Registration Dossier
Registration Dossier
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EC number: 230-256-0 | CAS number: 6990-06-3
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
- Principles of method if other than guideline:
- Clinical trials of 2% fucidin creme are reported with observations of skin irritation.
- GLP compliance:
- 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:
- The creme contained 2% fusidic acid.
Test animals
- 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.
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Applicant's summary and conclusion
- 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.
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