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EC number: 203-733-6
CAS number: 110-05-4
SUMMARY OF PERFORMANCE F0
ANIMALS BREEDING FOR F1 LITTERS
Number of females paired
Number of females mated
Number of non pregnant females(A)
Number of females, which lost their
Number of females which reared
their pups until day 4 post partum
(A) = Female No. 79
was not pregnant
The purpose of this study was to generate
preliminary information concerning the effects of Di-tert- butyl
peroxide on the possible health hazards likely to arise from repeated
exposure over a relatively limited period of time. In addition,
information on possible effects on male and female reproductive
performance such as gonadal function, mating behavior, conception,
development of the conceptus and parturition was provided.
Di-tert-butyl peroxide was administered once
daily orally (by gavage) at dosages of 0, 100, 300, and 1000 mg/kg/day,
to male rats for 42 days in total and to female rats throughout the
prepairing, the pairing, the gestation and the lactation periods until
day 4 post partum (last dosing).
Treatment at 1000 mg/kg was associated with
body weight effects in male animals. Food consumption was decreased in
male animals during the study. A sign of discomfort was noted in all
animals at 1000 mg/kg/day in the way that the animals moved their heads
through the bedding material after the daily administration of test
item. Some male and female animals were noted with ruffled fur.
Treatment at 1000 mg/kg/day and 300
mg/kg/day was associated with increased liver and kidney weights.
Histopathological effects were noted in liver (minimal centrilobular and
diffuse hepatocellular hypertrophy with association of a consequent
increase in diffuse follicular cell hypertrophy in thyroid glands in
males and females at 1000 mg/kg/day), kidneys (moderate diffuse tubular
degeneration/regeneration with slight multifocal single cell necrosis
and hyaline casts as well as hyaline droplets in males at 1000
mg/kg/day), and fore stomach (minimally increased incidence and severity
of diffuse hyperkeratosis in males at 1000 mg/kg/day and females at 1000
mg/kg/day and 300 mg/kg/day).
Behavioral effects were considered to be not
influenced by the treatment with the test item. No effects were noted on
reproduction data, for the parameters during the clinical laboratory
investigations, or for macroscopic findings during necropsy.
Based on these data, it can be concluded
that the No Observed Effect Level (NOEL) was at 100 mg/kg body
microscopic findings occurring in the high dose group animals or being
increased in the high dose animals, were considered to be likely related
to an effect of the test item. All other microscopic findings noted in
various organs and in all groups examined were considered to be
incidental in nature since their morphology, severity, and incidence
were indistinguishable from controls. Therefore,
300 mg/kg/day will be used as the NOAEL for DNEL calculation.
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