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EC number: 407-560-9
CAS number: 107934-68-9
The oral repeated dose toxicity of the test
material was evaluated according to the OECD guideline 407 and following
GLP principles. It was formulated daily as 0.1, 1.0 and 10% (w/v)
suspensions in 1% aqueous methylcellulose and administered by
intragastric intubation to groups of ten rats (five males and five
females) at dosage levels of 10, 100 and 1000 mg/kg/day, for 28 days.
Control rats received the vehicle alone.
No treatment-related observations were made
for bodyweight changes, food consumption, clinical signs and blood
The following treatment-related observations
were recorded, but all are considered as not toxicologically relevant. A
dose-dependent increase in water consumtion was recorded for female rats
receiving 100 and 1000 mg/kg/day. The trend among male rats was for a
slight decrease in consumption among all treated rats in comparison with
controls. A reduced lymphocyte and total white blood cell counts were
recorded for one female rat at 1000 mg/kg/day. Significantly higher
adjusted adrenal and liver weights were recorded at termination for
female rates at 1000 mg/kg. Minimal centrilobular hepatocyte enlargement
was seen in the leiver of one female at 1000 mg/kg/day.
Therefore, the NOAEL for the oral repeated
dose toxicity of the test material is considered to be 1000 mg/kg/day
(highest dose tested). No classification or labeling needs to be applied.
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