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EC number: 446-990-1
CAS number: -
The objective of this study was to evaluate the potential of the test
item LCAO5 005 to induce structural or numerical damage in bone marrow
cells of mice. The study was performed according to the international
guidelines (OECD 474 and Commission Directive No. B12) and in compliance
with the Principles of Good Laboratory Practice Regulations.
A preliminary toxicity test was performed to define the dose-levels to
be used for the cytogenetic study. In the main study, three groups of
five male and five female Swiss Ico: OF1 (IOPS Caw) mice were given oral
administrations of LCAO5005 at dose-levels of 500, 1000 or 2000
mg/kg/day, over a 2-day period. One group of five males and five females
received the vehicle (water for injections) under the same experimental
conditions, and acted as control group. One group of five males and five
females received the positive control test item (cyclophosphamide) once
by oral route at the dose-level of 50 mg/kg. The animals of the treated
and vehicle control groups were killed 24 hours after the last treatment
and the animals of the positive control group were killed 24 hours after
the single treatment. Bone marrow smears were then prepared. For each
animal, the number of the micronucleated polychromatic erythrocytes
(MPE) was counted in 2000 polychromatic erythrocytes. The polychromatic
(PE) and normochromatic (NE) erythrocyte ratio was established by
scoring a total of 1000 erythrocytes (PE + NE).
The highest dose-level for the cytogenetic test was selected according
to the criteria specified in the international guidelines; since no
toxic effects were observed, the highest dose-level was 2000 mg/kg/day.
The two other selected dose-levels were 1000 and 500 mg/kg/day. For both
males and females, the mean values of MPE as well as the PEINE ratio in
the groups treated with the test item, were equivalent to those of the
vehicle control group. The mean values of MPE as well as the PEINE ratio
for the vehicle and positive controls were consistent with our
historical data. Cyclophosphamide induced a significant increase in the
frequency of MPE, indicating the sensitivity of the test system under
our experimental conditions. The study was therefore considered valid.
Under our experimental conditions, the test item LCAO5 005 did flot
induce any damage to the chromosomes or the mitotic apparatus of mice
bone marrow cells after two oral administrations, at a 24-hour interval,
at the dose-levels of 500, 1000 or 2000 mg/kg/day.
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