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EC number: 915-730-3
CAS number: -
Frequency of Micronuclei in Peripheral Blood Erythrocytes
of Rats Following Dermal Application of OTNE for 3 Months
OTNE was tested in the micronucleus test in rat to evaluate its
genotoxic effect on peripheral blood erythrocytes. The test was
performed as part of a repeated dose toxicity study, in a procedure
comparable to OECD Guideline 474, and rated Klimisch 2 due to
methodological restrictions to the study; 1. Dermal application, but no
info on occlusion: thus oral exposure cannot be excluded, 2. No positive
control is included, and 3. There is no mention of historical control
Five groups of rats, each comprising 5 males and 5 females, received
dermal doses of 6.25, 12.5, 25, 50, and 100%. In rats these percentages
resulted in estimated doses of 31.25, 62.5, 125, 250, and 500 mg/kg
bw/day, 5 days per week for 3 months. Sample collection time started 24
hours after the last dosing. A vehicle (Ethanol) treated group, and an
untreated group served as negative control. Observations were made of
peripheral blood erythrocytes from heparinized blood samples.
Furthermore, flow cytometric analysis was performed. In the
micronucleus assay, a positive response is preferably based on the
observation of both a significant trend as well as an observation of at
least one dose group significantly elevated over the concurrent control
group. If only one statistical test (trend or pairwise) is significant,
the micronucleus assay is judged to be equivocal. The absence of both a
significant trend and a significant dose results in a negative call for
No significant increases in micronucleated reticulocytes or erythrocytes
were seen in male or female F344/NTac rats following exposure to OTNE,
and no changes in the percentage of reticulocytes was observed in either
sex of rat. In the in 250 mg/kg bw/day male rats, the mean frequency of
micronucleated reticulocytes was significantly (P < 0.025) elevated over
the control in the two highest dose groups, but the magnitudes of the
increases were very small, the trend test was not significant, and the
response measured in the group that received the highest dose of OTNE
(500 mg/kg bw/day) was lower than either of these two values; therefore,
the response in male rat reticulocytes in the multidose test was judged
to be negative. Under the conditions of this study, OTNE did not
statistically significantly raise the frequency of micronucleated
erythrocytes in male/female rats, and therefore is not considered to be
negative in this micronucleus test.
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