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EC number: 413-910-1
CAS number: 95718-78-8
Signs Following Dose Administration of
Pilot Toxicity Study
Number of Animals
of Animals Dosed
Irregular breathing _
Toxicity Study Using 3-hydroxy-1,l-dimethylbutylperoxyneodecanoate In
Body Weight and Mortality Data
Group Mean Body Weights (gms)
TA, 1 mg/kg
100 mg/kg .
weiqht - Pretreatment weiqht) x 100Pretreatment
Signs Following DoseAdministration
Number of Animais
of Animais Dosed
Signs Following Dose Administration of
Summary of bone marrow micronucleus study using the substance:
The purpose of this study was to evaluate the clastogenic
potential of the test article as measured by its ability to induce
micronucleated polychromatic erythrocytes in mouse bone marrow (OECD 474
test, GLP study)
The test article, 3-hydroxy-1,1-dimethylbutylperoxyneodecanoate, was
tested in the mouse micronucleus assay. The assay was performed in two
phases. The first phase, designed to set dose levels for the definitive
study, consisted of a pilot assay followed by a toxicity study. The
second phase, the micronucleus study, evaluated the potential of the
test article to increase the incidence of micronucleated polychromatic
erythrocytes in bone marrow of male and female mice. In both phases of
the study, test and control articles were administered in a constant
volume of 10 mL/kg body weight by a single intraperitoneal injection.
Corn oil was determined to be the solvent of choice based on a
solubility determination of the test article and compatibility of the
vehicle with the test system animals. The test article was soluble in
corn oil at 200 mg/mL, the maximum concentration tested. Dosing
preparations were delivered to the test system as solutions.
In the pilot assay, male mice were dosed with 1, 10, 100, or 1000 mg
test article/kg body weight and male and female mice were dosed with
2000 mg test article/kg body weight. Mortality was observed in 2/2 male
mice at 1000 mg/kg and in 5/5 male and 5/5 female mice at 2000 mg/kg.
Clinical signs following dose administration included lethargy in male
mice at 100 mg/kg and 1000 mg/kg, piloerection in male mice at 1000
mg/kg, prostration in all mice at 1000 and 2000 mg/kg and irregular
breathing in male and female mice at 2000 mg/kg.
In the toxicity assay, male and female mice were dosed with 200, 400,
600, or 800
mg test article/kg body weight. Mortality was observed in 1/5 male mice
and 2/5 female mice at 600 mg/kg and in 3/5 male mice and 3/5 female
mice at 800 mg/kg. Clinical signs following dose administration included
lethargy and piloerection in ail male and female mice at ail dose levels
and hunched position in ail male and female mice at 600 and 800 mg/kg.
The high dose for the micronucleus test was set at 450 mg/kg which was
estimated to be approximately 60% of the LD50.
In the micronucleus assay, male and female mice were dosed with 113, 225
or 450 mg test article/kg body weight. No mortality was observed in any
male or female mice in the micronucleus study. Clinical signs following
dose administration included: lethargy in 2/5 female mice at 113 mg/kg
and lethargy and piloerection in ail male and female mice at 225 and 450
mg/kg. Bone marrow cells, collected 24 and 48 hours after treatment,
were examined microscopically for micronucleated polychromatic
erythrocytes. A moderate reductions (up to 40%) in the ratio of
polychromatic erythrocytes to total erythrocytes were observed in some
of the test article-treated groups relative to the respective vehicle
controls. These reductions suggest bioavailability of the test article
to the bone marrow target.
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