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EC number: 257-913-4
CAS number: 52434-90-9
The objective of this study was to evaluate the test article for clastogenic activity in polychromatic erythrocyte (PCE) stem cells in treated mice.
Adult male and female mice, strain CD-1, healthy and random-bred strain have been selected to maximize genetic heterogeneity and at the same time assure access to a common source.
Thirty-two outbred mice, 4 males and 4 females per dose level, were used. Prior to study initiation, animals were weighed to calculate dose levels according to SOP “Animal Weight Determinazion.” The volume of test article administrered per animal was established using this method unless there was significant variation among individuals, in which case individual calculations were made.
The route of administration was oral gavage, the most common route of administration for this test procedure. A subchronic dosing regimen was used: it consisted of two administrations approximately 24 hours apart. Treatment covered a 30-hour period or two cell cycles. Stock solutions of the test compound were prepared in dimethylsulfoxide (DMSO) at initial concentrations of 800 mg/ml and 100 mg/ml for administering the high (5 g/kg/day) and low (0.63 g/kg/day) doses respectively. The total doses were 10 g/Kg (highest dose) and 1.25 g/kg (lowest dose).
The negative control article was administered by the same route as, and concurrently with, the test article and in volumes equal to the maximum amount administered to the experimental animals (0.25 ml per male mouse and 0.20 ml per female mouse).
Triethylenemelamine (TEM) at 1.0 mg/kg was dissolved in saline and used as the positive control article and was administered via a split dose intraperitoneal (IP) injection.
The frequency of micronuclei in mouse bone marrow from the negative control animals is within the normal range for this laboratory.
The positive control compound, triethylenemelamine (TEM) induced a large increase in micronuclei, to a total of about 7%.
There is no evidence for induction of micronuclei by the test compound.
In conclusion, the test item did not induce micronuclei at the doses tested.
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