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EC number: -
CAS number: -
The objective of this study was to determine the potential toxicity of
EXP0700332 when given orally for 91 consecutive days to rats.
40 male and 40 female rats were randomly organized into 4 (1-4) dose
groups of 10 animals per sex per dose with dosage levels of 0, 100, 300
and 1000 mg/kg/day.
The following parameters and end points were evaluated in this study:
clinical signs, body weights, body weight changes, food consumption,
ophthalmology, detailed functional observations, clinical pathology
parameters (haematology, coagulation, clinical chemistry, and
urinalysis), gross necropsy findings, organ weights, and histopathologic
All analysed formulation concentrations were found to be within the
acceptable range and homogeneous.
There were no unscheduled deaths during the study.
There were no clinical observations noted that were considered to be
treatment related. Excess salivation was noted in 3 animals, however,
these were isolated incidences and were considered to be related to the
Any differences seen were considered unrelated to the administration of
In conclusion, administration of EXP0700332 by once daily oral gavage
was well tolerated in rats at levels of 100, 300 and 1000 mg/kg/day.
There were no clinical observations or target organ effects. Based on
these results, the no-observed-adverse-effect level (NOAEL) was
considered to be 1000 mg/kg/day.
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