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EC number: 811-213-0
CAS number: 66711-86-2
The purpose of this inhalation study was
to assess the cumulative toxicity of the test substance when
administered 6 hours daily and 5 days per week to rats by nose-only,
flow-past inhalation exposure for a period of 28 days. The reversibility
or progression of any test substance related effects or any delayed
toxicity was assessed during a 2-week exposure free recovery period. In
addition, potential genotoxicity was investigated by the evaluation of
micronuclei level in the blood. Groups of 10 male and 10 female Wistar
rats each were exposed by nose-only flow-past inhalation to target
concentrations of 1000, 10000 and 20000 / 15000 ppm test substance in
each of groups 2 to 4, respectively. The rats of the control group were
exposed to filtered air only (group 1). An additional 5 male and 5
female rats were kept for a 2-week recovery period. Mortality, clinical
signs, functional observation battery, grip strength, body temperature,
locomotor activity, body weights, food consumption, clinical laboratory
investigations, micronucleus evaluation, organ weights, macroscopic and
microscopic findings were recorded.
Exposure to chemically determined
atmosphere concentrations of 1000, 10010 and 20239 / 15076 ppm test
substance were achieved in groups 2 to 4, respectively, and were close
to the respective targets. Temperature, relative humidity and oxygen
concentration during exposure were considered to be suitable for this
type of study.
Four male animals died during the 20000 /
15000 ppm exposure period. The cause of these deaths could not be
established. No exposure related clinical signs were noted during the
course of the study. In addition, no test substance related effects were
noted in the functional observational battery, on the grip strength, the
body temperature and on the locomotor activity at the end of the
exposure period. Reduced food consumption was noted in males exposed to
20000/15000 ppm. There was no effect on mean animal body weights during
the course of this study. Body weight gain was concentration-dependently
reduced in males exposed to 10000 ppm and 20000/15000 ppm during the
exposure period; however, this was not considered adverse since the
animal’s body weight was not affected. Potassium and phosphorus levels
were increased in both sexes of group 4 at the end of the exposure
period. These increases were considered test substance-related; however,
they were not considered adverse since the values were within the
historical control range. Complete reversal was observed for these
parameters at the end of recovery period.
Based on the reduction in body weight
gain and mortality observed in group 4 (20000/15000 ppm), the
No-Observed-Adverse-Effect-Concentration (NOAEC) was considered to be
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