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EC number: 601-409-2
CAS number: 116020-44-1
Because of the molecular structure, low molecular weight (234.42 g/mol)
and octanol-water partition coefficient (>5.7), resorption of the test
item via the gastrointestinal tract is considered to be likely. After
single treatment of rats with the test item at a dose of 2000 mg/kg bw
no signs of toxicity were observed (acute oral: key study).
Daily oral treatment with 5, 20 and 100 mg/kg the test material to
Wistar (Han) rats was clinically tolerated over 90 days.
At main kill on day 90 histopathology of the main kill animals revealed
a multifocal/focal minimal to mild intracytoplasmic vacuolation of
hepatocytes due to lipid storage at all dose levels in both sexes. In
addition, a slight increase of absolute (females only) and relative
liver weights was seen in both sexes at 100 mg/kg/d. These findings are
considered to be non-adverse.
At the end of the treatment-free recovery period the treatment-related
lesions in the liver showed full reversibility in all dose groups,
except for a minor finding in the liver of a single 100 mg/kg/d male.
From these effects it can be concluded that the compound is resorbed
after oral administration.
Due to the low water solubility and the high octanol/water-coefficient,
in combination with the low molecular weight, permeation of membranes is
assumed to be possible. The toxicological effects found in the repeat
dose toxicity study (90d: key study) clearly show that this compound is
distributed throughout the body after oral uptake and is thus
Specific information on the metabolism and excretion of the substance is
not available. Metabolism in the liver can be assumed as a tendency
towards an increase of absolute and relative liver weights in both sexes
at 100 mg/kg/d was found. Because of the reversibility of the observed
effects (e.g. on relative organ weight of liver), the substance is most
likely eliminated from the body. Due to the molecular properties,
excretion via the kidneys is considered to be the main route of
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