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EC number: 619-496-0
CAS number: 960404-59-5
Accuracy of the preparations was between 100% and 103%. The
concentrations analysed in the formulations of Group 2, Group 3 and
Group 4 were in agreement with target concentrations (i.e. mean
accuracies between 90% and 110%).
Homogeneity coefficient of variation was 0.27 -0.75%. The
formulations of Group 2 and Group 4 were homogeneous (i.e. coefficient
of variation ≤ 10%).
Analysis of Group 2 formulations after storage yielded a relative
difference of 0.6%. Based on this, the formulations were found to be
stable during storage at room temperature under normal laboratory light
conditions for at least 6 hours.
BMS-587319-03 was administered
by daily oral gavage to male and female Wistar Han rats at dose levels
of 1.5, 15 and 150 mg/kg bw/day. Males were exposed for 2 weeks prior to
cohabitation, during cohabitation, and up to termination (for 29-33
days). The females were exposed for 2 weeks prior to cohabitation,
during cohabitation, during post-coitum, and at least 4 days of
lactation (for 40-55 days). Formulation analysis showed that the
formulations were prepared accurately and homogenously, and were stable
for at least 6 hours at room temperature.
Treatment up to 150 mg/kg bw/day
was well-tolerated; no mortality occurred, no treatment-related changes
during functional observation tests were seen, and no toxicologically
relevant clinical signs or changes in body weights and food intake were
noted. Test-substance related effects were observed in high dose animals
and included changes in haematological parameters (Hb, RDW, counts of
neutrophils, lymphocytes, reticulocytes), clinical biochemical
parameters (prot, chol, Ca, Cl, ALAT), urinalysis (volume, glu, Na, pH),
organ weight of liver, prostate gland, uterus, thymus (f), and
microscopic findings (hypertrophy in cells of thyroid, trachea, liver,
adrenals, haematopoiesis spleen). Based on the effects obeserved in high
dose animals, the NOAEL for parental (systemic) toxicity for BMS-587319
-03 in this study is 15 mg/kg bw/day.
No treatment-related changes
were noted in any of the reproductive parameters investigated in this
study (i.e. mating, fertility and conception indices, precoital time,
and numbers of corpora lutea and implantation sites, spermatogenic
profiling, and histopathological examination of reproductive organs).
Based on these results, the NOAEL for reproduction toxicity in this
study is at least 150 mg/kg bw/day, the highest dose tested.
No treatment-related changes
were noted in any of the developmental parameters investigated in this
study (i.e. maternal care and early postnatal pup development consisting
of mortality, clinical signs, body weight and macroscopy). Based on
these results, the NOAEL for developmental toxicity in this study is at
least 150 mg/kg bw/day, the highest dose tested.
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