Fusidic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

Eight male rabbits were shaved on their backs (area = 6*10cm)
4 rabbits were treated with sodium lauryl sulphate in vaseline / 4 served as control and were not treated.
24 h later all animals were treated with fusidin salve (1g) and after 0, 2, 4,6, 8,24 and 48 h blood samples were taken.

Serum was prepared from the blood samples and 1 ml samples mixed with a little water and 10 ml dimilume assed and counted up to 50min. each in Beckman CPM-100 liquid scintillation counter.

Test method is comparable to recognised guideline for acute dermal toxicity testing.

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

Constituent 1

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

Specific details on test material used for the study:

2% tritiated fusidin in fusidin salve (without lanolin). The salve contained 0.68MCi/g.
Total concentration of fusidic acid in salve was 2%.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

weight: 2.55-3.05kg

Administration / exposure

Vehicle:

not specified

Details on dermal exposure:

Eight male rabbits were shaved on their backs (area = 6*10cm)
4 rabbits were treated with sodium lauryl sulphate in vaseline (to damage the skin) / 4 served as control (undamaged skin).
24 h later all animals were treated with fusidin salve (1g)

Duration of exposure:

24h

Doses:

1g of 2% triated fusidin in fusidin salve (without lanolin) corresponding to 6.4-10 mg/kg bw.

No. of animals per sex per dose:

4 males (only one dose)

Control animals:

yes

Details on study design:

please refer to section "principels of method if other than guideline"

Statistics:

NA

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

other:

Effect level:

> 10 mg/kg bw

Based on:

test mat.

Remarks on result:

other: serum levels were measured over time. In exposure groups levels were 3-45 times blank counts. Animals with intact skin had substantially lower levels.

Mortality:

No mortality

Clinical signs:

NA

Body weight:

NA

Gross pathology:

NA

Other findings:

Serum levels showed no effects from application of fucidin salve on intact skin.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

In this cutaneous absorption study using 8 rabbits, 1g of 2% triated fusidin in fusidin salve (without lanolin) corresponding to 6.4 -10 mg/kg bw was applied to the rabbit skin. 4 rabbits were treated with sodium lauryl sulphate in vaseline (to damage skin) / 4 served as control and were not treated (undamaged skin). 24 h later all animals were treated with fusidin salve (1g) and after 0, 2, 4,6, 8,24 and 48 h blood samples were taken. Absorption was measured in serum samples.
This test method is comparable to recognised guideline for acute dermal toxicity testing in terms of application. Bsed on the results form the cutaneous absorption study using up to 10 mg/kg bw, an LD50 for dermal toxicity can be established to > 10 mg/kg bw.

Executive summary:

In this cutaneous absorption study using 8 rabbits, 1g of 2% triated fusidin in fusidin salve (without lanolin) corresponding to 6.4-10 mg/kg bw was applied to the rabbit skin.

Eight male rabbits were shaved on their backs (area = 6*10cm). 4 rabbits were treated with sodium lauryl sulphate in vaseline (to damage skin) / 4 served as control and were not treated (undamaged skin). 24 h later all animals were treated with fusidin salve (1g) and after 0, 2, 4,6, 8,24 and 48 h blood samples were taken. Absorption was measured in serum samples.

This test method is comparable to recognised guideline for acute dermal toxicity testing in terms of application. Bsed on the results form the cutaneous absorption study using up to 10 mg/kg bw, an LD50 for dermal toxicity can be established to > 10 mg/kg bw.