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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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2006-01-17 to 2006-01-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to GLP
- Principles of method if other than guideline:
- OECD Guideline no 202
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Sodium Fusidate NOS (011060; Lot. no. A4620; Afd. 221 ompd.)
Manufacturing date: 22-03-2006
Expiry date: 22-03-2006
Form: White powder
Purity: 99.3% (w/w)
The degree of dissociation of fusidic acid can be calculated as a function of pH (α = Ka/(Ka+[H+]) with the pKa for fusidic acid determined to be 4.9:
pH α
6.00 0.93
6.50 0.98
7.00 0.99
7.50 1.00
8.00 1.00
For environmental realistic conditions at pH 7-8, fusidic acid will be almost completely (99-100%) dissociated and will be present in the fusidate form. Due to the dissociation of the substance, it is therefore justified to use environmental data on the fusidate form to describe fusidic acid under these conditions. - Analytical monitoring:
- yes
- Details on sampling:
- In order to verify test concentrations throughout the test, subsamples (2*10mL) were withdrawn at the start of the test, after 24 hours (before and after renewal) and at 48 hours. Samples were stored at -20°C and sent for analysis of sodium fusidate at LEO Pharma A/S.
- Details on test solutions:
- A stock solution of 600 mg/L was prepared by weighing out 0.180 gof the test substance and adding 300 mL of the test medium. The stock solution was used to prepare a dilution series of the test substance in the test medium.
Nominal concentrations of sodium fusidate were: 0 (control); 30; 60; 300 and 600 mg/L - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia magna was cultured at DHI. Young animals < 24hours old were applied for the test.
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- Not included
- Hardness:
- 250+/-25 mg/L expressed as CaCO3
- Test temperature:
- 19.5+/-0,2 °C
- pH:
- 7.8+/-0.2
- Dissolved oxygen:
- 98-100%
- Salinity:
- NA
- Conductivity:
- NA
- Nominal and measured concentrations:
- Time
Nominal concentration T = 0h(new solution) T =24h(old solution) T = 24h(new solution) T =48 h(old solution)
Control na na na na
30 mg/L 29 na na na
100 mg/L na na na na
300 mg/L 297 309 301 309
600 mg/L 591 610 614 615 - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC10
- Effect conc.:
- 225 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 367 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- EC10 (24h) = 1.05 (0.274 -1.25)
EC50 (24h) = 1.74 (1.56 -1.98) - Validity criteria fulfilled:
- yes
- Conclusions:
- EC10 (48h) = 225 (124-284)
EC50 (48h) = 367 (294-443) - Executive summary:
The acute toxicity of Sodium fusidate was tested during a Daphnia immobilization test (according to OECD guideline no 201). For environmental realistic conditions at pH 7-8, fusidic acid will be almost completely (99-100%) dissociated and will be present in the fusidate form. Due to the dissociation of the substance, it is therefore justified to use environmental data on the fusidate form to describe fusidic acid under these conditions.
The test was performed with Daphnia magna, as a semi static test (renewal of test solutions after 24 hours) and was performed according to GLP. Test concentrations were analysed and as recovery was 97 -103% the test substance was considered stable during the test and concentrations reported as nominal concentrations.
The resulting EC10 and EC 50 values were:
EC10 (48h) = 225 (124-284)
EC50 (48h) = 367 (294-443)
Reference
Description of key information
The acute toxicity of Sodium fusidate was tested during a Daphnia immobilization test (according to OECD guideline no 201).
For environmental realistic conditions at pH 7-8, fusidic acid will be almost completely (99-100%) dissociated and will be present in the fusidate form. Due to the dissociation of the substance, it is therefore justified to use environmental data on the fusidate form to describe fusidic acid under these conditions.
The test was performed with Daphnia magna, as a semi static test (renewal of test solutions after 24 hours) and was performed according to GLP. Test concentrations were analysed and as recovery was 97 -103% the test substance was considered stable during the test and concentrations reported as nominal concentrations.
The resulting EC10 and EC 50 values were:
EC10 (48h) = 225 (124-284)
EC50 (48h) = 367 (294-443)
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 367 mg/L
Additional information
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