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EC number: 254-179-7
CAS number: 38888-98-1
Summary of results and statistical analysis:
TM SAS 40 including 3% of CEL 2021P
% ie/(ie+me) Proportion of immature erythrocytes
mie Number of micranucleated cells observed per 2000 immature
mme Number of micranucleated cells calculated per 2000 mature
Results of statistical analysis using the appropriate nonparametric
method of analysis based on permutation (one-sided probabilities): *** P
< 0.001 (highly significant) ** P < 0.01 (significant) otherwise P >
0.01 (not significant)
This study was designed to assess the potential induction of
micronuclei by SAS 40 including 3% of CEL 2021P in bone marrow cells of
mice. Mice were treated with a single intraperitoneal administration of
the test substance at dose levels of 250, 500 and 1000 mg/kg bodyweight.
A preliminary toxicity test had previously shown that a dose of 1000
mg/kg was expected to be approximately the maximum tolerated; 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.
No statistically significant increases in the frequency of
micronucleated immature erythrocytes and no substantial decrease in the
proportion of immature erythrocytes were observed in mice treated with
SAS 40 including 3% of CEL 2021P 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
It is concluded that SAS 40 including 3% of CEL 2021P did not show
any evidence of causing chromosome damage or bone marrow cell toxicity
when administered by intraperitoneal injection in thisin vivotest
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