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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

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

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1980

Materials and methods

Principles of method if other than guideline:
Standard protocol described in Pharmacopea Nordica. 1969, vol. IV: 30.3 - 30.8
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
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 animals

Species:
mouse
Strain:
CBA
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.