toxicity as well as for developmental effects.
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