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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
No data available from in vitro/in vivo studies evaluating the skin sensitising potential of fusidic acid.
Clinical data on Fusidic acid as active ingredient in the product Fucidin (R) topical are available.
To identify cases reporting sensitisation and hypersensitivity, a cumulative search in the LEO Pharma A/S safety database was done covering the period from 1969 to 2018. In the last 5 years, the number of reported hypersensitivity reactions has fluctuated between 2 and 11 events per year. The estimated patients exposure in the corresponding period has fluctuated between 17 and 20 million patients per year. When adverse events are reported, they are reported on product level. It is therefore not possible to determine whether the reported adverse event is caused by the active substance or excipient(s) in the product.
From the epidemiological evidence showing relatively low but no substantial incidence of allergic contact dermatitis in relation to relatively high exposure it is concluded that the substance does not meet the criteria for classification as skin sensitising.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- epidemiological evidence
- Type of information:
- other: epidemiological evidence
- Adequacy of study:
- weight of evidence
- Study period:
- 1969-2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Principles of method if other than guideline:
- To identify cases reporting sensitisation and hypersensitivity in humans, a cumulative search in the LEO Pharma A/S safety database was done covering the period from 1969 to 2018.
- Type of study:
- other: epidemiological evidence
- Specific details on test material used for the study:
- The search was done for the Fucidin (R) for topical use.
Fusidic acid is the active ingredient in Fucidin (R) topical. - Positive control results:
- Not relevant
- Other effects / acceptance of results:
- No cases reported events of sensitisation. A total of 80 hypersensitivity reactions were reported cumulatively. In the last 5 years, the number of reported hypersensitivity reactions has fluctuated between 2 and 11 events per year. The estimated patients exposure in the corresponding period has fluctuated between 17 and 20 million patients per year. The estimated number of patients exposed to Fucidin(R) topical is based on the total sales volume realised from LEO to LEO affiliates, distributors, etc.
When adverse events are reported, they are reported on product level. It is therefore not possible to determine whether the reported adverse event is caused by the active substance or excipient(s) in the product, unless it is specifically reported. As most of these reports are non-serious and reported by consumers, very limited information is available and it is therefore not known whether it is the active substance or excipient(s), which have caused the reaction.
According to the company core safety information (CCSI) for Fucidin (R) topical, use is contraindicated in patients with known hypersensitivity to the active substance or any of the excipients in the product. It is known that several of the excipients (e.g. butyl hydroxyanisole and sorbic acid and its salts) in the products can cause local skin reactions, and according to Martindale hydrous lanolin (wool fat) can cause sensitivity reactions and hypersensitivity reactions have occasionally been attributed to the presence of cetyl alcohol in topical preparations. - Key result
- Remarks on result:
- other: results are based on epidemiological evidence
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It is concluded that compared to the high patient exposure, very few case reports concerning hypersensitivity reactions have been noted. No cases of sensitisation have been received. From the epidemiological evidence showing relatively low but no substantial incidence of allergic contact dermatitis in relation to relatively high exposure it is concluded that the substance does not meet the criteria for classification as skin sensitising.
- Executive summary:
To identify cases reporting sensitisation and hypersensitivity, a cumulative search in the LEO Pharma A/S safety database was done covering the period from 1969 to 2018. In the last 5 years, the number of reported hypersensitivity reactions has fluctuated between 2 and 11 events per year. The estimated patients exposure in the corresponding period has fluctuated between 17 and 20 million patients per year. When adverse events are reported, they are reported on product level. It is therefore not possible to determine whether the reported adverse event is caused by the active substance or excipient(s) in the product.
From the epidemiological evidence showing relatively low but no substantial incidence of allergic contact dermatitis in relation to relatively high exposure it is concluded that the substance does not meet the criteria for classification as skin sensitising.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on a weight of evidence approach, taking into account the large clinical database on Fusidic acid as active ingredient in the product Fucidin (R) topical, no classification is proposed.
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.
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