Registration Dossier
Registration Dossier
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EC number: 230-256-0 | CAS number: 6990-06-3
Endpoint summary
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
- 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.
Referenceopen allclose all
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.
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