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EC number: 284-932-5
CAS number: 84989-41-3
No mortalities occurred in any group in any
part of the study.
PRELIMINARY TOXICITY TEST
Results showed that a dose level of 2000
mg/kg (the standard limit), was considered to be the appropriate maximum
for use in the micronucleus test. Dose levels of 500, 1000 and 2000
mg/kg bodyweight were chosen for use in the main test.
Clinical signs and mortalities
No mortalities were obtained in the
micronucleus test. Clinical signs for the high level group were
consistent with the maximum tolerated dose having effectively been
achieved. No adverse clinical signs were obtained for the vehicle
control or positive control treated animals over the duration of the
Micronucleated immature erythrocyte counts
The test substance did not cause any
statistically significant increases in the number of micronucleated
immature erythrocytes at either sampling time (P>0.01). Mitomycin C
caused large, highly significant increases (P<0.001) in the frequency of
micronucleated immature erythrocytes.
Micronucleated mature erythrocytes (mme) The
test substance did not cause any substantial increases in the incidence
of micronucleated mature
erythrocytes at either sampling time.
Proportion of immature erythrocytes (% ie/ie
The test substance failed to cause any
significant decreases in the proportion of immature erythrocytes (P>0.0
1 ). Mitomycin C caused statistically significant decreases in the
This study was designed to assess the
potential induction of micronuclei by P-2290 in bone marrow cells of
mice. Mice were treated with a single intraperitoneal administration of
the test substance at dose levels of 500, 1000 and 2000 mg/kg
bodyweight. A preliminary toxicity test had previously
shown that a dose of 2000 mg/kg was expected
to be approximately the maximum tolerated and standard limit; this level
was therefore selected as an appropriate maximum for use in the
The test substance and negative control were
administered by intraperitoneal injection. The negative control group
received the vehicle, corn oil. A positive control group was dosed
orally, by intragastric gavage, with mitomycin C at 12 mg/kg bodyweight.
Bone marrow smears were obtained from five male and five female animals
in the negative control, each of the test substance groups and the
positive control group 24 hours after dosing. In addition bone marrow
smears were obtained from five male and five female animals in the
negative control and high level treatment groups 48 hours after dosing.
One smear from each animal was examined for the presence of micronuclei
in 2000 immature erythrocytes. The proportion of immature
erythrocytes was assessed by examination of
at least 1000 erythrocytes from each animal. A record of the incidence
of micronucleated mature erythrocytes was also kept. Mice treated with
the test substance did not show any significant increase in the
frequency of micronucleated immature erythrocytes at either sampling
time. There was no significant decrease in the proportion of immature
erythrocytes after treatment of the animals with the test substance. No
statistically significant increases in the frequency of micronucleated
immature erythrocytes or any substantial decrease in the proportion of
immature erythrocytes were observed in mice treated with P-2290 and
killed 24 or 48 hours later, compared to vehicle control values (p>0.01
in each case). The positive control compound, mitomycin C, produced
large, highly significant increases in the frequency of micronucleated
immature erythrocytes and a highly significant decrease in the
proportion of immature erythrocytes (p<0.001 in each case). It is
concluded that P-2290 did not show any evidence of causing chromosome
damage or bone marrow cell toxicity when administered by intraperitoneal
injection in this in vivo test procedure.
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