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EC number: 207-481-8 | CAS number: 474-25-9
The repeated oral toxicity of chenodeoxycholic acid has been evaluated basing on aread-across approach with ursodeoxycholic acid. The substance was tested in a 26-week study (1987). No Guideline or followed method is available in the source RTECS. Moreover a 1-year study in squirrel monkeys did not reveal advers effects related to chenodeoxycholic acid oral exposure.
On the basis of a read-across approach with ursodeoxycholic acid, the lowest toxic dose identified was 91 g/kg bw. The numerical dose data is a cumulative amount over the duration of the study.
Observed effects were: gastrointestinal hypermotility, diarrhea, hepatitis and diffuse hepatocellular necrosis, and changes in serum composition.
The available study in RTECS reported effects at the total dose of 91 g/kg bw for ursodeoxycholic acid. The TDL0/day was calculated to be 500 mg/kg bw. Since the negative effects in the read-across study were noted at a high dose and the results of the 52-week study in monkeys revealed no adverse effects, basing on a weight of evidence approach, the classification of the substance for repeated dose toxicity is not judged needed.
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