Registration Dossier

Administrative data

Description of key information

Weight of evidence:

Acute toxicity: oral.: Based on the available data, the oral LD50 for fusidic acid was determined to be 1070.5 mg/kg + 21.9 mg/kg body weight in mice.

Acute toxicity: oral.: Based on the available data, the oral LD50 for fusidic acid was determined to be 1500 mg/kg body weight in mice.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
No data on method, no data on GLP
Principles of method if other than guideline:
Standard protocol described in Pharmacopea Nordica. 1969, vol. IV: 30.3 - 30.8
GLP compliance:
not specified
Species:
mouse
Strain:
CBA
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
>= 1 070.5 - <= 1 092.4 mg/kg bw
Based on:
test mat.
Mortality:
No data available.
Clinical signs:
No data available.
Body weight:
No data available.
Gross pathology:
No data available.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 in mice is 1070.5 mg/kg + 21.9 mg/kg.
Executive summary:

The acute oral toxicity of the test substance was evaluated on mice. According to the results, the oral LD50 is 1070.5 mg/kg + 21.9 mg/kg.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
No data on method, no data on GLP.
Principles of method if other than guideline:
No data on method.
GLP compliance:
not specified
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 500 mg/kg bw
Based on:
test mat.
Mortality:
No data available.
Clinical signs:
No data available.
Body weight:
No data available.
Gross pathology:
No data available.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 in mice is 1500 mg/kg.
Executive summary:

The acute oral toxicity of the test substance was evaluated on mice. According to the results, the oral LD50 is 1500 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 070.5 mg/kg bw
Quality of whole database:
Diverse oral-DL50 from publications are taken as a weight of evidence. The results of the whole database lead to the same classification of the substance according to CLP regulation.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Weight of evidence:

Acute toxicity: oral.: The acute oral toxicity of the test substance was evaluated on mice. GLP study not specified. According to the results, the oral LD50 is 1070.5 mg/kg + 21.9 mg/kg bw.

Acute toxicity: oral.: The acute oral toxicity of the test substance was evaluated on mice. GLP study not specified. According to the results, the oral LD50 is 1500 mg/kg body weight bw.

Justification for classification or non-classification

Based on the available data the oral LD50 was determined to be 1070.5 mg/kg + 21.9 mg/kg bw in mice. Fusidic acid is classified for Acute oral toxicity Category 4 according to CLP Regulation (EC) 1272/2008.