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EC number: 939-478-9
CAS number: -
Results dose range finding study:
No mortality occurred. At 500 mg/kg bw/day, hunched posture was noted
mostly at 1 and/or 3 hours after dosing in all three animals. At 1000
mg/kg bw/day, hunched posture was noted mostly at 3 hours after dosing
(and/or sometimes after 1 hour) in all three animals. Salivation was
noted on one day immediately after dosing in all three animals. No
unexpected effects were seen on body weight and at necropsy.
The concentrations analysed in the test item formulations of all exposed
groups were in agreement with target concentrations (i.e. mean
accuracies between 85% and 112%).
A small response at the retention time of the test substance was
observed in one of the chromatograms of the control group formulation
prepared for use in Week 1. It was considered not to derive from the
formulation since the response was not observed in the duplicate study
sample. In all other formulations of the control group, no test
substance was detected.
The formulations of the low dose group were homogeneous (i.e.
coefficient of variation ≤ 7.3%). For the formulation of the high dose
group prepared for use in Week 1, the coefficient of variation was above
the criterion for homogeneity of 10% (i.e. coefficient of variation
15%). Measurements in Week 4 and Week 13 showed that formulations of the
high dose group were homogeneous (i.e. coefficient of variation ≤ 5.5%).
Analysis of the low and high dose group formulations prepared in Week 1
yielded a relative difference of ≤ 8.4% after storage. Based on this,
formulations at the entire range were found to be stable during storage
at room temperature under normal laboratory light conditions for at
least 6 hours. Analysis of the high dose group formulation prepared in
Week 4 showed a significant decrease in concentration (relative
difference of up to -17%). Additional analysis of the high dose group
formulation prepared in Week 6 however confirmed stability of the high
dose group formulations (relative difference -7.0%).
A 90-day study was performed with URALAC P 1920C according to OECD/EC
guidelines and GLP principles. Male and female rats were exposed for 90
consecutive days by daily oral gavage at dose levels of 100, 300 and
1000 mg/kg bw/day. Chemical analysis of the test item formulations and
the control formulations showed that the rats were dosed correctly.
No mortality occurred during the study. No toxicologically significant
changes were noted in any of the parameters determnined in this study,
i.e. clinical appearance, functional observations, ophthalmoscopy, body
weight, food consumption, clinical laboratory investigations,
macroscopic examination, organ weights, and microscopic examination.
Clinical biochemistry revealed a higher alanine phosphatase activity and
a higher glucose level in males at 1000 mg/kg bw/day. These changes were
not supported by any corroborative changes in parameters determined in
this study, including microscopic examination and therefore considered
not toxicologically significant.
Based on these results it is concluded that the NOAEL for repeated
sub-chronic exposure exceeds 1000 mg/kg bw/day, as no adverse effects
were seen up to and including the highest dose used in this study.
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