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EC number: 203-733-6
CAS number: 110-05-4
Clinical signs and mortality
All animals survived until scheduled
sacrifice. No treatment-related clinical signs were observed in animals
exposed to the test material or treated with the positive control
substance. The few signs observed were incidental findings unrelated to
Mean body weights of animals exposed to the
test material showed no biologically or statistically significant
differences from controls.
The organ weight results for male animals
showed the following statistically significant differences between
animals exposed to the test material and controls:
- Higher relative liver weight at the
high-concentration (relative difference from control 9%).
- Higher relative kidney weight at the
high-concentration (relative difference from control 11%).
The purpose of this mammalian in vivo
micronucleus test was to examine the potential of di-tert-butyl peroxide
CAS# 110-05-4 to cause damage to the chromosomes and/or the mitotic
apparatus of erythroblasts (micronuclei). This micronucleus test was
part of a sub-chronic (13-week) inhalation toxicity study in which
Wistar Hannover rats were exposed nose-only to target concentrations of
0 (control, clean air), 100, 300 and 1000 mg/m3 of the test material 6
hours/day, 5 days/week for 13 consecutive weeks (resulting in 65
exposure days in total).
The micronucleus test was conducted in
accordance with the OECD Guideline for the Testing of Chemicals 474.
Mammalian Erythrocyte Micronucleus Test, adopted 21st July 1997. At
scheduled necropsy at the end of the 13-week study period, bone marrow
cells of one of the femurs of five male rats per group (negative
control, low, mid and high concentration) were collected, processed into
smears and examined microscopically. The study included a positive
control group of five male rats treated with the mutagen Mitomycin C
(single intraperitoneal injection; 1.5 mg/kg body
weight) and sacrificed 24 hours after
administration of the mutagen.
The target concentrations were accurately
achieved as demonstrated by the results of total carbon analysis of the
test atmospheres. The overall mean actual concentrations (± standard
deviation of the daily mean concentration) were 101 (± 3), 299 (± 3) and
993 (± 10) mg/m3 for the low-, mid- and highconcentration level
Di-tert-butyl peroxide CAS# 110-05-4 did not
adversely affect the general health, appearance or body weight
development of the animals. Microscopic examination of bone marrow
smears of male rats revealed no signs of toxicity to the bone marrow and
no evidence of chromosomal damage and/or
damage to the mitotic apparatus of bone
marrow erythrocytes. There was no reason to assume that the negative
bone marrow response was due to lack of systemic exposure because
treatment-related systemic effects (including increases in liver and
kidney weight) occurred in male rats of the high-concentration group.
Positive controls (five male rats treated with the mutagen Mitomycin C)
showed the expected bone marrow response (cytotoxicity and increased
number of micronucleated polychromatic erythrocytes).
Under the conditions of this study exposure
to di-tert-butyl peroxide CAS# 110-05-4 did not induce chromosomal
damage or damage to the mitotic apparatus of bone marrow erythrocytes of
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