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EC number: 830-217-3
CAS number: 1393932-71-2
Refer to the attached background material for details on results.
An in vivo bone marrow micronucleus
test was performed with di-TMPTTA according to OECD Guideline 474, in
compliance with GLP. The study was conducted in two phases: a dose
range-finding assay and a definitive micronucleus assay. In both phases
of the study, test and/or control mice were administered at a dose
volume of 10 mL/kg bw by a single oral gavage. The dose range-finding
assay was performed exposing two males/group at 1, 10, 100, 1,000 mg/kg
bw, while five male and five females were exposed to 2,000 mg/kg bw. No
mortality was observed in any of the treatment groups. All mice at 1, 10
and 100 mg/kg bw appeared normal during the study period. Piloerection
was noted in males at 1,000 and 2,000 mg/kg bw, while this clinical sign
was noted transiently in females. No appreciable reductions in mean
group body weights were observed. In the definitive micronucleus assay,
mice were dosed either with the control (vehicle or positive) or with
the test substance at 500, 1,000 or 2,000 mg/kg bw. No mortality was
observed in any of the treatment groups. All mice in the control groups
and in the treated groups at 500 mg/kg bw appeared normal. Piloerection
was noted at 1,000 and 2,000 mg/kg bw. No appreciable reductions in the
ratio of polychromatic erythrocytes to total erythrocytes in the treated
groups relative to the respective vehicle control groups were observed,
suggesting that the test substance did not inhibit erythropoiesis. No
statistically significant increase in the incidence of micronucleated
polychromatic erythrocyte cells in treated groups relative to the
respective vehicle control groups was observed at 24 or 48 h after dose
administration. Under the conditions of the mouse micronucleus assay,
the test substance was negative (not clastogenic) (Kulkarni, 2013).
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