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Diss Factsheets
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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
Data available from clinical trials with skin application of 2% fucidin creme:
Side effects from application of 2% fucidin creme in clinical trials were observed and reported. A total, of 337 patients were involved in the trials performed in 12 clinical centers in West Germany. Treatment was ambulant and continued until cure was achieved. Duration of treatment was dependent on the diagnoses and varied from one day to 62 days. Mean treatment period for each individual diagnose varied between from 6.6 days (insect bites) to 28 days (infected radiation injuries). Side effects as slight to moderate burning sensation were observed in 26 patients and burning and redness was observed in 4 patients.
Based on the observations of side effects after application of 2% fucidin creme to skin, Fusidic acid is classified as Skin irritant, cat.2.
No data available from clinical trials with eye application of 2% fucidin creme:
There are no data available on eye irritation of Fusidic acid.
Historically, fusidic acid has been classified as an eye irritant. As no data contradict this, the classification as Eye irritant, cat 2 has been maintained as precationary measure.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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:
- Clinical trials of 2% fucidin creme are reported with observations of skin irritation.
- GLP compliance:
- no
- Specific details on test material used for the study:
- The creme contained 2% fusidic acid.
- Species:
- other: Clinical trials on humans
- Details on test animals or test system and environmental conditions:
- A total of 337 patients between the ages of 1 to 90 years were involved in the trials. The patients were divided into 13 groups dependent on their diagnoses. The trials were performed in 12 clinical centres in West Germany. Men represented 54.8 %, women 36.5 % and for 8.7% there was no information of sex.
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- other: creme - fat-free with water
- Amount / concentration applied:
- Application of creme once or twice a day.
- Duration of treatment / exposure:
- Ambulant treatment, which was continued until cure was achieved. Duration of treatment was dependent on the diagnoses and varied from one day to 62 days. Mean treatment period for each individual diagnose varied between from 6.6 days (insect bites) to 28 days (infected radiation injuries).
- Number of animals:
- A total of 337 patients were involved.
- Irritation parameter:
- other: Slight burning sensation
- Basis:
- other: 21 patients
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- other: Moderate burning sensation
- Basis:
- other: 5 patients
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- other: Burning sensation and redness
- Basis:
- other: 3 patients
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- other: Redness
- Basis:
- other: 1 patient
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- other: all patients
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- edema score
- Basis:
- other: all patients
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritant / corrosive response data:
- Total number of patients with reported side effects was 30 (8.9%). All side effects were considered treatment-related. Treatments for 2 patients (0.6%) were discontinued.
- Other effects:
- No sensitisation was observed during the treatments.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on observations of side effects (burning and redness of skin) after application of 2% fucidin creme to skin, Fusidic acid is classified as Skin irritant, cat.2.
- Executive summary:
Side effects from application of 2% fucidin creme in clinical trials were observed and reported. A total, of 337 patients were involved in the trials performed in 12 clinical centers in West Germany. Treatment was ambulant and continued until cure was achieved. Duration of treatment was dependent on the diagnoses and varied from one day to 62 days. Mean treatment period for each individual diagnose varied between from 6.6 days (insect bites) to 28 days (infected radiation injuries). Side effects as slight to moderate burning sensation were observed in 26 patients and burning and redness was observed in 4 patients.
Based on the observations of side effects after application of 2% fucidin creme to skin, Fusidic acid is classified as Skin irritant, cat.2.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Based on the irritative properties of Fusidic acid to skin and eye, Fusidic acid may also cause irritation of the respiratory tract. Thus, as a precationary approach Fusidic acid is classified as STOT Single Exp. 3.
Justification for classification or non-classification
From the available database, primarily based on clinical data using 2% fucidin creme, it is concluded that Fusidic acid should be classified as Skin and Eye irritant, cat.2. Further, as a precationary approach Fusidic acid is classified as STOT Single Exp. 3.
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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