Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 1984_06_07
- Deviations:
- no
- 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%
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:
- Subsamples (25 mL) were withdrawn for chmical analysis after 0, 24, 48 and 72 hours of exposure. Samples were stored at -20°C until analysis at LEO Pharma A/S. Please also refer to section on result displaying the results from the chemical analysis.
- Vehicle:
- no
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- not included
- Test temperature:
- 23.5+/-0.2°C
- pH:
- 7.9 (stock solution)
- Salinity:
- freshwater
- Nominal and measured concentrations:
- 0; 0.1; 0.3; 1; 3; 10; 30; 100; 300 (nominal concentrations)
- Details on test conditions:
- Cell density at start: 7500 cells/mL
Cells were incubated under continuous shaking and illuminated from a panal of fluorecent light at an intensity of approximately 3.5-7*10E15 quanta x cm-2 x sec-1. Density was meassured in the control mixture as an in vivo fluorescence at the beginning of the test and after 24, 48 and 72 hours of incubation in triplicate test flasks and six controls. Fluorescence was meassured with a TD-700 Laboratory Fluorometer. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.7 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 4.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- Sampling time, hours 0 24 48 72 Mean+/-Std. dev.
Nominal concentrations (mg/L) Measured concentration (mg sodium fusidate/L)
1 ≤1 ≤1 ≤1 2 ≤1
3 3 2 2 4 3+/-1
10 11 9 9 9 10+/-1
30 30 29 29 29 29+/-1
90-110% of the initially added sodium fusidate was recovered during 0-72 hours, the test substance was considered stable during the test and results were therefore reported as nominal concentrations - Results with reference substance (positive control):
- The EC50 value calculated for the reference substance potassium dichromate was 1 (0.95-1.04) mg/L
- Validity criteria fulfilled:
- yes
- Conclusions:
- The resulting EC10; EC50 and NOEC values (72h) for sodium fusidate were: 0.7 mg/L 4.3 mg/L and 0.3 mg/L respectively.
- Executive summary:
The toxicity of sodium fusidate towards algae was studied according to the OECD Guideline no 201 "Algae growth inhibition test".
The study was performed according to GLP.
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.
90-110% of the initially added sodium fusidate was recovered during 0-72 hours, the test substance was considered stable during the test and results were therefore reported as nominal concentrations
The resulting EC10; EC50 and NOEC values (72h) were: 0.7 mg/L 4.3 mg/L and 0.3 mg/L respectively based on growth rate.
The EC50 value calculated for the reference substance potassium dichromate was 1 (0.95-1.04) mg/L
Reference
Description of key information
The toxicity of sodium fusidate towards algae (Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)) was studied according to the OECD Guideline no 201 "Algae growth inhibition test". The study was performed according to GLP. 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 resulting EC10; EC50 and NOEC values (72h) were: 0.7 mg/L 4.3 mg/L and 0.3 mg/L respectively (nominal concentration, based on growth rate).
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 4.3 mg/L
- EC10 or NOEC for freshwater algae:
- 0.3 mg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.