Fusidic acid

Endpoint summary

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

Reference

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

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)

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.